KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 KEYNOTE-355 trial investigating KEYTRUDA, Mercks anti-PD-1 therapy, in combination with chemotherapy met one of its dual primary endpoints of progression-free survival (PFS) in patients with metastatic triple-negative breast cancer (mTNBC) whose tumors expressed PD-L1 (Combined Positive Score [CPS] 10). Based on an interim analysis conducted by an independent Data Monitoring Committee (DMC), first-line treatment with KEYTRUDA in combination with chemotherapy (nab-paclitaxel, paclitaxel or gemcitabine/carboplatin) demonstrated a statistically significant and clinically meaningful improvement in PFS compared to chemotherapy alone in these patients. Based on the recommendation of the DMC, the trial will continue without changes to evaluate the other dual primary endpoint of overall survival (OS). The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety signals were identified.

Triple-negative breast cancer is an aggressive malignancy. It is very encouraging that KEYTRUDA in combination with chemotherapy has now demonstrated positive results as both a first-line treatment in the metastatic setting with this trial, and as neoadjuvant therapy in the KEYNOTE-522 trial, said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. We look forward to sharing these findings with the medical community at an upcoming congress and discussing them with the FDA and other regulatory authorities.

The KEYTRUDA breast cancer clinical development program encompasses several internal and external collaborative studies. In addition to KEYNOTE-355, in TNBC these include the ongoing registration-enabling studies KEYNOTE-242 and KEYNOTE-522.

About KEYNOTE-355

KEYNOTE-355 is a randomized, two-part, Phase 3 trial (ClinicalTrials.gov, NCT02819518) evaluating KEYTRUDA in combination with one of three different chemotherapies (investigators choice of either nab-paclitaxel, paclitaxel or gemcitabine/carboplatin) compared with placebo plus one of the three chemotherapy regimens for the treatment of locally recurrent inoperable or mTNBC that has not been previously treated with chemotherapy in the metastatic setting. Part 1 of the study was open-label and evaluated the safety and tolerability of KEYTRUDA in combination with either nab-paclitaxel, paclitaxel or gemcitabine/carboplatin in 30 patients. Part 2 of KEYNOTE-355 was double-blinded, with dual primary endpoints of OS and PFS in all participants and in participants whose tumors expressed PD-L1 (CPS 1 and CPS 10). The secondary endpoints include objective response rate (ORR), duration of response (DOR), disease control rate (DCR) and safety.

Part 2 of KEYNOTE-355 enrolled 847 patients who were randomized to receive KEYTRUDA (200 mg intravenously [IV] on day 1 of each 21-day cycle) plus nab-paclitaxel (100 mg/m2 IV on days 1, 8 and 15 of each 28-day cycle), paclitaxel (90 mg/m2 IV on days 1, 8 and 15 of each 28-day cycle) or gemcitabine/carboplatin (1,000 mg/m2 [gemcitabine] and Area Under the Curve [AUC] 2 [carboplatin] on days 1 and 8 of each 21-day cycle); or placebo (normal saline on day 1 of each 21-day cycle) plus nab-paclitaxel (100 mg/m2 IV on days 1, 8 and 15 of each 28-day cycle), paclitaxel (90 mg/m2 IV on days 1, 8 and 15 of each 28-day cycle) or gemcitabine/carboplatin (1,000 mg/m2 [gemcitabine] and AUC 2 [carboplatin] on days 1 and 8 of each 21-day cycle).

About Triple-Negative Breast Cancer (TNBC)

TNBC is an aggressive type of breast cancer that characteristically has a high recurrence rate within the first five years after diagnosis. While some breast cancers may test positive for estrogen receptor, progesterone receptor or human epidermal growth factor receptor 2 (HER2), TNBC tests negative for all three. As a result, TNBC does not respond to therapies targeting these markers, making it more difficult to treat. Approximately 15-20% of patients with breast cancer are diagnosed with TNBC.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,000 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) 10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High (MSI-H) Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (<0.1%). Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of adrenal insufficiency, hypophysitis (including hypopituitarism), thyroid function (prior to and periodically during treatment), and hyperglycemia. For adrenal insufficiency or hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 adrenal insufficiency or hypophysitis and withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 adrenal insufficiency or hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

Immune-Mediated Skin Reactions

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barr syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and postmarketing use.

Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic HSCT after treatment with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after KEYTRUDA, 6 (26%) developed graft-versus-host disease (GVHD) (1 fatal case) and 2 (9%) developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning (1 fatal case). Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptorblocking antibody before transplantation. Follow patients closely for early evidence of transplant-related complications such as hyperacute graft-versus-host disease (GVHD), Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease (VOD), and other immune-mediated adverse reactions.

In patients with a history of allogeneic HSCT, acute GVHD (including fatal GVHD) has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after KEYTRUDA. Consider the benefit of KEYTRUDA vs the risk of GVHD in these patients.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with a PD-1 or PD-L1 blocking antibody in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

In KEYNOTE-002, KEYTRUDA was permanently discontinued due to adverse reactions in 12% of 357 patients with advanced melanoma; the most common (1%) were general physical health deterioration (1%), asthenia (1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%). The most common adverse reactions were fatigue (43%), pruritus (28%), rash (24%), constipation (22%), nausea (22%), diarrhea (20%), and decreased appetite (20%).

In KEYNOTE-054, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (20%) with KEYTRUDA was diarrhea (28%).

In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).

In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.

In KEYNOTE-042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients with advanced NSCLC; the most common were pneumonitis (3%), death due to unknown cause (1.6%), and pneumonia (1.4%). The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (7%), pneumonitis (3.9%), pulmonary embolism (2.4%), and pleural effusion (2.2%). The most common adverse reaction (20%) was fatigue (25%).

In KEYNOTE-010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC; the most common was pneumonitis (1.8%). The most common adverse reactions (20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%).

Adverse reactions occurring in patients with SCLC were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent.

In KEYNOTE-048, KEYTRUDA monotherapy was discontinued due to adverse events in 12% of 300 patients with HNSCC; the most common adverse reactions leading to permanent discontinuation were sepsis (1.7%) and pneumonia (1.3%). The most common adverse reactions (20%) were fatigue (33%), constipation (20%), and rash (20%).

In KEYNOTE-048, when KEYTRUDA was administered in combination with platinum (cisplatin or carboplatin) and FU chemotherapy, KEYTRUDA was discontinued due to adverse reactions in 16% of 276 patients with HNSCC. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonia (2.5%), pneumonitis (1.8%), and septic shock (1.4%). The most common adverse reactions (20%) were nausea (51%), fatigue (49%), constipation (37%), vomiting (32%), mucosal inflammation (31%), diarrhea (29%), decreased appetite (29%), stomatitis (26%), and cough (22%).

In KEYNOTE-012, KEYTRUDA was discontinued due to adverse reactions in 17% of 192 patients with HNSCC. Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. The most common adverse reactions (20%) were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of facial edema and new or worsening hypothyroidism.

In KEYNOTE-087, KEYTRUDA was discontinued due to adverse reactions in 5% of 210 patients with cHL. Serious adverse reactions occurred in 16% of patients; those 1% included pneumonia, pneumonitis, pyrexia, dyspnea, GVHD, and herpes zoster. Two patients died from causes other than disease progression; 1 from GVHD after subsequent allogeneic HSCT and 1 from septic shock. The most common adverse reactions (20%) were fatigue (26%), pyrexia (24%), cough (24%), musculoskeletal pain (21%), diarrhea (20%), and rash (20%).

In KEYNOTE-170, KEYTRUDA was discontinued due to adverse reactions in 8% of 53 patients with PMBCL. Serious adverse reactions occurred in 26% of patients and included arrhythmia (4%), cardiac tamponade (2%), myocardial infarction (2%), pericardial effusion (2%), and pericarditis (2%). Six (11%) patients died within 30 days of start of treatment. The most common adverse reactions (20%) were musculoskeletal pain (30%), upper respiratory tract infection and pyrexia (28% each), cough (26%), fatigue (23%), and dyspnea (21%).

In KEYNOTE-052, KEYTRUDA was discontinued due to adverse reactions in 11% of 370 patients with locally advanced or metastatic urothelial carcinoma. Serious adverse reactions occurred in 42% of patients; those 2% were urinary tract infection, hematuria, acute kidney injury, pneumonia, and urosepsis. The most common adverse reactions (20%) were fatigue (38%), musculoskeletal pain (24%), decreased appetite (22%), constipation (21%), rash (21%), and diarrhea (20%).

In KEYNOTE-045, KEYTRUDA was discontinued due to adverse reactions in 8% of 266 patients with locally advanced or metastatic urothelial carcinoma. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.9%). Serious adverse reactions occurred in 39% of KEYTRUDA-treated patients; those 2% were urinary tract infection, pneumonia, anemia, and pneumonitis. The most common adverse reactions (20%) in patients who received KEYTRUDA were fatigue (38%), musculoskeletal pain (32%), pruritus (23%), decreased appetite (21%), nausea (21%), and rash (20%).

In KEYNOTE-057, KEYTRUDA was discontinued due to adverse reactions in 11% of 148 patients with high-risk NMIBC. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.4%). Serious adverse reactions occurred in 28% of patients; those 2% were pneumonia (3%), cardiac ischemia (2%), colitis (2%), pulmonary embolism (2%), sepsis (2%), and urinary tract infection (2%). The most common adverse reactions (20%) were fatigue (29%), diarrhea (24%), and rash (24%).

Adverse reactions occurring in patients with gastric cancer were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

Adverse reactions occurring in patients with esophageal cancer were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

In KEYNOTE-158, KEYTRUDA was discontinued due to adverse reactions in 8% of 98 patients with recurrent or metastatic cervical cancer. Serious adverse reactions occurred in 39% of patients receiving KEYTRUDA; the most frequent included anemia (7%), fistula, hemorrhage, and infections [except urinary tract infections] (4.1% each). The most common adverse reactions (20%) were fatigue (43%), musculoskeletal pain (27%), diarrhea (23%), pain and abdominal pain (22% each), and decreased appetite (21%).

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Merck's KEYTRUDA (pembrolizumab) in Combination with Chemotherapy Met Primary Endpoint of Progression-Free Survival (PFS) as First-Line Treatment for...

Cardiac Stem Cells Comments Off on Merck’s KEYTRUDA (pembrolizumab) in Combination with Chemotherapy Met Primary Endpoint of Progression-Free Survival (PFS) as First-Line Treatment for… | February 14th, 2020

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INDIANAPOLIS (WISH)A near north side representative called for a crackdown on crime along the 38th Street corridor, between Capitol Avenue and Meridian Street, weeks after a News 8 report highlighted a string of incidents at an area McDonalds.

The restaurant, located at 37 W 38th St, shares a facility with a BP gas station convenience store.

Drivers and restaurant regulars described shootings, stabbings, fights and an attack on the McDonalds franchise owner near 38th and Illinois streets.

Annually, there are hundreds of [police] runs to this area, city-county council member John Barth said Sunday night in a Tweet. Historically, many runs have been attributed to the BP/McDonalds.

In the six-part Tweet thread, Barth detailed plans to hold monthly neighborhood meetings, review data-driven crime research and combat addiction-related issues.

Conversations with community leaders and police officers led him to believe substance abuse and addiction were significant contributing factors to violent crime along 38th Street, he told News 8.

I did a ride-along with the IMPD and spent 8 hours driving all around this area, Barth said Wednesday. And what I hear, over and over, is an increasing concern about substance abuse and the need for enhanced treatment options.

Some community members pointed to a disconnect between what they described as city hall narratives and real neighborhood needs.

Talk to the people and really get their point of view, said Diamond Taylor, a Chicago native who relocated to the near north side of Indianapolis. Everybody in this area is not homeless. Everybody in this area is not on drugs. They are not alcoholics. Theyre very good, hardworking people that live here [and] require assistance from the higher-ups; and they havent been getting it.

Lavorah Brady, a longtime resident, said she believed increased business investments and youth programs would be more beneficial to the community than an anti-drug campaign.

