Pompano Beach, Fl, Dec. 24, 2020 (GLOBE NEWSWIRE) -- BioStem Technologies, Inc. (OTC PINK: BSEM) ("BioStem" or the "Company"), a leading life sciences company specializing in perinatal tissue allografts for use in regenerative therapies, today announced that it has filed its quarterly reports for 2020 to become current with OTC Markets.

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BioStem Technologies, Announces Filing of 2020 Quarterly Reports

Global News Feed Comments Off on BioStem Technologies, Announces Filing of 2020 Quarterly Reports | December 26th, 2020

HALIFAX, Nova Scotia, Dec. 24, 2020 (GLOBE NEWSWIRE) -- MedMira Inc. (MedMira) (TSXV: MIR), reported today on its financial results for the quarter ended October 31, 2020.

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MedMira Reports First Quarter Results FY2021

Global News Feed Comments Off on MedMira Reports First Quarter Results FY2021 | December 26th, 2020

A group of scientists in the US, including an Indian-American from the prestigious Cleveland Clinic, have identified a potential new class of drugs that may prove effective in treating certain common types of blood and bone marrow cancers.

First published in the latest edition of Blood Cancer Discovery, the decade long research which reports that a new pharmacological strategy to preferentially target and eliminate leukemia cells with TET2 mutations, was carried out by Jaroslaw Maciejewski and his collaborator Babal Kant Jha from the Cleveland Clinic Department of Translational Hematology & Oncology Research.

Myeloid leukemias are cancers derived from stem and progenitor cells in the bone marrow that give rise to all normal blood cells.

One of the most common mutations involved in driving myeloid leukemias are found in the TET2 gene, which has been investigated for the last decade by Maciejewski and Jha.

In preclinical models, we found that a synthetic molecule called TETi76 was able to target and kill the mutant cancer cells both in the early phases of disease--what we call clonal hematopoiesis of indeterminate potential, or CHIP--and in fully developed TET2 mutant myeloid leukemia, said Dr Maciejewski.

According to a media release, the research team designed TETi76 to replicate and amplify the effects of a natural molecule called 2HG (2-hydroxyglutarate), which inhibits the enzymatic activity of TET genes.

The TET DNA dioxygenase gene family codes for enzymes that remove chemical groups from DNA molecules, which ultimately changes what genes are expressed and can contribute to the development and spread of disease.

While all members of the TET family are dioxygenases, the most powerful enzymatic activity belongs to TET2, the press release said.

Even when TET2 is mutated, however, its related genes TET1 and TET3 provide residual enzymatic activity. While significantly less, this activity is still enough to facilitate the spread of mutated cancer cells.

Maciejewskis and Jhas new pharmacologic strategy to selectively eliminate TET2 mutant leukemia cells centers on targeting their reliance on this residual DNA dioxygenase activity, it said.

We took lessons from the natural biological capabilities of 2HG, explained Jha, a principal investigator.

We studied the molecule and rationally designed a novel small molecule, synthesized by our chemistry group headed by James Phillips, PhD. Together, we generated TETi76a similar, but more potent version capable of inhibiting not just TET2, but also the remaining disease-driving enzymatic activity of TET1 and TET3, Jha said.

Cleveland Clinic said that the researchers studied TETi76s effects in both preclinical disease and xenograft models (where human cancer cells are implanted into preclinical models). Additional studies will be critical to investigate the small molecules cancer-fighting capabilities in patients.

We are optimistic about our results, which show not just that TETi76 preferentially restricts the growth and spread of cells with TET2 mutations, but also gives survival advantage to normal stem and progenitor cells, Jha said.

(This story has been published from a wire agency feed without modifications to the text.)

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New class of drugs to treat blood and bone marrow cancers: Research - Hindustan Times

Bone Marrow Stem Cells Comments Off on New class of drugs to treat blood and bone marrow cancers: Research – Hindustan Times | December 26th, 2020

Cade Cridland thought a lot about fate as he sat tethered to a machine that drained blood from one arm and pumped it back into his body through the other arm.

After four hours, blood stem cells processed by the machine would be flown thousands of miles to a young child he has never met. A child whose name he does not know.

A child battling blood cancer.

This story unfolded in a Denver hospital in September. But it began 14 years earlier with a split-second decision in Las Vegas when Cridland was 24.

Before the child was born.

Im not a religious person by any means, Cridland, now 38, said. But I do believe that theres a lot of fate that takes place in our actions on a day-to-day basis.

The year is 2006. George W. Bush is president.

And Cridland, a recent UNLV graduate with a bachelors degree in journalism and media studies, had just left his part-time job with Vegas PBS for a full-time job with the local chapter of the Leukemia and Lymphoma Society.

Through his new job, Cridland soon found himself at a donation drive, hosted by a charity called Be the Match, for a family desperately searching for a bone marrow donor.

For patients diagnosed with leukemia or lymphoma, a bone marrow or cord blood transplant may be their only hope for a cure.

Cridland was there to work the event, but he drew inspiration from those around him getting swabbed. Whats the harm, he thought.

That day, his DNA was packaged and shipped off to be entered in the National Bone Marrow Registry.

He wasnt a match. Life went on, and eventually Cridland forgot about the swab.

In the meantime, he moved on to a job with the Clark County School District, got married, adopted a dog, had two children, bought a house, got another dog.

Fourteen years came and went, and now it was 2020.

The phone call

The call came at the best time, during arguably one of the worst years in modern history. The 2020 pandemic was in full swing. Protests over racism and police brutality had taken hold of a divided nation.

Cridland, a spokesman for the school district, needed something good to focus on.

But when that something good came calling earlier this year, he almost didnt answer. A toll-free number lit up the screen. A telemarketer maybe, or a scam?

Cridland surprised himself and took the call.

I dont know if you remember this, Cridland recalled a woman on the other end explaining. But you gave a cheek swab at one of our events, and theres a possibility that this cheek swab is a match for a child in need of stem cells or marrow to help them fight blood cancer.

The woman, an employee of Be the Match, ended the call with a question: Would you be willing to donate?

She gave Cridland the weekend to think it over. But for Cridland and his wife, who have two young children, it was a no-brainer.

Not long after, a second cheek swab confirmed what the woman had told Cridland during their phone call.

He was a match for the patient. In this case, that meant at least eight specific genetic markers in Cridlands DNA, called human leukocyte antigens, matched the patients DNA.

Every one individual has their own unique genetic DNA code, said Erica Sevilla, a spokeswoman for Be the Match. What were looking to attach to that code is protein markers that tell your body what cells belong in the body and what cells do not. Essentially, youre looking to match immune systems between the donor and the patient.

From there, the patients doctor will decide the best course for treatment.

According to Be the Match, many believe that the only way to donate blood stem cells is through a surgical procedure, during which the donor receives anesthesia and a needle is used to extract liquid marrow from the pelvic bone. But 79 percent of donations are done through a nonsurgical procedure known as a peripheral blood stem cell donation.

The doctor in Cridlands donation case chose the nonsurgical route.

During the week leading up to the donation, Be the Match sent a nurse to Cridlands home in Henderson once a day for five consecutive days to administer injections of a medication that increased the number of blood-forming cells in Cridlands bloodstream.

Cridland and his wife were flown to Denver for the procedure.

At times throughout the donation process, which spanned about five months from the first phone call to the day of the procedure, Cridland would find himself moved to tears, overcome by his gratitude for the chance to help save a young child.

To me, the crazy thing about all this is that my actions from 14 years ago have had a dramatic effect on how somebody else is living in 2020, he said in an interview this month at his home. With all the negativity weve seen this year, this one family may look at 2020 as the best year of their lives because of this one specific moment in my life that took place 14 years ago.

