Abstract:Vaccine therapies for treatment andprevention of cancer have seen modest degrees of efficacy with wide variationrelated to the tumor type, vaccine type, adjuvants and clinical setting fortheir study. Over the course of the last two decades, various peptide vaccinesfor breast cancer have been studied. The current leading peptide vaccine forhuman application is a HER2-based vaccine known as Nelipepimut-S, which hasdemonstrated immune activity and promising clinical activity in some settings.This review covers the development of this newer peptide vaccine for both HER2amplified and non-amplified breast cancer.

Keywords:vaccine, breast cancer, HER2, peptide,human

INTRODUCTION

The human epidermal growth factor receptor 2 (HER2) proteinhas been one of the most extensively studied and targeted markers in oncologyin the last 30 years. The identification of the HER2 receptor and thedevelopment of antibodies to target it such as trastuzumab, pertuzumab andothers, are among the most successful advances in the treatment of breastcancer in the past 50 years. The research community learned that HER2signalling through its membrane-bound tyrosine kinase domain results indownstream activation of a cascade of events leading to angiogenesis, cellularinvasiveness, proliferation and survival proficiency. It is well known thatabout 20 percent of breast cancers will have marked overexpression of the HER2receptor and will benefit from HER2 targeting agents. It is generally acceptedthat most of the other 80% of breast cancers will express HER2, but at lowerlevels. There remains debate about the potential role of the HER2 protein andHER2 targeting in lower expressing breast cancers. Nevertheless, as a targetfor either passive or active immunotherapy, HER2 has been immunogenic due toantigens such as HER2369-377(also known as the E75 peptide)that are easily recognized by T cells and dendritic cells.

The currently available agents approved for HER2-overexpressing breast cancer include: trastuzumab, ado-trastuzumab, pertuzumab, lapatinib, neratinib, most recently trastuzumab deruxtecan, and five trastuzumab biosimilars (as of 1/2020). Additionally, the novel HER2 targeted monoclonal antibody, margetuximab, and a small molecule inhibitor, tucatinib, are currently being reviewed by the US FDA for possible approvals. While some of those drugs have been tested in HER2-low settings and non-breast settings, none have been approved to date for an indication outside of HER2-high or HER2 over-expressed cancer. Likewise, vaccine strategies have tested peptides, whole cell vaccines, dendritic cell vaccines, DNA vaccines and multipeptide vaccine in both HER2-high and HER2-low settings. The present review will examine the activity, development, efficacy and safety of the E75 peptide (also known as Nelipepimut-S when combined with GMCSF) as a peptide vaccine for breast cancer. Nelipepimut-S is currently in Phase III clinical development (NCT01479244) and has strong evidence of immunologic activity, though there is mixed evidence to date of clinical activity against early stage HER2-overexpressed breast cancer and there is little clinical activity reported against advanced metastatic disease. There is emerging data on Nelipepimut-S for HER2-low and triple negative breast cancer that will be reviewed.1

METHODS: LITERATURE SEARCH, INCLUSION AND EXCLUSION CRITERIA

We performed a systematic search of peer-reviewed literaturedatabases from 11/1/2019 to 12/9/2019. This review was limited to manuscripts,abstracts and chapters available in the English language and catalogued inPubmed, Web of Science, Scopus and proceedings of national meetings including:ASCO, SITC, SABCS, ESMO (American Society of Clinical Oncology, Society forImmunoTherapy of Cancer, San Antonio Breast Cancer Symposium, and EuropeanSociety of Medical Oncology). We searched for keywords including: HER2peptide E75 peptide, Nelipepimut-S, Neu-vax, breast cancer. Weexcluded trials examining cancers other than breast cancer and other related peptidesoutside the studied amino acid sequence from HER2369-377.Multipeptide vaccine studies were included for completeness.

BACKGROUND OF NELIPEPIMUT-S

The aim of a cancer vaccine is to stimulate a cancerpatients immune system to recognize tumor associated antigens via activeimmunotherapy. Successful active immunotherapy results in T cell recognitionand killing of cells expressing the antigen of interest. Ideally, successful Tcell mediated tumor killing should lead to epitope spreading to increase therepertoire of T cells for cytolysis, and lead to long term T cell memory.Several peptide vaccines have been investigated for these purposes, and apeptide sequence that is successful to date is the E75 HER2 peptide vaccine,otherwise known as Nelipepimut-S.2This vaccine has severalpublished clinical and preclinical reports and has been studied in aregistrational phase III study.3Nelipepimut-S, or the E75vaccine, is a 9 amino acid sequence from the extracellular domain of the HER2receptor (residues 369377 of HER2neu: KIFGSLAFL4). This 9 aminoacid sequence has long been known to be the immunologically dominant epitope ofthe protein and is presented both by HLA-A2 and HLA-A3 (HLA restricted).2,5,6Thesetwo alleles represent a majority of patients with breast cancer. HER2 is ofcourse a self-antigen, but overexpression is largely limited to breast cancers(and occasionally lung, gastric and colon cancers). Surprisingly, there doesnot appear to be negative thymic selection of HER2369-377specificT cells as shown by several groups.710Thus the E75 antigenfrom HER2 is a reasonable target for a variety of immunotherapies.

During in vitro preclinical development, the E75 peptide wasrecognized by CD8+ T lymphocytes. Subsequently, it was demonstrated thatE75-stimulated cytotoxic T lymphocytes were capable of lysis of HER2-expressingcancer cell lines.4,10,11The specificity of pulsed T cells forHER2 expressing cells was replicated in mouse models of cancer.8,12Additionally,it was found by multiple groups that lymphocytes in circulation occasionallyharbor pre-existing responses against the E75, 9 amino acid sequence HER2neu369-377usedin the subsequent development of Nelipepimut-S.6,11-13Likewise,dendritic cells from normal donor blood sources have been shown to be able topresent the E75 peptide and to generate E75-specific T cells.14

CLINICALS TRIALS WITH THE E75 PEPTIDE

The earliest Phase I pilot study of the E75 peptide inhumans also incorporated a MUC1 peptide (M1.2) in an autologous dendritic cellvaccine in breast and ovarian cancer.14Among 10 patients, CD8responses to E75 and M1.2 were observed (via intracellular interferon assay andchromium release assays) in 5 patients. The authors also reported evidence ofepitope spreading in two patients after repeat vaccination.

A study by Zaks and Rosenberg (Table 1) examined theactivity of the single E75 peptide formulated with incomplete Freunds adjuvantin various solid tumors, including breast cancer. CD8 responses were againobserved in human leukocyte antigen (HLA) -A2 and HLA-A3 patients, but anergyrather than memory was the long term outcome,15possibly due tooverstimulation related to incomplete Freunds adjuvant.

Subsequently, the E75 peptide was combined with GM-CSF toattempt to overcome the anergy suspected to be due to the incomplete Freundsadjuvant in the prior study. When combined with GM-CSF, the vaccine is termedNelipepimut-S (also previously called Neu-vax). Two phase I studies of 6 and 14patients respectively with advanced disease were completed using Nelipepimut-Sby intradermal injection, and safety was observed for up to 1000 micrograms(mcg) of Nelipepimut-S along with 250mcg of GM-CSF. Immune response wasobserved by means of ELIspot and delayed type hypersensitivity analysis.16,17Patientsreceived monthly vaccinations for up to 10 months and no dose limiting toxicitywas observed.

Given the challenge of developing an immunotherapy inheavily pre-treated metastatic patients, the Nelipepimut-S was subsequentlytested in early stage, surgically resected breast cancer patients. Testing inearly stage disease was expected to be safe given the excellent safety profileobserved in the metastatic setting. Thus, a paired set of trials (NCT00841399,NCT00584789) were performed for stage II or stage III, HER2-expressing breastcancer as defined as any immunohistochemical (IHC) staining from 1+ to 3+. Thesister clinical trials (phase II) were performed in the United States and havesince been published.7,18,19In the studies, all patients wereclinically disease-free and were permitted to use concomitant endocrinetherapies as well as prior Trastuzumab therapy. The dose and schedule wereoptimized in these early adjuvant trials. Ultimately, 195 patients wereenrolled and followed for 60 months.18,19There were 100patients vaccinated and 95 control patients. In the primary analysis, with amedian 20 months follow-up after vaccination, the recurrence rates were 5.6% vs14.2% in vaccinated vs unvaccinated participants (p=0.04).20Thusthe studies met their primary endpoint. However, for secondary analysis it wasfound that the short-term recurrence difference observed at 20 months did notpersist at any of the later analyses. For example, there was no difference inrecurrence at the 26month analysis (p=0.15) nor at 60 months (p=0.08). Therewas no difference in overall survival (OS) with p value=0.1. The authorssuggested that waning immunity due to lack of boosting contributed to the lackof long term benefit of the vaccine strategy.20Interestingly,there was a higher rate of visceral metastases in the vaccine-treated patientswhen they recurred. The toxicities of this vaccine strategy included flu-likesymptoms, fatigue, and bone pain. Less than 2% of patients experienced any highgrade toxicity (highest grade=3). The study concluded that an optimal dosewould be 1000mcg and that a potential phase III trial should be performed.

In the sister Phase II trials, boosting was explored and asuggestion of benefit was observed with boosting once every 6 months.Exploratory analysis also showed that the low-grade breast cancers seemed toderive greater benefit from Nelipepimut-S vaccination than higher grade breastcancers. In a late followup report, there was only one recurrence observed inthe 21 participants with optimal dosing of booster vaccines.18

Following completion of the phase II studies, a phase IIIstudy of Nelipepimut-S as a single agent, was designed and given the acronym,PRESENT. The PRESENT study (NCT01479244) fully accrued across 197 researchsites by Galena Biopharma Inc. PRESENT was a registrational study of 758patients with early stage, node positive breast cancer with low to intermediateHER2 expression with a primary endpoint of 3 year disease free survival (DFS).Patients received either Nelipepimut-S with GM-CSF or GM-CSF alone over thecourse of six intradermal injections followed by boosting every 6 months for 3years.3The interim analysis was published in 2019 anddemonstrated no overall difference in disease free survival (DFS) between armsat 16 months follow-up. There was a numerically higher number ofimaging-detected recurrences in the Nelipepimut-S vaccinated patients (54.1%)compared to placebo (29.2%).3The phase III PRESENT study wasdiscontinued due to futility in 2016, based on that interim analysis and thedata monitoring committee recommendation. No new safety signals were reported,and no cardiac signals were seen. The protocol design required empiriccross-sectional body imaging yearly in all patients. This imaging requirementwas a deviation from the existing standard of care (which would be for no crosssectional imaging unless symptoms arise). The required cross sectional imagingmay have impacted on the early termination of the study. The control arm had arecurrence rate comparable to rates seen in contemporary trials in early stagepatients. There is some speculation about whether pseudoprogression findingsmight have been observed in the radiographic recurrences, but biopsyconfirmation was not undertaken, so no conclusion can be drawn. Given anegative phase III result in PRESENT, there is unclear future for thedevelopment of Nelipepimut-S in the node positive, HER2-low, adjuvant breastcancer population.

COMBINATION CLINICAL TRIALS WITH NELIPEPIMUT-S

Given the challenge and phase III disappointment ofdeveloping Nelipepimut-S as a stand-alone therapy, it is now also beingexamined in combinatorial studies. Preclinical data had suggested thattrastuzumab could increase cross presentation of the E75 epitope and moreefficient expansion of specific CD8+T cells. The first phaseIIb combination trial of E75 and trastuzumab (NCT01570036) enrolled 275patients with HER2 low (IHC 1+ or 2+) breast cancer in the United States andcombined Nelipepimut-S with trastuzumab.1The patients receivedeither Nelipepimut-S with trastuzumab or trastuzumab/GM-CSF. The study designwas based on the observation, during the early phase Nelipepimut-S studies,that 12 patients were concurrently exposed to trastuzumab as a standard of careand none of those 12 patients experienced recurrent breast cancer.21Inthis newer phase IIb combinatorial study of Nelipepimut-S with trastuzumab,overall, there was no statistically significant difference in DFS (p=0.18),although there was a benefit seen in the subgroup of patients deemed to betriple negative. In this subset of 97 patients, the DFS for Nelipepimut-S plustrastuzumab was 92.6% compared with 71.9% for the trastuzumab/GM-CSF group (HR=0.26, p=0.01).1This encouraging subset finding has reportedlyled to the design of an upcoming clinical trial in the triple-negative earlystage setting.

NELIPEPIMUT-S WITH TRASTUZUMAB IN HER2 IHC3+ BREAST CANCER

In a recently completed randomized phase II trial (NCT02297698), 100 patients with traditionally-defined HER2 overexpression (IHC 3+) and otherwise high risk, non-metastatic breast cancer were enrolled to 1 to 1 randomized study of trastuzumab Nelipepimut-S and followed for DFS. This study completed accrual in 2017, and interim results demonstrated that Nelipepimut-S was well tolerated, and no significant difference in side effect profile nor cardiac ejection fraction was observed between the two arms of the study.22Clinical results have not been released to date.

