There is no stronger risk factor for cancer than age. At the time of diagnosis, the median age of patients across all cancers is 66. That moment, however, is the culmination of years of clandestine tumor growth, and the answer to an important question has thus far remained elusive: When does a cancer first arise?

At least in some cases, the original cancer-causing mutation could have appeared as long as 40 years ago, according to a new study by researchers at Harvard Medical School and the Dana-Farber Cancer Institute.

Reconstructing the lineage history of cancer cells in two individuals with a rare blood cancer, the team calculated when the genetic mutation that gave rise to the disease first appeared. In a 63-year-old patient, it occurred at around age 19; in a 34-year-old patient, at around age 9.

The findings, published in the March 4 issue ofCell Stem Cell, add to a growing body of evidence that cancers slowly develop over long periods of time before manifesting as a distinct disease. The results also present insights that could inform new approaches for early detection, prevention, or intervention.

"For both of these patients, it was almost like they had a childhood disease that just took decades and decades to manifest, which was extremely surprising," said co-corresponding study author Sahand Hormoz, HMS assistant professor of systems biology at Dana-Farber.

"I think our study compels us to ask, when does cancer begin, and when does being healthy stop?" Hormoz said. "It increasingly appears that it's a continuum with no clear boundary, which then raises another question: When should we be looking for cancer?"

In their study, Hormoz and colleagues focused on myeloproliferative neoplasms (MPNs), a rare type of blood cancer involving the aberrant overproduction of blood cells. The majority of MPNs are linked to a specific mutation in the gene JAK2. When the mutation occurs in bone marrow stem cells, the body's blood cell production factories, it can erroneously activate JAK2 and trigger overproduction.

To pinpoint the origins of an individual's cancer, the team collected bone marrow stem cells from two patients with MPN driven by the JAK2 mutation. The researchers isolated a number of stem cells that contained the mutation, as well normal stem cells, from each patient, and then sequenced the entire genome of each individual cell.

Over time and by chance, the genomes of cells randomly acquire so-called somatic mutations--nonheritable, spontaneous changes that are largely harmless. Two cells that recently divided from the same mother cell will have very similar somatic mutation fingerprints. But two distantly related cells that shared a common ancestor many generations ago will have fewer mutations in common because they had the time to accumulate mutations separately.Cell of origin

Analyzing these fingerprints, Hormoz and colleagues created a phylogenetic tree, which maps the relationships and common ancestors between cells, for the patients' stem cells--a process similar to studies of the relationships between chimpanzees and humans, for example.

"We can reconstruct the evolutionary history of these cancer cells, going back to that cell of origin, the common ancestor in which the first mutation occurred," Hormoz said.

Combined with calculations of the rate at which mutations accumulate, the team could estimate when the JAK2 mutation first occurred. In the patient who was first diagnosed with MPN at age 63, the team found that the mutation arose around 44 years prior, at the age of 19. In the patient diagnosed at age 34, it arose at age 9.

By looking at the relationships between cells, the researchers could also estimate the number of cells that carried the mutation over time, allowing them to reconstruct the history of disease progression.

"Initially, there's one cell that has the mutation. And for the next 10 years there's only something like 100 cancer cells," Hormoz said. "But over time, the number grows exponentially and becomes thousands and thousands. We've had the notion that cancer takes a very long time to become an overt disease, but no one has shown this so explicitly until now."

The team found that the JAK2 mutation conferred a certain fitness advantage that helped cancerous cells outcompete normal bone marrow stem cells over long periods of time. The magnitude of this selective advantage is one possible explanation for some individuals' faster disease progression, such as the patient who was diagnosed with MPN at age 34.

In additional experiments, the team carried out single-cell gene expression analyses in thousands of bone marrow stem cells from seven different MPN patients. These analyses revealed that the JAK2 mutation can push stem cells to preferentially produce certain blood cell types, insights that may help scientists better understand the differences between various MPN types.

Together, the results of the study offer insights that could motivate new diagnostics, such as technologies to identify the presence of rare cancer-causing mutations currently difficult to detect, according to the authors.

"To me, the most exciting thing is thinking about at what point can we detect these cancers," Hormoz said. "If patients are walking into the clinic 40 years after their mutation first developed, could we have caught it earlier? And could we prevent the development of cancer before a patient ever knows they have it, which would be the ultimate dream?"

The researchers are now further refining their approach to studying the history of cancers, with the aim of helping clinical decision-making in the future.

While their approach is generalizable to other types of cancer, Hormoz notes that MPN is driven by a single mutation in a very slow growing type of stem cell. Other cancers may be driven by multiple mutations, or in faster-growing cell types, and further studies are needed to better understand the differences in evolutionary history between cancers.

The team's current efforts include developing early detection technologies, reconstructing the histories of greater numbers of cancer cells, and investigating why some patients' mutations never progress into full-blown cancer, but others do.

"Even if we can detect cancer-causing mutations early, the challenge is to predict which patients are at risk of developing the disease, and which are not," Hormoz said. "Looking into the past can tell us something about the future, and I think historical analyses such as the ones we conducted can give us new insights into how we could be diagnosing and intervening."

Reference:Egeren DV, Escabi J, Nguyen M, et al. Reconstructing the lineage histories and differentiation trajectories of individual cancer cells in myeloproliferative neoplasms. Cell Stem Cell. 2021;28(3):514-523.e9. doi:10.1016/j.stem.2021.02.001

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

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Retracing the Lineage of Cancer Cells - Technology Networks

Bone Marrow Stem Cells Comments Off on Retracing the Lineage of Cancer Cells – Technology Networks | March 8th, 2021

LANSING, Mich. (WLNS) More than three-quarters of African Americans are unable to find a bone marrow or stem cell transplant who need one, according to the nations largest bone marrow registry, Be the Match.

There are more than 20 million people on the registry, a database of people who volunteer to donate their stem cells or bone marrow if theyre found to be a match to someone seeking a transplant, and oftentimes, a transplant can mean giving people a second chance at life.

In fact, a blood stem cell transplant can be a cure for more than 70 diseases including blood cancer (leukemia, lymphoma, etc), sickle cell anemia and aplastic anemia to name a few.

However, the likelihood for people of color and Black people specifically, is staggeringly low.

Every year, millions of people are diagnosed with a life-threatening blood disorder.

That means millions of people are looking for a donor, someone whose special protein cells, called HLA proteins, match their own.

Patients are most likely to match donors who share the same ethnic background, according to Be the Match, but this is not always the case.

There is a catch though more often than not, there are not enough donors available and willing to give blood.

As the coronavirus pandemic has struck the world and cut blood donations severely, the challenge of finding a blood donor match has become more difficult.

Charles Poldo is a 51-year-old Black man living in mid-Michigan. In 2012, Poldo was diagnosed with acute myeloid leukemia, a type of cancer of the blood and bone marrow with excess immature white blood cells.

Acute myeloid leukemia runs in his family too but Poldo said he was determined to beat the cancer.

My mom and her dad died from it so when I got diagnosed, I knew I was not going to die, Poldo said.

So, Poldo embarked on a 7 year-long search for a donor.

But doctors could not find anyone of the more than 20+ million people on the Be the Match Registry who were exactly compatible with Poldo.

Doctors decided to proceed with an imperfect solution and Poldo received a treatment that did not fully cure his AML.

As a result, Poldo went into remission and was re-diagnosed with AML again in Nov. 2019.

By this time, technology had advanced to where Poldo could receive an imperfect match.

Even so, Poldos scenario is not an ideal one, especially because of the adverse effects of an imperfect match namely, his own immune system attacking and rejecting the donors cells.

In the medical field, they refer to this adverse effect as a post-transplant complication or graft-versus-host (GVHD) disease.

In Feb. 2020 just before the pandemic hit, Poldo received an umbilical cord transplant, which uses stem cells from umbilical cords donated at the time of a persons birth for instances like these.

Fortunately, Poldos immune system did not reject his transplants. But thats not the case for everyone.

Poldo said the person whose umbilical cord he received is now 8 years old. While he did not have the opportunity to meet his donor face-to-face, he is thankful.

Poldo is one of many African Americans who are unable to find a donor whose proteins match up exactly.

Even though Poldos transplant was successful, others are not as lucky.

People of color are underrepresented in the registry for a number of reasons, although there is no clear evidence as to why.

According to CBS News, a couple of reasons why people of color are underrepresented include a history of medical abuse of Black people in healthcare research, a lack of multi-lingual resources and stigma or fear of donating out of health concerns.

The Black community is more likely to be skeptical to sign up to be volunteers for medical trials or even the registry due to their abuse and mistreatment by medical researchers in the past.

For example, the 1932 Tuskegee syphilis trials also known as: Tuskegee Study of Untreated Syphilis in the Negro Male purposely infected several hundred Black people with syphilis without their informed consent or cure of the disease.

The trial that was supposed to last six months ended up lasting 40 years.

In addition, language barriers and access to knowledge about donating blood and stem cells exist among minority communities including Asian, Hispanic and Black people.

Here are some facts that Be the Match has clarified for those on the fence about donating.

Many mistakenly believe that donating blood stem cells is painful, when in reality its not.

It is a common misconception that donating blood stem cells is dangerous. The truth is that there are few risks in donating blood stem cells.

Many people think that donating to a patient in need is expensive for them, but Be The Match covers every cost related to donation.

If you are interested in signing up for the national bone marrow registry, text cure29 to 61474Or join.bethematch.org/cure29

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Black people are three times less likely to find a bone marrow donor than white people - WLNS

Bone Marrow Stem Cells Comments Off on Black people are three times less likely to find a bone marrow donor than white people – WLNS | March 8th, 2021

Stem Cell Therapy Market is valued at USD 9.32 Billion in 2018 and expected to reach USD 16.51 Billion by 2025 with the CAGR of 8.5% over the forecast period.

In its latest report on Stem Cell Therapy Market provides a concise analysis of the recent market trends. The report further includes statistics, market forecasts and revenue estimations, which in addition highlights its status in the competitive domain as well as expansion trends adopted by major industry players.

Rising prevalence of chronic diseases, increasing spend on research & development and increasing collaboration between industry and academia driving the growth of stem cell therapy market.

