Paroxysmal Nocturnal Hemoglobinuria (PNH) Treatment Market Growth, Trends and Demands Research Report and Forecast 2025 – The Denton Chronicle

By daniellenierenberg

Paroxysmal nocturnal hemoglobinuria (PNH) is an ultra-rare blood disease of bone marrow stem cells, which are genetically characterized by the somatic mutation in the phosphatidylinositol glycan protein A (PIG-A) gene. PNH generally occurs in the early 30s. Around 10% patients develop PNH symptoms at 21 years of age or earlier. Around 1 to 5 individuals per million people in the U.S. are estimated to suffer from PNH. This is much lower than the incidence rate of bone marrow aplasia. PNH often goes unrecognized; delay in diagnosis may range from one year to more than 10 years.

The global PNH treatment market is anticipated to expand at a rapid pace during the forecast period. It is a niche market, with many pharmaceutical and biotech companies investing in research of bone marrow stem cells. According to current studies, the ideal treatment available is to replace all the hematopoietic stem cells with normal stem cells via stem cells transplantation. However, this treatment is not ideal in some cases as stem cell transplantation requires a stable histocompatible donor.

Complete stem cells transplantation is usually considered in severe cases of PNH, for instance aplastic anemia and transformation to leukemia, as these can be life threatening complications. Factors driving the PNH treatment market include rise in number of blood & bone marrow related disorders, increase in aging population, and technological advancements in stem cells transplantation. However, increase in cost of medical equipment, specifically surgical equipment required for stem cell transformation; lack of reimbursement policies in developing regions; and occurrence of side effects in related current available treatments may hamper the PNH treatment market.

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The global PNH treatment market can be segmented based on diagnosis test, type of treatment, drugs, and end-user. In terms of diagnosis test, the market can be divided into complete blood count test (CBC), lactate dehydrogenase test (LDH), bilirubin test, bone marrow examination, urine test for hemosiderin, flow cytometry, and others.

Based on the type of treatment, the PNH treatment market can be segregated into treatment of PNH patients associated with hemolysis, treatment of PNH patients associated with thrombosis, treatment of PNH patients associated with non-hemolytic anemia, allogeneic stem cell transplant (SCT)/bone marrow transplant (BMT), treatment of pregnant PNH patients, treatment of pediatric PNH patients, and others. In terms of drugs, the market can be classified into eculizumab (Soliris), ALXN1210, and others. Based on end-user, the PNH treatment market can be split into hospitals, pharmaceutical & biotech companies, clinics, academic & research institutes, and others.

Geographically, the market for PNH treatment can be divided into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa (MEA). North America dominates the global PNH treatment market due to the rise in the number of blood & bone marrow related diseases, availability of satisfactory reimbursement policies, and increase in awareness about the early diagnosis of the disease in the region.

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The market in Europe is also expected to expand rapidly, as key players are collaborating with research institutions and labs to develop new innovative products. The PNH treatment market in Asia Pacific is anticipated to expand at a fast pace owing to the unmet needs regarding PNH treatment of the growing population. Additionally, factors such as development of the health care network, rise in disposable income, increase in health care awareness, and availability of reimbursement facilities are boosting the PNH treatment market in Asia Pacific.

Key players operating in the PNH treatment market include Alexion Pharmaceuticals, Inc., Thermo Fisher Scientific Inc., GE Healthcare, and Johnson & Johnson.

Transparency Market ResearchAlbany, NY 12207United StatesTel: +1-518-618-1030Website:www.transparencymarketresearch.comEmail:[emailprotected]Research Blog:https://theglobalhealthnews.com/

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November 22nd, 2019

Count it all joy, Part III: Coach Hill-Eley has his own cancer struggle – Montgomery Advertiser

By daniellenierenberg

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Count It All Joy is a three-part series that unfolds the struggles of two Alabama State football playersas their parents battle a life-threatening disease. These circumstanceswould hit these players at a time whenlife is already hectic: football season. Here's how they got through and the testimony their parents carry.

In the distance, clouds mount across the skyline on the fringe of downtown Montgomery. They grow deeper in color as the weather evolves, the already ashen hues of the mass becoming a smoke grey that oddly soothes the eye because of its stark contrast with the taupe pavement of I-85 near Alabama State.

It was roughly 30 minutes before the 2 p.m. kickoff between ASU and Alcorn State, when the first strike of lightning split the sky of a previously sunny day, interrupting everything that was planned.