Even now, three months removed from donation day, Cridland at random will break down in tears.

Sometimes he thinks about his blood pumping through the childs body. How a piece of him will always be with that child. How someone he has never met, and may never meet, could be such a close genetic match to him.

How were all more alike than we think.

Epilogue

I wish I could take this feeling, put it in a can and throw a lid on top, Cridland said of his experience donating stem cells.

If that were possible, Cridland said, he would pass it around like a party favor but he cant.

So instead, hes hoping his story will inspire others, especially people of color, to join the registry and give the gift of a cure to another patient in need.

Currently, there is a severe shortage of diverse donors in the national registry, which consists of 22 million donors. More than 13 percent of the American population is Black, for example, yet only about 4 percent of registered donors are Black.

And the disparity is costing lives.

Matching is based on genetic markers that can be traced back to your grandparents and your great-grandparents, said Sevilla, the spokeswoman for Be the Match. Theyre traced back to the very origins of your family, so thats why people who are of European descent have an easier time finding a match, whereas people who descended from slavery, for example, have a harder time.

To join the National Bone Marrow Registry and request a cheek swab kit, visit http://www.join.bethematch.org.

Meanwhile, as of mid-December, Cridland knew only that the patient had received his stem cells. He wasnt sure, even, if hed ever meet the child.

Both parties must consent to meeting, and different countries operate under varied cooling-off periods. For some countries, a patient and a donor must wait two years before they can meet or even speak.

As a donor, Cridland was told the patients age, specific diagnosis and city and country of residence. But he is not allowed to disclose that information to protect the patients privacy.

According to Be The Match, 50 percent of all marrow or stem cell donations are international.

We are either exporting cells or importing cells, said Sevilla, the charity spokeswoman.

Cridland gave his consent for the patients family to reach out to him in the future. For now, its a waiting game.

If the moment comes that they try to connect, Ill be there, he said.

Contact Rio Lacanlale at rlacanlale@reviewjournal.com or 702-383-0381. Follow @riolacanlale on Twitter.

Continued here:
He got his cheek swabbed at 24. Nothing happened for 14 years. - Las Vegas Review-Journal

Bone Marrow Stem Cells Comments Off on He got his cheek swabbed at 24. Nothing happened for 14 years. – Las Vegas Review-Journal | December 26th, 2020

By shifting mouse elderly hematopoietic stem cells (aged HSCs) to the environment of young mice (bone marrow niche), it was shown that the pattern of stem cell gene expression was rejuvenated to that of young hematopoietic stem cells. On the other hand, the function of elderly HSCs failed to recover in the young bone marrow niche. The epigenome (DNA methylation) of aged HSCs didnt change significantly even in the young bone marrow niche, and DNA methylation profiles were found to be a better index than the gene expression pattern of aged HSCs.

A research group headed by Professor Atsushi Iwama in the Division of Stem Cell and Molecular Medicine, The Institute of Medical Science, The University of Tokyo (IMSUT) declared these world-first Outcomes and was published in the Journal of Experimental Medicine (online) on November 24th.

The results will contribute to the development of treatments for age-related blood diseases.

Professor Atsushi Iwama, Lead Scientist, IMSUT

The research group investigated whether rejuvenating aged HSCs in a young bone marrow market environment would rejuvenate.

Tens of thousands of elderly hematopoietic stem/progenitor cells gathered from 20-month-old mice were transplanted into 8-week-old young mice without pretreatment like irradiation. After two months of follow-up, they collected bone marrow cells and performed flow cytometric analysis.

The research team also transplanted 10-week-old young mouse HSCs for comparison. In addition, engrafted aged HSCs were fractionated and RNA sequence analysis and DNA methylation analysis were conducted.

They discovered that engrafted elderly HSCs were less capable of producing hematopoietic cells compared to younger HSCs. They also showed that differentiation of aged HSCs into multipotent progenitor cells was persistently impaired even in the young bone marrow market, and that the direction of differentiation was biased. It was found that the transfer of aged HSCs into the young bone marrow market does not enhance their stem cell function.

A more detailed analysis may reveal mechanisms that irreversibly affect aged HSC functionAging studies focusing on HSCs have been chased in mice with a bone marrow transfer model. However, the effect of aging on HSCs remains to be clarified.

Professor Iwama says as follows. This analysis has a substantial impact because it clarified the effect of aging on HSCs. Our results are expected to contribute to further elucidation of the mechanism of aging in HSCs and comprehension of the pathogenic mechanism of age-related blood disorders.

Source:

Journal reference:

Kuribayashi, W.,et al.(2020) Limited rejuvenation of aged hematopoietic stem cells in young bone marrow niche.Journal of Experimental Medicine.doi.org/10.1084/jem.20192283.

Go here to read the rest:
Study clarifies the impact of getting old on hematopoietic stem cells - Microbioz India

Bone Marrow Stem Cells Comments Off on Study clarifies the impact of getting old on hematopoietic stem cells – Microbioz India | December 26th, 2020

A group of scientists in the US, including an Indian-American from the prestigious Cleveland Clinic, have identified a potential new class of drugs that may prove effective in treating certain common types of blood and bone marrow cancers.

First published in the latest edition of Blood Cancer Discovery, the decade long research which reports that a new pharmacological strategy to preferentially target and eliminate leukemia cells with TET2 mutations, was carried out by Jaroslaw Maciejewski and his collaborator Babal Kant Jha from the Cleveland Clinic Department of Translational Hematology & Oncology Research.

Myeloid leukemias are cancers derived from stem and progenitor cells in the bone marrow that give rise to all normal blood cells.

One of the most common mutations involved in driving myeloid leukemias are found in the TET2 gene, which has been investigated for the last decade by Maciejewski and Jha.

In preclinical models, we found that a synthetic molecule called TETi76 was able to target and kill the mutant cancer cells both in the early phases of disease--what we call clonal hematopoiesis of indeterminate potential, or CHIP--and in fully developed TET2 mutant myeloid leukemia," said Dr Maciejewski.

According to a media release, the research team designed TETi76 to replicate and amplify the effects of a natural molecule called 2HG (2-hydroxyglutarate), which inhibits the enzymatic activity of TET genes.

The TET DNA dioxygenase gene family codes for enzymes that remove chemical groups from DNA molecules, which ultimately changes what genes are expressed and can contribute to the development and spread of disease.

While all members of the TET family are dioxygenases, the most powerful enzymatic activity belongs to TET2, the press release said.

Even when TET2 is mutated, however, its related genes TET1 and TET3 provide residual enzymatic activity.

While significantly less, this activity is still enough to facilitate the spread of mutated cancer cells.

Maciejewski's and Jha's new pharmacologic strategy to selectively eliminate TET2 mutant leukemia cells centers on targeting their reliance on this residual DNA dioxygenase activity, it said.

We took lessons from the natural biological capabilities of 2HG, explained Jha, a principal investigator.

We studied the molecule and rationally designed a novel small molecule, synthesized by our chemistry group headed by James Phillips, PhD. Together, we generated TETi76a similar, but more potent version capable of inhibiting not just TET2, but also the remaining disease-driving enzymatic activity of TET1 and TET3, Jha said.

Cleveland Clinic said that the researchers studied TETi76's effects in both preclinical disease and xenograft models (where human cancer cells are implanted into preclinical models). Additional studies will be critical to investigate the small molecule's cancer-fighting capabilities in patients.

We are optimistic about our results, which show not just that TETi76 preferentially restricts the growth and spread of cells with TET2 mutations, but also gives survival advantage to normal stem and progenitor cells, Jha said.