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*The sample pages of this report is immediately accessible on-demand.**

Scope of Stem Cell TherapyMarket-

Stem cells therapy also known as regenerative medicine therapy, stem-cell therapy is the use of stem cells to prevent or treat the condition or disease. Stem cell are the special type of cells those differentiated from other type of cell into two defining characteristics including the ability to differentiate into a specialized adult cell type and perpetual self-renewal. Under the appropriate conditions in the body or a laboratory stem cells are capable to build every tissue called daughter cells in the human body; hence these cells have great potential for future therapeutic uses in tissue regeneration and repair. Among stem cell pluripotent are the type of cell that can become any cell in the adult body, and multipotent type of cell are restricted to becoming a more limited population of cells.

The stem cell therapy has been used to treat people with conditions including leukemia and lymphoma, however this is the only form of stem-cell therapy which is widely practiced. Prochymal are another stem-cell therapy was conditionally approved in Canada in 2012 for the treatment of acute graft-vs-host disease in children those are not responding to steroids. Nevertheless, hematopoietic stem cell transplantation is the only established therapy using stem cells. This therapy involves the bone marrow transplantation.

Stem cell therapy market report is segmented based on type, therapeutic application, cell source and by regional & country level. Based upon type, stem cell therapy market is classified into allogeneic stem cell therapy market and autologous market.

Based upon therapeutic application, stem cell therapy market is classified into musculoskeletal disorders, wounds and injuries, cardiovascular diseases, surgeries, gastrointestinal diseases and other applications. Based upon cell source, stem cell therapy market is classified into adipose tissue-derived mesenchymal stem cells, bone marrow-derived mesenchymal stem cells, cord blood/embryonic stem cells and other cell sources

The regions covered in this stem cell therapy market report are North America, Europe, Asia-Pacific and Rest of the World. On the basis of country level, market of stem cell therapy is sub divided into U.S., Mexico, Canada, U.K., France, Germany, Italy, China, Japan, India, South East Asia, GCC, Africa, etc.

Stem Cell TherapyCompanies:

Stem cell therapy market report covers prominent players like,

Osiris Therapeutics, Inc

MEDIPOST

Anterogen, Ltd.

Cynata

Pharmicell

Cytori Therapeutics

Holostem Terapie Avanzate S.r.l.

JCR Pharmaceuticals

NuVasive

RTI Surgical

STEMCELL Technologies

BIOTIME

Osiris Therapeutics

Human Longevity

Advanced Cell Technology

Promethera Biosciences

Mesoblast and AlloSource

others

Stem Cell TherapyMarket Dynamics

Rising spend on research and development activities in the research institutes and biotech industries driving the growth of the stem cell therapy market during the forecast period. For instance, in January 2010, U. S. based Augusta University initiated Phase I clinical trial to evaluate the safety and effectiveness of a single, autologous cord blood stem infusion for treatment of cerebral palsyin children. The study is estimated to complete in July 2020. Additionally, increasing prevalence of chronic diseases creating the demand of stem cell therapy. For instance, as per the international diabetes federation, in2019, around 463 million population across the world were living withdiabetes; by 2045 it is expected to rise around 700 million. Among all 79% of population withdiabeteswere living in low- and middle-income countries. These all factors are fuelling the growth of market over the forecast period. On the other flip, probabilities of getting success is less in the therapeutics by stem cell may restrain the growth of market. Nevertheless, Advancement of technologies and government initiative to encourage research in stem cell therapy expected to create lucrative opportunity in stem cell therapy market over the forecast period.

Stem Cell TherapyMarketRegional Analysis

North America is dominating the stem cell therapy market due increasing adoption rate of novel stem cell therapies fueling the growth of market in the region. Additionally, favorable government initiatives have encouraging the regional market growth. For instance, government of Canada has initiated Strategic Innovation Fund Program, in which gov will invests in research activities carried out for stem cell therapies. In addition, good reimbursing scheme in the region helping patient to spend more on health. Above mentioned factors are expected to drive the North America over the forecast period.

Asia Pacific is anticipated to grow at a highest CAGR over forecast period due to rising awareness of benefits of stem cell therapies among the population. In addition, increasing collaboration between industry-academia to initiate research and development in the stem cell therapy expected to create the huge growth over the forecast period. For instance, as per the report of Pharma Focus Asia, members of Asia-Pacific Economic Cooperation collaborated with Life Sciences Innovation Forum to involve professionals having expertise in stem cell therapies from academia and research centers to promote developments in stem cell research which will foster regional market growth.

Key Benefits for Stem Cell TherapyMarketReports

Global Market report covers in depth historical and forecast analysis.

Global Market research report provides detail information about Market Introduction, Market Summary, Global market Revenue (Revenue USD), Market Drivers, Market Restraints, Market opportunities, Competitive Analysis, Regional and Country Level.

Global Market report helps to identify opportunities in market place.

Global Market report covers extensive analysis of emerging trends and competitive landscape.

Stem Cell TherapyMarketSegmentation

By Type

By Therapeutic Application

By Cell Source

Regional & Country AnalysisNorth America, U.S., Mexico, Canada , Europe, UK, France, Germany, Italy , Asia Pacific, China, Japan, India, Southeast Asia, South America, Brazil, Argentina, Columbia, The Middle East and Africa, GCC, Africa, Rest of Middle East and Africa

Table of Content

1.1. Research Process

1.2. Primary Research

1.3. Secondary Research

1.4. Market Size Estimates

1.5. Data Triangulation

1.6. Forecast Model

1.7. USPs of Report

1.8. Report Description

2.1. Market Introduction

2.2. Executive Summary

2.3. Global Stem Cell Therapy Market Classification

2.4. Market Drivers

2.5. Market Restraints

2.6. Market Opportunity

2.7. Stem Cell Therapy Market: Trends

2.8. Porters Five Forces Analysis

2.9. Market Attractiveness Analysis

Continued

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Brandessence market research publishes market research reports & business insights produced by highly qualified and experienced industry analysts. Our research reports are available in a wide range of industry verticals including aviation, food & beverage, healthcare, ICT, Construction, Chemicals and lot more. Brand Essence Market Research report will be best fit for senior executives, business development managers, marketing managers, consultants, CEOs, CIOs, COOs, and Directors, governments, agencies, organizations and Ph.D. Students. We have a delivery center in Pune, India and our sales office is in London.

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Stem Cell Therapy Market expected to reach USD 16.51 Billion by 2025 KSU | The Sentinel Newspaper - KSU | The Sentinel Newspaper

Bone Marrow Stem Cells Comments Off on Stem Cell Therapy Market expected to reach USD 16.51 Billion by 2025 KSU | The Sentinel Newspaper – KSU | The Sentinel Newspaper | March 8th, 2021

TheBone Marrow-Derived Stem Cells (BMSCS) Marketresearch report thoroughly explains each and every aspect related to the Global Bone Marrow-Derived Stem Cells (BMSCS) Market, which facilitates the reports reader to study and evaluate the upcoming market trend and execute the analytical data to promote the business.

Bone Marrow-Derived Stem Cells (BMSCS) Market Insight:

Bone marrow-derivedstem cells(BMSCS) market is expected to gain market growth in the forecast period of 2020 to 2027. Data Bridge Market Research analyses the market to growing at a CAGR of 10.4% in the above-mentioned forecast period. Increasing awareness regarding the benefits associates with the preservation of bone marrow derived stem cells will boost the growth of the market.

Avail Your Free Sample Copy of the Bone Marrow-Derived Stem Cells (BMSCS) Market Report (Including Full TOC, List of Tables & Figures, Chart)@ https://www.databridgemarketresearch.com/request-a-sample/?dbmr=global-bone-marrow-derived-stem-cells-bmscs-market#utm_source=KA

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The report also inspects the financial standing of the leading companies, which includes gross profit, revenue generation, sales volume, sales revenue, manufacturing cost, individual growth rate, and other financial ratios.

Prominent Key Players Covered in the report:

CBR Systems, Inc, Cordlife Sciences India Pvt. Ltd., Cryo-Cell International, Inc.ESPERITE N.V., LifeCell International Pvt. Ltd., StemCyte India Therapeutics Pvt. Ltd, PerkinElmer Inc, Global Cord Blood Corporation., Smart Cells International Ltd., Vita 34 among other domestic and global players.

Key Pointers Covered in the Bone Marrow-Derived Stem Cells (BMSCS) Market Industry Trends and Forecast

TheBone Marrow-Derived Stem Cells (BMSCS) marketreport provides successfully marked contemplated policy changes, favorable circumstances, industry news, developments, and trends. This information can help readers fortify their market position. It packs various parts of information gathered from secondary sources, including press releases, web, magazines, and journals as numbers, tables, pie-charts, and graphs. The information is verified and validated through primary interviews and questionnaires. The data on growth and trends focuses on new technologies, market capacities, raw materials, CAPEX cycle, and the dynamic structure of the Bone Marrow-Derived Stem Cells (BMSCS) market.

Major Regions as Follows:

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The report includes accurately drawn facts and figures, along with graphical representations of vital market data. The research report sheds light on the emerging market segments and significant factors influencing the growth of the industry to help investors capitalize on the existing growth opportunities.

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Table Of Contents: Bone Marrow-Derived Stem Cells (BMSCS) Market

Part 01:Executive Summary

Part 02:Scope of the Report

Part 03:Research Methodology

Part 04:Market Landscape

Part 05:Pipeline Analysis

Part 06:Market Sizing

Part 07:Five Forces Analysis

Part 08:Market Segmentation

Part 09:Customer Landscape

Part 10:Regional Landscape

Part 11:Decision Framework

Part 12:Drivers and Challenges

Part 13:Market Trends

Part 14:Vendor Landscape

Part 15:Vendor Analysis

Part 16:Appendix

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To summarize:

The global Bone Marrow-Derived Stem Cells (BMSCS) market report studies the contemporary market to forecast the growth prospects, challenges, opportunities, risks, threats, and the trends observed in the market that can either propel or curtail the growth rate of the industry. The market factors impacting the global sector also include provincial trade policies, international trade disputes, entry barriers, and other regulatory restrictions.