A lot of the people dont have good examples to follow, Brady told News 8. If [city leaders] could do more in the communitymaybe open up more community centers where the people have positive things to doI think it would make a world of difference.

There are a variety of causes for the crime along [the 38th Street] corridor, Barth acknowledged.

Drugs and violence were not contained within the corridor. Residential areas throughout his district had been impacted by rising crime rates, including the Crown Hill, Butler Tarkington and Meridian-Kessler neighborhoods, he said.

Members of the Butler Tarkington Neighborhood Association collaborated with gas station and restaurant franchise owners to implement new security measures following Januarys assault.

I am thankful that there are so many people in my district who want to focus on these issues and work together at the grass-roots level, Barth Tweeted.

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Makeup artist shares her FOUR favorite eye creams that you CANNOT buy in a store - WISHTV.com

Skin Stem Cells Comments Off on Makeup artist shares her FOUR favorite eye creams that you CANNOT buy in a store – WISHTV.com | February 13th, 2020

In the rush to get ready for work or kick back in front of Netflix at night, its easy to forget to look after your skin. But as winter bites, its time to step up your skincare routine, or risk developing dry, flaky and uncomfortable skin.

Of course, everyones skin is different and one mans rich moisturiser is anothers potential acne, but from vitamin-infused face washes, to SPF and face oil, weve got something to keep everyones skin looking its best.

(Image credit: Mr Porter)

The best mist to keep your skin juicy

+Great for freshening up+Contains hyaluronic acid

If you work in a highly heated or air-conditioned office and you have dry or dehydrated skin, youll need a little something to keep you skin happy. Face mists are brilliant because you can spritz and go without any mess or a mirror. Dr Barbara Sturms hydrating face mist is infused with hyaluronic acid which is great for hydrating dry and dehydrated skin, as well as purslane extract to nourish skin while protecting cells from free radicals. If thats not enough, its also packed with detoxifying extracts such as lemon, aloe vera and broccoli to minimise the effects of pollution and stress.

(Image credit: Mr Porter)

The best SPF to block harmful rays

+SPF 50+Great price

Whether youre whooshing down ski slopes or going for a wintery walk, an SPF is essential to block harmful rays and to keep you looking younger for longer. Jaxon Lanes Rain or Shine moisturising sunscreen is designed to shield your skin from UVA and UBV rays and offers SPF 50+ protection. Lightweight and non-greasy, it's infused with vitamin E, hyaluronic acid, green tea, liquorice root and ginseng so it not only protects but moisturises and enlivens your skin too.

(Image credit: Mr Porter)

Best deep-cleaning cleanser

+Great price point+Deep cleaning power of charcoal+Suitable for all face types

Washing your face in the winter isnt always the most pleasurable experience if your bathroom is cold. But a nice face wash can help. Clinque for Mens charcoal face wash harnesses the deep-cleaning power of charcoal, which is great for all skin types, especially those with slightly greasy complexions. The detoxifying gel formula is designed to work into a foam and draw out dirt, oil and impurities but isnt drying. Like all Clinque products its non-scented, which makes it a winner for sensitive skin too.

(Image credit: Mr Porter)

Best for the winter sports

+Hydrating, soothing solution+Designed to protect

Gliding down ski slopes and playing in powdery snow may fun, but a dry, red face blasted by the wind and sun isnt, so you definitely dont want to go off-piste with your skincare. If youre going skiing or are spending lots of time in the great but freezing outdoors, try Dr Barbara Sturms aptly-named Ski Cream. Its definitely not cheap, but it does promise a lot, acting as a protective shield against wind and extreme climates. Suitable for all skin types, the cream contains balloon vine, blackcurrant oil and purslane to soothe skin and reduce redness, while shea butter and jojoba oil lock in moisture.

(Image credit: Mr Porter)

The best moisturising serum

+Natural ingredients+Lighter than creams+Beautiful packaging

-Empty List

Aesop may be a favourite on Instagram thanks to its seriously stylish packaging, but the skincare brands parsley seed range packs a botanical punch. The anti-oxidant serum is a lighter alternative to creams and can be used daily after cleaning. The aloe-vera based formula contains other botanical extracts, such as parsley and grape seed oils to soften and moisturise. Plus, its designed to give skin strength and flight of environmental aggressors, which is ideal for winter months and city living alike. Its a stylish skincare solution that wont break the bank.

(Image credit: Mr Porter)

Best for brightening the complexion

+Exfoliates and brightens in one+Can help with pigmentation problems+A good multitasker

You remember to eat your five a day, but vitamin-infused skincare is great for keeping your face looking good too. 111SKINs vitamin C brightening cleanser is a great multitasker, tackling lots of issues in the time it takes to wash your face. A great addition to your morning routine during the winter months, its packed with radiance-boosting vitamin C to help reduce hyper-pigmentation, age spots and uneven skin tone. The exfoliating formula promises leaves your complexion looking clear, even and illuminated, which isnt bad for a quick scrub. Its not cheap, but it might just work miracles.

(Image credit: Mr Porter)

The best anti-ageing moisturiser

+High tech formula+Free from parabens, sulphates and gluten+For all skin types

Not all moisturisers are created equal. Sure, some are a couple of quid and do a little to keep your skin soft, but others, like MALIN + GOETZ advanced renewal moisturiser do much more. Of course, all this comes at a cost and the stylish brands high-tech daily moisturiser is pretty expensive. But its blended with antioxidant-rich meadowfoam seed oil and a combination of sugar molecules, barley and sodium hyaluronate to reduce the appearance of fine lines and wrinkles. Meanwhile, linseed extract, which is rich in Omega-3 fatty acids, trap water molecules to make your skin look healthier and plumper, and apple stem cell protects against harsh environments, which is ideal in winter.

(Image credit: Mr Porter)

Best moisturiser for dry and sensitive skin

+Hypoallergenic and gentle+Good for everyday use+Also has some anti-ageing benefits

Everyones skin needs a little extra TLC in the colder months, but those with dry and sensitive complexions can really suffer as chilly winds and harsh heating take their toll. But, PERRICONE MDs hypoallergenic nourishing moisturiser can help. Designed for specifically for dry and sensitive skin, its hypoallergenic and paraben-free, and harnesses the antioxidant properties of vitamin E along with with nourishing olive polyphenols. Gentle enough for everyday use, the brand also claims its good for keeping fine lines and wrinkles at bay.

(Image credit: Mr Porter)

Best lip balm for outdoors

+SPF 30+Water-resistant+Contains natural oils

If youre hitting the slopes or spend a lot of time outside, its important to protect your lips from the elements to avoid them becoming chapped, or sunburnt if theres snow around. Shiseidos Suncare UV Lip Color Splash SPF30 may be a bit of a mouthful, but it will protect your lips admirably. The balm is infused with natural oils to lock in moisture, as well as that all-important SPF protection. It costs considerably more than the likes of Carmex, but its water resistant, you wont need to apply it too often.

(Image credit: Mr Porter)

Best scrub for exfoliating

+Soothing and brightening+Uses sand for exfoliation

-Empty List

Regular exfoliation helps keeps skin healthy and clear, and when done before shaving can reduce bumps and irritation. While its important all year round, its great for preventing patches of dry skin building up and blocking pores in the winter and can make your complexion look brighter. Anthonys facial scrub is formulated with boro boro sand to remove dead cells, as well as soothing aloe vera, algae and chamomile. Antioxidant-rich Vitamin C is also included to protect from environmental stressors and brighten the complexion. The scrub is a handy multitasker and offers a lot of bang for its buck.

(Image credit: Mr Porter)

The best luxury hand cream

+Trendy fragrance+Easily absorbed formula+Luxe packaging

Its not just your face you need to look after in the cold and a hand cream is essential. Byredos Tulipmania hand cream is one of the trendiest options out there. Named after the infamous "tulip mania" period during the Dutch Golden Age when the flowers were in high demand, the cream is lightly fragranced with notes of Freesia and Blond Woods. Byredos hand cream is formulated with moisturising ingredients and has a gel-like consistency that's quick-drying and absorbent, which is a big selling point for busy men and women alike.

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Winter skincare routine: products to protect your face from cold weather - T3

Skin Stem Cells Comments Off on Winter skincare routine: products to protect your face from cold weather – T3 | February 13th, 2020

Penn State researchers have received a $2.8 million grant to investigate 3D bioprinting tissue for facial reconstructions, according to a Penn State news release.

The grant, from the National Institutes of Healths National Institute of Dental and Craniofacial Research, funds five years of research exploring methods for bioprinting face, mouth and skull tissue directly into patients during surgery, with the ultimate goal of developing a bioprinting technology, according to the release.

Craniomaxillofacial reconstruction currently presents challenges for doctors because it requires precisely stacking several different types of tissue. Penn States researchers hope to solve this problem by bioprinting the tissue directly into the subject, according to the release. Researchers will also be investigating the use of stem cells, biomaterials and differentiation factors in this process.

The team of researchers that received the grant includes professors of plastic surgery, biomedical engineering, and orthopedics and rehabilitation.

The researchers plan to investigate printing each type of tissue necessary for craniomaxillofacial reconstruction bone, fat and skin tissue individually, then study composite tissues that include all three of these layers. They hope that this will help them better understand how vascularization occurs in each type of tissue.

Ultimately, researchers hope to learn how different types of tissue interact and how bioprinting tissue directly into subjects will affect the facial reconstruction process.

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Penn State receives grant to study bioprinting tissue for facial reconstructions - The Daily Collegian Online

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Liposuction is a surgical procedure to remove extra fat from your body. It started in the 1980s and has become one of the most popular plastic surgeries in the US. An estimated 258,000 Americans got it in 2018.

Today, you can expect to pay around $3,500 for liposuction and most health insurance plans won't cover the cost. But if you're willing to pay the price, liposuction is a relatively safe and quick procedure that can help you shed fat that diet and exercise can't.

Here's what you need to know about how liposuction works and why it's not a weight-loss tool.

Liposuction is a 1-to2-hour-long procedure where fat cells are permanently removed from your body, usually for cosmetic reasons. People who get liposuction don't do it to lose large amounts of weight but rather to help sculpt the shape of their body.

Some of the most common places to have fat removed are the belly, thighs, buttocks, arms, back, the upper neck just under the chin, and jawline/jowls.

Depending on where you're getting the procedure, doctors will either provide a local anesthetic to numb the area of operation or they will give you a general anesthetic so you're unconscious during the procedure.

Then, surgeons will often inject into the area of operation a solution containing a mix of saline solution, a numbing medicine, and medicine the decreases bleeding. This is to help the skin and fat separate from important structures like muscles and blood vessels so they aren't damaged during the suctioning process.

After that, the surgeon inserts a long metal instrument called a cannula under your skin. The cannula then vacuums out your fat. During this process, surgeons may also use a smaller microcannula to remove fat in nearby areas to achieve a more natural, smoother contour.

Once the fat is removed through liposuction it can be discarded or it can be injected back into your body to enhance features like breasts, buttocks, or face. Or, more recently, in the last decade or so, liposuction has also been used to retrieve stem cells a type of cell that can form other specialized cells in the body for laboratory research.

After liposuction, your surgeon will likely recommend you wear a temporary band or brace over the area of operation to help the skin heal. The band or brace also helps prevent fluid from building up in the area of operation where the fat was removed, between the skin and deeper structures like muscles and blood vessels.

Whether you are awake or asleep during liposuction, you shouldn't feel any pain during the procedure, says Marco A. Pelosi II, MD, a cosmetic surgeon with experience performing liposuction procedures. The recovery, also, should be a relatively mild process.

After getting liposuction, you will feel soreness similar to a muscle ache. "The level of this soreness is typically a 2 or 3 out of 10 for a few weeks," says Pelosi, adding that you should be able to go back to work in 2 to 3 days.

Ongoing pain near the area where the cannula was inserted is a risk of liposuction, and if the pain grows or pain killers don't help, you should tell your surgeon.