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

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Scientists find new class of drugs that may treat blood, bone marrow cancer - Business Standard

Bone Marrow Stem Cells Comments Off on Scientists find new class of drugs that may treat blood, bone marrow cancer – Business Standard | December 26th, 2020

Multiple chimeric antigen receptor (CAR) T-cell therapies for the treatment of lymphomas and multiple myeloma have moved forward in the regulatory process, with 1 new FDA approval in 2020 and others anticipated in the near future.

In July, brexucabtagene autoleucel (Tecartus; KTEX19) received accelerated approval for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) based on the results of the phase 2 ZUMA-2 trial (NCT02601313), bringing the treatment landscape of this hematologic malignancy into a new era.1

This approval is only the very beginning, and we are walking into a sophisticated CAR T-cell therapy era with many constructs being designed with [different mechanisms of action], Michael Wang, MD, said in an interview with Targeted Therapies in Oncology (TTO).

Additional actions by the FDA this year included granting priority review designations to lisocabtagene maraleucel (liso-cel) for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma, after at least 2 prior therapies,2 as well as to idecabtagene vicleucel (ide-cel; bb2121)as treatment of adult patients with multiple myeloma who have received at least 3 prior therapies, including an immunomodulatory drug (IMiD), a proteasome inhibitor (PI), and an anti-CD38 antibody.3

The approval of brexucabtagene autoleucel, an antiCD19 CAR T-cell product, in MCL was based on objective response rate (ORR) data from patients treated on a single-arm trial who had previously received anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antibody, and a Bruton tyrosine kinase inhibitor (n = 74).2,4 Eligible patients received leukapheresis and optional bridging therapy, followed by conditioning chemotherapy and a single infusion of brexucabtagene autoleucel 2 106CAR T cells/kg.

The results of ZUMA-2 were published in the New England Journal of Medicine in April and demonstrated a 93% (95% CI, 84%-98%) ORR in 60 response-evaluable patients, 67% (95% CI, 53%-78%) of whom had a complete response (CR). ORRs were consistent across key patient subgroups. Two patients (3%) each had stable and progressive disease.

Progression-free and overall survival (OS) rates at 12 months were 61% and 83%, respectively, and 57% of patients remained in remission at the 12.3-month median follow-up.4 Cytokine release syndrome (CRS) was the most concerning adverse event, occurring in 91% of patients; grade 3 or higher CRS occurred in 15%.

Notably, the patient cohort comprised patients with a median of 3 prior lines of therapy (range, 1-5) and more than half (56%) were considered to have intermediateor high-risk features by the simplified Mantle Cell Lymphoma International Prognostic Index at baseline.

Before CAR T-cell therapy, we did not have any effective means [of getting patients with high-risk MCL into remission]. We used allogeneic transplantation [and] were able to put some of the patients into a long-term remission, but at a heavy price of mortality, said Wang, a professor in the Department of Lymphoma & Myeloma, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center in Houston. Overall, this brings hope to the high-risk patient population. It looks as though fewer patients are relapsing.

Lisocabtagene Maraleucel In February, the FDA granted liso-cel a priority review designation, an action supported by the safety and efficacy findings of the phase 1 TRANSCEND-NHL-001 trial (NCT02631044).2

Histologic subtypes eligible for treatment included diffuse large B-cell lymphoma (DLBCL); high-grade double- or triple-hit B-cell lymphoma; transformed DLBCL from indolent lymphoma; primary mediastinal B-cell lymphoma; and grade 3B follicular lymphoma. Patients were administered 2 sequential infusions of CD8+ and CD4+ CAR T cells following optional bridging therapy and lymphodepleting chemotherapy and were assigned to 1 of 3 target dose levels: 50 106 (1 or 2 doses), 100 106 , or 150 106 CAR-positive T cells. Investigators determined that the recommended target dose was 100 106 CAR-positive T cells.

In the 256 patients who received at least 1 dose of liso-cel and were included in the efficacy-evaluable group, the ORR was 73% (95% CI, 67%-78%), with 53% (95% CI, 47%-59%) achieving a CR. Investigators observed all-grade CRS (42%) and neurological events (30%), but most cases were grade 1 or 2 in severity.

Due to relatively low rates of CRS and neurological events, the administration of liso-cel has been explored in both the inpatient and outpatient settings. One that included a cohort of patients treated in the outpatient setting with proper monitoring versus the traditional inpatient setting demonstrated consistent safety.6

Based on these results, the indication is that you can deliver [liso-cel] in the outpatient setting and the outcomes are good compared with those treated in the inpatient setting, explained study author Carlos R. Bachier, MD, the director of cellular research at Sarah Cannon in Nashville, Tennessee, in an interview with TTO. Aside from that, they also showed that liso-cel could be safely administered outside of university programs and in more community-based programs, most of them being aligned [with] or part of stem cell and bone marrow transplant programs.

The target action date for a decision on the biologics license application (BLA) for liso-cel was extended twice in 2020 and remains under review. In May, the FDA moved the Prescription Drug User Fee Act (PDUFA) goal date out 3 months from its original August deadline.2,7 Bristol Myers Squibb, the company responsible for developing the product, submitted additional information to the agency following the initial BLA submission, which resulted in more review time. Once again, the target action date was pushed in November, this time due to incomplete manufacturing facility inspections resulting from ongoing travel restrictions due to COVID-19. The FDA provided no new action date.8

For patients with multiple myeloma, the B-cell maturation antigen (BCMA)-targeting CAR T-cell therapy idecel is currently under review for approval in patients who have received at least 3 prior therapiesincluding an immunomodulatory drug (IMiD), a proteasome inhibitor (PI), and an anti-CD38 antibodybased on results of the phase 2 KarMMa trial (NCT03361748).9

Updated trial results were presented at the American Society of Clinical Oncology 2020 Virtual Scientific Program, and showed that both the primary and key secondary end points of ORR and CR rate were 75% and 33%, respectively. The median duration of response was 10.7 months, and the median progression-free survival was 8.8 months in all patients receiving ide-cel. Corresponding medians were 19.0 and 20.2 months among those achieving a CR or stringent CR. The median OS was 19.4 months in all treated patients.

The 128 patients treated received 1 of 3 target dose levels: 150, 300, or 450 106 CAR-positive T cells. The investigators noted that the highest efficacy outcomes were seen in patients in the 450 106 CAR-positive T-cell group, with an ORR of 82% and a 39% CR rate.

The incidence of CRS was 84% across the treatment cohort and increased with higher target doses. Overall, less than 6% of patients have grade 3 or higher CRS and only 1 patient in the highest target dose cohort had a grade 5 event. Neurological toxicity was low across target doses, with no grade 4 or 5 events reported.

At baseline, the majority of patients (51%) had high tumor burden, 39% had extramedullary disease, and 35% had high-risk cytogenetics including deletion 17p or translocations in t(4;14) or t(14;16).

In May, the FDA issued a refusal letter regarding the BLA for ide-cel because the Chemistry, Manufacturing, and Control (CMC) module required more information before they could complete the review.10 In September, the resubmitted application received a priority review and the agency assigned a PDUFA action date of March 27, 2021.11

If approved, ide-cel would be the first CAR T-cell therapy available for the treatment of patients with multiple myeloma.