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Bone Marrow-Derived Stem Cells (BMSCS) Market To Witness Relatively Significant Growth During Forecast to 2027 The Courier - The Courier

Bone Marrow Stem Cells Comments Off on Bone Marrow-Derived Stem Cells (BMSCS) Market To Witness Relatively Significant Growth During Forecast to 2027 The Courier – The Courier | March 8th, 2021

PHOENIX, March 4, 2021 /PRNewswire/ --(OTC - CELZ)Creative Medical Technology Holdings announced today a publication in the pre-print server SSRN describing data from its first 15 patients treated in a clinical trial evaluation perispinal injection of bone marrow cells in patients with disc degenerative disease. Evaluation of patients at 30,60 90, 180, and 360 days revealed significant improvement in mobility and reduction in pain score . The mean pain changed from 8.9 at baseline to 4.3 at 30 days and sustained to 1.8 at 6 months and 1.3 at 12 months with a gradual reduction in overall pain medication utilization guided by their healthcare team. No serious adverse effects were noted with some short-term bruising in two patients at the harvest site and no long term adverse events where reported related to the procedure.

"This publication, which is "pre-peer review" describes what to our knowledge is the first demonstration of a signal of clinical efficacy by injecting stem cells in areas surrounding the disc." Said Dr Amit Patel, Board Member and Co-Founder of the Company. "While others have intra-disc injection may help disc pain, the current work regenerates the blood supple to the disc, allowing the disc to heal itself."

The autologous utilization of bone marrow falls under the "minimal manipulation exception" and can be commercialized rapidly, in the same manner that the Company commercialized Caverstem for treatment of erectile dysfunction.

Granted United States Patent #9,598,673 which is owned by the Company covers the use of any mesenchymal stem cells, both from the patient or from donors, for reduction of lower back pain when injected into the major muscles of the lower back.

"Disc degenerative disease represents a multi-billion dollar market for which current medical solutions do not address the underlying cause, while surgery is expensive and not applicable for a significant number of patients." Said Timothy Warbington, President and CEO of the Company. "We are excited to follow the path we did with CaverStem and initiate commercialization of this technology for American patients."

To view our Publication: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3797402

About Creative Medical Technology HoldingsCreative Medical Technology Holdings, Inc. is a commercial stage biotechnology company specializing in regenerative medicine/stem cell technology in the fields of immunotherapy, urology, neurology and orthopedics and is listed on the OTC under the ticker symbol CELZ. For further information about the company, please visitwww.creativemedicaltechnology.com.

Forward Looking StatementsOTC Markets has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This news release may contain forward-looking statements including but not limited to comments regarding the timing and content of upcoming clinical trials and laboratory results, marketing efforts, funding, etc. Forward-looking statements address future events and conditions and, therefore, involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated in such statements. See the periodic and other reports filed by Creative Medical Technology Holdings, Inc. with the Securities and Exchange Commission and available on the Commission's website atwww.sec.gov.

http://www.StemSpine.comwww.CaverStem.comwww.FemCelz.com

SOURCE Creative Medical Technology Holdings, Inc.

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Creative Medical Technology Holdings Publishes Efficacy in Pain Reduction and Mobility in Patients with Disc Degenerative Disc Using StemSpine...

Bone Marrow Stem Cells Comments Off on Creative Medical Technology Holdings Publishes Efficacy in Pain Reduction and Mobility in Patients with Disc Degenerative Disc Using StemSpine… | March 8th, 2021

Jakobe Kobe Washington is eight years old, loves baseball and is fighting an aggressive form of leukemia.

The Florida boy, who is known to pray for other kids in the hospital, needs life-saving blood stem cells or a bone marrow transplant. So far, his family has been unable to find a match.

On Saturday, Be The Match and the Icla da Silva Foundation will host a drive-through swab event at Irving Mall to try to find a match for Kobe, who has extended family in North Texas.

Its tough to see your kid fighting a fight, and you cant do anything but be there to support him, no control in it at all, Kobes father Jordan Washington, who is from Dallas, told the ABC affiliate in Tampa Bay, Fla.

Every year, more than 12,000 patients turn to Be The Match, a national marrow donation program, to search for blood stem cells or a bone marrow donor to help cure them of blood cancers, such as leukemia and lymphoma, according to a release about the event.

Roughly half of those patients are unable to find a match, with only 23% of Black patients like Kobe finding a match, compared to 77% of white patients, according to the Icla da Silva Foundation, which serves as a recruitment center for Be The Match and focuses on minority populations.

Thats because race and ethnicity play a key role in stem cells and marrow, and of the 22 million potential donors on the registry, only 4% are Black.

Potential donors ages 18 to 44 are encourages to go to the Irving Mall, 3880 Irving Mall, between 10 a.m. and 2 p.m. Saturday.

Participants will then register from their phones and take a swab of their inner cheek.

Those unable to attend can text 4Kobe to 61474 to complete the online registration and have a cheek swab kit sent to their home.

Follow this link:
An 8-year-olds search for bone marrow match in battle with leukemia comes to North Texas - The Dallas Morning News

Bone Marrow Stem Cells Comments Off on An 8-year-olds search for bone marrow match in battle with leukemia comes to North Texas – The Dallas Morning News | March 8th, 2021

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Mar 3, 2021--

Magenta Therapeutics (Nasdaq: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplants to more patients, today reported financial results for the fourth quarter and full-year ended December 31, 2020 and recent program highlights.

Building on our momentum from 2020, we continue to advance our portfolio with now two active Phase 2 clinical trials evaluating MGTA-145 plus plerixafor in patients with blood cancers undergoing autologous and allogeneic stem cell transplant and an additional planned Phase 2 clinical trial evaluating stem cell mobilization and collection in patients with sickle cell disease in partnership with bluebird bio. We have also made additional progress in our preparations for an IND filing for our MGTA-117 targeted conditioning program based on communications with the FDA and the advancement of our IND-enabling studies, said Jason Gardner, D.Phil., President and Chief Executive Officer, Magenta Therapeutics. We very much look forward to generating clinical data during the course of 2021 in these multiple disease settings.

MGTA-145: Stem Cell Mobilization and Collection for Hematopoietic Stem Cell Transplantation and Gene Therapy

Magenta is developing MGTA-145 plus plerixafor to harness these agents complementary mechanisms to mobilize hematopoietic stem cells (HSCs) for collection and transplantation, including for use with gene therapies. The ability to provide rapid, reliable, predictable and safe mobilization and collection of HSCs in stem cell transplantation and gene therapy could position MGTA-145 plus plerixafor to be the preferred mobilization regimen across multiple diseases due to improved patient experience and collection outcomes.

MGTA-145 Current and Planned Activity:

MGTA-145 Recent and Upcoming Scientific Conference Presentations:

MGTA-117: Targeted Conditioning

Magenta is developing a platform of novel antibody-drug conjugates (ADCs) for conditioning, a step in the transplant process that currently relies on the use of systemic chemotherapy agents and radiation. Magentas targeted conditioning programs are designed to selectively eliminate stem cells and/or immune cells from a patient prior to transplant or gene therapy, and to reduce or potentially eliminate the need for high dose or high intensity chemotherapy-based regimens.

MGTA-117, Magentas most advanced conditioning program, is a CD117-targeted antibody conjugated to amanitin and intended for use in patients undergoing transplant. MGTA-117 is designed to deplete hematopoietic stem and progenitor cells to clear space in the bone marrow prior to transplant in support of long-term engraftment and improved disease outcomes in patients. MGTA-117 has shown high selectivity, potent efficacy and tolerability in multiple preclinical studies.

Targeted Conditioning Current and Planned Activity:

Targeted Conditioning Recent and Upcoming Scientific Conference Presentations:

Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2020, were $148.8 million, compared to $145.7 million as of December 31, 2019. Magenta anticipates that its cash, cash equivalents and marketable securities will be sufficient to fund operations and capital expenditures into 2023.

Research and Development Expenses: Research and development expenses were $12.3 million in the fourth quarter of 2020, compared to $18.7 million in the fourth quarter of 2019. The decrease was driven primarily by decreased preclinical costs for manufacturing related to the conditioning programs, lower manufacturing and clinical trial costs due to the discontinuance of enrollment in the Phase 2 clinical trial of MGTA-456 in inherited metabolic diseases in June 2020 and lower clinical trial costs for the MGTA-145 Phase 1 clinical trial which was completed in the first quarter of 2020.

General and Administrative Expenses: General and administrative expenses were $6.8 million for the fourth quarter of 2020, compared to $5.9 million for the fourth quarter of 2019. The increase was primarily due to an increase in personnel costs, professional services and insurance costs associated with Magentas expanded clinical trial preparations.

Net Loss: Net loss was $18.2 million for the fourth quarter of 2020, compared to net loss of $23.2 million for the fourth quarter of 2019.

About Magenta Therapeutics

Magenta Therapeutics is a clinical-stage biotechnology company developing medicines to bring the curative power of immune system reset through stem cell transplant to more patients with blood cancers, genetic diseases and autoimmune diseases. Magenta is combining leadership in stem cell biology and biotherapeutics development with clinical and regulatory expertise, a unique business model and broad networks in the stem cell transplant community to revolutionize immune reset for more patients.

Magenta is based in Cambridge, Mass. For more information, please visit http://www.magentatx.com.

Follow Magenta on Twitter: @magentatx.

Forward-Looking Statement

This press release may contain forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 and other federal securities laws, including express or implied statements regarding Magentas future expectations, plans and prospects, including, without limitation, statements regarding expectations and plans for presenting pre-clinical and clinical data, projections regarding future revenues and financing performance, our long-term growth, cash, cash equivalents and marketable securities, the anticipated timing of our clinical trials and regulatory filings, the development of our product candidates and advancement of our preclinical programs, the timing, progress and success of our collaborations, as well as other statements containing the words anticipate, believe, continue, could, endeavor, estimate, expect, anticipate, intend, may, might, plan, potential, predict, project, seek, should, target, will or would and similar expressions that constitute forward-looking statements under the Private Securities Litigation Reform Act of 1995. The express or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: uncertainties inherent in clinical studies and in the availability and timing of data from ongoing clinical studies; whether interim results from a clinical trial will be predictive of the final results of the trial; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future trials; the expected timing of submissions for regulatory approval or review by governmental authorities; regulatory approvals to conduct trials or to market products; whether Magenta's cash resources will be sufficient to fund Magenta's foreseeable and unforeseeable operating expenses and capital expenditure requirements; risks, uncertainties and assumptions regarding the impact of the continuing COVID-19 pandemic on Magentas business, operations, strategy, goals and anticipated timelines, Magentas ongoing and planned preclinical activities, Magentas ability to initiate, enroll, conduct or complete ongoing and planned clinical trials, Magentas timelines for regulatory submissions and Magentas financial position; and other risks concerning Magenta's programs and operations are described in additional detail in its Annual Report on Form 10-K expected to be filed on or about March 3, 2021, its Quarterly Reports on Form 10-Q and its other filings made with the Securities and Exchange Commission from time to time. Although Magenta's forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Magenta. As a result, you are cautioned not to rely on these forward-looking statements. Any forward-looking statement made in this press release speaks only as of the date on which it is made. Magenta undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.