TRIAL OF NELIPEPIMUT-S IN DCIS OF THE BREAST

A phase II study (NCT02636582) termed the VADIS study isassessing Nelipepimut-S against GM-CSF for ductal carcinoma in situ (DCIS) inthe neo-adjuvant window of opportunity design.23The premisefor this is supported by work published by Lowenfeld et al.24Inthis ongoing VADIS study, Nelipepimut-S or GM-CSF is given as two injectionsprior to definitive breast surgery. The primary endpoint is circulating immuneresponse at 6 months after vaccination. Secondary endpoints are toxicity andsafety. The study completed accrual in July 2019, and findings are stillpending.

OTHER E75 STUDIES IN BREAST CANCER

The potential promise of Nelipepimut-S vaccines, butnegative results in the large phase III trial, raise questions of whetheralternate vaccine formulations may induce stronger and more effective immuneresponses. A recently published study created and tested a liposomalformulation of the vaccine by attaching the E75 peptide to the surface ofdistearoyl phosphocholine and distearoyl phophoglycerol of nano-liposomes forvaccination.25ELISpot analysis and flow cytometry demonstratedsignificantly enhanced antitumor responses as well as tumor inhibition andprolonged survival time in the mouse TUBO model, which is a cell line thatoverexpresses the rHER/neu protein. Thus, this approach offers promise fortranslation to human clinical trials. There is also an ongoing autologous dendriticcell vaccine of the E75 peptide in combination with vinorelbine and trastuzumabin human cancer patients at the University of North Carolina (NCT00266110).26Finally,a series of four clinical trials performed at the University of Virginiaincorporated the E75 peptide into multipeptide vaccines for breast and ovariancancer, and using either polyICLC or incomplete Freunds adjuvant, rather thanGM-CSF (NCT00892567, NCT00304096, NCT01532960, NCT00091273). Immune responseswere detected, but clinical activity was not observed.27,28

DISCUSSION

The Nelipepimut-S vaccine alone demonstrates immune activityin patients expressing HLA-A2 or HLA-A3. As detailed above, the use of theNelipepimut-S vaccine in adjuvant breast cancer settings has not led toclinically meaningful improvements in overall survival or disease free survivalin a large randomized trial to date. Nevertheless, there are hints that thisparticular vaccine may hold potential clinical value in selected settings. Forexample, a meta-analysis of the 5 human clinical trials that involvedrandomization was performed in an effort to combine data from the smallertrials. In a published meta-analysis, the delayed hypersensitivity (DTH)responses and DFS combined data across trials suggested significant benefits tovaccination over control (p<0.05 and p=0.001 respectively). The combineddata for OS and recurrence were suggested to also have relevance (p=0.863 andp=0.388).29The conclusions of the meta-analysis do notablydiffer from some of the individual trials and obviously the patient populationshad major differences, thus rendering the impact of a meta-analysis unclear.Despite the criticisms of aggregation of data in the meta-analysis, it doessuggest that in appropriate settings that the Nelipepimut-S may have clinicalbenefits for some patients without untoward toxicity. Raw data from the large750 patient randomized phase III PRESENT trial, which was stopped for futility,was not available for analysis in that meta-analysis.

Thus, vaccine researchers in breast cancer are leftwondering which direction to focus limited resources on. Clearly there isimmunogenicity when vaccinating with the E75 peptide, and it tends todemonstrate synergy with passive antibody-based immunotherapy (ie, trastuzumabcombinations). It is also intriguing that the triple negative early stagebreast cancer population may have the greatest relative benefit afterNelipepimut-S vaccination. To date, there has been little traction indeveloping combinatorial strategies with checkpoint inhibitors or with myeloidsuppressing immunotherapy strategies. With checkpoint inhibitors approved inthe metastatic triple negative setting and expected in the triple negativeadjuvant setting, it is unclear what role peptide vaccination strategies may beable to play in the future triple negative treatment landscape.

Some remaining concerns for the E75 HER2 peptide developmentinclude the criticism that the peptide is HLA restricted and thus not availableuniversally to all patients. Also there is an unresolved question about how toaddress waning immunity and the need for long-term boosting strategies. Finally,the question about how best to select patients, especially in light of majorimmune system modulation that occurs during and immediately following adjuvantchemotherapy. It remains unknown whether the rebounding immune system in the 6months following cytotoxic chemotherapy presents a stimulatory or suppressiveenvironment for peptide vaccine generally and specifically for thisNelipepimut-S vaccine. Likewise, since HER2 targeting antibodies also impact onthe immune recognition of antigens from HER2, it is further unclear whetherearly adjuvant vaccination at the time of adjuvant HER2 antibodies or followingthe course of HER2 maintenance antibodies will be optimal.

CONCLUSION

Nelipepimut-S demonstrated immune activity against HER2positive breast cancer and suggestion of activity against triple negativebreast cancer. Its development in the adjuvant HER2 low to intermediatepopulation might be unlikely to continue based on the negative phase IIIPRESENT trial. Nevertheless, several important studies are yet to be performedfor the Nelipepimut-S and related E75 vaccines, such as combinatorial studies,novel adjuvant studies, boosting strategies, and biomarker driven studies.Recently there is rising interest in vaccine therapy for breast cancer, so thisor related vaccine strategies are likely to continue to be explored. Optimalpatient selection and monitoring may aid in future development of this cancertherapy.

Acknowledgments

Drs. Dillon, Brenin and Slingluff are supported by NCIsupport grant: 2P30CA044579-26 for the University of Virginia Cancer Center.

Disclosure

Drs. Dillon and Slingluff have published studies on peptidesreferenced in this manuscript. The University of Virginia was a subsite for aclinical trial referenced in this manuscript. Dr Dillon participated in aclinical trial for Galena Pharmaceuticals. Dr. Slingluff is an inventor onlicensed patents held by the University of Virginia Licensing and Venturesgroup for peptides used in melanoma vaccines. Dr Slingluff reports grants,non-financial support from Celldex for providing antibodies for clinical trialsand for preclinical studies. He also reports grants and/or non-financialsupport from Merck, Immatics, Polynoma, and GlaxoSmithKline; non-financialsupport from Theraclion, outside the submitted work. Dr Slingluff also in theprocess of joining the scientific advisory board with CureVac. In addition, DrSlingluff has patents on peptides used in cancer vaccines with royalties paid,a pending patent on biomarkers, a patent for a surgical device issued. Theauthors report no other conflicts of interest in this work.

Patrick M. Dillon,1Christiana M. Brenin,1Craig L. Slingluff Jr2

1University of Virginia, Division of Hematology/Oncology, Charlottesville, VA 22908, USA;2University of Virginia, Department of Surgery, Charlottesville, VA 22908, USA

Correspondence: Patrick M DillonDivision of Hematology/Oncology, University of Virginia, Box 800716, Charlottesville, VA 22908, USATel +1-434-982-1495Fax +1-434-244-7534Email Pmd5b@hscmail.mcc.virginia.edu

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Source: Breast Cancer: Targets and Therapy.Originally published April 3, 2020.

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TEL AVIV, Israel & PARSIPPANY, N.J. & INCHEON, South Korea--(BUSINESS WIRE)-- Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Celltrion Healthcare, Co., Ltd. (KRX KOSDAQ:091990), today announced that TRUXIMA (rituximab-abbs) injection is now available in the United States for the treatment of:

TRUXIMA is the only biosimilar to the reference product Rituxan1 (rituximab) available to treat rheumatoid arthritis in the United States. See important safety information below including Boxed Warning regarding fatal infusion-related reactions, severe mucocutaneous reactions, hepatitis B virus reactivation and progressive multifocal leukoencephalopathy.

We are proud to make TRUXIMA available to patients and providers as a treatment option for these indications, especially as this is the only rituximab biosimilar indicated for rheumatoid arthritis, said Brendan OGrady, Executive Vice President, North America Commercial, Teva. Following the launch of our other biosimilar earlier this year, we remain focused on our commitment to lower healthcare costs and increase price competition through the availability of biosimilars.

Celltrion Healthcare and Teva Pharmaceutical Industries Ltd. entered into an exclusive partnership in October 2016 for Teva to commercialize TRUXIMA in the U.S. and Canada. In May 2019, TRUXIMA was approved by the U.S. Food and Drug Administration (FDA) to match all of the reference products oncology indications described below.

We are pleased that patients in the United States can now have access to TRUXIMA for these new indications, said Mr. Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare. We believe that the continued use of biosimilars in the U.S. market will contribute to addressing unmet needs for patients and providers.

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Teva also offers dedicated patient support services through the CORE program. CORE is available to help eligible patients, caregivers and healthcare professionals navigate the reimbursement process. CORE offers a range of services, including benefits verification and coverage determination, support for precertification and prior authorization, assistance with coverage guidelines and claims investigation, and support through the claims and appeals process. A savings program is also available for eligible commercially insured patients. To learn more, please visit TevaCORE.com.

Please see the Important Safety Information below including the Boxed Warning regarding fatal infusion-related reactions, severe mucocutaneous reactions, hepatitis B virus reactivation and progressive multifocal leukoencephalopathy. For more information, please see the full prescribing information.

Indications TRUXIMA (rituximab-abbs) is indicated for the treatment of adult patients with:

Non-Hodgkins Lymphoma (NHL)

Chronic Lymphocytic Leukemia (CLL)

Rheumatoid Arthritis (RA)

Granulomatosis with Polyangiitis (GPA) (Wegeners Granulomatosis) and Microscopic Polyangiitis (MPA)

Important Safety Information

WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY

Infusion-Related Reactions: Administration of rituximab products, including TRUXIMA, can result in serious, including fatal, infusion-related reactions. Deaths within 24 hours of rituximab infusion have occurred. Approximately 80% of fatal infusion-related reactions occurred in association with the first infusion. Monitor patients closely. Discontinue TRUXIMA infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion-related reactions

Severe Mucocutaneous Reactions: Severe, including fatal, mucocutaneous reactions can occur in patients receiving rituximab products

Hepatitis B Virus (HBV) Reactivation: HBV reactivation can occur in patients treated with rituximab products, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with TRUXIMA. Discontinue TRUXIMA and concomitant medications in the event of HBV reactivation

Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving rituximab products

WARNINGS AND PRECAUTIONS

Infusion-Related Reactions - Rituximab products can cause severe, including fatal, infusion-related reactions. Severe reactions typically occurred during the first infusion with time to onset of 30-120 minutes. Rituximab product-induced infusion-related reactions and sequelae include urticaria, hypotension, angioedema, hypoxia, bronchospasm, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, cardiogenic shock, anaphylactoid events, or death

Premedicate patients with an antihistamine and acetaminophen prior to dosing. For RA, GPA, and MPA patients, methylprednisolone 100 mg intravenously or its equivalent is recommended 30 minutes prior to each infusion. Institute medical management (e.g. glucocorticoids, epinephrine, bronchodilators, or oxygen) for infusion-related reactions as needed. Depending on the severity of the infusion-related reaction and the required interventions, temporarily or permanently discontinue TRUXIMA. Resume infusion at a minimum 50% reduction in rate after symptoms have resolved. Closely monitor the following patients: those with pre-existing cardiac or pulmonary conditions, those who experienced prior cardiopulmonary adverse reactions, and those with high numbers of circulating malignant cells (25,000/mm3)

Severe Mucocutaneous Reactions - Mucocutaneous reactions, some with fatal outcome, can occur in patients treated with rituximab products. These reactions include paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis. The onset of these reactions has been variable and includes reports with onset on the first day of rituximab exposure. Discontinue TRUXIMA in patients who experience a severe mucocutaneous reaction. The safety of re-administration of rituximab products to patients with severe mucocutaneous reactions has not been determined

Hepatitis B Virus Reactivation - Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, can occur in patients treated with drugs classified as CD20-directed cytolytic antibodies, including rituximab products. Cases have been reported in patients who are hepatitis B surface antigen (HBsAg) positive and also in patients who are HBsAg negative but are hepatitis B core antibody (anti-HBc) positive. Reactivation also has occurred in patients who appear to have resolved hepatitis B infection (i.e., HBsAg negative, anti-HBc positive and hepatitis B surface antibody [anti-HBs] positive)

HBV reactivation is defined as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA levels or detection of HBsAg in a person who was previously HBsAg negative and anti-HBc positive. Reactivation of HBV replication is often followed by hepatitis, i.e., increase in transaminase levels. In severe cases increase in bilirubin levels, liver failure, and death can occur

Screen all patients for HBV infection by measuring HBsAg and anti-HBc before initiating treatment with TRUXIMA. For patients who show evidence of prior hepatitis B infection (HBsAg positive [regardless of antibody status] or HBsAg negative but anti-HBc positive), consult with physicians with expertise in managing hepatitis B regarding monitoring and consideration for HBV antiviral therapy before and/or during TRUXIMA treatment

Monitor patients with evidence of current or prior HBV infection for clinical and laboratory signs of hepatitis or HBV reactivation during and for several months following TRUXIMA therapy. HBV reactivation has been reported up to 24 months following completion of rituximab therapy