According to the Cleveland Clinic, you should not use liposuction as a weight loss alternative. It recommends that if you want to lose weight, you should first try diet and exercise, then use liposuction to take care of more stubborn areas like the chin or belly fat.

Moreover, research shows that people who keep up other weight loss practices like a healthy diet and exercise will see better results after liposuction and keep fat from returning to a particular area.

This is because while liposuction permanently removes fat cells from your body, there is nothing to stop the remaining fat cells from getting bigger if you gain more weight.

There are some important safety tips to look for when choosing a liposuction provider.

First, look for a facility that meets national safety requirements. You can verify if a facility is accredited on the American Society of Plastic Surgeons' website here.

Pelosi says that doctors should also do blood work testing and medical clearances before a liposuction procedure to ensure your safety. These tests are to make sure you can safely undergo general anesthesia without complication. If, for example, you have an infection or are pregnant, you may not qualify for the surgery.

Last, but not least, is to look for a surgeon who is board-certified in performing these types of procedures and also has extensive experience with liposuction procedures so you know that they are well versed in the technique. To find out more about a practitioner's experience with liposuction, you can check the American Society of Plastic Surgeons' website.

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What is liposuction? How the procedure works and how painful it is - Insider - INSIDER

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The defense for Joseph Sentore Coleman Jr. rested their case Wednesday with witnesses who contradicted previous statements by the prosecutions witnesses.

Both sides of the aisle are expected to make their closing statements today, before the jury is let out to deliberate the verdict in the case against Coleman, 38.

Coleman, who allegedly robbed and murdered Christopher Wilkins on Aug. 30, 2016, at 505 Park Ave., is already serving two life sentences for a double homicide on Halloween 2016.

Previously unknown to the jury, Louis Martin, frequent visitor of the Park Avenue residence, was called by Jeana Longo, Colemans attorney.

As Coleman and James Rooks allegedly entered the Park Avenue home with the intention of robbing the known drug dealers, Wilkins and Savoy Jennings, Martin said he was just waking up in Jeff Greenes adjacent bedroom from a long night of doing drugs and watching movies.

I was sitting in a chair, just closing my eyes, said Martin, when he heard shouts from the second bedroom.

I aint got nothing, I aint got nothing,' he said a voice shouted.

Then a pop it was a gunshot, said Martin.

Peering out from inside the room, he said two masked people came out of the room and looked at the body of Wilkins before running out.

One was short, slim and was built, he said. One was taller with really dark skin neither of them had dreadlocks.

Martin said he was familiar with Coleman from passing him in the street, but was not a friend of his.

However, Martin said he was familiar enough with Coleman that if his face were covered in a mask that he would know.

When they left, I waited two to three seconds. I see Chris on the floor, he said. I shook him, but Wilkins didnt move.

Martin said he alerted Jeff Greene before he left. The situation had traumatized him.

Ill be honest, I needed a drink to calm down, so I went to the bar, he said.

Later that day in initial police interviews, Martin told police that he drank about a six-pack of beer.

Martin gave a description of the men he thought murdered Wilkins for sketches to be made of their faces after police insisted, he said.

You cant make out their features, but I know what I saw, he said.

Martin said he suspected that one of the masked men was Jamal Brown, who previously testified to have given Coleman the layout of the building and advice on the chances of a successful robbery.

The defense also called John Greene, brother of Jeff Greene, and who lived in the second floor apartment of 505 Park Ave.

He too said he doubted Coleman committed the crime.

(Coleman) had been there plenty of times, he said, and didnt need help figuring out the layout of the home.

John Greene testified that he had seen Brown a native of New York wearing a hat similar to the one found at the scene. Namely, a Brooklyn Dodgers baseball hat.

Although Wilkins killer is still legally unproven, Dr. Barbara Bollinger, the forensic pathologist who conducted the autopsy on Wilkins, said she knew the man died immediately from the gunshot.

The projectile entered Wilkins brain near his left earlobe, passed through his cerebellum and brain stem, which collectively control balance, coordinating movement and breathing.

I think this would have incapacitated him within the span of seconds, she said.

Additionally, the gunshot caused stippling, she said, or abrasions from unburned gunpowder or debris, which typically indicates the gun was 12 inches to three feet away.

Colemans DNA was found on both the hat and a cut-off pant leg, which were used as disguises in the crime and discarded at the scene, said Regina Kuzero and Brittney Lenig, forensic scientists with the Pennsylvania State police, and Jennifer Bracamontes, a data analyst.

Though up to five peoples DNA was found on the two articles, Bracamontes said using a supercomputer to allow her to identify Coleman as the major contributor. This method does not allow anyone to learn when or how the DNA, which is typically obtained through skin cells, was rubbed into the masks.

The trial resumes at 10 a.m. today in courtroom three before Judge Marc F. Lovecchio.

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Defense presents witnesses on day 3 of trial | News, Sports, Jobs - Williamsport Sun-Gazette

Skin Stem Cells Comments Off on Defense presents witnesses on day 3 of trial | News, Sports, Jobs – Williamsport Sun-Gazette | February 13th, 2020

The market analysis and insights included in the Cosmetic Skin Care market report presents key statistics on the market status of global and regional manufacturers and is an essential source of guidance which provides right direction to the companies and individuals interested in the industry. To prosper in this competitive market place, businesses are highly benefited if they adopt innovative solutions such as this Cosmetic Skin Care market research report. This wide-ranging market research report acts as a backbone for the success of business in any sector. The market drivers and restraints have been explained in the report with the use of SWOT analysis.

Global cosmetic skin care marketis set to witness a substantial CAGR of 5.5% in the forecast period of 2019- 2026. The report contains data of the base year 2018 and historic year 2017. Increasing self-consciousness among population and rising demand for anti- aging skin care products are the factor for the market growth.

Global Cosmetic Skin Care Market By Product (Anti-Aging Cosmetic Products, Skin Whitening Cosmetic Products, Sensitive Skin Care Products, Anti-Acne Products, Dry Skin Care Products, Warts Removal Products, Infant Skin Care Products, Anti-Scars Solution Products, Mole Removal Products, Multi Utility Products), Application (Flakiness Reduction, Stem Cells Protection against UV, Rehydrate the skins surface, Minimize wrinkles, Increase the viscosity of Aqueous, Others), Gender (Men, Women), Distribution Channel (Online, Departmental Stores and Convenience Stores, Pharmacies, Supermarket, Others), Geography (North America, Europe, Asia-Pacific, South America, Middle East and Africa) Industry Trends and Forecast to 2026 ;

Complete report on Global Cosmetic Skin Care Market Research Report 2019-2026 spread across 350 Pages, profiling Top companies and supports with tables and figures

Market Definition: Global Cosmetic Skin Care Market

Cosmetic skin care is a variety of products which are used to improve the skins appearance and alleviate skin conditions. It consists different products such as anti- aging cosmetic products, sensitive skin care products, anti- scar solution products, warts removal products, infant skin care products and other. They contain various ingredients which are beneficial for the skin such as phytochemicals, vitamins, essential oils, and other. Their main function is to make the skin healthy and repair the skin damages.

Key Questions Answered in Global Cosmetic Skin Care Market Report:-

Our Report offers:-

Top Key Players:

Market Drivers:

Market Restraints:

Key Developments in the Market:

Customize report of Global Cosmetic Skin Care Market as per customers requirement also available.

Market Segmentations:

Global Cosmetic Skin Care Market is segmented on the basis of

Market Segmentations in Details:

By Product

By Application

By Gender

By Distribution Channel

By Geography

North America

Europe

Asia-Pacific

South America

Middle East & Africa

Competitive Analysis: Global Cosmetic Skin Care Market

Global cosmetic skin care market is highly fragmented and the major players have used various strategies such as new product launches, expansions, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of cosmetic skin care market for Global, Europe, North America, Asia-Pacific, South America and Middle East & Africa.

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Data Bridge Market Researchset forth itself as an unconventional and neoteric Market research and consulting firm with unparalleled level of resilience and integrated approaches. We are determined to unearth the best market opportunities and foster efficient information for your business to thrive in the market. Data Bridge endeavors to provide appropriate solutions to the complex business challenges and initiates an effortless decision-making process.

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COSMETIC SKIN CARE MARKET ENHANCEMENT AND ITS GROWTH PROSPECTS FORECAST 2019 TO 2026 - Reporting 99

Skin Stem Cells Comments Off on COSMETIC SKIN CARE MARKET ENHANCEMENT AND ITS GROWTH PROSPECTS FORECAST 2019 TO 2026 – Reporting 99 | February 13th, 2020

Cardiac rhythm management refers to a process of monitoring functioning of the heart through devices. Cardiac rhythm management devices are used to provide therapeutic solutions to patients suffering from cardiac disorders such as cardiac arrhythmias, heart failure, and cardiac arrests. Cardiac disorders lead to irregular heartbeat. Technological advancements and rise in the number of deaths due to increasing incidences of heart diseases and increasing aging population are some of the major factors driving the cardiac rhythm management market. Heart disease is one of the primary causes of death in the U. S. Excess of alcohol consumption; smoking, high cholesterol levels, and obesity are some of the major causes of heart diseases. Cardiac rhythm management is conducted through two major devices: implantable cardiac rhythm devices and pacemakers. Implantable cardiac rhythm devices treat patients with an improper heartbeat. Based on the device, the cardiac rhythm management market can be segmented into defibrillators, pacemakers, cardiac resynchronization therapy devices, implantable defibrillators, and external defibrillators. Pacemakers are used to treat patients with a slow heartbeat. Based on the end user, the cardiac rhythm management market can be segmented into hospitals, home/ambulatory, and others.

North America has the largest market for cardiac rhythm management due to improved healthcare infrastructure, government initiatives, rise in incidences of cardiac disorders, growing number of deaths due to cardiovascular diseases,and increasing healthcare expenditure in the region. The North America market for cardiac rhythm management is followed by Europe. Asia is expected to witness high growth rate in the cardiac rhythm management market in the next few years due to increasing incidences of cardiovascular diseases, growing disposable income, rise in awareness regarding heart disorders and relevant treatments, and improving healthcare infrastructure in the region.

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Increasing the prevalence of cardiovascular diseases, technological advancements, rise in life expectancy, increasing awareness regarding cardiac disorders, and government initiatives are some of the major factors that are expected to drive the market for cardiac rhythm management. In addition, factors such as a rise in disposable income, increasing aging population, and high cost associated with heart disease treatment are expected to drive the market for cardiac rhythm management. However, economic downturn, reimbursement issues, the importance of biologics and stem cells, and inappropriate use of the devices are some of the factors restraining the growth of the global cardiac rhythm management market.

Growing population and economies in the developing countries such as India and China are expected to drive the growth of the cardiac rhythm management market in Asia. In addition,factors such as innovations along with technological advancements such as miniaturization, introduction of MRI pacemakers, biocompatible materials and durable batteries, and continuous rise in aging population and increasing cardiovascular diseases such as arrhythmias, stroke, and high blood pressure are expected to create new opportunities for the global cardiac rhythm management market. An increasing number of mergers and acquisitions, rise in the number of collaborations and partnerships, and new product launches are some of the latest trends in the global cardiac rhythm management market.

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Some of the major companies operating in the global cardiac rhythm management market are Medtronic, Abbott Laboratories, Boston Scientific, St. Jude Medical, Altera, and Sorin. Other companies with significant presence in the global cardiac rhythm management market include

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Cardiac Rhythm Management Market to Witness Rapid Increase in Consumption During 2015 2021 - Lake Shore Gazette

Cardiac Stem Cells Comments Off on Cardiac Rhythm Management Market to Witness Rapid Increase in Consumption During 2015 2021 – Lake Shore Gazette | February 13th, 2020

Motor neuron disease is a degenerative condition which destroys the nerve cells (motor neurons) in the brain and spinal cord, which control movement, speech, swallowing and breathing. The most common type of motor neuron disease is amyotrophic lateral sclerosis (ALS), which affects around 5,000 people in the UK at any one time.A new study found that in this disease, the motor neurons in the brain and spinal cord become sick and die when a protein, called TDP-43, misfolds and accumulates in the wrong place within the motor neurons. Conversely, when this happens in a type of cell that supports motor neurons, called astrocytes, these cells appear comparatively resistant and survive.