2020

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12,256

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50,615

59,208

6,809

5,923

28,087

23,761

19,065

24,637

78,702

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(19,065

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(24,637

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(78,702

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(82,969

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897

1,400

3,766

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Magenta Therapeutics Reports Fourth Quarter and Full-Year 2020 Financial Results and Recent Program Highlights - Tullahoma News and Guardian

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COSELA is the first myeloprotection therapy indicated to reduce the incidence of chemotherapy-induced myelosuppression in adult patients. Credit: G1 Therapeutics. Small cell lung cancer represents nearly 10% to 15% of all lung cancer cases. Credit: BonD80 / Shutterstock. Trilaciclib is a competitive inhibitor of cyclin dependent kinases 4 and 6 (CDK4/6). Credit: StudioMolekuul / Shutterstock.

COSELA (trilaciclib) is the first approved myeloprotection therapy indicated to reduce the occurrence of chemotherapy-induced bone marrow suppression in adult patients.

Developed by G1 Therapeutics (GTHX), a US-based clinical-stage biopharmaceutical company, the drug is available in a single-dose vial as a sterile, preservative-free, yellow lyophilised cake in a 300mg dosage strength for intravenous administration.

In June 2020, G1 Therapeutics signed a three-year co-promotion agreement with German pharmaceutical firm Boehringer Ingelheim (BI) to jointly promote trilaciclib for the treatment of small cell lung cancer in the US and Puerto Rico.

Under the agreement, G1 Therapeutics will lead marketing, market access and medical engagement initiatives for COSELA while Boehringer Ingelheim will undertake salesforce engagements.

In August 2020, China-based Simcere Pharmaceutical Group was granted the development and commercialisation rights of the drug in all indications for Greater China.

The New Drug Application (NDA) for trilaciclib was submitted to the US Food and Drug Administration (FDA) in June 2020 and granted priority review in August 2020.

In February 2021, the FDA approved trilaciclib to reduce chemotherapy-induced myelosuppression in extensive-stage small cell lung cancer (ES-SCLC) patients, prior to chemotherapy treatments involving platinum-etoposide or topotecan options. The FDA also bestowed breakthrough therapy designation to trilaciclib in August 2019.

Myelosuppression, also known as bone marrow suppression, is a chemotherapy-induced bone marrow damage condition that lowers blood cell production.

Although chemotherapy drugs are used to destroy cancer cells, they can also cause damage to healthy cells in the bone marrow such as hematopoietic stem and progenitor cells (HSPCs), which produce white blood cells, red blood cells and platelets.

Myelosuppression is a side effect of chemotherapy and occurs when the hematopoietic stem and progenitor cells are damaged by chemotherapy treatment, thereby suppressing the ability of bone marrow to produce blood cells.

The common symptoms associated with myelosuppression include fatigue, shortness of breath, and dizziness. Myelosuppression can also lead to serious blood cell diseases such as anaemia, neutropenia and thrombocytopenia.

Trilaciclib is a transient and competitive inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6). The drug delivers a myeloprotective therapy against chemotherapy-induced bone marrow suppression by inhibiting CDK4/6 that regulates cell cycle.

By inhibiting CDK4/6, trilaciclib temporarily and reversibly induces G1 cell cycle arrest in hematopoietic stem and progenitor cells (HSPCs) and prevents transition to the synthesis phase (S phase) of cell cycle, thus protecting the HSPCs from the damaging effects of chemotherapy and maintaining the normal function of the bone marrow.

COSELAs FDA approval was based on the outcome of three randomised, double-blind, placebo-controlled clinical trials in patients with extensive-stage small cell lung cancer. The effectiveness of drug was evaluated in combination with carboplatin-etoposide, with or without atezolizumab and topotecan chemotherapy.

The studies randomly enrolled 245 patients to receive either intravenous (IV) trilaciclib or placebo prior to the start of chemotherapy.

The primary endpoints of the studies were the percentage of patients with severe neutropenia and its duration during the first chemotherapy cycle.

The trials demonstrated clinical reduction in the duration and severity of neutropenia among ES-SCLC patients who received trilaciclib before chemotherapy.

A positive impact on red blood cell transfusions and other myeloprotective measures was also observed.

The most frequent side effects observed in the patients during the clinical trials were fatigue, hypophosphatemia, hypocalcaemia, hypokalaemia, headache, high aspartate aminotransferase levels and pneumonia. More than 3% of the patients who received COSELA experienced serious adverse reactions, including respiratory failure, haemorrhage and thrombosis.

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COSELA (trilaciclib) for the Treatment of Chemotherapy-Induced Myelosuppression - Clinical Trials Arena

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Eight labs who were recipients of the University Cancer Centers funding in December for projects advancing cancer research will use the funds to delve into cancer biology, cancer therapeutics and population science.

Four of the eight projects are investigating immunotherapy for gastrointestinal cancers, the tumor environments impact on cancer cell growth, the potential application of an FDA-approved Parkinsons drug to treat glioma brain tumors and the ability of a novel drug to target cancer cells that exhibit heightened aggressiveness following immunotherapy, The Herald previously reported.

The Herald spoke with three of the four other principal investigators that received grants.

Assistant Professor of Medicine Hina Khans pilot project will study the effects of blocking the antibody for chitinase 3-like-1, or CHI3L1, in advanced non-small cell lung cancer. CHI3L1 is a protein that plays an important role in tissue repair, and elevated levels of the protein indicate poor outcomes in advanced stage cancer patients. The researchers will test whether blocking the antibody a molecule that binds CHI3L1 will prevent cell resistance to immune checkpoint inhibitors in this type of lung cancer.

Assistant Professor of Medicine Olin Liang is interested in exploring womens ability to fight off leukemia and other blood diseases later in life relative to men. While the effect of aging on blood cancer development has been well-studied, not much research has gone into studying sex differences, Liang said.

Past work from the Liang lab has shown that the bone marrow environment remains healthier longer in women, leading to better blood cell production and immune response. By transplanting bone marrow stem cells from young male mice into middle-aged male and female mice, the researchers were able to compare the expression of these cells amongst the two sexes. They found higher expression in female middle-aged mice, which is indicative of a healthier bone marrow environment. This observation was due to receptors molecules that can interact with hormones to produce a response in a cell on the surface of bone marrow stem cells that were uniquely responsive to sex hormones predominantly found in women.

We have narrowed it down to two sex hormone receptors that may play a role, Liang said, referring to the receptors for follicle-timulating hormone and androgen hormone. The lab plans to use the Cancer Center pilot project funds to further study the importance of these receptors.

Using gene editing technology, the researchers plan on removing genes that code for these hormone receptors from model organisms. This step will allow them to test the effect that the loss of one or both of the receptors has on female stem cell expression levels. If the elimination of the sex hormone receptor diminishes stem cell expression, that may indicate that the receptor plays a regulatory role.

The Liang lab believes that results from these experiments will not only offer greater insight to the development of blood cancers, but also help in the formulation of sex-specific treatments. Liang hopes this research leads to treatments that enhance the male (blood cell producing) system to reduce risk of age-related blood cancer, or even other diseases.

Assistant Professor of Molecular Biology, Cell Biology and Biochemistry Mamiko Yajima studies the expression of germline molecules, which are normally only expressed during development, and how they contribute to plasticity, or the cells adaptability. Her pilot project will focus on the specific germline factor DEAD-Box Helicase 4 (DDX4), which has been found to be abnormally expressed in the tumors of certain cancers, such as small cell lung cancer and melanoma.

Yajimas lab has previously studied the expression of DDX4 in cells and organisms like sea urchins and mice. She plans to test if (DDX4) actually contributes to plasticity in the context of cancer. Yajima believes that as a germline factor, DDX4 may increase cancer cells adaptability, allowing them to develop drug resistance and migrate throughout the body more frequently.

The Yajima lab plans on using the Cancer Center funding to partner with Director of Thoracic Oncology at Rhode Island Hospital Christopher G. Azzoli and Associate Professor of Pathology and Laboratory Medicine Maria L. Garcia-Moliner to analyze DDX4 expression in cancer patient samples.

I applied for this funding with the specific goal to have access to clinical samples, Yajima said. This next stage of the project will facilitate collaboration between me, a basic biologist, and physician scientists that have the expertise to help me answer the question I want to study in a clinical setting.

To identify whether DDX4 expression correlates with patient survival, the lab will also use the funds to conduct clinical data mining of patient gene expression using the Universitys supercomputer.

Associate Professor of Dermatology and Epidemiology Eunyoung Cho studies the role of dietary factors in the development of chronic diseases. Previous work from Chos lab found that eating foods containing high levels of citrus, such as grapefruits, oranges and figs, is associated with an increased risk of skin cancer. The Cho lab plans to use the Cancer Center pilot project funds to determine the component of citrus fruit responsible for the increased risk of melanoma, the most fatal type of skin cancer.

Cho believes that furanocoumarins, a class of compounds present in high levels in citrus fruits, are what lead to the higher rates of skin cancer. These compounds can absorb ultraviolet radiation from sunlight and become activated, damaging DNA and causing mutations that can result in cancer.

To test this hypothesis, Cho has partnered with Associate Professor of Medical Science Elena Oancea, who specializes in melanoma research at the molecular level. They plan on measuring whether melanin-forming skin cells show increased levels of DNA damage when exposed to furanocoumarins and UV light.