In patients who develop reactivation of HBV while on TRUXIMA, immediately discontinue TRUXIMA and any concomitant chemotherapy, and institute appropriate treatment. Insufficient data exist regarding the safety of resuming TRUXIMA treatment in patients who develop HBV reactivation. Resumption of TRUXIMA treatment in patients whose HBV reactivation resolves should be discussed with physicians with expertise in managing HBV

Progressive Multifocal Leukoencephalopathy (PML) - JC virus infection resulting in PML and death can occur in rituximab product-treated patients with hematologic malignancies. The majority of patients with hematologic malignancies diagnosed with PML received rituximab in combination with chemotherapy or as part of a hematopoietic stem cell transplant. Most cases of PML were diagnosed within 12 months of their last infusion of rituximab

Consider the diagnosis of PML in any patient presenting with new-onset neurologic manifestations. Evaluation of PML includes, but is not limited to, consultation with a neurologist, brain MRI, and lumbar puncture

Discontinue TRUXIMA and consider discontinuation or reduction of any concomitant chemotherapy or immunosuppressive therapy in patients who develop PML

Tumor Lysis Syndrome (TLS) - Acute renal failure, hyperkalemia, hypocalcemia, hyperuricemia, or hyperphosphatemia from tumor lysis, sometimes fatal, can occur within 12-24 hours after the first infusion of rituximab products in patients with NHL. A high number of circulating malignant cells ( 25,000/mm3) or high tumor burden, confers a greater risk of TLS

Administer aggressive intravenous hydration and anti-hyperuricemic therapy in patients at high risk for TLS. Correct electrolyte abnormalities, monitor renal function and fluid balance, and administer supportive care, including dialysis as indicated

Infections - Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can occur during and following the completion of rituximab product-based therapy. Infections have been reported in some patients with prolonged hypogammaglobulinemia (defined as hypogammaglobulinemia >11 months after rituximab exposure). New or reactivated viral infections included cytomegalovirus, herpes simplex virus, parvovirus B19, varicella zoster virus, West Nile virus, and hepatitis B and C. Discontinue TRUXIMA for serious infections and institute appropriate anti-infective therapy. TRUXIMA is not recommended for use in patients with severe, active infections

Cardiovascular Adverse Reactions - Cardiac adverse reactions, including ventricular fibrillation, myocardial infarction, and cardiogenic shock may occur in patients receiving rituximab products. Discontinue infusions for serious or life-threatening cardiac arrhythmias. Perform cardiac monitoring during and after all infusions of TRUXIMA for patients who develop clinically significant arrhythmias, or who have a history of arrhythmia or angina

Renal Toxicity - Severe, including fatal, renal toxicity can occur after rituximab product administration in patients with NHL. Renal toxicity has occurred in patients who experience tumor lysis syndrome and in patients with NHL administered concomitant cisplatin therapy during clinical trials. The combination of cisplatin and TRUXIMA is not an approved treatment regimen. Monitor closely for signs of renal failure and discontinue TRUXIMA in patients with a rising serum creatinine or oliguria

Bowel Obstruction and Perforation - Abdominal pain, bowel obstruction and perforation, in some cases leading to death, can occur in patients receiving rituximab in combination with chemotherapy. In postmarketing reports, the mean time to documented gastrointestinal perforation was 6 (range 1-77) days in patients with NHL. Evaluate if symptoms of obstruction such as abdominal pain or repeated vomiting occur

Immunization - The safety of immunization with live viral vaccines following rituximab product therapy has not been studied and vaccination with live virus vaccines is not recommended before or during treatment

Prior to initiating TRUXIMA physicians should ensure patients vaccinations and immunizations are up-to-date with guidelines. Administration of any non-live vaccines should occur at least 4 weeks prior to a course of TRUXIMA

Embryo-Fetal Toxicity - Based on human data, rituximab products can cause fetal harm due to B-cell lymphocytopenia in infants exposed to rituximab in-utero. Advise pregnant women of the risk to a fetus. Females of childbearing potential should use effective contraception while receiving TRUXIMA and for 12 months following the last dose of TRUXIMA

Concomitant Use With Other Biologic Agents and DMARDS Other Than Methotrexate

Observe patients closely for signs of infection if biologic agents and/or DMARDs are used concomitantly as limited safety data is available.

Use of concomitant immunosuppressants other than corticosteroids has not been studied in GPA or MPA patients exhibiting peripheral B-cell depletion following treatment with rituximab products

Use in RA Patients Who Have Not Had Prior Inadequate Response to TNF Antagonists

TRUXIMA should only be used in patients who have had a prior inadequate response to one or more TNF antagonist

Most common adverse reactions in clinical trials of NHL (25%) were: infusion-related reactions, fever, lymphopenia, chills, infection, and asthenia

Most common adverse reactions in clinical trials of CLL (25%) were: infusion-related reactions and neutropenia

Most common adverse reactions in clinical trials of RA (10%) were: upper respiratory tract infection, nasopharyngitis, urinary tract infection, and bronchitis (other important adverse reactions include infusion-related reactions, serious infections, and cardiovascular events)

Most common adverse reactions in clinical trials of GPA and MPA (15%) were: infections, nausea, diarrhea, headache, muscle spasms, anemia, peripheral edema, and infusion-related reactions

Nursing Mothers - There are no data on the presence of rituximab in human milk, the effect on the breastfed child, or the effect on milk production. Since many drugs including antibodies are present in human milk, advise a lactating woman not to breastfeed during treatment and for at least 6 months after the last dose of TRUXIMA due to the potential for serious adverse reactions in breastfed infants

About TRUXIMA TRUXIMA (rituximab-abbs) is a U.S. Food and Drug Administration (FDA)-approved biosimilar to RITUXAN (rituximab) for the treatment of: adult patients with CD20-positive, B-cell NHL to be used as a single agent or in combination with chemotherapy or CLL in combination with fludarabine and cyclophosphamide (FC); for rheumatoid arthritis (RA) in combination with methotrexate in adult patients with moderately-to severely-active RA who have inadequate response to one or more TNF antagonist therapies; and granulomatosis with polyangiitis (GPA) (Wegeners Granulomatosis) and microscopic polyangiitis (MPA) in adult patients in combination with glucocorticoids

TRUXIMA has the same mechanism of action as Rituxan and has demonstrated biosimilarity to Rituxan through a totality of evidence.

About Celltrion Healthcare, Co. Ltd. Celltrion Healthcare conducts the worldwide marketing, sales and distribution of biological medicines developed by Celltrion, Inc. through an extensive global network that spans more than 120 different countries. Celltrion Healthcares products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US Food and Drug Administration (FDA) cGMP guidelines and the EU GMP guidelines.

About Teva Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve peoples lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at http://www.tevapharm.com.

Teva's Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the launch of TRUXIMA Injection for Rheumatoid Arthritis in the United States, which are based on managements current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:

and other factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2019, including in the sections captioned "Risk Factors and Forward Looking Statements. Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

1 RITUXAN is a registered trademark of Genentech and Biogen.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200504005064/en/

Link:
Teva and Celltrion Healthcare Announce the Launch of TRUXIMA (rituximab-abbs) Injection for Rheumatoid Arthritis, the Only Biosimilar to Rituxan...

Cardiac Stem Cells Comments Off on Teva and Celltrion Healthcare Announce the Launch of TRUXIMA (rituximab-abbs) Injection for Rheumatoid Arthritis, the Only Biosimilar to Rituxan… | May 4th, 2020

When the axons that extend from neurons break during a spinal cord injury, the result is often a lifelong loss of motor functioning, because vital connections from the brain to other body parts cannot be restored. Now, researchers from Temple Universitys Lewis Katz School of Medicine say they may have found a way to recover some functions lost to axon breaks.

The researchers discovered that boosting levels of a protein called Lin28 in injured spinal cords of mice prompts the regrowth of axons and repairs communication between the brain and body. Lin28 also helped repair injured optic nerves in the animals, they reported in the journal Molecular Therapy.

The Temple team zeroed in on Lin28 because its a known regulator of stem cells, meaning it controls their ability to differentiate into various cells in the body. The researchers examined the effects of Lin28 on spinal cord and optic nerve injuries using two mouse models: one that was engineered to express extra Lin28 and another that was normal and was given the protein after injury via a viral vector.

Maintaining Momentum: Applying Recent Regulatory Guidance in the Midst of the Coronavirus

A panel of CATO SMS experts will review the key issues contained in the emerging Agency Guidance and offer thoughts on what changes and options for sponsors may be seen in the coming months.

All of the mice experienced axon regeneration, the researchers reported. But they found that the best results occurred in the normal mice that received Lin28 injections post-injury. In fact, in animals with optic nerve injuries, the axons regrew to the point where they filled the entire tract of the nerve.

Lin28 treatment after injury improved coordination and sensation in the mice, the researchers reported.

"We observed a lot of axon regrowth, which could be very significant clinically, since there currently are no regenerative treatments for spinal cord injury or optic nerve injury," said senior author Shuxin Li, M.D., Ph.D., professor of anatomy and cell biology at the Lewis Katz School of Medicine, in a statement.

RELATED: Gene therapy with 'off switch' restores hand movement in rats with spinal cord injury

Lin28 is already a target of interest, though it has garnered the most attention so far in cancer research. Startup Twentyeight-Seven Therapeutics is developing a small molecule that inhibits the protein in the hopes that doing so will boost Let-7, a cancer-suppressing microRNA. The company raised more than $82 million in a series A financing last year.

Several new approaches for repairing spinal cord injuries are under investigation, most notably gene therapy. King's College researchers are working on a gene therapy that repairs axons by prompting the production of the enzyme chondroitinase. A UT Southwestern team is targeting the gene LZK to increase levels of supportive nervous system cells called astrocytes in response to spinal injuries.

The Temple team has a two-pronged approach to further developing their Lin28-directed treatment. They hope to develop a vector that can be safely delivered by injection and that would deliver the therapy directly to damaged neurons. They also plan to study other molecules in the Lin28 signaling pathway.

"Lin28 associates closely with other growth signaling molecules, and we suspect it uses multiple pathways to regulate cell growth," Li said, potentially revealing other therapeutic molecules that could further boost neuron repair.

Link:
Repairing spinal cord injuries with a protein that regulates axon regeneration - FierceBiotech

Spinal Cord Stem Cells Comments Off on Repairing spinal cord injuries with a protein that regulates axon regeneration – FierceBiotech | May 4th, 2020

Getty

"Do you really need an eye cream?" It's a question that has intrigued many myself includedever since the tiny pots and tubes hit Sephora shelves.

One might wonder why you need a separate cream for your eye area when you already have a moisturizer for the face. Besides, your bathroom cabinet is probably already too crowded without having to add any more products, right?

In an attempt to resolve this skincare dilemma, three dermatologists weigh in on whether eye creams are actually a necessary skincare component or merely a nice-to-have:

Why you should invest in an eye cream?

"The skin around the eyes is thinner and shows signs of aging more quickly than other areas of the face do. This thinness makes it more delicate, vulnerable and prone to allergic reactions than other facial skin," says Dr. Craig Kraffert, board-certified dermatologist and president of Amarte Skin Care.

This is why the delicate skin around your eyes needs an extra dose of TLC, which a regular face moisturizer might not be able to deliver.

Moreover, the skin around your eyes also gets a much greater workout. "Every time you move your eyes, whether you squint, smile or widen them in surprise, you're using muscles around your eyes," notes Dr. Kraffert. Over time, factors like dryness and loss of collagen and elasticity lead to the formation of small wrinkles near your eyes, commonly known as 'crow's feet'. "Smoking and exposure to the sun's harmful ultraviolet rays can also contribute to wrinkle formation," adds the dermatologist.

Incorporating an eye cream into your daily skincare routine can help minimize the appearance of these wrinkles as well as tackle other skin concerns like dryness, puffiness, dark circles and pigmentation, tells Dr. Amy Ross, board-certified dermatologist and advisor for MONATs scientific advisory board.

And the sooner you start using one, the better. "The best time to start using an eye cream is before you think you need one," tells Dr. Ross. "Its easier to prevent signs of aging than correct them, so I recommend investing in an eye cream starting in your 20s," she says. Dr. Kraffert recommends applying an eye cream twice every day for optimal results.

What ingredients should you look for in an eye cream?

"Some key ingredients to look for are caffeine, hyaluronic acid and peptides," says Dr. Ross. Caffeine helps shrink under-eye bags by constricting the blood vessels and reducing inflammation. While peptides boost collagen production, making your skin plumper and more youthful.

Since the skin around your eyes has very few active oil glands, hydrating ingredients like hyaluronic acid, squalane and ceramides are essential for drawing in and sealing in the moisture.

For anti-aging benefits, "choose an eye cream contains retinol or a retinol derivative in a moisturizing baselook for ceramides, dimethicone, glycerin and oils in the ingredient list," says Dr. Estee Williams, a board-certified dermatologist and assistant clinical professor in dermatology at Mount Sinai Medical Center.