When these two types of cells are close together, the more-resistant astrocytes are able to protect motor neurons from the misfolded protein. This rescue-mechanism helps the motor neurons, which are needed to control muscles, live longer.

The role astrocytes have played in dealing with toxic forms of TDP-43 in motor neurons has not been previously well documented in motor neuron disease. Its exciting that weve now found that they may play an important protective role in the early-stages of this disease, explains Phillip Smethurst, lead author. This has huge therapeutic potential finding ways to harness the protective properties of astrocytes could pave the way to new treatments. This could prolong their rescue function or find a way to mimic their behavior in motor neurons so that they can protect themselves from the toxic protein.

This research also established a new model for studying motor neuron disease. This new method more closely resembles the disease in patients as it uses healthy human stem cells, derived from skin cells, and spinal cord tissue samples donated by patients with motor neuron disease, collected post-mortem.

It is thanks to the selfless donations from people with motor neuron disease, that we were able to study the interplay between motor neurons and astrocytes in conditions that closely resemble what happens in humans. These human cell models are a powerful tool for further studies of motor neuron disease and in the hunt for effective therapies. explains Katie Sidle, co-senior author.

For the first time, we have been able to create a model of sporadic motor neuron disease by essentially transferring the toxic TDP-43 protein from post-mortem tissue into healthy human stem cell-derived motor neurons and astrocytes in order to understand how each cell type responds to this insult, both in isolation and when mixed together. The insights made in this work are testament to the power of creative collaboration and interdisciplinarity. It is through many years working together as a group of clinicians, pathologists, stem cell biologists, protein biochemists and other experts, and with a joint aim of increasing knowledge about motor neuron disease (to ultimately help find a cure), that these results have been possible, says Rickie Patani, co-senior author.ReferenceSmethurst et al. (2020) Distinct responses of neurons and astrocytes to TDP-43 proteinopathy in amyotrophic lateral sclerosis. Brain. DOI: https://doi.org/10.1093/brain/awz419

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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Astrocytes Show Protective Role in Early-stage ALS - Technology Networks

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10 February 2020

A study, published in Cell Reports, investigating when and how human stem cells develop into egg and sperm cells could one day help generate lab-grown gametes to treat infertility.

Human pluripotent stem cells can evolve into germ cells, which are the precursor cells for gamete development. By growing these human germ cells in vitro, the theory is that gametes engineered in a laboratory setting could someday be used, instead of natural eggs and sperm, in IVF treatment.

The research conducted within the Eli and Edythe Broad Centre of Regenerative Medicine and Stem Cell Research at University of California, Los Angeles (UCLA) provides great hope for those who are unable to produce gametes naturally,including thosewhose fertility has been affected by injury, illness or medical treatment.

'With donated eggs and sperm, the child is not genetically related to one or both parents. To treat patients who want a child who is genetically related, we need to understand how to make germ cells from stem cells, and then how to coax those germ cells into eggs or sperm'Dr Amander Clark, lead author of the study at UCLA, explained.

'Right now, if your body doesn't make germ cells, then there's no option for having a child that's biologically related to you. What we want to do is use stem cells to be able to generate germ cells outside the human body so that this kind of infertility can be overcome.'

In previous studies, scientists have been able to grow similarinduced pluripotent stem calls (iPS cells), and develop them into human skin cells and blood cells. The researchers, in collaboration with Massachusetts Institute of Technology, analysed the hundreds of thousands of genes active when both human embryonic stem cells and iPS cells transition to germ cells.

The data obtained allowed the researchers to firstly formulate when the germ cells are likely to form, which was between 24-48 hours after starting differentiation, and secondly which lineages of the differentiating stem cells give rise to the germ cells.

They also found that the activation and manifestation of germ cells was identical when developed from embryonic stem cells and iPS cells. This information was essential as they needed to ensure that the in vitro environment they had created was mimicking the molecular signals of the testis and ovaries to give hope for successful sperm and egg cell development.

Dr Clark stated: 'This tells us that the approach we're using to begin the process of making germ cells is on the right track. Now we're poised to take the next step of combining these cells with ovary or testis cells.'

Although current research is far from generating gametes, the end goal is that one day scientists are able to use a patient's skin cells to form stem cells, which can be programmed into egg or sperm cells to be used in fertility treatment.

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Lab-grown eggs and sperm a step closer - BioNews

Skin Stem Cells Comments Off on Lab-grown eggs and sperm a step closer – BioNews | February 11th, 2020

CORPUS CHRISTI, Texas In today's world, millions are spent on cosmetic surgery to keep that healthy glow everywhere we go. However, if you don't have thousands of dollars to pay for it, there are other, more safe alternatives that are non-surgical.

A few years ago I started noticing that no matter how much sleep I got, I just didn't look as fresh as I did when I was younger. I thought maybe it was time to talk to a professional about how I could get back that youthful appearance.

Stress, the daily rigor of life, and gravity all take their toll on the face, and there's nothing wrong with admitting you need a little help to look and feel a little better.

I visited with Dr. Vijay Bingdingdavale, a local cosmetic surgeon, to address my concerns and explore some options. The first thing he suggested was injections to relax my forehead area.

"That'll lift the eyebrows as well. What happens is when we inject these two areas, your eyebrows come a little bit higher, and giving you more of a refreshed look," Dr. Bingdingdavale said.

Then adding fullness to the upper cheeks would bring some balance to my face.

"You see how when you have a little bit more cheek fullness it harmonizes the face? It lifts this and fill this in as well," Dr. Bingdingdavale said.

Using fat transfer as opposed to artificial fillers has an additional benefit.

"We see this a lot, because there are stem cells in the fat, it makes the overlying skin more refreshed and more young-looking," Dr. Bingdingdavale said.

In the end, that's what we all want -- a more refreshed appearance even if we don't get our eight hours every night.

You can catch Dr. Vijay Bingdingdavale on First Edition on Sundays discussing skin care and healthy living.

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Fountain of Youth within reach without surgery - KIIITV.com

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Photo: Yulia Gorbachenko

BEST ACNE-REDUCING FACIALRejuran Healer+ Laser Peel$737 for 60 minutes, Priv ClinicAt the heart of this facial is polynucleotide, a biopolymer molecule highly compatible with the human body. Delivered into the skin via a series of micro injections, it reportedly helps repair damaged skin cells, boost collagen synthesis, reduce sebum production and even out the skins moisture-oil balance. The miniscule punctures in the skin also trigger its natural wound-healing response, boosting cellular turnover. Some light swelling may appear post-treatment, but it goes away within 24 hours. Meanwhile, skin is visibly suppler, and looks smoother and healthier.

BEST ANTI-AGEING FACIALInstant Youth ProgrammeFrom $260 for 75 minutes, EstheClinicBehold the ultimate helping hand to counter the signs of mature skin. Each treatment is uniquely tailored to your specific skin type and needs, with subsequent sessions building on and enhancing the effects of prior treatments to maximise collagen production for firmer skin. By using the latest in aesthetic technology alongside EstheClinics specially selected cosmeceutical products, the signs of ageing are thus tackled from the inside out, with effects continuing to last up to four months after completing the programme.

BEST ANTI-BLEMISH FACIALTetra+ $398 per session, The Aesthetics Medical ClinicThis four-in-one treatment features a symphony of lasers with varying wavelengths to tackle multiple issues in just one sitting. A pigment wavelength breaks down melanin clusters to improve discoloration; a custom fractional laser refines texture; a superficial wavelength zaps clogged pores clean; and a long-pulse wavelength stimulates collagen production. Expect minimal to no downtimeand a smoother complexion in no time at all.

BEST BRIGHTENING FACIALRejuvenation Laser and Stem Cell Infusion$1,888 for five sessions, The Aesthetics Medical ClinicCombining two laser machinesQ Switch and yellow laserthat work in tandem to give you radiant, glowy skin, this also removes dirt, dead skin cells, oil and superficial hair, so skin is not only brightened, but also clearer and cleaner. The laser also helps to regulate oil production and reduce pigmentation, while the potent 80percent stem cell-derived serum delivers proteins, growth factors and cytokines intoskin to help boost regeneration and repair.

BEST CLEANSING FACIALJet Set$129 for 30 minutes, EPIONIdeal as a maintenance facial for time-strapped individuals, this express purifying solution rejuvenates weary skin in 30 minutes. A highpressure aqua jet peel gently sweeps away any build-up of dry and dead skin, before an ultrasonic deep cleanse purges pores of dirt, sebum and impurities. Jet technology is then used to infuse skin with potent actives with intense hydrating and brightening benefits.

Related article:BAZAAR Spa Awards 2020: Best Face Therapies To Transform And Pamper Your Skin

BEST DETOXIFYING FACIALVitamin C Infusion$288 for 45 minutes, Simply AestheticsBid adieu to skin woes such as open pores, blemishes, pigmentation and dullness with a super-potent dose of medical-grade vitamin C, which smooths and revitalises the skin. Besides getting rid of pore-clogging impurities that can make the skin appear dull or lacklustre, the facial also stimulates the dermal cells to actively produce collagen in order to regain that plump, fresh-faced radiance.

BEST EXPRESS FACIALIDS Electro Infusion (IEI)$280 for 45 minutes, IDS AestheticsGreat as a lunchtime facial, this uses a combination of electronic-magnetic pulses and LED light to brighten and firm skin. Designed to tackle various skin conditionspigmentation, fine lines, wrinkles, dryness, dullnessthis quickie facial is deemed a universal beauty enhancer and works its magic in less than an hour.

BEST EYE LIFT TREATMENTSygmaLift Eyes$670 for 60 minutes, Clifford AestheticsWhether its eyebags or dark circles that no concealer can hide, the root causes of your undereye issues are sussed out with a consultation in order to tailor an effective treatment. SygmaLift therapy, which utilises high-intensity focused ultrasound technology, is then applied to the under-eye area to contract the connective tissues deep within to tighten and smooth skin. The end resulta marked improvement in the appearance of under-eye bags, sagginess, discoloration and linestakes years off your face!

BEST HYDRATING FACIALHydraFacial$250 for 35 minutes, Dr Kevin Chua Medical & AestheticsThis all-in-one treatment starts off with a deep cleanse, and an exfoliating cocktail of salicylic and glycolic acids to break up pore-clogging impurities, allowing the HydraPeel Tip to essentially vacuum out sebum, product build-up, blackheads and dirt, before infusing skin with intensive serums to replenish hydration levels and provide antioxidant protection.

BEST LIFTING & FIRMING FACIALThermage FLX$5,350 for 90 minutes, Priv ClinicWant to reduce the look of fine lines, wrinkles, sagging skin and other signs of ageing, or simply delay their dreaded appearance? Promising just that is the Thermage FLX, which uses radio frequency to stimulate cell regeneration and collagen production. This newgen treatment is optimised for improved comfort and more controlled delivery, and the results from one session is said to last for months.

BEST PORE-REFINING FACIAL3D Deep Pore Cleansing Facial$588 for 90 minutes, Aesthetics Central ClinicFlawless skin can now be had with this signature treatment that utilises a patented device called 50 Micron Jet Technology, where high-pressure micro-jets of water gently push out the sebum and impurities trapped in pores. As the pores are being cleaned out, the machine delivers a serum, designed to lift and tighten skin while encouraging microcirculation, deep into the skin.

BEST REJUVENATING FACIALPicoWay RESOLVE $650 for 30 minutes, Dr Kevin Chua Medical & AestheticsSo named for the technology where laser pulses are delivered in picosecondsa unit of measurement that refers to one trillionth of a seconda PicoWay facial sends small bursts of intense laser energy deep into the skin to stimulate its natural healing abilities. The short pulsations mean that less heat is emitted during the procedure, so you neednt worry about post-treatment burns. Benefits of the treatment, which is suitable for most skin types, include plumper, suppler skin with improved tone and texture.