If their data supports that furanocoumarins increase risk of cancer, this could open the door to population-based studies. Cho described one potential future direction as assessing whether furanocoumarin levels in human urine samples are indicative of melanoma risk.

Its very interesting to think about citrus fruit is something you eat all the time, Cho said. People dont understand that when you eat grapefruit (and) then go into the sunlight, you may actually increase your chance of (getting) skin cancer.

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U. Cancer Center pilot projects: investigating cancer connections - The Brown Daily Herald

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EDMONTON -- Thirteen months old with her health deteriorating in an orphanage in China, Hosanna Crowell was introduced to a Canadian couple, Greg and Cathy Crowell, who would prove to be game changers in her life.

"I remember when they first handed her to us in the orphanage and we looked at her and she had such determination and this frail, little body," remembers Cathy Crowell. "She was sucking her two little fingers, looking around and taking it all in. I said to my husband, she's a fighter."

Now 14, Hosanna has never stopped fighting. Born with a heredity condition called Beta Thalissemia Major, her bone marrow produces deformed blood cells, preventing oxygen from sticking to them. Without the blood of donors, her organs would be starved of oxygen. Every two weeks she visits the Stollery Children's Hospital where she receives her transfusions. To date, she's had 286. But with other people's blood, comes complications. Each night she's given intravenous drugs over 11 hours to keep her body working.

"Right now it's becoming a burden to me," says Hosanna Crowell. "I have to get poked so much my veins are becoming really scar tissued and it's starting to be really hard to find spots."

The only cure is a stem cell transplant. "In terms of any individual, a sibling will have a one-in-four chance of being a match for any individual," says pediatric hematologist Dr. Catherine Corriveau-Borque.

The journey to find a match has been years in the making. "It's like finding a needle on the bottom of the ocean. It's way harder than in a haystack," according to Crowell.

A post on the Chinese version of Facebook garnered a lot of attention, viewed more than 27 million times. "The process was quite something and then seeing the response from China with so many people and it going viral... wow," recounts Crowell from her Stony Plain home. "The kindness of strangers just so impacted us."

The posts reached Hosanna's biological family. Her mother and father as well as two siblings came forward, did the DNA testing and underwent a procedure to see if there was a match. "Yes," says Hosanna Crowell, "one of my siblings is a perfect match."

A stem cell transplant is now scheduled for late 2021. The cost to make this happen sits around $80,000 to cover incidentals such as travel visas, transportation, accommodation and COVID-19 testing. A GoFundMe campaign is a quarter of the way there.

"Really we're just trying to jump through all the little hoops to get them here," Crowell adds. "This is an amazing thing that's happened, we've been given a gift for our daughter and we're very grateful. I also feel for people who are waiting for a donor and so I just encourage people to go and get tested, it's a simple thing. You can change someone's life forever."

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'Like finding a needle on the bottom of the ocean': Local teen finds perfect bone marrow match - CTV News Edmonton

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SASKATOON -- An effort to increase stem cell donors within Black communities across Canada is being driven by a group of women whove had difficulty finding full genetic matches themselves.

Genetic matches are crucial for patients in need of stem cell transplants, such as those with leukemia and lymphoma, and matches are more commonly found within their own racial, ethnic and ancestral groups.

But the new Black Donors Save Lives campaign notes that fewer than two per cent of those in the Canadian Blood Services stem cell donor registry are Black.

And that decreases their chance of finding a match, campaign lead Sylvia Okonofua told CTVNews.ca in a phone interview. It becomes a numbers game for Black people on the stem cell waiting list, where its like finding a needle in a hay stack for them.

The recent University of Regina biochemistry graduate, with sights on becoming a hematologist, timed the virtual campaign to kick off during Black History Month.

It was overall frustrating to know that a patient from my community is so much less likely than other patients to be helped, she told CTVNews.ca. When you see that your people have a really, really low chance of being helped out, it takes you aback.

Okonofua noted part of the campaign uses TikToks, shareable infographics, and even an original song to get the message out and reach a wide audience.

And she said part of the outreach involves having Black stem cell recipients talk about their experiences with the health-care system and speak to the historical mistrust the Black community has towards the medical community.

She founded her campus chapter of Stem Cell Club, a non-profit organization with chapters across Canada which recruits Canadians as potential stem cell donors.

Registration for Black Donors Save Lives can be done online, where participants between the ages of 17 to 35 can fill out a questionnaire and have a swab kit mailed to their address. After they swab the inside of their cheeks and send the sample back, if there is a person in need, 90 per cent of donors will be asked to donate stem cells very similar to the way a person would be giving blood.

But a big difference is the donor is given a growth hormone a week before donation in order to increase the number of stem cells, as well as the process taking four to six hours.

Alternatively, one out of 10 donors will be asked if theyd like to donate stem cells via bone marrow surgery, which can take place over a day.

In 2017, Reve Agyepong experienced firsthand the lack of Black stem cell donors, to treat her sickle cell disease, which involve red blood cells becoming misshapen, which can block blood vessels and lead to damage to bones, brain, kidneys, and lungs, and can ultimately be fatal.

But Agyepong, who was born in Edmonton to Ghanaian parents, was fortunate to receive a stem cell transplant from her sister.

It is such a blessing to have a match within your own family because the percentages are just so low, she told CTVNews.ca by email. I am so fortunate to have found a match in my family or else transplant would have been off the table for me.

In fact, only one in four patients who need a stem cell transplant are able to find a matched donor within their family, with Black patients being less than half as likely as white patients to find a unrelated person they match with on a donor registry, according to the campaign.

For Jamaican-Canadian Dorothy Vernon-Brown, who helped inspire this months campaign, the current efforts are deeply personal. In 2013, she was diagnosed with acute myeloid leukaemia and was heartbroken to discover there were no stem cell matches in Canada's registry or internationally.

She ultimately received stem cells from her sister, who was a half-match, and has been spreading information to Black Canadians ever since, through her own advocacy group, Donor Drive for Dorothy.

Stem cell transplantation is a miracle for patients, and I wish people knew how easy it is to be a stem donor, she recounted on a Twitter thread for another stem cell awareness campaign. You could give someone an opportunity like my sister gave me, to be around and live the life I want. People want to live, so if that gift is in your hands, I appeal to you to see it as something significant to do in your life.

Okonofua and Vernon-Browns efforts are being aided by Dr. Warren Fingrut, a hematologist whos the director of the aforementioned Stem Cell Club.

He told CTVNews.ca in an email hes seen firsthand far too many patients from ethnic and racial minority groups in situations where they dont have fully-matched donors and are forced to seek other treatments.

I find this heart wrenching and I am very motivated to work to address this, Fingrut said.

That led to him founding his non-profit a decade ago, which has gone on to recruit more than 20,000 Canadians as stem cell donors, with more than 55 per cent being non-white. But in cases such as Vernon-Brown and others, those figures need to be much higher.

We started running national campaigns last year, focused on the recruitment of diverse peoples as donors, as well as males who are also preferred by transplant physicians (all else being equal) as they are associated with better outcomes for patients, Fingrut explained.

The campaign is also being done in partnership with several other groups, including the Katelyn Bedard Bone Marrow Association, Black Physicians of Canada, Black Medical Students Association of Canada and the National Black Law Students Association of Canada.

This campaign is one example of an initiative in the health-care sector, which seeks to address racial disparity impacting the care of Black patients, he wrote, noting Black people face many such disparities in access to care, and we want to see others in the health-care sector working with Black Canadians to tackle these issues and address them, in collaboration with Black communities.

Okonofua hopes next Black History Month, theyll be able to have in-person swabbing events in places of worship, community hubs, and cultural gatherings to show how easy it is.

Fingrut said this the first time his group has specifically engaged with one racial group and hopes to expand it to other ethnic and racial communities including South Asians, Indigenous peoples, and those of mixed ancestry in the near future.

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Meet the women hoping to recruit more stem cells donors from Black communities - CTV News

Bone Marrow Stem Cells Comments Off on Meet the women hoping to recruit more stem cells donors from Black communities – CTV News | February 19th, 2021

The life-changing phone call came at 4:30 in the morning on Christmas Eve.

All of a sudden, Ashley Peddle went from making final preparations for the holiday season to planning cancer treatments that had to start within days.

The East Greenwich resident, 37, had been experiencing fatigue, shortness of breath and headaches for some time, but when her husband Ryan encouraged her to get checked out, she chalked it up to being a busy mother of four kids 10 and younger. Finally, in the week leading up to Christmas, her symptoms became too much to bear as she could not even climb the steps in her house and was falling asleep on the couch around dinnertime.

She saw a doctor and later some troubling results of blood tests led to the early-morning phone call to get to the hospital immediately.

We rushed right to the emergency room and in about an hour or two, our world was kind of rocked with the diagnosis of leukemia, Ryan Peddle says. (Penn Medicine) was great and started her treatment right away because the type of leukemia she has is very aggressive, so the sooner she started, the better.

Two months and two rounds of chemotherapy after being told she has acute myeloid leukemia, Peddles prognosis is good, her husband said, but she is not out of the woods yet. She recently returned home after a six-week hospital stay but will soon go back to receive a stem cell transplant, also known as a bone marrow transplant, which will help restore her bone marrow, produce healthy blood cells and strengthen her immune system. In turn, she will be better suited to fighting the leukemia and preventing a reoccurrence down the line.

The best donors for stem cell transplants are usually a family member such as a sibling, but if they are not a match, an unrelated volunteer whose tissue type matches that of the patient may be used. Not only have Ashley and Ryan become educated about the process throughout their ordeal, but so have a group of Ashleys friends, who decided to take action when they learned how badly donors are needed.

Shawn Keating, also of East Greenwich, took the lead and helped organize a drive-thru bone marrow registration event in Peddles honor, which will be held this Saturday, Feb. 20, from 10 a.m. until 2 p.m., at Samuel Mickle School, 559 Kings Highway, in Mickleton. Sponsored by Be The Match which runs the largest and most diverse bone marrow registry in the world to help people battling blood cancers like leukemia and lymphoma the event will allow adults between the ages of 18 and 44 to join the national list of potential donors.

Ashley Peddle was diagnosed with leukemia and is in need of a bone marrow transplant. A registration event is being held Feb. 20 from 10 a.m. until 2 p.m. at Samuel Mickle School, 559 Kings Highway, in Mickleton.