In addition, you should also consider factors like your skin type, what skin concern you wish to target, whether you'll be layering makeup on top, etc. when picking an eye cream, suggests Dr. Williams.

The best eye creams for every skin concern:

Whether you want to tackle fine lines, treat dark circles or reduce puffiness, these skincare picks have got you covered:

For dryness: Neutrogena Hydro Boost Gel-Cream

Neutrogena Hydro Boost Gel-Cream

Formulated with ultra-moisturizing hyaluronic acid, Neutrogenas Hydro Boost Gel-Cream penetrates quickly into the skin, plumping the skin cells with long-lasting moisture, making the delicate eye area visibly smooth and supple. It's lightweight, fragrance-free formula makes it suitable for all skin types, including oily and sensitive skin.

For dark circles: Sisley Paris Black Rose Eye Contour Fluid

Sisley Paris Black Rose Eye Contour Fluid

Infused with black rose extract, shea oil and caffeine, this luxe eye cream visibly smooths, revitalizes and brightens the skin around your eyes, making your peepers appear fresh and well-rested.

For de-puffing: Sunday Riley Auto Correct Brightening and Depuffing Eye Contour Cream

Sunday Riley Auto Correct Brightening and Depuffing Eye Contour Cream

Sunday Riley's Auto Correct Brightening and Depuffing Eye Contour Cream features a powerful blend of Brazilian ginseng root extract and caffeine that instantly invigorates and firms up the delicate eye area, reducing the appearance of under-eye bags. In addition, it contains horse chestnut extract that helps improve skin tone and smooth out fine lines.

For fighting photo-damage: Colorescience Total Eye 3-in-1 Renewal Therapy SPF 35

Colorescience Total Eye 3-in-1 Renewal Therapy SPF 35

The skin around your eyes is more sensitive and vulnerable to sun damage than the rest of your facial skin. This is why investing in an eye cream that also provides broad-spectrum protection is a good idea. Colorescience's three-in-one eye cream not only shields the eye area from harmful UVA and UVB rays but also noticeably improves the appearance of dark circles, wrinkles and fine lines.

For firming: No7 Lift & Luminate Triple Action Eye Cream

No7 Lift & Luminate Triple Action Eye Cream

Made with skin-nourishing ingredients like shea butter, ginseng root extract and white mulberry leaf extract, No7s Lift & Luminate Triple Action Eye Cream combats both uneven skin tone and fine lines, leaving your skin noticeably smooth, firm and radiant.

For dull, dry skin: Saturday Skin Wide Awake Brightening Eye Cream

Saturday Skin Wide Awake Brightening Eye Cream

Packed with date seed extract, peptides and avocado protein extract, this ultra-hydrating cream is like a tall glass of water for your skin. Its antioxidant-rich formula nourishes and brightens the delicate eye areamaking it instantly refreshed and reinvigorated.

For wrinkle repair: La Roche-Posay Redermic R Eyes Retinol Eye Cream

La Roche-Posay Redermic R Eyes Retinol Eye Cream

Featuring a potent formula supercharged with pure retinol, caffeine and thermal spring water, La Roche Posay's antioxidant-packed eye cream is a perfect pick for those whose primary skincare concern is wrinkles or fine lines.

For tackling signs of aging: Monat Eye Smooth Nourishing Eye Cream

Monat Eye Smooth Nourishing Eye Cream

Monat Eye Smooth Nourishing Eye Cream

From smoothing out wrinkles and fine lines to diminishing the appearance of dark circles, this rejuvenating cream does it all. Formulated with antioxidant-rich caffeine, peptides and plant stem cells, it plumps, brightens and evens skin tone, revealing a visibly smoother and youthful look around the eyes. Plus, it comes with a compact rose gold eye-roller that helps soothe puffy, stressed-out skin and improve circulation.

Excerpt from:
Heres Why You Should Never Skip Eye Cream, According To Dermatologists - Forbes

Skin Stem Cells Comments Off on Heres Why You Should Never Skip Eye Cream, According To Dermatologists – Forbes | May 4th, 2020

Washington: A recent study has suggested that adding a drug once commonly used to treat schizophrenia to traditional radiation therapy helped improve overall survival in mice with glioblastoma, one of the deadliest and most difficult-to-treat brain tumours.

The findings of the study conducted by researchers at the UCLA Jonsson Comprehensive Cancer Center and colleagues was published in the journal 'Proceedings of the National Academy of Sciences'.

It shows that a combination of radiation and the drug trifluoperazine not only targets glioblastoma cells but also helps overcome the resistance to treatment so common to this aggressive form of cancer. The results could prove promising for patients with the disease, for whom the median survival time is only 12 to 18 months following diagnosis.

Radiation is an integral part of therapy for people with cancer and one of the most effective treatments. In many cases, it can help cure the disease. But in glioblastoma, tumour cells often become resistant to radiation treatment because the radiation itself can induce "phenotype conversion," a process that turns certain non-tumour stem cells into tumour-producing cells, causing cancer to reoccur.

"While radiotherapy is one of the few treatments that prolong survival in glioblastoma patients, radiation alone does very little in treating the disease in our models because we are dealing with highly aggressive tumours," said the study's senior author, Dr Frank Pajonk, a professor of radiation oncology at the David Geffen School of Medicine at UCLA and a member of the Jonsson Cancer Center.

"The drug trifluoperazine by itself does not do much either, but we found when you combine them, they become highly efficient. Importantly, the drug does not sensitise cells to radiation but rather prevents the occurrence of resistant glioma stem cells," Pajonk added.

UCLA researchers have been exploring new ways to prevent glioblastoma tumour cells from becoming resistant to radiation by adding drugs to the treatment regimen that have traditionally been used for other purposes.

To find out if there were any existing drugs that could interfere with the radiation-induced phenotype conversion, the team screened more than 83,000 compounds through the shared resources at UCLA, which provides researchers access to specialised equipment and services to help them pursue cutting-edge research.

They were able to identify nearly 300 compounds, including the dopamine receptor antagonist trifluoperazine, that had the potential to block phenotype conversion and improve the efficacy of radiation therapy.

Once trifluoperazine was identified, it was tested on mice with patient-derived orthotopic tumours. The team found that when used in combination with radiation, trifluoperazine successfully delayed the growth of the tumours and significantly prolonged the overall survival of the animals.

Combining radiation treatment with trifluoperazine extended survival in 100 per cent of the mice to more than 200 days, compared to 67.7 days in the control group receiving only radiation.

"Many preclinical glioblastoma studies report fairly small increases in overall survival in mice, and that rarely translates into benefits for patients," said Pajonk, who is also a member of the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA.

"But here, we see pretty drastic effects in improved overall survival and I find that very encouraging. It gives us hope that this is all going to translate into a benefit for people," Pajonk further said.

The team plans to start a clinical trial this summer for people with recurrent glioblastoma to test using dopamine receptor antagonist with radiation therapy.

"I think we can find a combination of treatments with radiation that is very tolerable to patients and can do well," said co-author Leia Nghiemphu, an associate professor of clinical neurology at the Geffen School of Medicine and principal investigator on the upcoming clinical trial. "The next step is to see if we can stop this resistance to radiation in humans," added Nghiemphu.

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Schizophrenia drug combined with radiation shows promise in treating deadly brain tumours, says study - Free Press Journal

Skin Stem Cells Comments Off on Schizophrenia drug combined with radiation shows promise in treating deadly brain tumours, says study – Free Press Journal | May 3rd, 2020

Asfiled with the Securities and Exchange Commission on May 1,2020

RegistrationNo. 333-

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM S-3

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

VISTAGEN THERAPEUTICS, INC.

(Exactname of registrant as specified in its charter)

Nevada

2834

20-5093315

(Stateor Other Jurisdiction of

Incorporationor Organization)

(PrimaryStandard Industrial

ClassificationCode Number)

(I.R.S.Employer

IdentificationNumber)

343 Allerton Ave.

South San Francisco, California 94090

(650) 577-3600

(Address,including zip code, and telephone number,

includingarea code, of registrants principal executiveoffices)

Shawn K. Singh

Chief Executive Officer

VistaGen Therapeutics, Inc.

343 Allerton Avenue

South San Francisco, California 94080

(650) 577-3600

(Name,address, including zip code, and telephone number,

includingarea code, of agent for service)

Copies to

Daniel W. Rumsey, Esq.

Jessica R. Sudweeks, Esq.

Disclosure Law Group, a Professional Corporation

655 West Broadway, Suite 870

San Diego, CA 92101

Telephone: (619) 272-7050

Facsimile: (619) 330-2101

Approximate date of commencement of proposed sale to thepublic: As soon as practicable after this registrationstatement becomes effective.

If the only securities being registered on this form are beingoffered pursuant to dividend or interest reinvestment plans, pleasecheck the following box.

If any of the securities being registered on this form are to beoffered on a delayed or continuous basis pursuant to Rule 415 underthe Securities Act of 1933, other than securities offered only inconnection with dividend or interest reinvestment plans, check thefollowing box.

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If this form is a post-effective amendment filed pursuant to Rule462(c) under the Securities Act, check the following box and listthe Securities Act registration statement number of the earliereffective registration statement for the sameoffering.

If this form is a registration statement pursuant to GeneralInstruction I.D. or a post-effective amendment thereto that shallbecome effective upon filing with the Commission pursuant to Rule462(e) under the Securities Act, check the followingbox.

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Indicateby check mark whether the registrant is a large accelerated filer,an accelerated filer, a non-accelerated filer, smaller reportingcompany, or an emerging growth company. See the definitions oflarge accelerated filer, acceleratedfiler, smaller reporting company, andemerging growth company in Rule 12b-2 of the ExchangeAct.

Largeacceleratedfiler

[]

Acceleratedfiler

[]

Non-acceleratedfiler

[ ]

Smallerreportingcompany

[X]

Emerginggrowth company

[ ]

If anemerging growth company, indicate by check mark if the registranthas elected not to use the extended transition period for complyingwith any new or revised financial accounting standards providedpursuant to Section 13(a) of the Exchange Act.

CALCULATION OF REGISTRATION FEE

Titleof each class of securities to be registered

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be

registered(1)(2)

Proposed

maximum

offeringprice per

share(3)

Proposed

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VistaGen Therapeutics, Inc. S-3 May. 1, 2020 4:59 PM - Seeking Alpha

Cardiac Stem Cells Comments Off on VistaGen Therapeutics, Inc. S-3 May. 1, 2020 4:59 PM – Seeking Alpha | May 3rd, 2020

Earlier, treating orthopedic problems just led to temporary cure but not the root cause of the problem. However, the case is not the same now. With emerging research and experience, Dr. David C. Karli says that regenerative medicine can completely repair the tissues using stem cell therapies. From professional athletes to ordinary people who strive to live a healthy and active life, regenerative medicine is a new ray of hope providing a healthy alternative for sports and musculoskeletal conditions and injuries.

Dr. David C. Karli is an Ivy-trained physician, a pioneer in orthopedic regenerative medicine and sports medicine, and the founder of Greyledge Technologies, one of the first FDA-audited biotech companies that prepare biologic implants to repair humans diseased or damaged tissues. Talking about the advancements in regen medicine, he says, Regenerative medicines multidisciplinary approach can cater to solutions for several untreatable orthopedic problems. With experts around the world pooling their knowledge, skills, and resources, a breakthrough in orthopedic treatment is leading to a miracle cure.

What is Regenerative Medicine?

Regenerative medicine is an interdisciplinary field that helps repair or replaces damaged or diseased human cells or tissues to restore normal function. The relatively new field of study comprises a broad range of scientific disciplines like molecular biology and genetics to immunology and biochemistry. Dr. Karli specializes in orthopedic applications where a patients diseased cells are replaced and re-implanted by the autologously collected healthy cells from the same patient.

About Dr. David C. Karli

Dr. David Karli graduated from Elizabethtown College, Pennsylvania, in 1993. Followed by receiving his MD degree from the University of Maryland, he pursued his residency in physical medicine and rehabilitation at Harvard Medical School, where he served as a chief resident in his final year. While serving as an attending physician at Harvard Medical School, Dr. Karli collaborated with his orthopedic surgeon colleagues and participated in the development of rehabilitation protocols for spinal disorders. He joined the Steadman Clinic in Vail, Colorado, where his research interest led him to take up Regenerative Medicine and successfully launch and develop Greyledge Technologies. This company focuses on autologous blood-based biotherapies for orthopedic injuries.

In his 23 years of experience, Dr. Karli has authored several research papers and publications on stem cell therapies and rehabilitation and lectured on spinal and musculoskeletal topics. He is a Diplomate of the American Board of Physical Medicine and Rehabilitation. Also, Dr. Karli is an active member of several societies, including the Regenerative Medicine Organization., the American Academy of PM&R, and the International Spinal Injection Society.

Greyledge Technologies

He founded the company Greyledge Technologies in 2010 with the mission to redefine orthopedic treatments and enhance the bodys response to injury. Greyledge Technologies develops biologic products by processing materials like human blood and bone marrow into implantable preparations. These biologic preparations are further developed and inserted into the human body replacing the diseased cells hence, stimulating the healing process and self-repair.