References:

1. FDA approves brexucabtagene autoleucel for relapsed or refractory mantle cell lymphoma. FDA. Updated July 27, 2020. Accessed November 18, 2020. https://bit. ly/3pEDQV5

2. US Food and Drug Administration (FDA) accepts for priority review Bristol-Myers Squibbs biologics license application (BLA) for lisocabtagene maraleucel (liso-cel) for adult patients with relapsed or refractory large B-cell lymphoma. Press release. Bristol Myers Squibb. February 13, 2020. Accessed November 18, 2020. https:// bit.ly/37ruQbs

3. US Food and Drug Administration (FDA) accepts for priority review Bristol Myers Squibb and bluebird bio application for anti-BCMA CAR T cell therapy idecabtagene vicleucel (ide-cel, bb2121). Press release. Bristol Myers Squibb. September 22, 2020. Accessed November 18, 2020. https://bit.ly/3kDhakH

4. Wang M, Munoz J, Goy A, et al. KTE-X19 CAR T-cell therapy in relapsed or refractory mantle-cell lymphoma. N Engl J Med. 2020;382(14):1331-1342. doi:10.1056/ NEJMoa1914347

5. Abramson JS, Palomba ML, Gordon LI, et al. Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study. Lancet. 2020;396(10254):839-852. doi:10.1016/ S0140-6736(20)31366-0

6. Bachier CR, Palomba ML, Abramson JA, et al. Outpatient treatment with lisocabtagene maraleucel (liso-cel) in 3 ongoing clinical studies in relapsed/refractory (R/R) large B cell non-Hodgkin lymphoma (NHL), including second-line transplant noneligible (TNE) patients: Transcend NHL 001, Outreach, and PILOT. Paper presented at: 2020 Transplantation & Cellular Therapy Meetings; February 19-23, 2020; Orlando, FL. Abstract 29. Accessed November 18, 2020. bit.ly/37I7DC9

7. Bristol Myers Squibb provides update on biologics license application (BLA) for lisocabtagene maraleucel (liso-cel). Press release. Bristol Myers Squibb. May 6, 2020. Accessed November 18, 2020.https://bit.ly/2YFWAs8

8. Bristol Myers Squibb provides regulatory update on lisocabtagene maraleucel (liso-cel). News release. Business Wire. November 16, 2020. Accessed November 18, 2020. https://bwnews.pr/3pKQMZI

9. Bristol Myers Squibb and bluebird bio announce submission of biologics license application (BLA) for anti-BCMA CAR T cell therapy idecabtagene vicleucel (ide-cel, bb2121) to FDA. Press release. Bristol Myers Squibb. March 31, 2020. Accessed November 18, 2020. https://bit.ly/2JwKbxO

10. Bristol Myers Squibb and bluebird bio provide regulatory update on idecabtagene vicleucel (ide-cel, bb2121) for the treatment of patients with multiple myeloma. News release. Business Wire. May 13, 2020.Accessed November 18, 2020. https:// bwnews.pr/3cpgJa1

11. US Food and Drug Administration (FDA) accepts for priority review Bristol Myers Squibb and bluebird bio application for anti-BCMA CAR T cell therapy idecabtagene vicleucel (ide-cel, bb2121). Press release. Bristol Myers Squibb. September 22, 2020. Accessed November 18, 2020. https://bit.ly/3kDhakH

Originally posted here:
CAR T-Cell Therapies Are Set to Expand Into More Hematologic Malignancy Indications - Targeted Oncology

Bone Marrow Stem Cells Comments Off on CAR T-Cell Therapies Are Set to Expand Into More Hematologic Malignancy Indications – Targeted Oncology | December 26th, 2020

Marco Kaltofen was 11 when he noticed his first white hairs. As his hair grew whiter, his middle-school friends started calling him the professor. By his mid-30s, it was completely white, as it had been for three of his grandparents. His parents went white in their 40s, so I had no chance of avoiding this, Kaltofen says.

Now 61, he is a civil engineer who lives in Boston. He wears his white hair in a ponytail. White hair is part of my identity, and I am completely at peace with it, he says.

Then there is Joe Rees, 75, a retired customs attache who lives in Washington. He is balding, but the hair that remains on the sides and in the back is the same dark brown it always has been. He jokingly attributes this to clean living and a pure heart, although, like Kaltofen, it probably is genetic. His mothers black hair didnt start to go gray until she was in her 70s, and was 50/50 when she died at 88, he says.

Still, Id rather be gray than bald, he says. That way, I wouldnt have to worry about wearing a hat all the time.

To be sure, Rees and Kaltofen are exceptions, since most people start graying in their 50s and 60s. Nevertheless, their experiences are among the many mysteries of gray, white or silver-looking hair that scientists are exploring to learn more about aging. They want to know why some people turn gray early and others late or not at all and what this might signal about their health. They also want to understand the factors that hasten graying, and even whether gray hair is reversible which could be a boon to those allergic to hair dye, or who hate spending money to keep the gray away.

Most important, studying gray hair could point to new approaches in promoting healthier aging, says Candace Kerr, health scientist administrator in the National Institute on Agings Division of Aging Biology.

While graying is one of the markers of aging aging is the ultimate risk factor for why hair goes gray it highlights the need for better understanding of the mechanisms that drive aging and age-related diseases, she says. To be able to target these pathways will be critically important for our aging population to live longer and happier lives.

Hair that looks gray, white or silver actually is colorless. Hair color comes from melanin, a pigment produced by cells in the hair follicles. Over time, these cells suffer damage and become depleted, losing their ability to make melanin. This results in new hair without pigment meaning, no color.

People use gray, white and silver interchangeably to describe hair that is turning or has turned. Its appearance whether it looks, gray, white or silver depends on how much natural color, or pigment, remains, experts say. Hair that has lost all its color typically appears white.

Studies have identified a number of factors that also may speed up gray hair, including smoking, diet, stress and genetics.

Our hair color depends on a set of specialized stem cells called melanocyte stem cells, and every time a new hair grows, these melanocyte stem cells have to divide in two and make a new melanocyte, [or] pigment cells, explains Melissa Harris, assistant professor of biology at the University of Alabama at Birmingham. These pigment cells stay in the base of your hair and their job is to produce pigment. These melanocytes reach out skinny arms, called dendritic processes, that shuttle the pigment to the hair shaft as it grows. So if all your melanocyte stem cells disappear, so do your melanocytes and so does your hair pigment. Thus gray hair.

Because stem cells directly influence hair color, studying gray hair can provide insights about why stem cells age and ultimately fail, offering important clues about the workings of other stem cells in the body for example, those found in muscles, bones and organs. In turn, these ultimately could point to whether gray hair could be a marker for disease, or the opposite, a longer life. Previous studies have not shown a relationship between life span and gray hair, including whether late onset of gray hair predicts longevity. Some research, however, indicates that gray or white hair can be a sign of early heart disease, regardless of age.

In some people, gray hair could potentially serve as indication of their health for instance when caused by stress, or a signal for those who may be developing cardiovascular disease, Kerr says. We still need to learn more about whether and, if so, how late onset of gray hair can signal better health and longevity in some people under certain circumstances, as well as whether early graying means stem cells might be aging.

There are many different stem cells in our body which may or may not age by different means, she says. How stem cells mark aging overall and how they could interact to promote aging is an important question.

This is why scientists who study gray hair regard it as a valuable research tool.

As gray hair researchers, we often have to defend why we study a cosmetic characteristic, rather than a life-threatening disease, Harris says. But what is very cool about gray hair from a scientific point of view is that we can see it with our own eyes, meaning we dont have to take invasive biopsies, and it doesnt kill you. We have asked a lot of important and interesting questions about stem cells by studying gray hair in mice. And, we are constantly on the lookout for gray-haired mice so we can use our scientific skills to find out what makes them gray.

A 2018 mouse study by Team Hair-Us (Harris nickname for her lab colleagues) found a connection between MITF (microphthalmia), a transcription factor (a protein involved in gene expression) important in managing pigment production, and the innate immune system, suggesting that some peoples hair may turn gray in response to serious illness or chronic stress. They discovered a relationship between genes involved in hair color and those that trigger an immune response to a viral infection, suggesting this interaction could increase the chances of developing gray hair.