It was supposed to be a joyous day, and now an intimidating forecast of scattered thunderstorms painted weather radars in the area like a room full of toddlers left unattended with with green, yellow and red finger paint.

Prior to what would become a four-hour rain delay, the energy in ASU stadium was electric. The players were excited to challenge Alcorn State and possibly take the lead in the SWAC East standings. The ASU faithful wereon one accord with this sentiment, and most important of all, it was BeatOutBreastCancer Day, the Pink game and a general tribute to cancer survivors of any kind everywhere.

Yet in its present state, rain drenched the turf, spectators retreated from the elements under the cover of the bleachers, and under the awnings of the visitors' side concession stands. At that time, all the day had to show for itself was a chain of bras stretched out across the Alcorn State sideline that were supposed to serve as a tribute during the anticipated pregame celebration.

Save the bras, the field was desolate.

The joy, the energy was drained. The buzz that surrounded the day was washed away by the conditions of the day.

But in ASUs locker room, the day still shone brightly. The anticipation to take part in a celebration of life, trials and triumph never dwindled for Michael Jefferson II (MJ) or Darius King.

Katrice Williams and Micheal Jefferson Sr. stand on the sideline together, before "Beat out Breast Cancer" game with Alcorn State, Oct. 5.(Photo: Katrice Williams/contributed)

It was a day for them to honor the struggle of being alongside their respective parents in their fight against cancer. As they sat at their lockers waiting for the weather delay to end, itching to get on the field and play for their loved ones, their parents and the road they traveled occupied their minds.

I was going to go out and play for him, MJ said. During the delay, I was texting him before the game, and he was telling me Stay focused and play hard.

King described the moment, the anticipation, as a blessing. He said he thought about the pain she was going through, times they were in the hospital and, the pain on her face. It all flashed before him.

When the weather finally cleared, kickoff now set for 6 p.m., Michael Jefferson Sr. and Katrice Williams, the parents of MJ and King, respectively, went out for the coin toss as a tribute to their battle with cancer; as a tribute to their victories.

In the summer of 2017, Williams was diagnosed with stage 4 stomach cancer and declared cancer free in May 2018. As for Jefferson Sr., he overcame his second bout with leukemia in June 2018, but is still waiting for his body to accept his brother's stem cells from a bone marrow transplant in May.

Count it all Joy, Part 1: ASU WR Michael Jefferson II battles through fathers bout with cancer

Their testimony and journeys are why ASU head coach Donald Hill-Eley insisted they flip the coin to start the game, after approaching administration and Deputy Director of Athletics Terrance Jones earlier in the week to make sure it was fine for them to do so, since the event hinged on breast cancer awareness.

The courtesy was the least he could do, considering the role both parties played in his life over the past couple years, and vice versa.

The ASU football team arrives to Hornet Stadium before their contest against Alcorn State. (Photo: Kirsten Fiscus/Advertiser)

In December 2017, Hill-Eleys father Vincent Eley, 68, was diagnosed with throat cancer, a disease that will take the life of 3,760Americans this year, according to the American Society of Clinical Oncology (ASCO).

Fittingly, he and his fathers battle was wedged right in the middle of the battles of these two players. He could relate, he could support and he could be supported.

Shes been an inspiration for me, because a couple months later my dad was diagnosed with stage 4 cancer, Hill-Eley said. So, weve all been able to share whats going on ... then Mikes dad was diagnosed, so it became more of a support group than anything.

Thus, they all leaned on one another.

A lot of time I get strength from them, and they get strength from me, Hill-Eley said. Just trying to find a way to get through.

Cancer is a sickness that spreads. Not just in the nature of the disease, but it spreads and touches the lives of all involved, from the patient to their family and friends to the friends and family of the latter.

Cancer and its reach is best repressedand even healed through dependency. The dependency on one another, on loved ones and those willing to share the burden with you.

This is whats been happening behind the doors of ASUs program for the past two years.

Michael Jefferson II and his teammates visit Micheal Jefferson Sr.at the hospital(Photo: Michael Jefferson Sr./contributed)

Teammates, such as Jeremiah Hixon, were with MJ every step of the way. Hixon allowed Jefferson to take his car to Birmingham to see his dad in treatment or would personally drive MJ there with a car full of teammates so they all could lift his dads spirits, MJ said.