At Greyledge Technologies, every patient is completely assessed and analyzed not only to guarantee that theyre fit to undergo the procedure yet additionally to create a personalized dynamic strategy that each patient can follow. The whole treatment takes a certain number of days wherein the family members and caretakers are informed about the medicinal dosages to follow after the procedure. After surgery, every patient is regularly followed-up by the rehabilitation team.

When asked in-depth about practicing regenerative medicine at Greyledge Technologies, Dr. Karli said, The treatment is entirely safe and effective as it requires no big surgeries or complicated operations. As the cells used are autologous, they do not pose any chances of immune rejection or untoward irreversible side effects. Neither do the cells need to be preserved. This makes the procedure swift and safe for all ages.

Dr. Karli says, Regenerative Medicine is emerging as one of the trending treatment options for patients who have lost all hope. Whats brilliant about this treatment is that it has the capability to thoroughly repair the damaged tissues at the molecular, structural, and functional level.

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David C. Karli is Offering a New Ray of Hope Through Regenerative Medicine - RESPECT.

Bone Marrow Stem Cells Comments Off on David C. Karli is Offering a New Ray of Hope Through Regenerative Medicine – RESPECT. | May 3rd, 2020

DetailsCategory: AntibodiesPublished on Saturday, 02 May 2020 12:42Hits: 149

- Innovative, fixed-dose formulation significantly reduces treatment time from hours to minutes and demonstrates consistent efficacy with a reduction in administration-related reactions compared to DARZALEX (daratumumab) for approved indications

- DARZALEX FASPRO is the only subcutaneous CD38-directed antibody approved in the treatment of multiple myeloma

HORSHAM, PA, USA I May 1, 2020 I The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approved DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a new subcutaneous formulation of daratumumab. DARZALEX FASPRO is approved in four regimens across five indications in multiple myeloma patients, including newly diagnosed, transplant-ineligible patients as well as relapsed or refractory patients.As a fixed-dose formulation, DARZALEX FASPRO can be administered over approximately three to five minutes, significantly less time than DARZALEX,which is given intravenously over hours. In the Phase 3 COLUMBA study supporting the approval, DARZALEX FASPRO demonstrated a consistent overall response rate (ORR) and pharmacokinetics and a similar safety profile compared with intravenous DARZALEX in patients with relapsed or refractory multiple myeloma. In addition, there was a nearly two-thirds reduction in systemic administration-related reactions (ARRs) for DARZALEX FASPRO compared to intravenous DARZALEX (13 percent vs. 34 percent, respectively).

"This approval exemplifies Janssen's mission and commitment to bringing together passion, science and ingenuity to advance novel solutions for patients," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, LLC. "We are excited about the potential of this meaningful innovation in transforming the treatment experience for patients with multiple myeloma where DARZALEX FASPRO can be administered in approximately three to five minutes, significantly less time than intravenous DARZALEX, which is given over hours. Based on its favorable profile, we are accelerating the development of DARZALEX FASPRO and evaluating its potential in multiple ongoing studies."

Click to Tweet: #NEWS: #FDA approves subcutaneous CD38-directed antibody for the treatment of multiple #myeloma. See here for more details: https://bit.ly/2VozhzY

The approval is based on data from the Phase 3 COLUMBA (MMY3012)and Phase 2 PLEIADES (MMY2040) studies.1,2 In the COLUMBA study, the ORR was non-inferior for patients taking DARZALEX FASPROas monotherapycompared to those taking intravenous DARZALEXas monotherapy (41 percent vs. 37 percent, respectively). In addition, there were fewer systemic ARRs with DARZALEX FASPRO versus intravenous DARZALEX (13 percent vs. 34 percent, respectively). In a pooled safety population of 490 patients who received DARZALEXFASPRO as monotherapy or in combination, the ARR rate wFas 11 percent. The safety profiles of intravenous DARZALEX and DARZALEX FASPRO were otherwise similar.1 Additionally, in the Phase 2 PLEIADES study evaluating the efficacy and safety of DARZALEX FASPRO in combination therapies, objective responses were demonstrated in combination with bortezomib, melphalan and prednisone (D-VMP) in newly diagnosed transplant ineligible patients. In addition, objective responses were demonstrated in combination with lenalidomide and dexamethasone (D-Rd) in relapsed or refractory patients who received one prior line of therapy.2

"The Multiple Myeloma Research Foundation shares a common goal with Janssen in advancing treatments for multiple myeloma and addressing the unmet needs of this patient community," said Paul Giusti, President and CEO of the Multiple Myeloma Research Foundation (MMRF). "The approval of DARZALEXFASPRO marks an important milestone which will help make a positive difference in the lives of patients who depend on this effective therapy."

Click to Tweet: .@theMMRF talks about advancing treatments for multiple #myeloma and addressing patient needs with latest #FDA approval. Read more here: https://bit.ly/2VozhzY

"Since the approval of daratumumab, a robust body of evidence has established its use as a treatment for multiple myeloma in both the frontline and relapsed and refractory settings," said Saad Z. Usmani, M.D., Division Chief of Plasma Cell Disorders, Levine Cancer Institute. "With DARZALEX FASPRO there may be fewer administration-related reactions compared to intravenous DARZALEX, providing an additional treatment option that may help patients, oncologists and nursing staff."

DARZALEX FASPROis co-formulated with recombinant human hyaluronidase PH20 (rHuPH20) [Halozyme'sENHANZEdrug delivery technology].DARZALEX FASPRO will be available to patients and physicians as soon as the week of May 11, 2020. The intravenous DARZALEX formulation will also remain available as an option for patients and their physicians.

DARZALEX FASPROis approved in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant, in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy, in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy, as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.

The U.S. FDA approval of DARZALEX FASPRO marks the first approval for this innovative subcutaneous formulation globally, and Janssen continues to work with health authorities around the world in an effort to bring this new treatment option to patients living with multiple myeloma.

Access to DARZALEX FASPRO (daratumumab and hyaluronidase-fihj)Janssen offers comprehensive access and support information, resources and services to assist U.S. patients in gaining access to DARZALEX FASPROthrough the Janssen CarePath Program. Through the program, eligible commercial patients pay no more than $5 per injection, regardless of individual income level. Information on the enrollment process is available online atwww.CarePathSavingsProgram.com/DARZALEX.

For more information, healthcare providers or patients can contact: 1-844-55DARZA (1-844-553-2792). Information will also be available atwww.DARZALEX.com. Dedicated case coordinators are available to work with both healthcare providers and patients.

About the COLUMBA Study 1The randomized, open-label, multicenter Phase 3 COLUMBA study (MMY3012) included 522 patients (median age of 67 years) with multiple myeloma who had received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or whose disease was refractory to both a PI and an IMiD. In the arm that received DARZALEX FASPRO(n=263), patients received a fixed dose of DARZALEX FASPRO1,800 milligrams (mg), co-formulated with recombinant human hyaluronidase PH20 (rHuPH20) 2,000 Units per milliliter (U/mL), subcutaneously weekly for Cycles 1 2, every two weeks for Cycles 3 6 and every four weeks for Cycle 7 and thereafter. In the intravenous DARZALEXarm (n=259), patients received DARZALEXfor intravenous infusion 16 milligrams per kilogram (mg/kg) weekly for Cycles 1 2, every two weeks for Cycles 3 6 and every four weeks for Cycle 7 and thereafter. Each cycle was 28 days. In the arm that received DARZALEX FASPRO, itwas given in a fixed volume of 15 mL over three to five minutes; the median injection time was five minutes. In the arm that received theintravenous administration, the median durations of the first, second and subsequent intravenous DARZALEXinfusions were 7.0, 4.3 and 3.4 hours, respectively.Patients in both arms continued treatment until disease progression or unacceptable toxicity.

About the PLEIADES Study 2The non-randomized, open-label, parallel assignment Phase 2 PLEIADES study (MMY2040) included more than 240 adults with multiple myeloma, including 67 patients with newly diagnosed multiple myeloma who were treated with 1,800 mg of DARZALEX FASPROin combination with bortezomib, melphalan, and prednisone (D-VMP) and 65 patients with relapsed or refractory disease who were treated with 1,800 mg of DARZALEX FASPROplus lenalidomide and dexamethasone (D-Rd). The primary endpoint for the D-VMP and D-Rd cohorts was overall response rate.

About DARZALEXand DARZALEX FASPROJanssen is committed to exploring the potential of DARZALEX (daratumumab) for patients with multiple myeloma across the spectrum of the disease. DARZALEX has been approved in seven indications, three of which are in the frontline setting, including newly diagnosed patients who are transplant eligible and ineligible.

DARZALEX has become a backbone therapy in the treatment of multiple myeloma, having been used in the treatment of more than 58,000 patients in the U.S. alone since its U.S. FDA approval in 2015. DARZALEX is the first CD38-directed antibody approved globally to treat multiple myeloma and in 2020, DARZALEX FASPRO(daratumumab and hyaluronidase human-fihj) follows as the only subcutaneous CD38-directed antibody approved to treat patients with multiple myeloma.2

CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease.4 DARZALEX binds to CD38 and inhibits tumor cell growth causing myeloma cell death.5 DARZALEX may also have an effect on normal cells.3 Data across seven Phase 3 clinical trials, in both the frontline and relapsed settings, have shown that DARZALEX-based regimens resulted in significant improvement in progression-free survival and/or overall survival. 4,5,6,7,8,9,10,11 Additional studies are underway to assess the efficacy and safety of DARZALEXFASPRO in the treatment of other malignant and pre-malignant hematologic diseases in which CD38 is expressed, including smoldering myeloma and in amyloidosis.12,13

Key DARZALEX Milestones:

Please see full Prescribing Information at http://www.DARZALEX.com.

About Multiple MyelomaMultiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.21,22When damaged, these plasma cells rapidly spread and replace normal cells with tumors in the bone marrow. In 2020, it is estimated that 32,270 people will be diagnosed and 12,830 will die from the disease in the U.S.24 While some patients with multiple myeloma have no symptoms, most patients are diagnosed due to symptoms, which can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems or infections.23

Please see full Prescribing Information at http://www.DARZALEX.com.

About the Janssen Pharmaceutical Companies of Johnson & Johnson At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

Learn more at http://www.janssen.com. Follow us at http://www.twitter.com/JanssenGlobal. Janssen Research & Development, LLC and Janssen Biotech, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

ENHANZEis a registered trademark of Halozyme.

1Mateos M-V et al. Efficacy and Safety of the Randomized, Open-Label, Non-inferiority, Phase 3 Study of Subcutaneous (SC) Versus Intravenous (IV) Daratumumab (DARA) Administration in Patients (pts) With Relapsed or Refractory Multiple Myeloma (RRMM): COLUMBA. 2019 American Society of Clinical Oncology Annual Meeting. June 2019.

2Janssen Research & Development, LLC. A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000 [cited July 5, 2019]. Available at: https://clinicaltrials.gov/ct2/show/NCT03412565. Identifier: NCT03412565.

32020Fedele G et al. CD38 Ligation in Peripheral Blood Mononuclear Cells of Myeloma Patients Induces Release of Protumorigenic IL-6 and Impaired Secretion of IFN Cytokines and Proliferation. Mediators Inflamm. 2013;564687.

4Janssen Research & Development, LLC. A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02076009?term=mmy3003&rank=1 Identifier: NCT02136134 .

5Janssen Research & Development, LLC. Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02136134?term=mmy3004&rank=1 Identifier: NCT02076009.

6Janssen Research & Development, LLC. A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma (Cassiopeia). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02541383?term=mmy3006 Identifier: NCT02541383.

7Janssen Research & Development, LLC. A Study of Combination of Daratumumab and Velcade (Bortezomib) Melphalan-Prednisone (DVMP) Compared to Velcade Melphalan-Prednisone (VMP) in Participants With Previously Untreated Multiple Myeloma In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02195479?term=mmy3007&rank=1 Identifier: NCT02195479.

8Janssen Research & Development, LLC. Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02252172?term=mmy3008&rank=1 Identifier: NCT02252172.

9Janssen Research & Development, LLC. A Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Participants With Previously Untreated Multiple Myeloma Who Are Ineligible for High-Dose Therapy (Asia Pacific Region). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT03217812?term=MMY3011&rank=1 Identifier: NCT03217812.

10European Myeloma Network. Compare Progression Free Survival Btw Daratumumab/Pomalidomide/Dexamethasone vs Pomalidomide/Dexamethasone (EMN14). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24] Available at: https://clinicaltrials.gov/ct2/show/NCT03180736?term=MMY3013&rank=2 Identifier: NCT03180736

11Amgen. Study of Carfilzomib, Daratumumab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma. (CANDOR). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24] Available at: https://clinicaltrials.gov/ct2/show/NCT03158688?term=NCT03158688&rank=1 Identifier: NCT03158688.