MITF, in a sense, shields melanocyte stem cells from our own immune system, she says. Normally our immune system protects our bodies from infection. But for melanocyte stem cells, too much immune response is bad for their health, and this leads to their loss and to gray hair. Why melanocyte stem cells are so sensitive to our own natural means for protection, we still dont know.

Im very curious to see whether we see an uptick in individuals with gray hair due to coronavirus infection, she says. Unfortunately, we probably wont know because gray hair is rarely documented clinically, unless it is very extreme.

Scientists still dont know why some people turn gray early, late, or not at all, although they suspect genes, nutrients and possibly the immune system play a role in depleting melanocyte stem cells.

There is still much to learn about what regulates these stem cells and what may contribute to their loss, says Ya-Chieh Hsu, associate professor of stem cell and regenerative biology at Harvard University and principal faculty member of the Harvard Stem Cell Institute.

Among other things, Hsu studies the effect of stress on graying. Most of us are familiar with those before-and-after photographs of U.S. presidents most recently Barack Obama showing a striking increase in gray hair during their terms, even in relatively young presidents. Its known as the Marie Antoinette Syndrome, after the 18th-century French queen whose hair allegedly turned white overnight before she went to the guillotine and her death at age 38 during the French Revolution.

With the aging process, we gradually lose melanocyte stem cells one-by-one over a very long period of time, Hsu says. What we found in our research was that the stress can accelerate that process.

Hsu and her colleagues found that stress stimulates the same nerves that trigger the fight-or-flight response, which in turn causes permanent damage to the pigment-producing cells in hair follicles. The fight or flight response is thought to be a good thing in stressful situations because it can drive us and other organisms to respond to danger rapidly, Hsu says. This activation causes a spike in the neurotransmitter norepinephrine. Norepinephrine raises our heartbeat and allows us to react quickly to danger without having to think about it.

But norepinephrine also tells melanocyte stem cells to pump up their activity and proliferate, and too much norepinephrine, in this case triggered by stress, causes the melanocyte stem cells to burst into so much activity it leads to rapid depletion of the stem cell reservoir, she says. If all the stem cells are depleted, no more pigment-producing cells can be produced anymore, and the hair turns gray.

Other stress hormones, ACTH (adrenocorticotropic hormone) for example, can cause melanocyte stem cells to migrate away from the hair follicle before they can produce the melanocytes needed for hair and skin color, according to research. Such hormones are known to increase in the body after stress, and may have the potential to promote the loss of these cells, regardless of age, says study author Mayumi Ito, associate professor in the departments of cell biology and dermatology at the New York University Grossman School of Medicine.

Hsu believes the connection between stress and hair color could reveal additional information about how stress affects other biological processes. How stress affects our tissues is still poorly understood, and one of the powerful aspects about the melanocyte is that it provides a visible and highly trackable system to study stress, she says.

Ito also found that certain cell signaling proteins called endothelins (substances known to constrict blood vessels and raise blood pressure) bind to melanocyte stem cells and, in doing so, keep them healthy. Interrupting the process causes cell loss and early graying in mice. They are studying whether the same happens in human hair follicles, hoping to find ways to preserve or regenerate the key stem cells that give hair its color.

All of this raises the intriguing possibility that scientists could discover ways to prevent or reverse gray hair.

Team Hair-Us recently published a paper describing a topical drug combination that increased melanocyte stem cells in gray mice, ridding them of their gray and restoring their original fur color perhaps for good. Because the treatment originally developed to regrow hair replenished pigment-producing stem cells, the effects could be long-lasting, Harris says.

We didnt keep the mice forever so we dont know, says Harris, who plans more studies. This has made us very interested in whether gray hair really is permanent, and if we can do something about it. We really want to know and so does everyone else we talk to is whether and when we can bring this to humans.

Excerpt from:
Getting to the root of why hair goes gray - messenger-inquirer

Skin Stem Cells Comments Off on Getting to the root of why hair goes gray – messenger-inquirer | December 26th, 2020

Chafing occurs when the skin rubs against something, such as clothing, for a prolonged period. The friction can cause a painful rash that typically resolves when the chafing stops.

A person can experience chafing on any part of the body that encounters friction. The resulting rash is often minor, but there are some possible complications.

In this article, we look at what causes chafing rash and how to treat it. We also look at how a person can prevent chafing from occurring.

A chafing rash occurs anywhere on the body where the skin is rubbing against clothing or other skin.

Mild chafing rashes tend not to be too painful, but more serious rashes could bleed, crust, or blister. Chafing can occur anywhere where there is friction, but some areas of the body are more prone to chafing than others.

Areas where chafing is most likely to happen are generally moist or generate friction. They include the:

The direct cause of chafing is the skin is rubbing against something for a prolonged period. This could happen, for instance, when someone is walking and their inner thighs are rubbing together.

Chafing is more likely to occur in particular areas of the body, and it tends to happen during physical activity, such as running.

Others causes of chafing include:

Additionally, an infant or toddler wearing a diaper may experience chafing due to the added moisture and movement in the area.

Learn more about the types of diaper rash here.

Chafing causes a burning or stinging rash to occur where the skin is rubbing against something. The rash will not spread to other areas.

Possible complications of chafing rashes include:

Bacteria could enter through the broken or damaged skin around a chafing rash and cause an infection. For that reason, a person should make sure that they take care of the rash and keep it clean. The Centers for Disease Control and Prevention (CDC) list several symptoms of a skin infection, which include:

Chafing rashes will typically clear up within a few days if a person stops the activity causing the chafing or takes action to prevent further chafing.

Excessive moisture and skin friction may lead to skin breakdown. Patting the skin dry to remove excess moisture may prevent complications of chafing rash.

A person may also wish to consider applying shea butter lotion to the rash. A 2012 study found that shea butter has anti-inflammatory properties, which could make it a good option for people who want to soothe a chafing rash with cream.

For pain, a person can try applying aloe vera to the skin, as it may soothe sore skin and help prevent infections.

People have also traditionally used a range of other plant oils, including olive oil and coconut oil, to treat skin-related issues. Further research is necessary to confirm the benefits of each of these oils.

Unless the skin becomes infected, doctors do not have a standard way of treating chafing rash. A person should avoid the activity that caused the chafing. If they cannot avoid the activity, they should take steps to prevent further chafing from occurring.

If a person needs treatment, a doctor may prescribe or recommend a corticosteroid cream or ointment to help reduce the inflammation resulting from the rash.

It is not always possible to prevent chafing from occurring, but a person can take certain steps to reduce the risk.

According to the American Academy of Dermatology Association, these steps include:

Other steps a person can take to help prevent chafing include:

Additionally, the findings of an older study suggest that a person can apply petroleum jelly to the skin to minimize friction and prevent chafing rash.

If a person develops a rash that spreads, it is likely not a chafing rash. A person should consider seeing their doctor if the rash does not go away within a few days of home treatment.

A person should also talk to their doctor if they suspect that their rash has become infected. A doctor can examine the rash and determine whether additional treatment is necessary.

A chafing rash is often a mild rash that occurs when skin rubs against clothing or other areas of skin. Many cases are mild and will go away when a person stops the activity causing the chafing.

A possible complication of chafing rash is a skin infection. A person should speak with their doctor if the rash is severe or they think that it has become infected.

At-home treatments for chafing rash include aloe vera and other soothing ointments. A person can take preventive steps to reduce the risk of a rash forming, such as wearing moisture-wicking clothing and applying petroleum jelly to areas prone to chafing.

Read more:
What causes chafing rash? Remedies, treatment, and prevention - Medical News Today

Skin Stem Cells Comments Off on What causes chafing rash? Remedies, treatment, and prevention – Medical News Today | December 24th, 2020

Rashes can appear differently on different skin tones. For example, a heat rash on darker skin may look like a series of gray or white spots, while many medical sources describe them as red.