Hixon was there to talk and console MJ. He never left MJ alone, no matter the distance or situation Hixon said.

Jeremiah Hixon touts fellow sophomore receiver Michael Jefferson as Alabama State's best against Tuskegee. A. Stacy Long, Montgomery Advertiser

The team rallied around both King and MJ in different ways, at different times.

Theyve been able as a group to find ways through it, Hill-Eley said. We constantly talk ... and weve been able to repay each out for whats going on and what's happening. Its been a great resource to me, and I know its been a great resource for them. Im 50 and Im trying to understand it, and theyre 19 and 20, so its been a lot of prayers going in and out, but these guys are very strong men, and theyve been able to deal with it.

Through the toughest times, the ASU football team has been there for one another as a team.

Katrice Williams plays around with her son Darius King in front of there home(Photo: Katrice Williams/contributed)

Through the times King would return home and become engrossedin disbelief by his mothers condition, begging for her to get out of bed, Williams said. Through the times shed adhere to his desperate cries, body broken and thinned out by her treatments. He needed to see her strong, Williams said, and he struggled to accept that she was not herself. So, Williams would get up to cook, clean and whatever else it took to prove to him that she wasnt as sick as she was, through the 60 pounds she lost, through her chemo treatments and the up and down nature of her health. Through it all, King thanks guys such as JLan Carson, Christian Clark and Joshua Hill for being there.

Count it all Joy, Part II: ASU LB Darius King helps carry mother's burden, stage 4 cancer

There were other times that Hill-Eley and his staff, present and past, made the clubhouse suites available for Williams during home games, or provided Jefferson Sr. and Williams with a closer parking spot or sent carts to them for transport to and from their cars.

And for that to even occur, Hill-Eley had to make sure he wasnt breaking NCAA rules by accommodating Williams and Jefferson, a tightrope he was willing to walk to give them a little touch of life, he said.

At that point, the human part of you has to kick in, Hill-Eley said. And that gets you past all of these bylaws.

The journey was about selflessness, relatability and empathy.

Alabama State head coach Donald Hill-Eley talks to his team in the first half of an NCAA college football game against Florida State in Tallahassee, Fla., Saturday, Nov. 16, 2019. Florida State won 49-12. (AP Photo/Mark Wallheiser)(Photo: Mark Wallheiser, AP)

MJ and King said they are grateful for all parties involved in this process, and speak for their parents in doing so. Beyond that, they are thankful for a coach like Hill-Eley who took time to make sure they were doing all right amid the many responsibilities of a college head coach.

They called that rare.

On many college teams, head coaches are not that close to players how he is with us, King said. Im just thankful for him.

MJ added: This is one of the best coaches Ive had ... always positive and thats what I need: people with positive energy around me to help me stay up.

These efforts are only a few compared to the many people that were involved in the healing process for MJs, Kings and Hill-Eleys family, and none of the efforts unmentioned went unnoticed.

Today, everyones healing is on the verge of being complete. Jefferson Sr. is expecting his new stem cells to be accepted by his body and is seeing improvement daily, while MJ leads ASU in receiving.

An obstruction in Williams bowel was a cause for concern, and as of last week her oncologist stated that her cancer might be back, but if it is, its too small to show on scans. She will be monitored every three months from now on as a preventative measure. Even so, her son, King, remains in good spirits and says he is humbled and encouraged to live every day like its my last day. Not to be sad or down about it, just keep my head up.

As for Hill-Eley, his father remains in the midst of a battle with throat cancer, and he says its growing, unfortunately, but right after the season he will return home to Virginiato take care of his father. He remains hopeful, however, as the five-year survival rate for his father'scancer is 61%, theASCO says.

Alcorn linebacker Solomon Muhammad (49) snags an interception on a pass intended for ASU wide receiver Tyrek allen (8). (Photo: Kirsten Fiscus/Advertiser)

Alabama State eventually lost that game to Alcorn State at home in early October, but the day wasnt spoiled. Rather, the Hornets counted it all joy, because compared to the trials of life this was just a hiccup and not worthy in the grand scheme, they said.

We needed to see them strong, and they needed to see that we were OK, Hill-Eley said. Just the emotions of seeing them make it another day and to be able to go out and watch their young men play, I know it wasnt the outcome we wanted (againstAlcorn), but the victory was having them in the middle of that field.