In addition to supporting Peddle, who she has become friends with through their childrens sports and school activities, Keating had two other reasons for getting involved.

Her kids are the same age as mine and when you see this happen to somebody, you realize it could happen to anybody, she said. The other thing was, I went to sign myself up for Be The Match and I realized that at one point I had already requested the kit and in the busyness of things, I must have forgotten to send it back. So I reached out to them, got to talking and thought this was the best option, especially for busy people. Its as easy as driving through, getting swabbed and being done. I just thought it would be an easier way to get as many people on the registry as possible.

Bree Amborn works for an organization called The Icla da Silva Foundation, which is a recruitment center for Be The Match, and she will be running Saturdays event. She said people can expect a simple process to getting registered, as they just need to fill out some forms on their phone and do a swab in each cheek for 10 seconds without even leaving their car.

Those who cannot attend but still want to join Be The Match can text PeddleStrong to the number 61474 or visit join.bethematch.org/PeddleStrong and have a kit mailed to their home. Amborn added that it is especially important to increase the numbers of donors in the African-American community, as Black patients chances of finding a match are only 23%, compared to 77% for white patients.

The need is super, super high to add more people and to work in diverse communities and increase those populations on the registry as well, she said, so if a patient is a person of color they have the same chances of finding their match as if the patient is white.

Amborn will be able to answer any questions people have on Saturday. She was actually a donor herself while in college; after signing up she found out she was a match for a 50-year-old woman battling myelofibrosis.

It was an extremely easy process and Be The Match was awesome, she said. They pay for everything, they organize everything and they schedule everything, and as the donor you just show up. Youre literally able to change someones life.

I think people have a misconception of how the donation process works, but 80% of the time the donation is actually taken from your bloodstream. It looks very similar to donating platelets, where you have a needle in each arm, they take blood out of one arm, they separate your stem cells from your blood and give you your blood back in the other arm. Theres a couple more steps to the process but thats really the basics. Youre awake the whole time and its not a surgery.

Keating is hopeful that when people hear that, their fears will disappear and they will be eager to register. She doesnt know what to expect for Saturdays turnout, predicting, we could get 50 people or we could get 300. But already the response in East Greenwich has been impressive, with more than 50 volunteers slated to be in attendance.

Some, like Keating and Jacqueline DAngelis, are bringing their teenaged children to help as well.

Like I told my daughter, we cant cure cancer, but we can certainly help others by collecting these swabs, said DAngelis, a neighbor of the Peddles who has known them for seven years.

Theres going to be a lot of people from our community out there this weekend to support Ashley and support this mission to increase that number. Ashley is such a wonderful part of the community and its nice to see how everyone can band together and try to make something good out of this difficult and trying situation for her family. Its nice to see so many families parents and their teenagers coming out to volunteer in the cold in the middle of a pandemic to do something nice.

Although the Peddles have been quarantining since Ashley returned home because her immune system is compromised, Ryan plans on stopping by the event and showing his appreciation for the volunteers and those joining the list.

I didnt know anything about the registry beforehand or else Id have been on it, he said. Thats one of the reasons were pushing this drive, to get as many people on the registry as we can. They may not help Ashley but theyll help someone just like her.

He said his wifes spirits have remained high during her treatment. One of the toughest parts was when she was in the hospital and could not get in-person visits from their daughter and three sons, ages 10, 8, 7 and 4. They were able to FaceTime frequently, however, for much-needed emotional support.

The family is also grateful for the outpouring of assistance from those around them.

Were honestly overwhelmed by the support weve received, Ryan said. Our kids are pretty active in sports and other activities in the township, and through that weve made a lot of really good friendships and met a lot of really great people. So many of them are stepping up, not only for this drive but to give blood, to donate platelets, to cook meals, to drop off little things for the kids like Valentines. Its just been overwhelming and we couldnt be more proud of the town we live in.

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N.J. mom of 4 has leukemia. A bone marrow registry is being held Saturday. - nj.com

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In people with polycythemia vera (PV), the bone marrow produces too many blood cells. This overproduction can lead to complications, such as abnormal blood clotting, unusual bleeding, and an enlarged spleen.

In rare cases, scar tissue may replace the bone marrow. When this happens, the bone marrow can no longer produce enough healthy blood cells. Experts refer to this condition, which is a type of chronic leukemia, as myelofibrosis (MF). It can sometimes lead to acute myeloid leukemia, though this is rare.

People with PV have a shorter-than-average life expectancy. Some of the possible complications of the disease can be life threatening.

Getting treatment can help reduce the risk of certain complications from PV, including blood clots. As a result, a person will likely lead a longer and healthier life with this disease if they receive treatment.

According to an article in Blood Cancer Journal, the median survival time for people with PV is 14 years after diagnosis. The authors take this survival time from a study in which half of the participants were still alive 14 years after diagnosis.

Younger people tend to live for longer with the disease. Research suggests that the median survival time for those under 60 years of age is 24 years following diagnosis.

Multiple factors affect the outlook and life expectancy of people with PV, including:

Blood clots are the most common cause of death in people with PV. When blood clots form in blood vessels, they can block the flow of blood to vital organs. This can lead to life threatening complications, such as stroke, heart attack, and venous thrombosis.

Treatment for PV can help relieve symptoms and lower the risk of blood clots. In this way, it also reduces a persons risk of life threatening complications.

In most cases, healthcare providers prescribe regular blood draws to treat PV. Blood draws reduce the number of blood cells in the body, which may help improve blood flow.

Healthcare providers may also prescribe low dose aspirin to help prevent the formation of blood clots. Additionally, they may prescribe other medications, such as hydroxyurea (Hydrea) or busulfan (Myleran).

If a person develops MF as a complication of PV, their healthcare provider may prescribe one or more of the following treatments:

These treatments may help improve symptoms, increase life expectancy, or both.

For example, scientists have found that stem cell transplants may help improve long-term survival in people with MF. However, this treatment comes with a high risk of life threatening side effects. It is especially risky for older adults and people with other health conditions. As a result, healthcare providers often avoid prescribing this treatment.

Some studies have found that treatment with JAK inhibitors may also improve survival rates in people with MF. However, when scientists reviewed the available evidence on Jakafi and Inrebic, they found that the quality of evidence on survival rates is limited. More research is necessary to confirm how these treatments affect life expectancy.

Early research involving people with PV found that the median survival time for those who did not receive treatment was less than 2 years after diagnosis. This research took place before the medical community recognized blood draws as a treatment option, and it reflects the high risk of blood clots in people not receiving treatment.

People with PV who do not receive treatment are more likely to develop blood clots. According to the Leukemia & Lymphoma Society, 4060% of people with untreated PV may develop blood clots within 10 years of diagnosis.

Scientists have not yet developed a cure for PV. However, healthcare providers may prescribe blood draws, medications, or other treatments to help manage symptoms, reduce the risk of complications, and increase life expectancy in people with this disease.

Researchers are also continuing to develop and test potential new treatments for PV, such as the anticancer drug imatinib mesylate (Gleevec) and novel types of JAK inhibitors.

In some cases, a persons healthcare provider may encourage them to take part in a clinical trial. In this type of study, participants receive an experimental treatment. People interested in learning more about the potential benefits and risks of taking part in a clinical trial can talk with their healthcare provider or the researchers running the study.

When a person receives a diagnosis of PV, getting treatment is important. Treatment may help minimize symptoms, lower the risk of complications, and improve life expectancy.

A persons recommended treatment plan for PV will depend on many factors, including their age, overall health, and whether they have developed certain complications.

People with PV who wish to learn more about their treatment options and outlook should talk with their healthcare provider.

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Polycythemia vera life expectancy: With treatment and more - Medical News Today

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Novartis and the Bill & Melinda Gates Foundation have partnered on a single-dose, in vivo gene therapy for sickle cell disease (SCD). The Foundation will offer funding for development of the therapy.

Existing gene therapy approaches to sickle cell disease are difficult to deliver at scale and there are obstacles to reaching the vast majority of those affected by this debilitating disease, said Jay Bradner, a hematologist and president of the Novartis Institutes for BioMedical Research (NIBR). This is a challenge that calls for collective action, and we are thrilled to have the support of the Bill & Melinda Gates Foundation in addressing this global unmet medical need.

The announcement comes only a day after bluebird bio announced that it has placed its Phase I/II and Phase III trial of LentiGlobin gene therapy for sickle cell disease (SCD) on temporary suspension. The cause is a Suspected Unexpected Serious Adverse Reaction (SUSAR) of acute myeloid leukemia (AML).

HGB-206 is the companys ongoing Phase I/II trial of LentiGlobin for SCD. It includes three cohorts, A, B and C. In Group C, a refined manufacturing process designed to increase vector copy number was used.

Group C also received LentiGlobin for SCD manufactured from hematopoietic (blood) stem cells (HSCs) collected from peripheral blood after mobilization with plerixafor, instead of by way of bone marrow harvest, which was the method used in Groups A and B.

HGB-210 is their ongoing Phase III single-arm open-label trial. It is evaluating efficacy and safety of LentiGlobin for SCD in patients between two years and 50 years of age with sickle cell disease.

Which underlines that even though gene therapy is making headway, it is still a cutting-edge technology.

SCD is a hereditary blood disease that affects millions of people globally, with more than 300,000 born with it each year. It primarily affects people of African descent, and sub-Saharan Africa bears about 80% of the disease burden. It affects the structure of red blood cells, causing a distinct sickle shape, which decreases the ability of red blood cells to transport oxygen efficiently.

Gene therapies might help end the threat of diseases like sickle cell, but only if we can make them far more affordable and practical for low-resource settings, said Trevor Mundel, president of Global Health at the Gates Foundation. Whats exciting about this project is that it brings ambitious science to bear on that challenge. Its about treating the needs of people in lower-income countries as a driver of scientific and medical progress, not an afterthought. It also holds the promise of applying lessons learned to help develop potentially curative options for other debilitating diseases affecting low-income populations, such as HIV.

Novartis also announced today that the U.S. Food and Drug Administration (FDA) approved the expanded indication for Entresto (sacubitril/valsartan) to decrease the risk of cardiovascular death and hospitalization for heart failure in adults with chronic heart failure. The biggest benefit was for patients with left ventricular ejection fraction (LVEF) below normal.