It is crucial for medical professionals to understand how health issues can present on the full range of skin tones. A lack of this understanding can lead to misdiagnoses.

It is generally advisable to contact a doctor about any rash that lasts longer than a week. The Skin of Color Society offer a database of dermatologists in the United States who have experience treating conditions in people of color.

In this article, we explore what rashes can look like on skin of color. We also describe the symptoms and treatments of specific issues.

The appearance of a rash varies with skin tone. On skin of color, a rash may be purple, gray, or white while medical texts often simply describe these rashes as red. Some redness may appear, but typically not very much.

This is due to melanin, a molecule that gives the skin and hair their color. Generally, the more melanin a person has in their skin, the darker their skin tone. It affects how the skin reacts to sunlight, damage, and health conditions that cause rashes.

Some doctors are unaware of how skin conditions present on darker skin. A 2018 study of four major medical textbooks found that darker skin tones were underrepresented in the imagery.

The studys authors report that while, at the time, 20.4% of the U.S. population was Black, only 4.5% of the photographs in the textbooks showed people with dark skin. They suggest that this is likely an example of racial bias in the healthcare system.

Below, we explore how various health issues can appear in skin of color.

Heat rash, sweat rash, and prickly heat are all common names for miliaria, a skin condition that occurs when the skins sweat ducts become blocked.

The symptoms of heat rash include:

On darker skin, the blisters may be gray or white.

This rash often occurs due to heat and humidity, but intense exercise, nonbreathable clothing, and medical dressings can also cause it. The condition typically improves within 12 days.

Cooling down, wearing more breathable clothing, and changing or, if recommended, removing dressings can help.

Eczema causes patches of dry, itchy skin, and the affected area may also be flaky or scaly. If the skin is very dry, it may crack or bleed.

In darker skin tones, patches of eczema may be red, pink, magenta, or darker than surrounding skin.

Eczema is also more likely to form in specific ways in people of color. For example, there is a higher chance that the rash may be papular, characterized by a series of small bumps like goosebumps.

There are several types of eczema, including:

This occurs when the skin comes into contact with an irritant, such as poison ivy, nickel, or fragrance. The skin may itch, sting, burn, or blister.

People with certain jobs have a higher risk of contact dermatitis. These jobs may involve regular contact with chemicals, food, or water. People with a higher risk may include:

Avoiding contact with the trigger, such as a specific chemical, is the best approach. A dermatologist can also describe products that can help and perform skin allergy testing to identify the trigger.

Atopic dermatitis is eczema with no clear cause. The condition often begins in childhood and may not last into adulthood. In the U.S., it appears to be more common among African Americans, Asian Americans, and Pacific Islanders than other groups.

There is no cure for atopic dermatitis, but there are ways of alleviating and preventing the rash from forming.

This typically involves using a non-irritating moisturizer regularly, after bathing or showering. It is also important to avoid fragranced products, food allergens, and irritating fabrics, such as wool. In addition, a person may need a topical corticosteroid, which a doctor can recommend or prescribe.

Learn more about eczema on black skin and its treatments.

Psoriasis is a long-term inflammatory condition that causes thickened patches of skin. On skin of color, these patches may be red or violet and have a top layer of silver or gray scales.

In the U.S., psoriasis is more common in white people than Black people. However, in Black people, it may be more likely to cover larger areas of the body.

Psoriasis can affect the nails as well as the skin, and a significant portion of people with psoriasis also have arthritis.

There is no cure, but it is possible to manage the symptoms. Among the range of options are:

Learn more about psoriasis on black skin and its treatments.

Lichen planus causes a series of bumps to form on the skin. Each bump is shiny, raised, and has a flat top. On skin of color, these bumps may be gray-brown or purple.

The most commonly affected areas are the back, neck, lower legs, ankles, and the insides of the wrists. In 20% of cases, lichen planus causes no symptoms beyond the bumps, but in others, it causes intense itching.

Lichen planus can last for months or years, and there is no known cure. Treatments that can relieve the symptoms include:

Learn more about the causes and treatments of lichen planus.

Vitiligo is a condition that causes patches of skin to lose its color, or become depigmented. If the condition affects areas with hair, the hair may turn white, too.

The condition occurs when the immune system attacks melanocytes, the cells that produce melanin. Scientists are not sure why this happens, but they believe that it could stem from an autoimmune response.

Areas commonly affected by vitiligo include:

Vitiligo can affect anyone, but it is more noticeable in people with darker skin. People with vitiligo are more likely to have a family history of autoimmune disorders.

The depigmentation often stops or slows over time. Treatments focus on reducing the spread of depigmentation and restoring color to the skin. This may include the use of medicated creams or light therapy.

Shingles is caused by the same virus as chickenpox. Anyone who has had chickenpox can develop shingles later on. One symptom that most people with shingles develop is a rash of small blisters.

The symptoms of shingles are:

Some people also experience a fever, headaches, muscle aches, stomach pain, or nausea and vomiting.

On highly pigmented skin, a shingles rash may be red, the same color as the skin, or slightly darker. The scabs may be grey.

While the rash often heals within 24 weeks, it is important for anyone with shingles symptoms to see a doctor for treatment within 23 days. This is because shingles can cause long-term complications.

The doctor can prescribe antiviral medication, which can reduce the risk of complications and shorten the healing time.

Ringworm is a fungal infection of the skin. It often causes a round or ring-shaped rash with a raised border, though the rash may be shaped differently on certain areas, such as the feet or hands.

On darker skin, the ringworm rash is often gray or brown.

Ringworm is contagious, so it is important to seek treatment right away and avoid touching the rash, even if it is itchy.

Other names for this infection include:

Treatment may involve antifungal cream or, if the rash covers a large area, oral medication.

The best approach to treatment at home depends on the cause of the rash. But there are some general strategies for preventing further irritation, such as:

It is also important to protect the skin from sun damage with a product that contains SPF 30 or higher. UV light can also worsen skin irritation for people with certain conditions.

In some cases, a rash signals a medical emergency. Seek urgent medical attention if a rash:

Anyone who may have shingles or ringworm should see a doctor promptly to prevent transmission. For shingles, a person should wait no more than 23 days.

Otherwise, it is generally a good idea to contact a doctor if any rash lasts longer than a week.

The Skin of Color Society provide a database of dermatologists in the U.S. who have experience treating conditions in people of color.

In skin of color, a rash may be red, brown, purple, or gray.

Some doctors may misdiagnose skin issues in people of color due to a lack of awareness. Skin of color is often underrepresented in medical texts.

A dermatologist who understands how rashes present in the full range of skin tones is best prepared to provide the right treatment.

Read more here:
Rash on black skin: Pictures, symptoms, and treatments - Medical News Today

Skin Stem Cells Comments Off on Rash on black skin: Pictures, symptoms, and treatments – Medical News Today | December 24th, 2020

As for your lips, we dont grow hair there because our lips are made up of a different type of cell, as theyre considered to be an extension of the gastrointestinal (GI) tract, says Mariwalla.

If having hair is so crucial to the function of our bodies, why have we been removing it for hundreds of years? Well, we have no one to blame but ourselves. We have, through communication with one another, established a globalized practice of removing hair to make women especially look very smooth and have baby-like skin; and for men to retain their body hair, says Jablonski. We tend to think, Oh, these signals are very ancient. These practices are very ancient. They're not. This is a pretty recent obsession. Jablonski estimates the practice of body hair removal started about only 500 years ago.

While modern societal standards of what femininity and masculinity are still very much linked to hairiness or lack of hairiness, weve begun to see a shift in the acceptance and normalization of body hair, thanks in part to social media, which has even helped us celebrate body hair for the first time. (Remember #freeyourpits?)