12Janssen Research & Development, LLC. A Study to Evaluate 3 Dose Schedules of Daratumumab in Participants With Smoldering Multiple Myeloma In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 March 19]. Available at: https://clinicaltrials.gov/ct2/show/NCT02316106?term=smm2001&rank=1 Identifier: NCT02316106.

13Janssen Research & Development, LLC. An Efficacy and Safety Proof of Concept Study of Daratumumab in Relapsed/Refractory Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 March 19]. Available at: https://clinicaltrials.gov/ct2/show/NCT02413489?term=lym2001&rank=1 Identifier: NCT02413489

14Janssen Biotech, Inc. "Janssen Biotech Announces Global License and Development Agreement for Investigational Anti-Cancer Agent Daratumumab." Issued August 30, 2012.

15Janssen Biotech, Inc. "DARZALEX (daratumumab) Approved by U.S. FDA: First Human Anti-CD38 Monoclonal Antibody Available for the Treatment of Multiple Myeloma." Issued November 16, 2015.

16Janssen Biotech, Inc. "DARZALEX (daratumumab) Approved by U.S. FDA in Combination with Two Standard of Care Regimens for the Treatment of Patients with Multiple Myeloma Who Have Received At Least One Prior Therapy." Issued November 21, 2016.

17Janssen Biotech, Inc. "DARZALEX (daratumumab) Approved by the U.S. FDA in Combination with Pomalidomide and Dexamethasone for Patients with Multiple Myeloma Who Have Received At Least Two Prior Therapies." Issued June 16, 2017.

18Janssen Biotech, Inc. "Janssen Announces DARZALEX (daratumumab) U.S. FDA Approval for Newly Diagnosed Patients with Multiple Myeloma who are Transplant Ineligible." Issued May 7, 2018.

19Janssen Biotech, Inc. "Janssen Announces U.S. FDA Approval of DARZALEX (daratumumab) in Combination with Lenalidomide and Dexamethasone for Newly Diagnosed Patients with Multiple Myeloma Who Are Transplant Ineligible." Issued June 27, 2019.

20Janssen Biotech, Inc. "Janssen Announces U.S. FDA Approval of DARZALEX (daratumumab) Combination Regimen for Newly Diagnosed, Transplant-Eligible Patients with Multiple Myeloma." Issued September 26, 2019.

21Kumar, SK et al. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study. Leukemia. 2012 Jan; 26(1):149-57.

22American Cancer Society. "What Is Multiple Myeloma?" Available at: http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what-is-multiple-myeloma. Accessed June 2019.

23American Cancer Society. "Key Statistics About Multiple Myeloma." Available at: https://www.cancer.org/cancer/multiple-myeloma/about/key-statistics.html. Accessed January 2020.

SOURCE: Janssen

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US Food and Drug Administration Approves DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a New Subcutaneous Formulation of Daratumumab in the...

Bone Marrow Stem Cells Comments Off on US Food and Drug Administration Approves DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a New Subcutaneous Formulation of Daratumumab in the… | May 2nd, 2020

Aging is an inevitable process. We cannot escape or prevent getting older but what if theres a fascinating field of medicine that can manage the aging process and prolong our health and vitality and longevity as we age?

Aging is an inevitable process. We cannot escape or prevent getting older but what if theres a fascinating field of medicine that can manage the aging process and prolong our health and vitality and longevity as we age?

Keeping in mind that there may never be an approach to totally stop or reverse aging, there have been some surprising disclosures to how Regenerative Medicine can naturally heal our body without the use of any surgical procedure.

Rejuvenating Old Cells to Healthy ones

The paces, stresses, and complexities in life drive us to age prematurely thereby breaking down our cells. Cell breakdown may lead to several health conditions like cancer, heart disease, Alzheimers and others.

Driving our bodies to age quickly, cell-breakdown is host to many age-related diseases, causing more than 100,000 deaths per day.

Dr David C Karli is an Ivy-trained physician, specialized in treating athletic injuries by inducing regenerative medicine and stem cell therapy in treatments.

He accepts the fact that patients can increase an additional 30 years of life by using Regenerative Medicine. One such innovation uses stem cells, however, there are issues with these cells.

They may not replace the original, diseased cells rapidly enough, or they may start to replicate uncontrollably, bringing about malignant growth.

Yet, Regenerative Medicine definitely guarantees the complete curing of a wide range of diseases, and ideally, slowing down the aging process too.

Stem Cell Therapy Programs with Promising Results

With solid funding and rapid advancements, one stem cell therapy that promises great outcomes is transfusions. In this therapy, stem cells are extracted from the patient and grown in cell culture to increase the number of cells. Following this, those cells are injected back into the patients body.

Dr. Karlis keen interest in Transfusions led him to create biologic products that can cause an age-related decline in a persons strength, endurance, and various other physical abilities.

At his biotech firm, Greyledge Technologies, biologic products are prepared by processing materials (blood or bone marrow) and implanting them into the human body to replicate the diseased tissues.

With an FDA-registered laboratory environment, the outcomes are promising and are an anti-aging protocol.

Telomeres may be the next-gen solution for Anti Aging

Telomeres are essential parts of our DNA that are connected to the premature aging cells. Situated at the end caps of our DNA strands, the information within Telomeres is lost while DNA replicates to the extent that they stop replicating.

If DNA replicates without losing information, scientists believe that Telomeres can significantly help to slow down the aging process.

Similar is the case with Metformin, a pharmaceutical reagent that improves wound healing. Proven to counteract aging, Metformin is now being tested for its unique ability to mimic calorie restriction.

Anti-Aging Through Regeneration

Utilizing induced tissue regeneration, this technology is a new approach to anti-aging treatment. Combining telomerase therapy and induced tissue regeneration, anti-aging through regeneration includes the study of the impact on age-related diseases like diabetes, metabolic disorders, cardiovascular disease, and others.

This technique focuses on the cells that are generated in our body during youth. As we age, these cells are lost and lead to a metabolic imbalance.

Scientists and Researchers are trying to find a way in which these cells can be restored to reverse the signs of aging and create a balance.

Humans have the ability to regenerate damaged and diseased tissues. However, this only happens during the first few weeks of development. With the help of Artificial Intelligence, scientists are trying to unlock this potential ability in humans.

The Future of Anti-Aging

With several breakthroughs on the horizon, cure-all promises and best outcomes, these anti-aging protocols have a long way to go.

While the introduction of regenerative medicine and stem cell therapies to redefine orthopedic treatment sounds like a miracle, there are still unexplored paths that need to be taken.

With all the benefits regenerative medicine has to offer, there will always be an eye on the never-ending search for the fountain of youth.

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Dr. David C. Karli's Opinion on Regenerative Medicine and Age Prevention | - SpaceCoastDaily.com

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Thursday, May 7, 2020, 8:30 a.m. EDT

NEW YORK, April 29, 2020 (GLOBE NEWSWIRE) -- BrainStorm-Cell Therapeutics Inc.(NASDAQ: BCLI), a leader in developing innovative autologous cellular therapies for highly debilitating neurodegenerative diseases, announced today, that the Company will hold a conference call to update shareholders on financial results for the first quarter endedMarch 31, 2020, and provide a corporate update, at 8:30 a.m, Eastern Daylight Time, onThursday, May 7, 2020.

BrainStorms CEO,Chaim Lebovits, will present a corporate update, after which, participant questions will be answered. Joining Mr. Lebovits to answer investment community questions will beRalph Kern, MD, MHSc, President and Chief Medical Officer, David Setboun, PhD, MBA, Executive Vice President and Chief Operating Officer andPreetam Shah, PhD, MBA, Executive Vice President and Chief Financial Officer.

Participants are encouraged to submit their questions prior to the call by sending them to:q@brainstorm-cell.com. Questions should be submitted by5:00 p.m. EDT, Tuesday, May 5, 2020.

Teleconference Details BRAINSTORM CELL THERAPEUTICS 1Q 2020

The investment community may participate in the conference call by dialing the following numbers:

Those interested in listening to the conference call live via the internet may do so by visiting the "Investors & Media" page of BrainStorm's website at http://www.ir.brainstorm-cell.com and clicking on the conference call link.

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available for 14 days.

ABOUT NUROWNNurOwn (autologous MSC-NTF cells) represent a promising investigational approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. NurOwn is currently being evaluated in a Phase 3 ALS randomized placebo-controlled trial and in a Phase 2 open-label multicenter trial in Progressive MS.

ABOUT BRAINSTORM CELL THERAPEUTICS INC.:BrainStorm Cell Therapeutics Inc.is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwnCellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. Autologous MSC-NTF cells have received Orphan Drug status designation from theU.S. Food and Drug Administration(U.S.FDA) and theEuropean Medicines Agency(EMA) in ALS. BrainStorm has fully enrolled the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in theU.S., supported by a grant from theCalifornia Institute for Regenerative Medicine(CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S.FDAapproval of autologous MSC-NTF cells in ALS. BrainStorm received U.S.FDAclearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) inDecember 2018and has been enrolling clinical trial participants sinceMarch 2019. For more information, visit the company'swebsite.

SAFE HARBOR STATEMENT:Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could causeBrainStorm Cell Therapeutics Inc.'sactual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorms need to raise additional capital, BrainStorms ability to continue as a going concern, regulatory approval of BrainStorms NurOwn treatment candidate, the success of BrainStorms product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorms NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorms ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorms ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available athttp://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

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BrainStorm-Cell Therapeutics to Announce First Quarter Financial Results and Provide a Corporate Update - Yahoo Finance

Bone Marrow Stem Cells Comments Off on BrainStorm-Cell Therapeutics to Announce First Quarter Financial Results and Provide a Corporate Update – Yahoo Finance | May 2nd, 2020

Cytokines are the cell signaling molecules which are secreted from the different body cells. Cytokines are the proteins which play an important role of messenger between cells and regulates various physiological and metabolic activities. Cytokines regulate various inflammatory responses, stimulate blood cells production, and stimulate tissue development & maintenance. Cytokine is a large family of the small protein which includes tumors necrosis factor, interleukins, interferons, lymphokines and chemokines. Cytokines are produced by a wide range of cells includes cells like macrophages, lymphocytes, T lymphocytes, endothelial cells, mast cells, fibroblasts, stromal cells and cells. Some cytokines developed into protein therapeutics to treat bone-related disorders, anemia, cancer, infection, multiple sclerosis. Cytokine is most commonly used in the research & development activities in the field of life sciences and drug development.

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Increasing research and development activities expected to favour the growth of the cytokines market. As well as growing life science research funding boost up the growth of the cytokines market. Increasing prevalence of diseases such as cancer and skin disorders expected to drive the growth of the cytokines market. The growing demand for regenerative medicines impels the growth of the cytokines market. The growing demand for cytokines for wound management and cancer therapeutics expected to drive the growth of the market. Growing funding for cancer-based research influencing the growth of cytokines market. Growing cell culture-based research activities and increasing demand for cytokines in stem cell biology are major factors expected to drive the growth of the cytokines market. Growing manufacturers investments in cell culture media production expected to favour the growth of the growth factors market over the forecast period. Growing strategic acquisition and merger activities among market players is the major trend in the cytokines market. The high cost of research-based cytokines products is the major factor expected to restrain the growth of the cytokines market.

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The global cytokines market is segmented on basis of product type, application, end users and region:

Cytokine is the large family of cytokines includes tumour necrosis factor-TNF, interleukins (IL), interferons, chemokines and other cytokines. Interleukins (IL) is the most commonly used cytokine and have large family. IL-1 family, IL-4 family, IL-6 family, IL-10 family are mostly commonly used interleukins family in the research. Cytokines are used in various field of the research such as dermatology, cancer, orthopedics, respiratory and other fields. Cytokines are used for the research application among end users such as pharmaceutical & biotechnology companies, contract research organizations and academic & research institutes.

North America expected to dominate the global cytokines market as increasing demand for cytokines products as increasing research and development activities. Europe expected to contribute second-highest revenue share in global cytokines market as a growing number of clinical trial and drug development activities. The Asia Pacific expected to grow with the highest growth rate in the cytokines market as an increasing number of pharmaceutical manufacturers, biotechnology companies and academic institutions in the Asia Pacific region. India, South Korea & China cytokines market expected to grow with a higher growth rate as growing research and development funding from the government. The Middle East & Africa cytokines market expected to grow with the lowest growth rate due to lack of research and development activities in the region.

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Some of the players operating in the global cytokines market are ,

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Increasing Demand for Cytokines Market to Substantially Surge the Revenues Through the COVID-19 Lockdown Phase and Forecast 2019 2029 Cole Reports -...

Skin Stem Cells Comments Off on Increasing Demand for Cytokines Market to Substantially Surge the Revenues Through the COVID-19 Lockdown Phase and Forecast 2019 2029 Cole Reports -… | May 2nd, 2020

Updated: May 25, 2018:

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Biopharma Develops Antibody and Stem Cell Therapies in the Fight Against COVID-19 - JD Supra

Bone Marrow Stem Cells Comments Off on Biopharma Develops Antibody and Stem Cell Therapies in the Fight Against COVID-19 – JD Supra | May 1st, 2020

Cryopreservation has become an indispensable step in the daily routine of scientific research as well as in a number of medical applications, ranging from assisted reproduction and transplantations to cell-based therapies and biomarker identification. It is hardly possible to picture todays scientific and medical advancements without this technique.The successful development and implementation of all the therapeutic and scientific discoveries involving cryopreservation relies on the correct and safe translation of the method from the laboratory to the clinical and manufacturing scale.