The expansion was based on data in the PARAGON-HF Phase III trial.

This approval is a significant advancement, providing a treatment to many patients who were not eligible for treatment before because their ejection fraction was above the region we normally considered reduced, said Scott Solomon, professor of Medicine at Harvard Medical School and Brigham and Womens Hospital, and PARAGON-HF Executive Committee co-chair. We can now offer a treatment to a wider range of patients who have an LVEF below normal.

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Novartis and Gates Foundation Team Up To Deliver Affordable Sickle Cell Gene Therapy - BioSpace

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A desperate family is facing a nervous wait after a stem cell donor finally found to give their four-year-old daughter a new chance at life fell ill.

Little Adeline Davidson has been waiting more than two years for the procedure to treat a rare form of blood cancer, and several arrangements with donors have fallen through during that time.

The Alness youngster had been due to go under the knife in Glasgow this week after it appeared that the search for a match had eventually come to an end.

But the family encountered yet another setback as the procedure was cancelled when the stem cell donor fell ill.

Adelines parents Steph, 26, and Jordan, 28, say their daughters transplant now hangs in the balance as they face an agonising wait to find out what is wrong with the donor.

They say the plans could be thrown into disarray with top level talks and a possible world-first procedure required if tests show that the illness is Covid-related.

The family will only be able to find out the nature of the donors condition after he is operated on and the cells removed.

If the donor has coronavirus, a team of international surgeons will assemble to debate whether it would be safe for Adeline to undergo the transplant.

Mrs Davidson said: We have been waiting more than two whole years for our ill child to get a bone marrow transplant.

The hospital have told me that the donor has to donate, and then they release the information on the cause of his illness.

If it is Covid, that would mean they would have to ask international doctors and surgeons if they could go ahead.

They have never given a child thats Covid-negative marrow from someone who is Covid-positive.

If they decide not to proceed, we are back to looking for someone else to begin the search again, which is just a crazy, horrible thought. I dont even want to think about it.

Mrs Davidson added that she would consider going ahead even if the cells have come from someone with coronavirus.

She said: I think we have to go with the doctors word, but Id be so frightened.

We wouldnt have another choice though, unfortunately.

If they, as professionals, believe doing it would outweigh the risks, we would just have to believe that too.

Over the last two years, Adeline has endured around 85 blood transfusions, one anaphylactic shock and emergency helicopter and ambulance transfers to hospital.

Mrs Davidosn added: There is potential for even worse news but we just hope that it isnt Covid he has.

If it isnt Covid, then everything moves along as it was meant to be.

We are aware that on the register there was no-one else, so we were lucky this guy popped up.

If all goes well, Adeline will receive her transplant in four weeks.

The latest setback comes almost two years to the day since her transplant journey began.

In December, the family were dealt a devastating blow as health officials postponed her procedure, scheduled to take place in January, due to Brexit complications.

The four-year-old requires a specific type off marrow, processed by a centre outwith the UK, which is then brought to the country by road.

Life-saving transplant for Highland youngster postponed due to delays caused by Brexit

Early last year, the family were forced to turn to the register and launch a public appeal in search for multiple new donors due to an array of complications.

Mrs Davidson praised Adelines resilience but admits it breaks her heart to not be able to see her daughter progress onto school in August.

She said: The first year I was so positive lets get on with it, this needs done and I never thought why us?

I just thought we have so much to be grateful for and thankful for.

However, the whole of the second year, Im just thinking is someone messing with us because thats what it feels like.

She added: Adelines been so good. She hardly complains and I just think its because she has no idea whats shes missing, which is sort of a good thing but sad.

She is lucky thats shes an outgoing kid. She is behind, she has not socialised and although she is switched on, shes probably not as far on as her peers.

Even now, she should have been staring primary one in August this year but shes not even been to nursery. Its hellish.

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Heartbreak for family of cancer-stricken four-year-old as stem cell donor falls ill at last minute - Press and Journal

Bone Marrow Stem Cells Comments Off on Heartbreak for family of cancer-stricken four-year-old as stem cell donor falls ill at last minute – Press and Journal | February 19th, 2021

This article was originally published here

Front Immunol. 2021 Jan 21;11:594572. doi: 10.3389/fimmu.2020.594572. eCollection 2020.

ABSTRACT

Mycobacterium tuberculosis (Mtb), the causative organism of pulmonary tuberculosis (PTB) now infects more than half of the world population. The efficient transmission strategy of the pathogen includes first remaining dormant inside the infected host, next undergoing reactivation to cause post-primary tuberculosis of the lungs (PPTBL) and then transmit via aerosol to the community. In this review, we are exploring recent findings on the role of bone marrow (BM) stem cell niche in Mtb dormancy and reactivation that may underlie the mechanisms of PPTBL development. We suggest that pathogens interaction with the stem cell niche may be relevant in potential inflammation induced PPTBL reactivation, which need significant research attention for the future development of novel preventive and therapeutic strategies for PPTBL, especially in a post COVID-19 pandemic world. Finally, we put forward potential animal models to study the stem cell basis of Mtb dormancy and reactivation.

PMID:33584661 | PMC:PMC7873989 | DOI:10.3389/fimmu.2020.594572

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Initiation of Post-Primary Tuberculosis of the Lungs: Exploring the Secret Role of Bone Marrow Derived Stem Cells - DocWire News

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REDWOOD CITY, Calif.--(BUSINESS WIRE)--Jasper Therapeutics, Inc., a biotechnology company focused on hematopoietic cell transplant therapies, today announced the launch of a Phase 1/2 clinical trial to evaluate JSP191, Jaspers first-in-class anti-CD117 monoclonal antibody, as a targeted, non-toxic conditioning regimen prior to allogeneic transplant for sickle cell disease (SCD). Jasper Therapeutics and the National Heart, Lung, and Blood Institute (NHLBI) have entered into a clinical trial agreement in which NHLBI will serve as the Investigational New Drug (IND) sponsor for this study.

SCD is a lifelong inherited blood disorder that affects hemoglobin, a protein in red blood cells that delivers oxygen to tissues and organs throughout the body. Approximately 300,000 infants are born with SCD annually worldwide, and the number of cases is expected to significantly increase. Currently, hematopoietic stem cell transplantation (HSCT) is the only cure available for SCD.

"This clinical trial agreement with the NHLBI expands the development of JSP191 for transplant conditioning and could bring curative transplants to more patients in need," said Kevin N. Heller, M.D., Executive Vice President, Research and Development, of Jasper Therapeutics. "We look forward to collaborating with the NHLBI and learning more about the potential for JSP191 in patients living with sickle cell disease."

About JSP191

JSP191 (formerly AMG 191) is a first-in-class humanized monoclonal antibody in clinical development as a conditioning agent that clears hematopoietic stem cells from the bone marrow. JSP191 binds to human CD117, a receptor for stem cell factor (SCF) that is expressed on the surface of hematopoietic stem and progenitor cells. The interaction of SCF and CD117 is required for stem cells to survive. JSP191 blocks SCF from binding to CD117 and disrupts critical survival signals in stem cells leading to cell death. This creates space in the bone marrow for engraftment of donor or gene-corrected transplanted stem cells.

Preclinical studies have shown that JSP191, as a single agent, safely depletes normal and diseased hematopoietic stem cells, including in animal models of severe combined immunodeficiency (SCID), myelodysplastic syndromes (MDS), and sickle cell disease (SCD). Treatment with JSP191 creates the space needed for transplanted normal donor or gene-corrected hematopoietic stem cells to successfully engraft in the host bone marrow. To date, JSP191 has been evaluated in more than 90 healthy volunteers and patients.

JSP191 is currently being evaluated in two separate Jasper Therapeutics-sponsored clinical studies in hematopoietic cell transplant. The first clinical study is evaluating JSP191 as a sole conditioning agent in a Phase 1/2 dose-escalation and expansion trial to achieve donor stem cell engraftment in patients undergoing hematopoietic cell transplant for SCID. Blood stem cell transplantation offers the only potentially curative therapy for SCID. JSP191 is also being evaluated in combination with another conditioning regimen in a Phase 1 study in patients with MDS or acute myeloid leukemia (AML) who are receiving hematopoietic cell transplant. For more information about the design of these clinical trials, visit http://www.clinicaltrials.gov (NCT02963064 and NCT04429191).

Additional studies are planned to advance JSP191 as a conditioning agent for patients with other rare and ultra-rare monogenic disorders and autoimmune diseases.

About Jasper Therapeutics

Jasper Therapeutics is a biotechnology company focused on the development of novel curative therapies based on the biology of the hematopoietic stem cell. The companys lead compound, JSP191, is in clinical development as a conditioning antibody that clears hematopoietic stem cells from bone marrow in patients undergoing a hematopoietic cell transplant. This first-in-class conditioning antibody is designed to enable safer and more effective curative hematopoietic cell transplants and gene therapies. For more information, please visit us at jaspertherapeutics.com.

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Jasper Therapeutics Announces Launch of New Clinical Trial with National Heart, Lung, and Blood Institute to Evaluate JSP191 in Sickle Cell Disease -...

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Transparency Market Research (TMR) has published a new report titled, Cord Blood Banking Services Market Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 20192027. According to the report, the globalcord blood banking services marketwas valued atUS$ 25.8 Mnin2018and is projected to expand at a CAGR of10.9%from2019to2027.

Overview

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High Incidence of genetic disorders and rise in hematopoietic stem cell transplantation rates to Drive Market

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Cord Blood Banking Services Market projected to expand at a CAGR of 10.9% from 2019 to 2027 KSU | The Sentinel Newspaper - KSU | The Sentinel...

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RESEARCH TRIANGLE PARK After 13 years as a clinical-stage oncology company,G1 Therapeuticsof Research Triangle Park transformed into a commercial-stage company overnight upon the approval of its first drug by the U.S. Food and Drug Administration.

The FDA on Feb. 12 approved G1s trilaciclib, to be marketed as Cosela, for protecting bone marrow from chemotherapy damage in adult patients with extensive-stage small cell lung cancer (ES-SCLC).