Contact Montgomery Advertiser reporter Andre Toranat 334-322-4631or AToran@gannett.com. Follow him on Twitter @AndreToran.

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Count it all joy, Part III: Coach Hill-Eley has his own cancer struggle - Montgomery Advertiser

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November 22nd, 2019

Vor Biopharma and MaxCyte Announce Clinical and Commercial License Agreement for Engineered Hematopoietic Stem Cells (eHSCs) to Treat Cancer -…

By daniellenierenberg

CAMBRIDGE, Mass. & GAITHERSBURG, Md.--(BUSINESS WIRE)--Vor Biopharma, an oncology company pioneering engineered hematopoietic stem cells (eHSCs) for the treatment of cancer, and MaxCyte, Inc., a global cell-based therapies and life sciences company, today announced a clinical and commercial license agreement under which Vor will use MaxCytes Flow Electroporation technology to produce eHSCs and initiate Investigational New Drug (IND)-enabling studies to accelerate its progress towards the clinic.

Under the terms of the agreement, Vor obtains non-exclusive clinical and commercial use rights to MaxCytes Flow Electroporation technology and ExPERT platform to develop up to five engineered cell therapies, including VOR33, Vors lead eHSC candidate, which is in development for acute myeloid leukemia (AML). In return, MaxCyte will receive undisclosed development and approval milestones and sales-based payments in addition to other licensing fees.

Vor will use MaxCytes cell engineering platform to deliver its gene editing machinery into hematopoietic stem cells to remove biologically redundant cell surface proteins that are also expressed on blood cancer cells. Once the eHSCs are transplanted into a cancer patient, these cells are effectively hidden from complementary targeted therapies that target the relevant protein, while diseased cells are left vulnerable to attack. Vors approach thereby could unleash the potential of targeted therapies by broadening the therapeutic window and improving the utility of complementary targeted therapies.

MaxCyte is a leader in GMP electroporation technology, and we are thrilled that this agreement provides us with long-term access to a platform technology applicable to a pipeline of eHSC programs used to treat AML and other blood cancers, said Sadik Kassim, Ph.D., Chief Technology Officer of Vor. As we build on promising in vivo data from our lead candidate VOR33, we can now expand our manufacturing capabilities to support later-stage studies, regulatory filings and commercialization of VOR33.

MaxCytes ExPERT instrument family represents the next generation of leading, clinically validated, electroporation technology for complex and scalable cellular engineering. By delivering high transfection efficiency with enhanced functionality, the ExPERT platform delivers the high-end performance essential to enable the next wave of biological and cellular therapeutics.

We look forward to expanding our relationship with Vor Biopharma as the company pioneers a potential future standard of care in hematopoietic stem cell transplants for cancer patients in need, said Doug Doerfler, President & CEO of MaxCyte. This agreement represents another key business milestone for MaxCyte, emphasizing the value of our technology platform applied to next-generation engineered cell therapies that may make a true difference in patient outcomes.

About VOR33Vors lead product candidate, VOR33, consists of engineered hematopoietic stem cells (eHSCs) that lack the protein CD33. Once these cells are transplanted into a cancer patient, CD33 becomes a far more cancer-specific target, potentially avoiding toxicity to the normal blood and bone marrow associated with CD33-targeted therapies. In so doing, Vor aims to improve the therapeutic window and effectiveness of CD33-targeted therapies, thereby potentially broadening the clinical benefit to patients suffering from AML.

About Vor BiopharmaVor Biopharma aims to transform the lives of cancer patients by pioneering engineered hematopoietic stem cell (eHSC) therapies. By removing biologically redundant proteins from eHSCs, these cells become inherently invulnerable to complementary targeted therapies while tumor cells are left susceptible, thereby unleashing the potential of targeted therapies to benefit cancer patients in need.

Vors platform could be used to potentially change the treatment paradigm of both hematopoietic stem cell transplants and targeted therapies, such as antibody drug conjugates, bispecific antibodies and CAR-T cell treatments. A proof-of-concept study for Vors lead program has been published in Proceedings of the National Academy of Sciences.

Vor is based in Cambridge, Mass. and has a broad intellectual property base, including in-licenses from Columbia University, where foundational work was conducted by inventor and Vor Scientific Board Chair Siddhartha Mukherjee, MD, DPhil. Vor was founded by Dr. Mukherjee and PureTech Health and is supported by leading investors including 5AM Ventures and RA Capital Management, Johnson & Johnson Innovation JJDC, Inc. (JJDC), Novartis Institutes for BioMedical Research and Osage University Partners.