With the need to correctly use this technique, more research is focusing on optimizing cryopreservation methods and investigating what the long-term effects and consequences are on the physiology of the cryopreserved material.

An important part of cell therapy research is focused on adult stem cells (ASCs). ASCs can be derived from different sources such as peripheral blood, bone marrow or adipose tissue and display strong promises because of their capacity to differentiate into any cell type of the human body.In recent work3, the team of Michael Pepper at the Institute for Cellular and Molecular Medicine in Pretoria, South Africa, explored the effects of cryopreservation on the differentiation ability of adipose tissue-derived stem cells (ADSCs). After analyzing gene expression of key adipogenic genes and the degree of differentiating cells, characterized with high levels of CD36 and intracellular lipid droplets, the scientists reported that slow freeze cryopreservation of cells shortly after their isolation causes no alterations on their ability to differentiate. Pepper is convinced of the necessity to perform such analysis when cryopreserving important cell pools: It is critical to do a post-thaw analysis of cell function to determine how the cryopreservation may have affected the cells.His team is analyzing the effects of cryopreservation on other cell types largely used in cell-based therapies such as hematological stem cells and peripheral blood mononuclear cells (PBMCs). Although they didnt observe major alterations in terms of immunophenotyping or the post-thaw proliferation of the cells, Pepper expresses his concern that more subtle characteristics might be affected.

Correct cryopreservation of cells intended for therapeutic use is crucial. This is very important particularly as cells may persist for a long time in the recipient. This area of cell therapy research definitely requires more attention, Pepper says. Moreover, his words reflect on the need to evaluate not only the direct post-thaw recovery, but to look deeper into the late-onset effects cryopreservation might have and ensure that transplanted cells have preserved their therapeutic properties.

In contrast to slow freezing, vitrification relies on the fast freezing of the material by putting it in high concentration of cryoprotectant and in contact with liquid nitrogen. This method allows the direct transition of water from liquid to solid state without crystal formation. The highly concentrated cryoprotectant prevents ice formation and therefore there is no need for slow cooling.

Although vitrification has a great potential, there are a couple of parameters that are a point of concern. The quick and drastic freeze is possible thanks to the high concentration of cryoprotectant, but the latter is also associated with higher toxicity. In some cases, an additional limitation is the direct contact of the sample with liquid nitrogen which is a predisposition for viral or bacterial contamination.The team of Christiani Amorim at the Institute for Experimental and Clinical Research in Louvain, Belgium, is approaching the challenges of vitrification in the context of ovarian auto-transplantation. Ovarian auto-transplantation consists of preserving a piece of ovarian tissue with active follicles from the pre-therapeutic ovary of a cancer patient, as chemotherapy often has damaging effects on the reproductive organs. This tissue sample will be conserved and auto-transplanted onto the patients ovary when she has recovered and wishes to become pregnant.In their recent research4, the authors used stepped vitrification, in which the concentration of the cryoprotectant is gradually increased while simultaneously temperature decreases. This avoids ice crystal formation and also prevents cryoprotectant toxicity.Although stepped vitrification has previously given good results in bovine ovarian tissue5, this was not the case for human ovarian tissue. The scientists didnt detect normal follicles following thawing and linked this to high cryoprotectant toxicity. Indeed, they observed all signs of dimethyl sulfoxide (DMSO)-related cell membrane damage: significant organelle damage, cell membrane disintegration and apoptosis. These observations imply on the variability of outcomes that the method could give when applied to the same type of tissue but from a different organism.Amorim is positive about the future of their method and recognizes the need for further research on the topic: I can see a great potential in the stepped vitrification approach, but I also believe that there is a lot we still need to learn before thinking about using it as method of choice for human ovarian tissue cryopreservation. The high cryoprotectant concentration that should be applied in this approach is my first concern. () Our study clearly showed that 50% DMSO is too high, so we need to try lower concentrations or combine it with other cryoprotectants.

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Freezing Life: The Current Trends in Cryopreservation - Technology Networks

Bone Marrow Stem Cells Comments Off on Freezing Life: The Current Trends in Cryopreservation – Technology Networks | May 1st, 2020

What is bone marrow cancer? Types, symptoms and treatment methods you must know  |  Photo Credit: Getty Images

New Delhi: Cancer is becoming a relatively very common disease, among people all around the world. It is a condition where abnormal cells divide uncontrollably in the body and destroy healthy body tissues as well. Cancer usually requires extensive treatment, and can also be life-threatening. Cancer accounted for 9.6 million deaths in 2018, according to WHO. Various popular personalities like Indian actors Irrfan Khan and Rishi Kapoor recently lost their lives to different types of cancer.

Rishi Kapoor was suffering from a bone marrow cancer, and breathed his last on Thursday morning, 30th of April. Here is what you need to know about bone marrow cancer, the cancer veteran actor was suffering from.

The bone marrow is a spongy tissue inside some of our bones. In humans, thesebones include the hips, thighs, etc. The bone marrow is the tissue where stem cells can develop into red blood cells, white blood cells, and platelets, all of which perform specific functions in the body.

Bone marrow cancer is a rare type of cancer. Bone marrow cancer happens when cells in the marrow start growing abnormally. It is a type of blood cancer and not bone cancer. Bone marrow cancer is the type that originates in the marrow and not the type that spreads to the bone or the marrow, after originating in some other part of the body.

Bone marrow cancer can be of various types, depending on the type of cells it affects -

Symptoms of bone marrow cancer vary, according to the type of cells that cancer affects. These include -

Multiple Myeloma Symptoms

Leukaemia symptoms

Lymphoma symptoms

Bone Marrow cancer can be treated by a medical professional. Chances of survival of the patient depend on the stage of cancer, how early the diagnosis is made, and other factors. Treatment methods include -

Disclaimer: Tips and suggestions mentioned in the article are for general information purposes only and should not be construed as professional medical advice. Always consult your doctor or a professional healthcare provider if you have any specific questions about any medical matter.

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What is bone marrow cancer? Leukaemia and other types, symptoms and treatment methods you must know - Times Now

Bone Marrow Stem Cells Comments Off on What is bone marrow cancer? Leukaemia and other types, symptoms and treatment methods you must know – Times Now | May 1st, 2020

Transforming old human cells into a youthful and vigorous state is what Regenerative Medicine is all about. Regenerative Therapy is a same-day nonsurgical procedure that involves working on cells and tissues either by replacing, engineering or growing them to establish normalcy. Contrary to surgeries, Regenerative Medicine gets to the root cause of the problem where stem cells communicate with the injured cells to initiate the healing process.

Stimulating the bodys mechanism to repair or heal tissues, regenerative therapy coaxes old human cells to express a panel of proteins involved in embryonic development. As cartilages, tendons, and nerves have limited healing capacity when compared to other parts of the body, regenerative therapies especially target these areas to treat common injuries, orthopedic problems or degenerative joint conditions.

Benefits of Regenerative Medicine

Regenerative medicines nullify the problem of reactions or infections. As it is a non-surgical procedure, it eliminates the pain and complications that occur otherwise. Enhancing healing and recovery, regenerative therapy is quick, long-lasting and mostly preferred by sportspersons. Biologic Products like PRP (platelet-rich plasma) and BMC (bone marrow concentrate) are actively developed for orthopedic procedures, enhancing usage potential and refinement.

PRP(Platelet Rich Plasma)

Focussed on patients platelets and blood cells, PRP releases concentrated proteins following implantation. The released proteins coordinate injured cells and stimulate healing.

BMC (Bone Marrow Concentrate)

Similar to PRP, BMC consists of several stem cells that have the potential to replace themselves as the original cells or can be used to release proteins and communicate with the injured cells to promote healing and repair.

Being an Ivy-trained physician and the founding CEO of Greyledge Technologies, Dr. Karlis medical practice integrates injection-based Regenerative Medicine and Cell Therapy techniques into a traditional non-operative orthopedic and sports medicine approach. Dr. David Karli develops biologic products in the regenerative medicine space. Earlier, degenerative joint problems were treated by blocking or inhibiting the bodys response to injury. Modernizing the traditional approach, Dr. Karli, at Greyledge Technologies prepares biologic products from a patients tissue and puts it back into the same patient. The human blood or bone marrow is processed as implantable materials.

During the biologic processing, he further collaborates with other medical faculty to develop and apply these products onto the injured tissues and stimulate healing. Dr. Karlis passion for regenerative medicine and the evolution of non-surgical procedures for various health problems helped him to develop Platelet Rich Plasma (PRP) and BMC(Bone Marrow Concentrate). The two stem cell injection therapy procedures cure acute and chronic musculoskeletal injuries.

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Familiarizing non-surgical Orthopaedic Treatments with Dr. David Karli - The American Reporter

Bone Marrow Stem Cells Comments Off on Familiarizing non-surgical Orthopaedic Treatments with Dr. David Karli – The American Reporter | May 1st, 2020

Now that your makeup layer is gone, you can proceed with washing your face. "A cleanser gets rid of dead skin, pollutants, oils, dirt, and bacteria," says Rabach. Both she and Ciraldo recommend also doing this step when you first wake up in the morning, in order to prep your skin to absorb the active ingredients in your other products.

The best cleanser for you will depend on your skin type. "It's important to pay attention to what's in your cleanser and what's not in it," says Ciraldo. She recommends avoiding sulfates, which can have a harsh, stripping effect on your faceand looking for actives that suit your needs. "For normal or dry skin, I favor a hydrating cleanser with peptides," she says. "If you're oily or acne-prone, use a mild exfoliating cleanser with salicylic acid, which dislodges the dead cells that can clog pores."

Do This Step: Morning and Night

The first product to go on your face? Eye cream. The reason is simplebecause you'll probably forget to do it otherwise. Ciraldo recommends patting eye cream on gently with your ring finger (this way you'll tug less at the delicate skin there) all the way around your eyes, not just underneath them. If you're worried about eye cream causing your concealer or eye makeup to smear, choose a more lightweight option, like a hydrating gel that sinks in quickly and stays put.

For the best results, look for ingredients like peptideswhich help tighten your skin and de-puffas well as antioxidants. Rabach recommends formulas that contain hydrating hyaluronic acid, brightening caffeine, and ceramides (these lock in moisture and help strengthen your skin barrier).

Do This Step: Morning and Night

Both toners and essences are meant to help further prime your skin to absorb active ingredients, but the one you choose will depend on your skin type. Old-school toners were meant to balance skin pH and counteract alkaline soaps, before soap-free cleansers became popular. Now, toner usually refers to liquid formulations geared toward oily skin that's in need of gentle exfoliation and resurfacing. Ciraldo says those with oily or acne-prone skin should look for toners with ingredients like glycolic or salicylic acid.

Essences, on the other hand, tend to be more hydrating. Rabach recommends looking for actives like hyaluronic acid, which will flood your skin with moisture that you can lock in during subsequent steps. To apply, soak a cotton pad in liquid and gently pat it over your face. Alternatively, you can use your hands to do the same thing.

Do This Step: Morning and Night

This is the step where you'll deliver the bulk of active ingredients to your toner/essence-primed face, and it's important to do it early on in your routine. "Serums are formulated with smaller molecular-weight actives so they penetrate into deeper skin layers," says Ciraldo. "If you apply your serum after a thicker formulation, the active ingredients may not penetrate as well."

While you should apply serum twice a day, you shouldn't be using the same formulation. "Serum actives differ for day and night," says Rabach. During the day, she likes to choose serums with antioxidants that protect skin from daytime stressors like free radicals (caused by UV rays), pollutants, and blue light. The most popular ingredient for this is vitamin C, which you will have no problem finding in serum form. (Just make sure to choose one that's properly stabilized for maximum effect.) At night, opt for a serum with peptides and growth factors to repair skin.

For both daytime and nighttime serums, Rabach also has a general list of ingredients she likes to look for across both formulations: Niacinamide to reduce redness, hyaluronic acid to pull moisture into your skin, and alpha and beta hydroxy acids (AHAs and BHAs), which help boost collagen and even out skin pigmentation. Ciraldo further splits up her preferred serum ingredients by skin type. "For acne-prone skin, look for stem cells, retinol, and green tea," she says. "For dehydrated skin, look for lipids, hyaluronic acid, and peptides. And for hyperpigmented skin, look for vitamin C."