Related article:Spa Awards 2020 Best Rejuvenating Facial: PicoWay RESOLVE

BEST RESURFACING FACIALPico Fractional Laser Treatment$300 for 60 minutes, Calvin Chan Aesthetic & Laser ClinicVia short but intense pulses of laser energy delivered deep into the dermis, the skin is transformed from the inside out as new collagen and elastin is produced to significantly improve the appearance of pitted acne scars, pigmentation and wrinkles. And if youre worried about downtime, dont. The surface of the skin is left intact while the deep tissue heals, which means theres no recovery time involved.

BEST SHAPING & TIGHTENING FACIALBiologique Recherche Remodeling Face $380 for 90 minutes, Freia AestheticsThis kicks off with a 60-minute booster customised to your skins needs, followed by a proprietary massage that promotes blood flow and stimulates the lymph nodes for a detoxifying effect. The Remodelling Face machine then uses a bespoke blend of electric, galvanic and high-frequency currents to enhance the benefits of the preceding steps, and deliver product actives deeper and more efficiently into skin for a supreme lifting, tightening and plumping effect.

BEST SOOTHING FACIALSeriously Soothing $209 for 90 minutes, EPIONLiving up to its name, this hydrates and calms thirsty skin with a side of sensitivity. Ultrasonic energy is first used to give skin a deep cleanse. This is followed by a dose of much-needed hyaluronic acid and the application of a soothing face mask. The final step: LED red light therapy to help stimulate collagen production and reduce redness or inflammation.

Related article:Cindy Crawford Shows How She Stays Fabulous At Every Age In Our February Issue

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Spa Awards 2020: Best Specialised Solutions Tackle Every Skin Concern - Harper's Bazaar Singapore

Skin Stem Cells Comments Off on Spa Awards 2020: Best Specialised Solutions Tackle Every Skin Concern – Harper’s Bazaar Singapore | February 11th, 2020

In our regular feature #TheBrand, Bazaars beauty team look into an exciting and efficacious brand taking the beauty industry by storm. This time, its an under-the-radar skincare line gaining traction for its transformative effects.

The latest brand making beauty editors fawn is surprisingly buzz-free. Theres no celebrity founder, attention-seeking packaging, or heavily filtered Instagram account. The brands website is unassuming, and stockists are scarce. So, why is everyone clamouring for iS Clinical, and is it worth the search? Here, we reveal the story behind beautys quietest game-changer.

Founded in 2002 by biochemist Bryan Johns and Alec Call and still privately owned iS Clinical is part of the Innovative Skincare umbrella, which creates products focused on pure, pharmaceutical-grade ingredients. The transformative effects of these meticulously created products made the brands professional treatments an awards-circuit mainstay, yet the buzz didnt quite reverberate across the pond.

Warming Honey Cleanser

30.99

Reparative Moisture Emulsion

66.99

Youth Complex

31.99

Cleansing Complex

29.99

Cue a few choice (not paid-for) endorsements from some enviably glossy influencers think Rosie Huntington-Whiteley, January Jones and celebrity facialist Shani Darden and iS Clinical has become the under-the-radar skincare line of the moment.

iS Clinical doesnt look like the type of brand to be touting buzzwords such as botanical and natural. In fact, it looks veritably like something youd only expect to find lining the white walls of a dermatologists office.

But the formulas in these gimmick-free blue bottles are actually a force of nature, combining highly active, plant-derived extracts (and omitting fragrance and parabens), to directly tackle specific skin concerns.

The brands skincare ethos comprises four steps: cleanse, treat, hydrate and protect, and the range offers products in each category for a variety of specific skin types. Every one is conceptualised and produced in-house, with no third-party involvement, meaning you wont' find a 'dupe' or replica anywhere else.

High-grade ingredients think plant-derived acids, vitamins A to E, stem cells and ceramides are combined to deliver the most notable results in the least amount of time. Users of the brands star serum (more on that later) have reported visible improvements in a matter of days.

The brands scientific approach is founded on the biological principle of xenohormesis: the concept that stressed plants produce bioactive compounds, which pass on stress-resistance and survival benefits to the people who consume (or apply) them.

While the brand offers a specific range for each skin type, theres one hero product that has made more waves than most. Praised in particular by those with acne and rough skin texture, the Active Serum is widely hailed as the product to solve the most persistent of breakouts, while fading scars and hyperpigmentation.

According to Dr. Charlene DeHaven M.D, clinical director of iS Clinical, the cult following is due to the unique combination of four naturally occurring acids that do more than just treat blemishes.

Sugar cane (a source of glycolic acid) and bilberry fruit extract (a source of lactic acid) both encourage gentle exfoliation of the outer layers of the epidermis, without dehydrating the skin. Willow bark extract (containing salicylic acid) deep-cleanse the pores, while kojic-acid rich mushroom extract has powerful antibacterial and antimicrobial properties, she explains. The addition of arbutin makes this serum a powerful tool in fading pigmentation, too combined with the kojic acid, it inhibits melanin-producing enzymes, therefore fading post-inflammatory pigmentation.

Active Serum

63.99

C Eye Advance+

44.99

Youth Serum

134.99

Pro-Heal Serum Advance+

15.00

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#TheBrand | iS Clinical Skincare Reviews - harpersbazaar.com

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Stem Cell Therapy Market: Snapshot

Of late, there has been an increasing awareness regarding the therapeutic potential of stem cells for management of diseases which is boosting the growth of the stem cell therapy market. The development of advanced genome based cell analysis techniques, identification of new stem cell lines, increasing investments in research and development as well as infrastructure development for the processing and banking of stem cell are encouraging the growth of the global stem cell therapy market.

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One of the key factors boosting the growth of this market is the limitations of traditional organ transplantation such as the risk of infection, rejection, and immunosuppression risk. Another drawback of conventional organ transplantation is that doctors have to depend on organ donors completely. All these issues can be eliminated, by the application of stem cell therapy. Another factor which is helping the growth in this market is the growing pipeline and development of drugs for emerging applications. Increased research studies aiming to widen the scope of stem cell will also fuel the growth of the market. Scientists are constantly engaged in trying to find out novel methods for creating human stem cells in response to the growing demand for stem cell production to be used for disease management.

It is estimated that the dermatology application will contribute significantly the growth of the global stem cell therapy market. This is because stem cell therapy can help decrease the after effects of general treatments for burns such as infections, scars, and adhesion. The increasing number of patients suffering from diabetes and growing cases of trauma surgery will fuel the adoption of stem cell therapy in the dermatology segment.

Global Stem Cell Therapy Market: Overview

Also called regenerative medicine, stem cell therapy encourages the reparative response of damaged, diseased, or dysfunctional tissue via the use of stem cells and their derivatives. Replacing the practice of organ transplantations, stem cell therapies have eliminated the dependence on availability of donors. Bone marrow transplant is perhaps the most commonly employed stem cell therapy.

Osteoarthritis, cerebral palsy, heart failure, multiple sclerosis and even hearing loss could be treated using stem cell therapies. Doctors have successfully performed stem cell transplants that significantly aid patients fight cancers such as leukemia and other blood-related diseases.

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Global Stem Cell Therapy Market: Key Trends

The key factors influencing the growth of the global stem cell therapy market are increasing funds in the development of new stem lines, the advent of advanced genomic procedures used in stem cell analysis, and greater emphasis on human embryonic stem cells. As the traditional organ transplantations are associated with limitations such as infection, rejection, and immunosuppression along with high reliance on organ donors, the demand for stem cell therapy is likely to soar. The growing deployment of stem cells in the treatment of wounds and damaged skin, scarring, and grafts is another prominent catalyst of the market.

On the contrary, inadequate infrastructural facilities coupled with ethical issues related to embryonic stem cells might impede the growth of the market. However, the ongoing research for the manipulation of stem cells from cord blood cells, bone marrow, and skin for the treatment of ailments including cardiovascular and diabetes will open up new doors for the advancement of the market.

Global Stem Cell Therapy Market: Market Potential

A number of new studies, research projects, and development of novel therapies have come forth in the global market for stem cell therapy. Several of these treatments are in the pipeline, while many others have received approvals by regulatory bodies.

In March 2017, Belgian biotech company TiGenix announced that its cardiac stem cell therapy, AlloCSC-01 has successfully reached its phase I/II with positive results. Subsequently, it has been approved by the U.S. FDA. If this therapy is well- received by the market, nearly 1.9 million AMI patients could be treated through this stem cell therapy.

Another significant development is the granting of a patent to Israel-based Kadimastem Ltd. for its novel stem-cell based technology to be used in the treatment of multiple sclerosis (MS) and other similar conditions of the nervous system. The companys technology used for producing supporting cells in the central nervous system, taken from human stem cells such as myelin-producing cells is also covered in the patent.

Global Stem Cell Therapy Market: Regional Outlook

The global market for stem cell therapy can be segmented into Asia Pacific, North America, Latin America, Europe, and the Middle East and Africa. North America emerged as the leading regional market, triggered by the rising incidence of chronic health conditions and government support. Europe also displays significant growth potential, as the benefits of this therapy are increasingly acknowledged.

Asia Pacific is slated for maximum growth, thanks to the massive patient pool, bulk of investments in stem cell therapy projects, and the increasing recognition of growth opportunities in countries such as China, Japan, and India by the leading market players.

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Global Stem Cell Therapy Market: Competitive Analysis

Several firms are adopting strategies such as mergers and acquisitions, collaborations, and partnerships, apart from product development with a view to attain a strong foothold in the global market for stem cell therapy.

Some of the major companies operating in the global market for stem cell therapy are RTI Surgical, Inc., MEDIPOST Co., Ltd., Osiris Therapeutics, Inc., NuVasive, Inc., Pharmicell Co., Ltd., Anterogen Co., Ltd., JCR Pharmaceuticals Co., Ltd., and Holostem Terapie Avanzate S.r.l.

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TMR Research is a premier provider of customized market research and consulting services to business entities keen on succeeding in todays supercharged economic climate. Armed with an experienced, dedicated, and dynamic team of analysts, we are redefining the way our clients conduct business by providing them with authoritative and trusted research studies in tune with the latest methodologies and market trends.

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Stem Cell Therapy Market Statistics, Trends, Size, Growth Opportunities, Share Demand and Forecast to 2025 - Jewish Life News

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Scientists using a new motor neuron disease (MND) model have shown astrocytes may protect neurons from toxic TDP-43 protein aggregates in the early stages of disease.

Researchers have discovered that astrocytes can protect motor neurons in the central nervous system (CNS) from the toxicity of misfolded protein, TDP-43, in sporadic motor neuron disease (MND). The team suggest this rescue mechanism could be harnessed to slow disease progression, particularly in amyotrophic lateral sclerosis (ALS).

The study, published in Brain, demonstrated that this neurodegenerative disease is caused by accumulation of TDP-43 in motor neurons, resulting in cell death. However, the scientists noted that TDP-43 accumulation in neural support cells, called astrocytes, does not cause death. Instead they appear comparatively resistant.

According to the paper, when the two cell types are together, astrocytes protect motor neurons from the protein aggregates, promoting their survival. The researchers from the Francis Crick Institute and University College London, both UK, suggest that these cells may therefore be supporting motor neurons early on in sporadic MND. They called this a rescue mechanism.

when the two cell types are together, astrocytes protect motor neurons from the protein aggregates, promoting their survival

The role astrocytes have played in dealing with toxic forms of TDP-43 in motor neurons has not been previously well documented in motor neuron disease. Its exciting that weve now found that they may play an important protective role in the early-stages of this disease, explains Phillip Smethurst, lead author and former postdoc in the Human Stem Cells and Neurodegeneration Laboratory at the Crick. This has huge therapeutic potential finding ways to harness the protective properties of astrocytes could pave the way to new treatments. This could prolong their rescue function or find a way to mimic their behaviour in motor neurons so that they can protect themselves from the toxic protein.