It's really wonderful when people examine those social norms and say, hold on, who started this? This is a bunch of nonsense, says Jablonski. And they realize, Hey, I can be a beautiful person inside and out without following these practices. It is tremendously liberating.

That sense of celebration seems to be more prevalent than ever before, as were living through a pandemic, which has put physical interactions between people on pause. Because of this, many of the performances we put on for others, like body hair removal, have become one-woman shows, with one-woman audiences.

So then you realize, in your heart of hearts, this is a waste of time, says Jablonski. Why should I take this time to do this thing that is socially acceptable and allows me to cleave towards a social norm? I'm doing just fine. People feel a lot of freedom now.

Of course, if you do choose to remove your body hair and thats fine too! depending on the location of the hair, there are a number of methods that will get the job done, says Mariwalla.

Shaving

For starters, theres shaving, the act of removing hair with a razor. When you shave the hair on your body (typically on the legs, underarms, and face), youre removing hair from above the top layer of skin, says Mariwalla. She recommends shaving with a cream or gel to keep the skin hydrated. The process of shaving is almost like exfoliating that top layer of skin, she says. So, it's like a two for one.

Tweezing

Tweezing, on the other hand, pulls the hair directly from the follicle. When you think about a hair follicle, it's like the little house that your hair lives in, explains Mariwalla. Any time you pull a hair from a follicle, it's always going to grow back. But its going to take longer than when you only remove it from above the skin.

Waxing and Sugaring

Waxing and sugaring use the same mechanism as tweezing but with warm substances (i.e. wax and sugar) that sit on top of the skin and around the hair to coax it out of the follicle. Its a process that is trying to warm the skin, so that the hair follicle opens up a little bit and the wax solidifies around the hair, says Mariwalla. When you remove the wax you basically rip the hair out of the follicle as you're doing it.

Depilatory Cream

There are also depilatory creams. Instead of grabbing onto the hair and pulling it, you're putting on a chemical that's dissolving the hair at the root, explains Mariwalla. So then you basically then just wipe it away.

More here:
Everything You've Ever Wanted to Know About Body Hair - Allure

Skin Stem Cells Comments Off on Everything You’ve Ever Wanted to Know About Body Hair – Allure | December 24th, 2020

VANCOUVER, British Columbia, Dec. 22, 2020 (GLOBE NEWSWIRE) -- Lui Franciosi is proud to announce the launch of his new YouTube channel. As a pharmacologist and former executive in the pharmaceutical industry, Dr. Franciosi’s videos will focus on topics related to health and pharma care, as well as topics related to entrepreneurship, seniors care and COVID-19.

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Lui Franciosi of Franciosi Consulting Launches YouTube Channel

Global News Feed Comments Off on Lui Franciosi of Franciosi Consulting Launches YouTube Channel | December 24th, 2020

Annual Meeting to be adjourned solely with respect to Item 2, and Item 2 to be modified to decrease the proposed aggregate number of shares of common stock that the Company would be authorized to issue from 500,000,000 shares to 400,000,000 shares Annual Meeting to be adjourned solely with respect to Item 2, and Item 2 to be modified to decrease the proposed aggregate number of shares of common stock that the Company would be authorized to issue from 500,000,000 shares to 400,000,000 shares

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Ocugen Inc. Announces Plan to Adjourn Annual Meeting of Stockholders, Modify Proposal Regarding Increase in Number of Authorized Shares

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Will Trade on the Nasdaq Global Market Under Ticker “GBS” Will Trade on the Nasdaq Global Market Under Ticker “GBS”

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GBS Inc. Announces Pricing of Initial Public Offering