Do This Step: At Night Only

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Best Skin Care Routine: Order of Products to Use Morning & Night - Glamour

Skin Stem Cells Comments Off on Best Skin Care Routine: Order of Products to Use Morning & Night – Glamour | May 1st, 2020

The GlobalProgenitor Cell Product Market2020 report implement in-depth research of the industry with a focus on the current market trends future prospects. The Global Progenitor Cell Product Market report aims to provide an overview of Progenitor Cell Product Market players with detailed market segmentation by product, application and geographical region. It also provides market share and size, revenue forecast, growth opportunity. The most recent trending report Worldwide Progenitor Cell Product Market Economy by Manufacturers, Regions, kind and application, forecast to 2025 provided bySupply demand Market Researchis an educational study covering the marketplace with detailed analysis.

All the reports consider COVID-19 impact for forecast and analysis.

Feel free to contact us for any inquiry, Get Free PDF Sample Copy of Progenitor Cell Product Market @https://www.supplydemandmarketresearch.com/home/contact/972493?ref=Sample-and-Brochure&toccode=SDMRPH972493

The analysis of Global Progenitor Cell Product Market includes market size, upstream situation, market segmentation, price & cost and industry environment. In addition, the report outlines the factors driving industry growth and the description of market channels. The report begins from overview of industrial chain structure, and describes the upstream. Besides, the report analyses market size and forecast in different geographies, type and end-use segment, in addition, the report introduces market competition overview among the major companies and companies profiles, besides, market price and channel features are covered in the report.

This report studies the Progenitor Cell Product Market status and outlook of Global and major regions, from angles of players, countries, product types and end industries; this report analyzes the top players in global market, and splits the Progenitor Cell Product Market by product type and applications/end industries. These details further contain a basic summary of the company, merchant profile, and the product range of the company in question. The report analyzes data regarding the proceeds accrued, product sales, gross margins, price patterns, and news updates relating to the company.

Global Progenitor Cell Product Market Type (Pancreatic progenitor cells, Cardiac Progenitor Cells, Intermediate progenitor cells, Neural progenitor cells (NPCs), Endothelial progenitor cells (EPC), Others) Application (Medical care, Hospital, Laboratory) Global Trends and Forecasts to 2025

Industry Insights

The Global Progenitor Cell Product Market is expected to grow at a CAGR of XX % during the forecast period 2018-2025.

The Global Progenitor Cell Product Market is segmented on the basis of Type and Application. The Global Progenitor Cell Product Market is segmented based on the basis of typePancreatic progenitor cells, Cardiac Progenitor Cells, Intermediate progenitor cells, Neural progenitor cells (NPCs), Endothelial progenitor cells (EPC), Others. By Application, it is classified as Medical care, Hospital, Laboratory. The regional outlook on the Global Progenitor Cell Product Market covers regions, such as North America, Europe, Asia-Pacific, and Rest of the World. Global Progenitor Cell Product Market for each region is further bifurcated for major countries including the U.S., Canada, Germany, the U.K., France, Italy, China, India, Japan, Brazil, South Africa, and others.

Report Scope:

The Global Progenitor Cell Product Market report scope covers the in-depth business analysis considering major market dynamics, forecast parameters, and price trends for the industry growth. The report forecasts market sizing at global, regional and country levels, providing comprehensive outlook of industry trends in each market segments and sub-segments from 2017 to 2024. The market segmentations include

GlobalProgenitor Cell Product Market, By Type

Pancreatic progenitor cells, Cardiac Progenitor Cells, Intermediate progenitor cells, Neural progenitor cells (NPCs), Endothelial progenitor cells (EPC), Others

In the same way, the study has divided by applications

Global Progenitor Cell Product Market, By Application

Medical care, Hospital, Laboratory

GlobalProgenitor Cell Product Market, By Region

The report scope also includes competitive landscape covering the competitive analysis, strategy analysis and company profiles of the major market players. The companies profiled in the report includeNeuroNova AB, StemCells, ReNeuron Limited, Asterias Biotherapeutics, Thermo Fisher Scientific, STEMCELL Technologies, Axol Bio, R&D Systems, Lonza, ATCC, Irvine Scientific, CDI

Report Highlights

How this report will add value to your organisation

This report provides the in-depth analysis of the complete value chain from the raw material suppliers to the end users. We have critically analysed following parameters and their impact in the industry:

1. Improvement in top line and bottom line growth

Analysis trend & forecasts by end use markets will help you to understand how the growth in consumption is expected in next 5 years and what will be the key factors that will support the growth. This will help to make a clear plan for the top line growth. Price analytics will also play a crucial role in making a plan for top line growth.

Raw material and other input factors analysis will help to plan effectively for the bottom line.

2. Competitive intelligence

In a competitive marketplace, up-to-date information can make the difference between keeping pace, getting ahead, or being left behind. A smart intelligence operation can serve as an early-warning system for disruptive changes in the competitive landscape, whether that change is a rivals new product or pricing strategy or the entrance of an unexpected player into your market.

We also provide you with information that allows you to anticipate what your competitors are planning next. For example, you might gain information on a new product they are getting ready to launch or new services they will add to the business. Hiring us to handle this information collection saves you time and energy, allowing you to focus on your own business while still gaining the necessary knowledge to keep track of competitors.

3. Identification of prospective customers and their satisfaction level with the current supplier:

We have provided the long list of customers and analysed them critically, based on various parameters such as consumption, market type, sustainable business etc. this will help your organisation to develop relations with the consumers. Also, we have identified the factors in which the others customer will switch to you.

Report Customizations

The customization research services cover the additional custom report features such as additional regional and country level analysis as per the client requirements.

Get More Information About Full Report Progenitor Cell Product Market @https://www.supplydemandmarketresearch.com/home/contact/972493?ref=Discount&toccode=SDMRPH972493

This comprehensive report can be a guideline for the industry stakeholders that helps in analyzing the Progenitor Cell Product Market and forecast of till 2024. This report aids to detection of the projected market size, market status, future predictions, growth prospect, main challenges of Progenitor Cell Product Market by analyzing the segmentations.

In the following section, the report provides the Progenitor Cell Product Market company outline, statements of the product, and performance values. With the support of the arithmetical study, the report demonstrates the complete international Progenitor Cell Product Market market inclusive of amplitude, production, manufacturing value, loss/gain, Progenitor Cell Product Market supply/demand and import/export. The Progenitor Cell Product Market report is divided into key companies, by regions, and by various sectors such as application, type for the competitive landscape analyze.

Analysis of various Progenitor Cell Product Market categories of product and end-user applications, product types of Progenitor Cell Product Market is estimated on the basis of previous market and present market scenario. It involved Global Progenitor Cell Product Market values with respect to growth rate, market size, and share and consumption. Further, it gives details, prerequisite, and features of Progenitor Cell Product Market that boost the growth of the industry.

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We have a strong network of high powered and experienced global consultants who have about 10+ years of experience in the specific industry to deliver quality research and analysis. Having such an experienced network, our services not only cater to the client who wants the basic reference of market numbers and related high growth areas in the demand side, but also we provide detailed and granular information using which the client can definitely plan the strategies with respect to both supply and demand side.

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Progenitor Cell Product Market 2020 Recent Industry Developments and Growth Strategies Adopted by Top Key Players Worldwide and Assessment to 2025 ...

Cardiac Stem Cells Comments Off on Progenitor Cell Product Market 2020 Recent Industry Developments and Growth Strategies Adopted by Top Key Players Worldwide and Assessment to 2025 … | May 1st, 2020

The healthcare industry has been focusing on excessive research and development in the last couple of decades to ensure that the need to address issues related to the availability of drugs and treatments for certain chronic diseases is effectively met. Healthcare researchers and scientists at the Li Ka Shing Faculty of Medicine of the Hong Kong University have successfully demonstrated the utilization of human induced pluripotent stem cells or hiPSCs from the skin cells of the patient for testing therapeutic drugs.

The success of this research suggests that scientists have crossed one more hurdle towards using stem cells in precision medicine for the treatment of patients suffering from sporadic hereditary diseases. iPSCs are the new generation approach towards the prevention and treatment of diseases that takes into account patients on an individual basis considering their genetic makeup, lifestyle, and environment. Along with the capacity to transform into different body cell types and same genetic composition of the donors, hiPSCs have surfaced as a promising cell source to screen and test drugs.

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In the present research, hiPSC was synthesized from patients suffering from a rare form of hereditary cardiomyopathy owing to the mutations in Lamin A/C related cardiomyopathy in their distinct families. The affected individuals suffer from sudden death, stroke, and heart failure at a very young age. As on date, there is no exact treatment available for this condition.

This team in Hong Kong tested a drug named PTC124 to suppress specific genetic mutations in other genetic diseases into the iPSC transformed heart muscle cells. While this technology is being considered as a breakthrough in clinical stem cell research, the team at Hong Kong University is collaborating with drug companies regarding its clinical application.

The unique properties of iPS cells provides extensive potential to several biopharmaceutical applications. iPSCs are also used in toxicology testing, high throughput, disease modeling, and target identification. This type of stem cell has the potential to transform drug discovery by offering physiologically relevant cells for tool discovery, compound identification, and target validation.

A new report by Persistence Market Research (PMR) states that the globalinduced pluripotent stem or iPS cell marketis expected to witness a strong CAGR of 7.0% from 2018 to 2026. In 2017, the market was worth US$ 1,254.0 Mn and is expected to reach US$ 2,299.5 Mn by the end of the forecast period in 2026.

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Customization to be the Key Focus of Market Players

Due to the evolving needs of the research community, the demand for specialized cell lines have increased to a certain point where most vendors offering these products cannot depend solely on sales from catalog products. The quality of the products and lead time can determine the choices while requesting custom solutions at the same time. Companies usually focus on establishing a strong distribution network for enabling products to reach customers from the manufacturing units in a short time period.

Entry of Multiple Small Players to be Witnessed in the Coming Years

Several leading players have their presence in the global market; however, many specialized products and services are provided by small and regional vendors. By targeting their marketing strategies towards research institutes and small biotechnology companies, these new players have swiftly established their presence in the market.

Link:
Induced Pluripotent Stem Cells Market to Witness CAGR 8.7% Growth in Revenue During the Period 2026 - Cole of Duty

Skin Stem Cells Comments Off on Induced Pluripotent Stem Cells Market to Witness CAGR 8.7% Growth in Revenue During the Period 2026 – Cole of Duty | April 30th, 2020

Transparency Market Research (TMR)has published a new report on theamniotic membrane marketfor the forecast period of2019-2027. According to the report, the global amniotic membrane market was valued at ~US$ 980 Mnin2018and is projected to expand at a CAGR of ~10%from2019to2027.

GlobalAmniotic Membrane Market:Overview

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Increase in Research on Stem Cell Biology & Regenerative Medicineto Drive Market

Cryopreserved Amniotic Membrane Products to Dominate Market

Request for Analysis of the COVID19 Impact on Amniotic Membrane Market - https://www.transparencymarketresearch.com/sample/sample.php?flag=covid19&rep_id=42059

Ophthalmology to be Promising Application

Hospitals Account for Major Share of Global Market

North America to Dominate Global Amniotic Membrane Market

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Global Amniotic Membrane Market: Competitive Landscape

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Amniotic Membrane Market: Locally Available Amniotic Allografts Increasingly Meeting Needs of Patients with Joint Pain - BioSpace

Skin Stem Cells Comments Off on Amniotic Membrane Market: Locally Available Amniotic Allografts Increasingly Meeting Needs of Patients with Joint Pain – BioSpace | April 30th, 2020

Home Topics Lung Infection

Mesoblast announced data from a phase 2/3 trial evaluating remestemcel-L, an allogeneic mesenchymal stem cell product candidate, in ventilator-dependent COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS).

Remestemcel-L consists of culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor. It is believed to work by down-regulating the production of proinflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.

The randomized, placebo-controlled trial is being conducted at Mount Sinai hospital in New York City. Patients were treated with a variety of experimental agents prior to receiving remestemcel-L. Findings from the study showed 83% survival in ventilator-dependent COVID-19 patients with moderate/severe ARDS (n=10/12) following 2 intravenous infusions of remestemcel-L within the first 5 days; 75% of patients (n=9/12) were able to successfully come off ventilator support at a median of 10 days. There have been 7 patients discharged from the hospital as of now.

Mesoblast Chief Executive Dr. Silviu Itescu stated: The remarkable clinical outcomes in these critically ill patients continue to underscore the potential benefits of remestemcel-L as an anti-inflammatory agent in cytokine release syndromes associated with high mortality, including acute graft versus host disease and COVID-19 ARDS. We intend to rapidly complete the randomized, placebo-controlled phase 2/3 trial in COVID-19 ARDS patients to rigorously confirm that remestemcel-L improves survival in these critically ill patients.

Additionally, the Food and Drug Administration recently accepted for Priority Review the Biologics License Application of remestemcel-L for the treatment of steroid-refractory acute graft vs host disease. The Company expects to launch remestemcel-L in 2020 if approved.

For more information mesoblast.com.

This article originally appeared on MPR

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Remestemcel-L Looks Promising for COVID-19 With Moderate to Severe ARDS - Pulmonology Advisor

Bone Marrow Stem Cells Comments Off on Remestemcel-L Looks Promising for COVID-19 With Moderate to Severe ARDS – Pulmonology Advisor | April 30th, 2020