In order to conduct this research, the team created a new model for MND, which more closely resembles the disease in patients. In the model they took healthy adult stem cells and exposed them to the toxic TPD-43 protein using post-mortem spinal cord tissue samples donated by patients with MND.

For the first time, we have been able to create a model of sporadic motor neuron disease by essentially transferring the toxic TDP-43 protein from post-mortem tissue into healthy human stem cell-derived motor neurons and astrocytes in order to understand how each cell type responds to this insult, both in isolation and when mixed together, said Dr Rickie Patani, co-senior author, group leader of the Human Stem Cells and Neurodegeneration Laboratory at the Crick and Professor of Human Stem Cells and Regenerative Neurology at UCL Queen Square Institute of Neurology.

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Astrocytes could be harnessed to protect motor neurons in MND - Drug Target Review

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Newswise A UCLA-led study reveals a new role for a gene thats associated with autism spectrum disorder, intellectual disability and language impairment.

The gene, Foxp1, has previously been studied for its function in the neurons of the developing brain. But the new study reveals that its also important in a group of brain stem cells the precursors to mature neurons.

This discovery really broadens the scope of where we think Foxp1 is important, said Bennett Novitch, a member of theEli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLAand the senior author of the paper. And this gives us an expanded way of thinking about how its mutation affects patients.

Mutations in Foxp1 were first identified in patients with autism and language impairments more than a decade ago. During embryonic development, the protein plays a broad role in controlling the activity of many other genes related to blood, lung, heart, brain and spinal cord development. To study how Foxp1 mutations might cause autism, researchers have typically analyzed its role in the brains neurons.

Almost all of the attention has been placed on the expression of Foxp1 in neurons that are already formed, said Novitch, a UCLA professor of neurobiology who holds the Ethel Scheibel Chair in Neuroscience.

In the new study published in Cell Reports, he and his colleagues monitored levels of Foxp1 in the brains of developing mouse embryos. They found that, in normally developing animals, the gene was active far earlier than previous studies have indicated during the period when neural stem cells known as apical radial glia were just beginning to expand in numbers and generate a subset of brain cells found deep within the developing brain.

When mice lacked Foxp1, however, there were fewer apical radial glia at early stages of brain development, as well as fewer of the deep brain cells they normally produce. When levels of Foxp1 were above normal, the researchers observed more apical radial glia and an excess of those deep brain cells that appear early in development.In addition, continued high levels of Foxp1 at later stages of embryonic development led to unusual patterns of apical radial glia production of deep-layer neurons even after the mice were born.

What we saw was that both too much and too little Foxp1 affects the ability of neural stem cells to replicate and form certain neurons in a specific sequence in mice, Novitch said. And this fits with the structural and behavioral abnormalities that have been seen in human patients.

Some people, he explained, have mutations in the Foxp1 gene that blunt the activity of the Foxp1 protein, while others have mutations that change the proteins structure or make it hyperactive.

The team also found intriguing hints that Foxp1 might be important for a property specific to the developing human brain.The researchers also examined human brain tissue and discovered that Foxp1 is present not only in apical radial glia, as was seen in mice, but also in a second group of neuralstem cells called basal radial glia.

Basal radial glia are abundant in the developinghuman brain, but absent or sparse in the brains of many other animals, including mice.However, when Novitchs team elevated Foxp1 function in the brains of mice, cells resembling basal radial glia were formed. Scientists have hypothesized that basal radial glia also are connected to the size of the human brain cortex: Their presence in large quantities in the human brain may help explain why it is disproportionately larger than those of other animals.

Novitch said that although the new research does not have any immediate implications for the treatment of autism or other diseases associated with Foxp1 mutations, it does help researchers understand the underlying causes of those disorders.

In future research, Novitch and his colleagues are planning to study what genes Foxp1 regulates in apical radial glia and basal radial glia, and what roles those genes play in the developing brain.

The studys first author is Caroline Alayne Pearson, a UCLA assistant project scientist. Other authors are from the University of Texas at Austin, the University of Alabama at Birmingham and the University of Puerto Rico.

The study was funded by the National Institutes of Health, the California Institute for Regenerative Medicine, the Cancer Prevention and Research Institute of Texas, the University of Texas at Austins Marie Betzner Morrow Centennial Endowment and the UCLA Broad Stem Cell Research Centers Research Award Program, including support from the Binder Foundation.

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Gene associated with autism also controls growth of the embryonic brain - Newswise

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CALGARY, Alberta, Feb. 10, 2020 (GLOBE NEWSWIRE) -- Hemostemix Inc. (Hemostemix or the Company) (TSXV: HEM; OTC: HMTXF) is pleased to announce the appointment of Dr. Ronnie Hershman, M.D., F.C.C.S., to its Board of Directors. Dr. Hershman is a successful, practicing cardiologist with over three decades of experience. Dr. Hershman graduated Magna Cum Laude from the Sophie Davis Center for Biomedical Research in 1980 and received his medical degree from Mount Sinai Medical Center in 1982. He then continued his medical and cardiovascular training at Mt. Sinai Medical Center.

Dr. Hershman has been an Invasive Cardiologist since 1987 and was involved in many clinical trials for emerging catheter technologies. He was a pioneer in performing laser-assisted coronary angioplasty, starting in private practice on Long Island in 1989. Presently the Medical Director of NYU Langone Long Island Cardiac Care he built and manages a large medical practice, employing cutting-edge technology and continues his practice for patients with cardiovascular and peripheral vascular diseases, employing a non-invasive therapy for patients with intractable Angina and Congestive Heart Failure.

Dr. Hershman has also been an entrepreneur and investor for more than two decades. He has been involved in life science investing and consulting for several years and previously or currently serves on the boards of medical biotechnology companies Solubest, Ltd., TheraVitae Inc., Nasus Pharma, SanoNash and Optivasive. He also serves as an advisor to a latestage, life science venture capital company that has funded 24 companies to-date. Dr. Hershman is now an investor in OurCrowd, Ltd., a leading crowd funding company and is the Co-Founder and CEO of HealthEffect, LLC and CLiHealth, LLC, SoLoyal and Nasus Pharma along with SanoNash.

Dr. Hershman continues to evaluate new medical technologies in the USA and Israel. His main interests lie in bringing improved medical technologies from the bench to the clinic, quickly and globally. He is actively seeking to commercialize technologies that improve lives and cure illnesses in the most effective and cost efficient manner.

Stem Cell therapies are the future in so many chronic illnesses and Hemostemix is an exciting company with a lot of promise in providing solutions and therapeutic options for many patients with critical Cardiovascular illnesses and ischemia, commented Dr. Hershman. As an investor and Board Member, I hope to assist in advancing these therapies further and create optimal value for patients and shareholders, alike, he said.

Dr. Hershman is replacing Mr. Yari Nieken and Mr. Bryson Goodwin who both resigned from their positions with the Company effective February 10, 2020. Ms. Natasha Sever has also resigned from the position of CFO. The Company will look for suitable replacements for both CEO and CFO positions and Mr. Smeenk will act as the interim CEO until a replacement is hired. The Company thanks Bryson, Yari and Natasha for their service and wishes them well in their future endeavors.

It is a great pleasure to welcome Dr. Hershman to the Board of Directors, said David Wood, Chairman, as he compliments us with his broad medical experience, biotechnology and business investment acumen and counsel.

I am honored and delighted to welcome Dr. Hershman to the Board of Directors and I very much look forward to his counsel, said Thomas Smeenk, President.

The Company also announces that on January 9, 2020, J.M. Wood Investment Inc. (JMWI) sent the Company a Notice of Default and Demand for the immediate repayment of the Companys previously announced convertible debenture and demand loan. Based on the repayment conditions of the debts, the Company took the position the January 9th notice was premature. On January 24th, JMWI made an application to the Court of Queens Bench of Alberta for the issuance of an order appointing a receiver. The Company responded with a 347 page affidavit including appendices, sworn on January 30th by David Wood, Chairman. The application was heard on January 31st by Madame Justice Horner, who granted a consent order to adjourn the JMWI receivership application to February 20, 2020 to enable the Company to close its financing; granted an order appointing Grant Thornton as inspector; granted an order that the costs of the application of January 31st would only be payable by the Company if the application proceeds on February 20th. On February 6, 2020 cross examinations on the Affidavits of David Wood and JMWI were heard.

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Also, on February 3, 2020 the Company received an action from Aspire Health Science, LLC filed with the Ninth Judicial Circuit Court for Orange County, State of Florida, in connection with the Amended and Restated License Agreement rescinded by Hemostemix on December 5, 2019 due to Aspires failure to meet the Condition Precedent of paying US$1,000,000 within 30 business days of September 30, 2019. The Company believes the action is frivolous, without merit, and it intends to vigorously defend its position.

The Company intends to effect repayment of the secured debts and it will provide a further update to the market at that time. Although the Company is optimistic that it will be successful in raising sufficient funds to meet its obligations, there can be no assurance that the financing will close as anticipated or within the time frames required.

ABOUT HEMOSTEMIX INC.

Hemostemix is a publicly traded autologous stem cell therapy company, founded in 2003. A winner of the World Economic Forum Technology Pioneer Award, the Company developed and is commercializing its lead product ACP-01 for the treatment of CLI, PAD, Angina, Ischemic Cardiomyopathy, Dilated Cardiomyopathy and other heart conditions. ACP-01 has been used to treat over 300 patients, including no-option end-stage heart disease patients, and it has been the subject of four open label phase II clinical studies which proved its safety and efficacy.

On October 21, 2019, the Company announced the results from its presentation from its Phase II CLI trial abstract presentation entitled Autologous Stem Cell Treatment for CLI Patients with No Revascularization Options: An Update of the Hemostemix ACP-01 Trial With 4.5 Year Followup which noted healing of ulcers and resolution of ischemic rest pain occurred in 83% of patients, with outcomes maintained for up to 4.5 years. The Companys clinical trial for CLI is ongoing at 20 clinical sites in North America and 56 of 95 subjects have been enrolled to-date.

The Company owns 91 patents across five patent families titled: Regulating Stem Cells, In Vitro Techniques for use with Stem Cells, Production from Blood of Cells of Neural Lineage, and Automated Cell Therapy. For more information, please visit http://www.hemostemix.com.

Contact:

Thomas Smeenk, President & CEO Suite 1150, 707 7th Avenue S.W.Calgary, Alberta T2P 3H6Tel: 905-580-4170

Neither the TSX Venture Exchange nor its Regulation Service Provider (as that term is defined under the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-Looking Statements

This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words expects, plans, anticipates, believes, intends, estimates, projects, potential, and similar expressions, or that events or conditions will, would, may, could, or should occur. Although Hemostemix believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in forward-looking statements. Forward-looking statements are based on the beliefs, estimates, and opinions of Hemostemix management on the date such statements were made. By their nature forward-looking statements are subject to known and unknown risks, uncertainties, and other factors which may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, the Companys ability to fund operations and access the capital required to continue operations and repay its secured debts, the Companys stage of development, the ability to complete its current CLI clinical trial, complete a futility analysis and the results of such, future clinical trials and results, long-term capital requirements and future developments in the Companys markets and the markets in which it expects to compete, risks associated with its strategic alliances and the impact of entering new markets on the Companys operations. Each factor should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. Hemostemix expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events, or otherwise. Additional information identifying risks and uncertainties are contained in the Companys filing with the Canadian securities regulators, which filings are available at http://www.sedar.com.