Cosela will help change the chemotherapy experience for people who are battling ES-SCLC, said Jack Bailey, the companys chief executive officer. G1 is proud to deliver Cosela to patients and their families as the first and only therapy to help protect against chemotherapy-induced myelosuppression.

Myelosuppression, or damage to the bone marrow, is the most serious and life-threatening side effect of chemotherapy. Chemotherapy-induced myelosuppression reduces the bodys essential supply of white blood cells, red blood cells and platelets, and can lead to increased risks of infection, severe anemia and bleeding.

RTP drug firm G1 secures FDA approval for treatment to prevent chemo damage to bone marrow

These complications impact patients quality of life and may also result in chemotherapy dose reductions and delays, said Jeffrey Crawford,M.D., Geller Professorfor Research in Cancer in theDepartment of MedicineandDuke Cancer Institute. In clinical trials, the addition of trilaciclib to extensive-stage small cell lung cancer chemotherapy treatment regimens reduced myelosuppression and improved clinical outcomes.The good news is that these benefits of trilaciclib will now be available for our patients in clinical practice.

Cosela is expected to be commercially available through G1s specialty distributor partner network in early March, the company said.

G1 is committed to helping patients with in theU.S.gain access to treatment with Cosela through access and affordability programs. Patients and healthcare can call the companys support center at 833-418-6663 for information.

Cosela is intended to be given as a 30-minute infusion four hours prior to chemotherapy treatments containing platinum/etoposide or topotecan. About 90 percent of all patients with ES-SCLC receive at least one of these chemotherapy regimens during their treatment, according to G1.

The approval of Cosela is based on data from three randomized, placebo-controlled trials. Data showed that patients receiving Cosela before the start of chemotherapy had less neutropenia, an abnormally low number of neutrophils, white blood cells that fight bacterial and fungal infection.

Data also showed a positive impact on red blood cell transfusions and other myeloprotective measures.

Chemotherapy is the most effective and widely used approach to treating people diagnosed with extensive-stage small cell lung cancer, Bailey said. However, standard-of-care chemotherapy regimens are highly myelosuppressive and can lead to costly hospitalizations and rescue interventions.

To date, oncologists have relied on rescue therapy, a mix of growth factor agents, antibiotics and red blood cell transfusions, to restore bone marrow after it has been damaged by chemotherapy.

By contrast, trilaciclib provides the first proactive approach to myelosuppression through a unique mechanism of action that helps protect the bone marrow from damage by chemotherapy, Crawford said.

Cosela helps protect bone marrow cells from chemotherapy damage by inhibiting cyclin- dependent kinase 4 and 6, two enzymes involved in cancer cell growth. Inhibiting these enzymes temporarily stops hematopoietic stem cells and progenitor cells in the bone marrow from dividing, making them resistant to damage from chemotherapy drugs that target dividing cells.

Bonnie J. Addario, lung cancer survivor, co-founder and board chair of theGo2 Foundation for Lung Cancer, said many people with extensive-stage small cell lung cancerrely on chemotherapy to extend their lives and alleviate their symptoms.

Unfortunately, the vast majority will experience chemotherapy-induced side effects, resulting in dose delays and reductions, and increased utilization of healthcare services, she said.

G1 shares our organizations goal to improve the quality of life of those diagnosed with lung cancer and to transform survivorship among people living with this insidious disease. We are thrilled to see new advancements that can help improve the lives of those living with small cell lung cancer.

About 30,000 small cell lung cancer patients are treated inthe United Statesannually. SCLC, one of the two main types of lung cancer, accounts for about 10 to 15 percent of all lung cancers but is the more aggressive disease, tending to grow and spread faster than the other type, non-small cell lung cancer.

InJune 2020, G1 announced a three-yearco-promotion agreementwithBoehringer Ingelheimfor Cosela in small cell lung cancer in theU.S.andPuerto Rico. G1 will lead marketing, market access and medical engagement initiatives for Cosela whileBoehringer Ingelheimsoncology commercial team will lead sales force engagement initiatives.

G1 will book revenue and retain development and commercialization rights to Cosela and payBoehringer Ingelheima promotional fee based on net sales.

The three-year agreement does not extend to additional indications that G1 is evaluating for trilaciclib: breast, colorectal, bladder and non-small cell lung cancers.

G1 is a 2008 spin-out of the University of North Carolina at Chapel Hill.

The company raised $108 million in an initial public offering of stock in 2017 after receiving more than $95 million in three rounds of venture capital funding. The North Carolina Biotechnology Center provided two early-stage loans totaling $500,000.

G1s stock is traded on the Nasdaq Global Select Market under the ticker symbol GTHX.

(C) N.C. Biotech Center

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After 13 years of trials and tribulations RTP firm G1 wins first FDA approval for cancer drug - WRAL Tech Wire

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Novartis and the Bill and Melinda Gates Foundation are joining forces to discover and develop a gene therapy to cure sickle cell disease with a one-step, one-time treatment that is affordable and simple enough to treat patients anywhere in the world, especially in sub-Saharan Africa where resources may be scarce but disease prevalence is high.

The three-year collaboration, announced Wednesday, has initial funding of $7.28 million.

Current gene therapy approaches being developed for sickle cell disease are complex, enormously expensive, and bespoke, crafting treatments for individual patients one at a time. The collaboration aims to instead create an off-the-shelf treatment that bypasses many of the steps of current approaches, in which cells are removed and processed outside the body before being returned to patients.

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Sickle cells cause is understood. The people it affects are known. But its cure has been elusive, Jay Bradner, president of the Novartis Institutes for BioMedical Research, told STAT.

We understand perfectly the disease pathway and the patient, but we dont know what it would take to have a single-administration, in vivo gene therapy for sickle cell disease that you could deploy in a low-resource setting with the requisite safety and data to support its use, he said. Im a hematologist and can assure you that in my experience in the clinic, it was extremely frustrating to understand a disease so perfectly but have so little to offer.

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Sickle cell disease is a life-threatening inherited blood disorder that affects millions around the world, with about 80% of affected people in sub-Saharan Africa and more than 100,000 in the U.S. The mutation that causes the disease emerged in Africa, where it protects against malaria. While most patients with sickle cell share African ancestry, those with ancestry from South America, Central America, and India, as well as Italy and Turkey, can also have the hereditary disease.

The genetic mutation does its damage by changing the structure of hemoglobin, hampering the ability of red blood cells to carry oxygen and damaging blood vessels when the misshapen cells get stuck and block blood flow. Patients frequently suffer painful crises that can be fatal if not promptly treated with fluids, medication, and oxygen. Longer term, organs starved of oxygen eventually give out. In the U.S., that pain and suffering is amplified when systemic and individual instances of racism deny Black people the care they need.

Delivering gene therapy for other diseases has been costly and difficult even in the best financed, most sophisticated medical settings. Challenges include removing patients cells so they can be altered in a lab, manufacturing the new cells in high volume, reinfusing them, and managing sometimes severe responses to the corrected cells. Patients also are given chemotherapy to clear space in their bone marrow for the new cells.

Ideally, many of those steps could be skipped if there were an off-the-shelf gene therapy. That means, among other challenges, inventing a way to eliminate the step where each patients cells are manipulated outside the body and given back the in vivo part of the plan to correct the genetic mutation.

Thats not the only obstacle. For a sickle cell therapy to be successful, Bradner said, it must be delivered only to its targets, which are blood stem cells. The genetic material carrying corrected DNA must be safely transferred so it does not become randomly inserted into the genome and create the risk of cancer, a possibility that halted a Bluebird Bio clinical trial on Tuesday. The payload itself mustnt cause such problems as the cytokine storm of immune overreaction. And the intended response has to be both durable and corrective.

In a way, the gene delivery is the easy part because we know that expressing a normal hemoglobin, correcting the mutated hemoglobin, or reengineering the switches that once turned off normal fetal hemoglobin to turn it back on, all can work, Bradner said. The payload is less a concern to me than the safe, specific, and durable delivery of that payload.

For each of these four challenges delivery, gene transfer, tolerability, durability there could be a bespoke technical solution, Bradner said. The goal is to create an ensemble form of gene therapy.

Novartis has an existing sickle-cell project using CRISPR with the genome-editing company Intellia, now in early human trials, whose lessons may inform this new project. CRISPR may not be the method used; all choices are still on the table, Bradner said.

Vertex Pharmaceuticals has seen encouraging early signs with its candidate therapy developed with CRISPR Therapeutics. Other companies, including Beam Therapeutics, have also embarked on gene therapy development.

The Novartis-Gates collaboration is different in its ambition to create a cure that does not rely on an expensive, complicated framework. Novartis has worked with the Gates Foundation on making malaria treatment accessible in Africa. And in October 2019, the Gates Foundation and the National Institutes of Health said together they would invest at least $200 million over the next four years to develop gene-based cures for sickle cell disease and HIV that would be affordable and available in the resource-poor countries hit hardest by the two diseases, particularly in Africa.

Gene therapies might help end the threat of diseases like sickle cell, but only if we can make them far more affordable and practical for low-resource settings, Trevor Mundel, president of global health at the Gates Foundation, said in a statement about the Novartis collaboration. Its about treating the needs of people in lower-income countries as a driver of scientific and medical progress, not an afterthought.

Asked which is the harder problem to solve: one-time, in vivo gene therapy, or making it accessible around the world, David Williams, chief of hematology/oncology at Boston Childrens Hospital, said: Both are going to be difficult to solve. The first will likely occur before the therapy is practically accessible to the large number of patients suffering the disease around the world.

Williams is also working with the Gates Foundation, as well as the Koch Institute for Integrative Cancer Research at MIT, Dana-Farber Cancer Institute, and Massachusetts General Hospital, on another approach in which a single injection of a reagent changes the DNA of blood stem cells. But there are obstacles to overcome there, too, that may be solved by advances in both the technology to modify genes and the biological understanding of blood cells.

Bradner expects further funding to come to reach patients around the world, once the science progresses more.

There is no plug-and-play solution for this project in the way that mRNA vaccines were perfectly set up for SARS-CoV-2. We have no such technology to immediately redeploy here, he said. Were going to have to reimagine what it means to be a gene therapy for this project.

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Novartis, Gates Foundation pursue a simpler gene therapy for sickle cell - STAT

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