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Basel, 23 December 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Phesgo®, a fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by subcutaneous (SC; under the skin) injection for the treatment of early and metastatic HER2-positive breast cancer. “This approval represents a significant step forward in the treatment of HER2-positive breast cancer,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “The innovation of Phesgo significantly reduces the time people spend receiving standard of care therapy with Perjeta and Herceptin, helping to minimise the impact of treatment on their everyday lives. It also addresses the increasing demand across healthcare systems for faster and more flexible treatment solutions.” Phesgo is available as a single-dose vial for SC injection and enables over 90% faster treatment than IV administration of standard of care therapy with Perjeta and Herceptin. SC administration of Phesgo takes approximately eight minutes for the initial loading dose and approximately five minutes for each subsequent maintenance dose. This is compared to approximately 150 minutes for infusion of a loading dose of Perjeta and Herceptin using the standard IV formulations, and between 60-150 minutes for subsequent maintenance infusions of the two medicines.4,5,6 The approval of Phesgo in Europe is based on results from the pivotal phase III FeDeriCa study, which showed that treatment with Phesgo produced non-inferior levels of Perjeta and Herceptin in the blood and demonstrated comparable efficacy versus IV administration of the two medicines. The safety profile of Phesgo with chemotherapy was comparable to IV administration of Perjeta plus Herceptin and chemotherapy. No new safety signals were identified, including no meaningful difference in cardiac toxicity.7 The development of Phesgo highlights Roche's commitment to improving patients’ experience of cancer treatment, looking beyond efficacy outcomes and focusing on more flexible treatment solutions. Phesgo has the potential to help minimise pressure on healthcare systems by reducing administration time, as well as other costs associated with treatment, such as time spent in the infusion chair and drug preparation.8,9 The COVID-19 pandemic has further highlighted the need to utilise novel approaches that help to manage healthcare capacity to free-up time and resources. About the FeDeriCa study7,10 FeDeriCa is an international, multi-centre, two-arm, randomised, open-label, pivotal phase III study evaluating the pharmacokinetics, efficacy and safety of subcutaneous injection of Phesgo in combination with chemotherapy, compared with standard intravenous (IV) infusions of Perjeta and Herceptin in combination with chemotherapy, in 500 people with HER2-positive early breast cancer treated in the neoadjuvant (before surgery) and adjuvant (after surgery) settings. The primary endpoint of the study is minimum levels of Perjeta in the blood during a given dosing interval (Ctrough), when compared to IV administration of Perjeta. Secondary endpoints include safety; minimum levels of Herceptin in the blood during a given dosing interval (Ctrough); and total pathological complete response, meaning there is no tumour tissue detectable in the tissue removed at the time of surgery. Data from the FeDeriCa study were presented at the San Antonio Breast Cancer Symposium in December 2019. The FeDeriCa study met its primary endpoint of non-inferior levels of Perjeta in the blood. The geometric mean ratio (GMR; a type of average used when assessing pharmacokinetics) for the primary endpoint was 1.22 (90% CI: 1.14 to 1.31), with the lower limit of the 90% CI of the GMR=1.14?0.80 (the pre-specified non-inferiority margin). A secondary endpoint of non-inferior levels of Herceptin was also met, with blood concentrations for people receiving Phesgo non-inferior to those receiving IV Herceptin (GMR=1.33 [90% CI: 1.24 to 1.43]; lower limit of 90% CI of GMR=1.24?0.80). A non-inferiority endpoint was chosen for the study to ensure that people were receiving sufficient dosing with Perjeta and Herceptin as compared to the established IV doses at the same treatment intervals. About Phesgo Phesgo combines the same monoclonal antibodies as Perjeta and Herceptin with Halozyme Therapeutics’ Enhanze® drug delivery technology in a novel formulation for subcutaneous (SC) use.4,11  This is the first time that Roche has combined two monoclonal antibodies that can be administered by a single SC injection. Halozyme’s Enhanze drug delivery technology may enable and optimise SC drug delivery for appropriate co-administered therapeutics. The technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that temporarily degrades hyaluronan – a glycosaminoglycan or chain of natural sugars in the body – to aid in the dispersion and absorption of other injected therapeutic drugs.11 Pertuzumab in Phesgo is the same monoclonal antibody as in intravenous (IV) Perjeta, and trastuzumab in Phesgo is the same monoclonal antibody as in IV Herceptin. The mechanisms of action of Perjeta and Herceptin are believed to complement each other as both bind to the HER2 receptor, but in different locations. The combination of Perjeta and Herceptin is thought to provide a more comprehensive, dual blockade of the HER signalling pathways.12,13 Phesgo is approved in the US for the treatment of early and metastatic HER2-positive breast cancer. The approved indications for Phesgo mirror those of Perjeta. The standard IV formulation of Perjeta in combination with IV Herceptin and chemotherapy (the Perjeta-based regimen) is approved in more than 100 countries for the treatment of both early and metastatic HER2-positive breast cancer. In the neoadjuvant (before surgery) early breast cancer (eBC) setting, the Perjeta-based regimen has been shown to almost double the rate of pathological complete response compared to Herceptin and chemotherapy.14 Additionally, the combination has been shown to significantly reduce the risk of recurrence of invasive disease or death in the adjuvant (after surgery) eBC setting.15 In the metastatic setting, the combination has shown an unprecedented survival benefit in previously untreated (first-line) patients with HER2-positive metastatic breast cancer.16 About Roche’s medicines for HER2-positive breast cancer Roche has been leading research into the HER2 pathway for more than 30 years and is committed to improving the health, quality of life and survival of people with both early and metastatic HER2-positive disease. HER2-positive breast cancer is a particularly aggressive form of the disease that affects approximately 25-30% of patients.17 Roche has developed three innovative medicines that have helped transform the treatment of HER2-positive breast cancer: Herceptin, Perjeta and Kadcyla® (trastuzumab emtansine). Eligibility for treatment with Roche’s HER2-targeted medicines is determined via a diagnostic test which identifies people who will likely benefit from these medicines at the onset of their disease. About Roche Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law. References [1] O’Shaugnessy J, et al. Patient (pt) preference for the pertuzumab-trastuzumab fixed-dose combination for subcutaneous use (PH FDC SC) in HER2-positive early breast cancer (EBC): Primary analysis of the open-label, randomised crossover PHranceSCa study. Presented at ESMO, 2020 Sept 19-21. Abstract #165MO.[2]  Xavier P, et al. Preference for subcutaneous or intravenous administration of trastuzumab in patients with HER2-positive early breast cancer (PrefHer): an open-label randomised study. Lancet Oncol. 2013;14(10):962-70. [3] Tjalma, et al. Trastuzumab IV versus SC: A time, motion and cost assessment in a lean operating day care oncology unit. Presented at: SABCS; 2016 Dec 6-10; San Antonio, TX, USA. Abstract #P4-21-15. [4] US Food and Drug Administration. Prescribing information for Phesgo. [Internet; cited December 2020]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761170s000lbl.pdf. [5] US Food and Drug Administration. Prescribing Information for Herceptin. [Internet; cited December 2020]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/. [6] US Food and Drug Administration. Prescribing information for Perjeta. [Internet; cited December 2020]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125409lbl.pdf. [7] Tan A. et al. Subcutaneous administration of the fixed-dose combination of trastuzumab and pertuzumab in combination with chemotherapy in HER2-positive early breast cancer: Primary analysis of the phase III, multicenter, randomized, open-label, two-arm FeDeriCa study. Presented at SABCS; 2019 Dec 10-14; San Antonio, Texas. Abstract #PD4-07. [8] Sripada et al. Subcutaneous fixed-dose combination of pertuzumab and trastuzumab for the treatment of metastatic breast cancer in Canada - a budget impact analysis. Presented at SABCS; 2020 Dec 08-11; San Antonio Texas: PS9-55. [9] Roche data on file. [10] Clinical trials.gov. A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer (FeDeriCa). [Internet: December 2020]. Available from: https://clinicaltrials.gov/ct2/show/NCT03493854. [11] Halozyme. Enhanze® Drug Delivery Technology. [Internet; cited December 2020]. Available from: https://www.halozyme.com/enhanze/overview/default.aspx. [12] Iqbal N, Iqbal N. Human Epidermal Growth Factor Receptor 2 (HER2) in Cancers: Overexpression and Therapeutic Implications. Mol Biol Int. 2014;2014:852748. [13] Baselga J, Swain SM. Novel anticancer targets: revisiting ERBB2 and discovering ERBB3. Nat Rev Cancer 2009;9:463-75. [14] Gianni L, et al. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. Lancet Oncol. 2012;13(1):25-32. [15] Minckwitz G, et al. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer. N Engl J Med. 2017;13;377(2):122-31. [16] Swain SM, et al. Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer. N Engl J Med. 2015;19;372(8):724-34. [17] Jarrett A, et al. Experimentally-driven mathematical modelling to improve combination targeted and cytotoxic therapy for HER2+ breast cancer. Sci Rep. 2019;9:12830. Roche Group Media Relations Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

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European Commission approves Roche’s Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) for people with...

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COPENHAGEN, Denmark, Dec. 23, 2020 (GLOBE NEWSWIRE) -- Evaxion Biotech, a clinical-stage biotechnology company developing AI-driven immunotherapies, announces today the dosing of the first patient in a Phase I/IIa clinical trial of its adjuvant immunotherapy EVX-02, in combination with checkpoint inhibitors in patients with advanced melanoma.

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Evaxion Biotech Doses First Patient in Phase I/IIa Melanoma Trial of Cancer Vaccine EVX-02 in Combination With Checkpoint Inhibitors

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VANCOUVER, Dec. 22, 2020 (GLOBE NEWSWIRE) -- BetterLife Pharma Inc. (“BetterLife” or the “Company”) CSE: BETR / OTCQB: BETRF / FRA: NPAU) an emerging biotech company, is pleased to announce that Patrick Kroupa and Justin Kirkland, two industry leaders in psychedelic therapeutics, have joined the Company. Mr. Kroupa and Mr. Kirkland will join the senior management team of BetterLife as Chief Psychedelics Officer and Chief Psychedelics Scientist, respectively.

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BetterLife Welcomes Psychedelic Industry Leaders to the Senior Management Team

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Novadip Biosciences Receives Rare Paediatric Disease Priority Review and Orphan Disease Designation

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Novadip Biosciences Receives Rare Paediatric Disease Priority Review and Orphan Disease Designation

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The Company began enrolling patients in Saturn-1 in September 2020 and expects to initiate its second pivotal registration trial, Saturn-2, in 2021 The Company began enrolling patients in Saturn-1 in September 2020 and expects to initiate its second pivotal registration trial, Saturn-2, in 2021

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Tarsus Pharmaceuticals, Inc. Announces Type C Meeting with FDA Regarding NDA Submission Requirements for Lead Candidate TP-03

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NEW YORK, NY, REHOVAT, ISRAEL, SINGAPORE, Dec. 23, 2020 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical (OTCQB: TOMDF), an in vitro diagnostics company focused on distributing comprehensive solutions for COVID-19 screening and diagnosis, and developing blood tests for early detection of cancer and Alzheimer’s disease, today announced that it has entered into a preferred vendor agreement to supply COVID-19 related testing products and services to Natural Wellness Clinics (“NWC”) for use in its efforts in testing the uninsured population in the Commonwealth of Kentucky. NWC is a US military veteran owned health care provider that offers communities a holistic and integrative approach and is establishing a niche in implementing large-scale testing programs and logistics for state governments that it hopes may dovetail into vaccine distribution logistics.

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Todos Medical Announces Agreement to Supply Natural Wellness Clinics with COVID-19 Testing Products to Support Initiatives in the Commonwealth of...

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