Link:
Hemostemix Announces the Appointment of Dr. Ronnie Hershman to the Board of Directors and Provides a Corporate Update - Yahoo Finance

Cardiac Stem Cells Comments Off on Hemostemix Announces the Appointment of Dr. Ronnie Hershman to the Board of Directors and Provides a Corporate Update – Yahoo Finance | February 11th, 2020

Autologous stem cell and non-stem cell based therapies is a significant therapeutic intervention that makes use of an individuals cells which are then cultured and reintroduced into the donor patients body. In the context of China-US trade war and global economic volatility and uncertainty, it will have a big influence on this market. Autologous Stem Cell and Non-Stem Cell Based Therapies Report by Material, Application, and Geography Global Forecast to 2023 is a professional and comprehensive research report on the worlds major regional market conditions, focusing on the main regions (North America, Europe and Asia-Pacific) and the main countries (United States, Germany, United Kingdom, Japan, South Korea and China).

In this report, the global Autologous Stem Cell and Non-Stem Cell Based Therapies market is valued at USD XX million in 2019 and is projected to reach USD XX million by the end of 2023, growing at a CAGR of XX% during the period 2019 to 2023.

The report firstly introduced the Autologous Stem Cell and Non-Stem Cell Based Therapies basics: definitions, classifications, applications and market overview; product specifications; manufacturing processes; cost structures, raw materials and so on. Then it analyzed the worlds main region market conditions, including the product price, profit, capacity, production, supply, demand and market growth rate and forecast etc. In the end, the report introduced new project SWOT analysis, investment feasibility analysis, and investment return analysis.

The major players profiled in this report include:U.S. STEM CELL, INC.Brainstorm Cell TherapeuticsCytoriDendreon CorporationFibrocellLion BiotechnologiesCaladrius BiosciencesOpexa TherapeuticsOrgenesisRegenexxGenzymeAntriaRegeneusMesoblastPluristem Therapeutics IncTigenixMed cell EuropeHolostemMiltenyi Biotec

The end users/applications and product categories analysis:On the basis of product, this report displays the sales volume, revenue (Million USD), product price, market share and growth rate of each type, primarily split into-Embryonic Stem CellResident Cardiac Stem CellsAdult Bone MarrowDerived Stem CellsUmbilical Cord Blood Stem Cells

On the basis on the end users/applications, this report focuses on the status and outlook for major applications/end users, sales volume, market share and growth rate of Autologous Stem Cell and Non-Stem Cell Based Therapies for each application, including-Neurodegenerative DisordersAutoimmune DiseasesCancer and TumorsCardiovascular Diseases

Table of Contents

Part I Autologous Stem Cell and Non-Stem Cell Based Therapies Industry Overview?Chapter One Autologous Stem Cell and Non-Stem Cell Based Therapies Industry Overview1.1 Autologous Stem Cell and Non-Stem Cell Based Therapies Definition1.2 Autologous Stem Cell and Non-Stem Cell Based Therapies Classification Analysis1.2.1 Autologous Stem Cell and Non-Stem Cell Based Therapies Main Classification Analysis1.2.2 Autologous Stem Cell and Non-Stem Cell Based Therapies Main Classification Share Analysis1.3 Autologous Stem Cell and Non-Stem Cell Based Therapies Application Analysis1.3.1 Autologous Stem Cell and Non-Stem Cell Based Therapies Main Application Analysis1.3.2 Autologous Stem Cell and Non-Stem Cell Based Therapies Main Application Share Analysis1.4 Autologous Stem Cell and Non-Stem Cell Based Therapies Industry Chain Structure Analysis1.5 Autologous Stem Cell and Non-Stem Cell Based Therapies Industry Development Overview1.5.1 Autologous Stem Cell and Non-Stem Cell Based Therapies Product History Development Overview1.5.1 Autologous Stem Cell and Non-Stem Cell Based Therapies Product Market Development Overview1.6 Autologous Stem Cell and Non-Stem Cell Based Therapies Global Market Comparison Analysis1.6.1 Autologous Stem Cell and Non-Stem Cell Based Therapies Global Import Market Analysis1.6.2 Autologous Stem Cell and Non-Stem Cell Based Therapies Global Export Market Analysis1.6.3 Autologous Stem Cell and Non-Stem Cell Based Therapies Global Main Region Market Analysis1.6.4 Autologous Stem Cell and Non-Stem Cell Based Therapies Global Market Comparison Analysis1.6.5 Autologous Stem Cell and Non-Stem Cell Based Therapies Global Market Development Trend Analysis

Chapter Two Autologous Stem Cell and Non-Stem Cell Based Therapies Up and Down Stream Industry Analysis2.1 Upstream Raw Materials Analysis2.1.1 Proportion of Manufacturing Cost2.1.2 Manufacturing Cost Structure of Autologous Stem Cell and Non-Stem Cell Based Therapies Analysis2.2 Down Stream Market Analysis2.2.1 Down Stream Market Analysis2.2.2 Down Stream Demand Analysis2.2.3 Down Stream Market Trend Analysis

Part II Asia Autologous Stem Cell and Non-Stem Cell Based Therapies Industry (The Report Company Including the Below Listed But Not All)

Chapter Three Asia Autologous Stem Cell and Non-Stem Cell Based Therapies Market Analysis3.1 Asia Autologous Stem Cell and Non-Stem Cell Based Therapies Product Development History3.2 Asia Autologous Stem Cell and Non-Stem Cell Based Therapies Competitive Landscape Analysis3.3 Asia Autologous Stem Cell and Non-Stem Cell Based Therapies Market Development Trend

Chapter Four 2014-2019 Asia Autologous Stem Cell and Non-Stem Cell Based Therapies Productions Supply Sales Demand Market Status and Forecast4.1 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Production Overview4.2 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Production Market Share Analysis4.3 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Demand Overview4.4 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Supply Demand and Shortage4.5 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Import Export Consumption4.6 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Cost Price Production Value Gross Margin

Chapter Five Asia Autologous Stem Cell and Non-Stem Cell Based Therapies Key Manufacturers Analysis5.1 Company A5.1.1 Company Profile5.1.2 Product Picture and Specification5.1.3 Product Application Analysis5.1.4 Capacity Production Price Cost Production Value5.1.5 Contact Information5.2 Company B5.2.1 Company Profile5.2.2 Product Picture and Specification5.2.3 Product Application Analysis5.2.4 Capacity Production Price Cost Production Value5.2.5 Contact Information5.3 Company C5.3.1 Company Profile5.3.2 Product Picture and Specification5.3.3 Product Application Analysis5.3.4 Capacity Production Price Cost Production Value5.3.5 Contact Information5.4 Company D5.4.1 Company Profile5.4.2 Product Picture and Specification5.4.3 Product Application Analysis5.4.4 Capacity Production Price Cost Production Value5.4.5 Contact InformationChapter Six Asia Autologous Stem Cell and Non-Stem Cell Based Therapies Industry Development Trend6.1 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Production Overview6.2 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Production Market Share Analysis6.3 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Demand Overview6.4 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Supply Demand and Shortage6.5 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Import Export Consumption6.6 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Cost Price Production Value Gross Margin

Part III North American Autologous Stem Cell and Non-Stem Cell Based Therapies Industry (The Report Company Including the Below Listed But Not All)

Chapter Seven North American Autologous Stem Cell and Non-Stem Cell Based Therapies Market Analysis7.1 North American Autologous Stem Cell and Non-Stem Cell Based Therapies Product Development History7.2 North American Autologous Stem Cell and Non-Stem Cell Based Therapies Competitive Landscape Analysis7.3 North American Autologous Stem Cell and Non-Stem Cell Based Therapies Market Development Trend

Chapter Eight 2014-2019 North American Autologous Stem Cell and Non-Stem Cell Based Therapies Productions Supply Sales Demand Market Status and Forecast8.1 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Production Overview8.2 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Production Market Share Analysis8.3 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Demand Overview8.4 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Supply Demand and Shortage8.5 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Import Export Consumption8.6 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Cost Price Production Value Gross Margin

Chapter Nine North American Autologous Stem Cell and Non-Stem Cell Based Therapies Key Manufacturers Analysis9.1 Company A9.1.1 Company Profile9.1.2 Product Picture and Specification9.1.3 Product Application Analysis9.1.4 Capacity Production Price Cost Production Value9.1.5 Contact Information9.2 Company B9.2.1 Company Profile9.2.2 Product Picture and Specification9.2.3 Product Application Analysis9.2.4 Capacity Production Price Cost Production Value9.2.5 Contact InformationChapter Ten North American Autologous Stem Cell and Non-Stem Cell Based Therapies Industry Development Trend10.1 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Production Overview10.2 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Production Market Share Analysis10.3 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Demand Overview10.4 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Supply Demand and Shortage10.5 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Import Export Consumption10.6 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Cost Price Production Value Gross Margin

Part IV Europe Autologous Stem Cell and Non-Stem Cell Based Therapies Industry Analysis (The Report Company Including the Below Listed But Not All)

Chapter Eleven Europe Autologous Stem Cell and Non-Stem Cell Based Therapies Market Analysis11.1 Europe Autologous Stem Cell and Non-Stem Cell Based Therapies Product Development History11.2 Europe Autologous Stem Cell and Non-Stem Cell Based Therapies Competitive Landscape Analysis11.3 Europe Autologous Stem Cell and Non-Stem Cell Based Therapies Market Development Trend

Chapter Twelve 2014-2019 Europe Autologous Stem Cell and Non-Stem Cell Based Therapies Productions Supply Sales Demand Market Status and Forecast12.1 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Production Overview12.2 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Production Market Share Analysis12.3 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Demand Overview12.4 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Supply Demand and Shortage12.5 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Import Export Consumption12.6 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Cost Price Production Value Gross Margin

Chapter Thirteen Europe Autologous Stem Cell and Non-Stem Cell Based Therapies Key Manufacturers Analysis13.1 Company A13.1.1 Company Profile13.1.2 Product Picture and Specification13.1.3 Product Application Analysis13.1.4 Capacity Production Price Cost Production Value13.1.5 Contact Information13.2 Company B13.2.1 Company Profile13.2.2 Product Picture and Specification13.2.3 Product Application Analysis13.2.4 Capacity Production Price Cost Production Value13.2.5 Contact InformationChapter Fourteen Europe Autologous Stem Cell and Non-Stem Cell Based Therapies Industry Development Trend14.1 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Production Overview14.2 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Production Market Share Analysis14.3 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Demand Overview14.4 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Supply Demand and Shortage14.5 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Import Export Consumption14.6 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Cost Price Production Value Gross Margin

Part V Autologous Stem Cell and Non-Stem Cell Based Therapies Marketing Channels and Investment Feasibility

Chapter Fifteen Autologous Stem Cell and Non-Stem Cell Based Therapies Marketing Channels Development Proposals Analysis15.1 Autologous Stem Cell and Non-Stem Cell Based Therapies Marketing Channels Status15.2 Autologous Stem Cell and Non-Stem Cell Based Therapies Marketing Channels Characteristic15.3 Autologous Stem Cell and Non-Stem Cell Based Therapies Marketing Channels Development Trend15.2 New Firms Enter Market Strategy15.3 New Project Investment Proposals

Chapter Sixteen Development Environmental Analysis16.1 China Macroeconomic Environment Analysis16.2 European Economic Environmental Analysis16.3 United States Economic Environmental Analysis16.4 Japan Economic Environmental Analysis16.5 Global Economic Environmental Analysis

Chapter Seventeen Autologous Stem Cell and Non-Stem Cell Based Therapies New Project Investment Feasibility Analysis17.1 Autologous Stem Cell and Non-Stem Cell Based Therapies Market Analysis17.2 Autologous Stem Cell and Non-Stem Cell Based Therapies Project SWOT Analysis17.3 Autologous Stem Cell and Non-Stem Cell Based Therapies New Project Investment Feasibility Analysis

Part VI Global Autologous Stem Cell and Non-Stem Cell Based Therapies Industry Conclusions

Chapter Eighteen 2014-2019 Global Autologous Stem Cell and Non-Stem Cell Based Therapies Productions Supply Sales Demand Market Status and Forecast18.1 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Production Overview18.2 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Production Market Share Analysis18.3 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Demand Overview18.4 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Supply Demand and Shortage18.5 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Import Export Consumption18.6 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Cost Price Production Value Gross Margin

Chapter Nineteen Global Autologous Stem Cell and Non-Stem Cell Based Therapies Industry Development Trend19.1 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Production Overview19.2 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Production Market Share Analysis19.3 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Demand Overview19.4 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Supply Demand and Shortage19.5 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Import Export Consumption19.6 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Cost Price Production Value Gross Margin

Chapter Twenty Global Autologous Stem Cell and Non-Stem Cell Based Therapies Industry Research Conclusions

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Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market 2020: Industry Analysis By Emerging Trends, Key Companies, Regional Outlook and...

Cardiac Stem Cells Comments Off on Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market 2020: Industry Analysis By Emerging Trends, Key Companies, Regional Outlook and… | February 11th, 2020

BOTHELL, Wash. and TOKYO, Feb. 10, 2020 /PRNewswire/ --Seattle Genetics, Inc.(Nasdaq: SGEN) and Astellas Pharma Inc.(TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced updated results from the phase 1b/2 clinical trial EV-103 in previously untreated patients with locally advanced or metastatic urothelial cancer who were ineligible for treatment with cisplatin-based chemotherapy. Forty-five patients were treated with the combination of PADCEV (enfortumab vedotin-ejfv) and pembrolizumab and were evaluated for safety and efficacy. After a median follow-up of 11.5 months, the study results continue to meet outcome measures for safety and demonstrate encouraging clinical activity for this platinum-free combination in a first-line setting. Updated results will be presented during an oral session on Friday, February 14 at the 2020 Genitourinary Cancers Symposium in San Francisco (Abstract #441). Initial results from the study were presented at the European Society of Medical Oncology Congress in September 2019.

PADCEV is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.1,2

"Cisplatin-basedchemotherapy is the standard treatment for first-line advanced urothelial cancer; however, it isn't an option for many patients,"said Jonathan E. Rosenberg, M.D., Medical Oncologist and Chief, Genitourinary Medical Oncology Service at Memorial Sloan Kettering Cancer Center in New York."I'm encouraged by these interim results, including a median progression-free survival of a year for patients who received the platinum-free combination of PADCEV and pembrolizumab in the first-line setting."

In the study, 58 percent (26/45) of patients had a treatment-related adverse event greater than or equal to Grade 3: increase in lipase (18 percent; 8/45), rash (13 percent; 6/45), hyperglycemia (13 percent; 6/45) and peripheral neuropathy (4 percent; 2/45); these rates were similar to those observed with PADCEV monotherapy.3Eighteen percent (8/45) of patients had treatment-related immune-mediated adverse events of clinical interest greater than or equal to Grade 3 that required the use of systemic steroids (arthralgia, dermatitis bullous, pneumonitis, lipase increased, rash erythematous, rash maculo-papular, tubulointerstitial nephritis, myasthenia gravis). None of the adverse events of clinical interest were Grade 5 events. Six patients (13 percent) discontinued treatment due to treatment-related adverse events, most commonly peripheral sensory neuropathy. As previously reported, there was one death deemed to be treatment-related by the investigator attributed to multiple organ dysfunction syndrome.

The data demonstrated the combination of PADCEV plus pembrolizumab shrank tumors in the majority of patients, resulting in a confirmed objective response rate (ORR) of 73.3 percent (33/45; 95% Confidence Interval (CI): 58.1, 85.4) after a median follow-up of 11.5 months (range,0.7 to 19.2). Responses included 15.6 percent (7/45) of patients who had a complete response (CR)and 57.8 percent (26/45) of patients who had a partial response. Median duration of response has not yet been reached (range 1.2 to 12.9+ months). Eighteen (55%) of 33 responses were ongoing at the time of analysis, with 83.9% of responses lasting at least 6 months and 53.7% of responses lasting at least 12 months (Kaplan-Meier estimate).The median progression-free survival was 12.3 months (95% CI: 7.98, -) and the 12-month overall survival (OS) rate was 81.6 percent (95% CI: 62 to 91.8 percent); median OS has not been reached.

"These updated data are encouraging and provide support for the recently initiated phase 3 trial EV-302 that includes an arm evaluating PADCEV in this platinum-free combination in the first-line setting," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics.

"These additional results support continued evaluation of PADCEV in combination with other agents and at earlier stages of treatment for patients withurothelial cancer," said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Oncology Therapeutic Area Head at Astellas.

About the EV-103 TrialEV-103 is an ongoing, multi-cohort, open-label, multicenter phase 1b/2 trial of PADCEV alone or in combination, evaluating safety, tolerability and efficacy in muscle invasive, locally advanced and first- and second-line metastatic urothelial cancer.

The dose-escalation cohort and expansion cohort A include locally advanced or metastatic urothelial cancer patients who are ineligible for cisplatin-based chemotherapy. Patients were dosed in a 21-day cycle, receiving an intravenous (IV) infusion of enfortumab vedotin on Days 1 and 8 and pembrolizumab on Day 1. At the time of this initial analysis, 45 patients (5 from the dose-escalation cohort and 40 from the dose-expansion cohort A) with locally advanced and/or metastatic urothelial cancer had been treated with enfortumab vedotin (1.25 mg/kg) plus pembrolizumab in the first-line setting.

The primary outcome measure of the cohorts included in this analysis is safety. Key secondary objectives related to efficacy include objective response rate (ORR), disease control rate (DCR), duration of response (DoR), progression free survival (PFS) and overall survival (OS). DoR,PFS and OS are not yet mature.

Additional cohorts in the EV-103 study will evaluate enfortumab vedotin:

More information about PADCEV clinical trials can be found at clinicaltrials.gov.

About Bladder and Urothelial CancerIt is estimated that approximately 81,000 people in the U.S. will be diagnosed with bladder cancer in 2020.5 Urothelial cancer accounts for 90 percent of all bladder cancers and can also be found in the renal pelvis, ureter and urethra.6 Globally, approximately 549,000 people were diagnosed with bladder cancer in 2018, and there were approximately 200,000 deaths worldwide.7

The recommended first-line treatment for patients with advanced urothelial cancer is a cisplatin-based chemotherapy. For patients who are ineligible for cisplatin, such as people with kidney impairment, a carboplatin-based regimen is recommended. However, fewer than half of patients respond to carboplatin-based regimens and outcomes are typically poorer compared to cisplatin-based regimens.8

About PADCEV PADCEV (enfortumabvedotin-ejfv) was approved by the U.S. Food and Drug Administration (FDA) in December 2019 and is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or in a locally advanced or metastatic setting. PADCEV was approved under the FDA's Accelerated Approval Program based on tumor response rate. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.9

PADCEV is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.2,9Nonclinical data suggest the anticancer activity of PADCEV is due to its binding to Nectin-4 expressing cells followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).9PADCEV is co-developed by Astellas and Seattle Genetics.

Important Safety Information

Warnings and Precautions

Adverse ReactionsSerious adverse reactions occurred in 46% of patients treated with PADCEV. The most common serious adverse reactions (3%) were urinary tract infection (6%), cellulitis (5%), febrile neutropenia (4%), diarrhea (4%), sepsis (3%), acute kidney injury (3%), dyspnea (3%), and rash (3%). Fatal adverse reactions occurred in 3.2% of patients, including acute respiratory failure, aspiration pneumonia, cardiac disorder, and sepsis (each 0.8%).

Adverse reactions leading to discontinuation occurred in 16% of patients; the most common adverse reaction leading to discontinuation was peripheral neuropathy (6%). Adverse reactions leading to dose interruption occurred in 64% of patients; the most common adverse reactions leading to dose interruption were peripheral neuropathy (18%), rash (9%) and fatigue (6%). Adverse reactions leading to dose reduction occurred in 34% of patients; the most common adverse reactions leading to dose reduction were peripheral neuropathy (12%), rash (6%) and fatigue (4%).

The most common adverse reactions (20%) were fatigue (56%), peripheral neuropathy (56%), decreased appetite (52%), rash (52%), alopecia (50%), nausea (45%), dysgeusia (42%), diarrhea (42%), dry eye (40%), pruritus (26%) and dry skin (26%). The most common Grade 3 adverse reactions (5%) were rash (13%), diarrhea (6%) and fatigue (6%).

Lab AbnormalitiesIn one clinical trial, Grade 3-4 laboratory abnormalities reported in 5% were: lymphocytes decreased, hemoglobin decreased, phosphate decreased, lipase increased, sodium decreased, glucose increased, urate increased, neutrophils decreased.

Drug Interactions

Specific Populations

For more information, please see the full Prescribing Information for PADCEV here.

About Seattle GeneticsSeattle Genetics, Inc. is a global biotechnology company that discovers, develops and commercializes transformative medicines targeting cancer to make a meaningful difference in people's lives. The company is headquartered in Bothell, Washington, and has offices in California, Switzerland and the European Union. For more information on our robust pipeline, visit https://www.seattlegenetics.comand follow @SeattleGenetics on Twitter.

About AstellasAstellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. For more information, please visit our website at https://www.astellas.com/en.

About the Astellas and Seattle Genetics CollaborationSeattle Genetics and Astellas are co-developing enfortumab vedotin-ejfv under a collaboration that was entered into in 2007 and expanded in 2009. Under the collaboration, the companies are sharing costs and profits on a 50:50 basis worldwide.

Seattle Genetics Forward-Looking StatementsCertain statements made in this press release are forward looking, such as those, among others, relating to the EV-103 and EV-302 clinical trials; clinical development plans relating to enfortumab vedotin; the therapeutic potential of enfortumab vedotin; and its possible safety, efficacy, and therapeutic uses, including in the first-line setting. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the possibility that ongoing and subsequent clinical trials of enfortumab vedotin may fail to establish sufficient efficacy; that adverse events or safety signals may occur and that adverse regulatory actions or other setbacks could occur as enfortumab vedotin advances in clinical trials even after promising results in earlier clinical trials. More information about the risks and uncertainties faced by Seattle Genetics is contained under the caption "Risk Factors" included in the company's Annual Report on Form 10-K for the year ended December 31, 2019 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Astellas Cautionary NotesIn this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties.

Information about pharmaceutical products (including products currently in development), which is included in this press release is not intended to constitute an advertisement or medical advice.

1 PADCEV [package insert]. Northbrook, IL: Astellas, Inc.2 Challita-Eid P, Satpayev D, Yang P, et al. Enfortumab Vedotin Antibody-Drug Conjugate Targeting Nectin-4 Is a Highly Potent Therapeutic Agent in Multiple Preclinical Cancer Models. Cancer Res 2016;76(10):3003-13.3 Rosenberg JE, O'Donnell PH, Balar AV, et al. Pivotal Trial of Enfortumab Vedotin in Urothelial Carcinoma After Platinum and Anti-Programmed Death 1/Programmed Death Ligand 1 Therapy. J Clin Oncol 2019;37(29):2592-600.4 ClinicalTrials.gov. A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer (EV-103). https://clinicaltrials.gov/ct2/show/NCT03288545.5 American Cancer Society. Cancer Facts & Figures 2020. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2020/cancer-facts-and-figures-2020.pdf. Accessed 01-23-2020.6National Cancer Institute. Surveillance, Epidemiology, and End Results Program. Cancer stat facts: bladder cancer. https://seer.cancer.gov/statfacts/html/urinb.html. Accessed 05-01-2019.7International Agency for Research on Cancer. Cancer Tomorrow: Bladder. http://gco.iarc.fr/tomorrow. 8 National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Bladder Cancer. Version 4; July 10, 2019. https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf.9 PADCEV [package insert]. Northbrook, IL: Astellas, Inc.

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Seattle Genetics and Astellas Announce Updated Results from Phase 1b/2 Trial of PADCEV (enfortumab vedotin-ejfv) in Combination with Immune Therapy...

Cardiac Stem Cells Comments Off on Seattle Genetics and Astellas Announce Updated Results from Phase 1b/2 Trial of PADCEV (enfortumab vedotin-ejfv) in Combination with Immune Therapy… | February 11th, 2020