About MaxCyteMaxCyte is a clinical-stage global cell-based therapies and life sciences company applying its proprietary cell engineering platform to deliver the advances of cell-based medicine to patients with high unmet medical needs. MaxCyte is developing novel CARMA therapies for its own pipeline, with its first drug candidate in a Phase I clinical trial. CARMA is MaxCytes mRNA-based proprietary therapeutic platform for autologous cell therapy for the treatment of solid cancers. In addition, through its life sciences business, MaxCyte leverages its Flow Electroporation Technology to enable its biopharmaceutical partners to advance the development of innovative medicines, particularly in cell therapy. MaxCyte has placed its flow electroporation instruments worldwide, including with all of the top ten global biopharmaceutical companies. The Company now has more than 80 partnered programme licenses in cell therapy with more than 45 licensed for clinical use. With its robust delivery technology platform, MaxCyte helps its partners to unlock the full potential of their products. For more information, visit http://www.maxcyte.com.

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Vor Biopharma and MaxCyte Announce Clinical and Commercial License Agreement for Engineered Hematopoietic Stem Cells (eHSCs) to Treat Cancer -...

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November 22nd, 2019

Fred Hutch at ASH: Latest CAR T data BCMA, CD19, CD20 plus new insights on transplantation, gene therapy and more – Newswise

By daniellenierenberg

MEDIA CONTACT

Available for logged-in reporters only

For Immediate Release

Newswise SEATTLE Nov. 21, 2019 Fred Hutchinson Cancer Research Centers latest findings on CAR (chimeric antigen receptor) T-cell therapy, gene therapy, precision oncology, immune repair and transplantation will be featured at the 61st American Society of Hematology Annual Meeting and Exposition, which will be held Dec. 710 in Orlando, Florida.

Fred Hutch transplantation physician-scientist Dr. Stephanie Lee will become the new president of ASH at the end of the meeting, T-cell therapy pioneer Dr. Philip Greenberg will give the E. Donnall Thomas Lecture, and Dr. Andrew Cowan will present the latest on a new BCMA, or B-cell maturation antigen, CAR T-cell therapy for multiple myeloma. More details and other meeting highlights can be found below. All presentations will be held in the Orange County Convention Center.

Reporters requesting additional information or interviews, contact Molly McElroy who will be at the conference: mwmcelro@fredhutch.org, 206.941.8146 (cell).

IMMUNOTHERAPY

See preliminary results of a Phase 1 multiple myeloma trial with a CAR T-cell therapy combined with a repurposed Alzheimers drug, discussion of a new CD20 CAR T trial, plus various deep dives on the science of how CD19 CAR T-cell therapy works and how to improve it.

BCMA CAR T-CELL THERAPY / MULTIPLE MYELOMA

Efficacy and safety of fully human BCMA CAR T cells in combination with a gamma secretase inhibitor to increase BCMA surface expression in patients with relapsed or refractory multiple myelomaFred Hutch scientists are developing a novel immunotherapy approach for multiple myeloma, which involves a CAR T cell that targets BCMA proteins on multiple myeloma cells, plus a drug called a gamma secretase inhibitor, which increases the BCMA target on cancer cells. In an oral presentation, Dr. Andrew Cowan will present promising results from the first cohort of patients on the trial, all of whom responded to the treatment. The researchers published earlier findings of the trial in Blood in September.Abstract No. 204 (oral presentation)Saturday, Dec. 7, 1:15 p.m.Valencia A (W415A), Level 4

Response to BCMA CART cells correlates with pretreatment target density and is improved by small-molecule inhibition of gamma secretase Dr. Damian Green will present findings from multiple myeloma patients that demonstrate a relationship between the number of BCMA targets on multiple myeloma cells and response to a BCMA-directed CAR T-cell therapy. The findings suggest that using a gamma secretase inhibitor to increase the amount of BCMAs on the cell surface could make CAR T work better. Abstract No. 1856 (poster presentation)Saturday, Dec. 7, 5:307:30 p.m.Hall B, Level 2

CD19 CAR T-CELL THERAPIES

With the success of CAR T-cell therapies for some blood cancers, Fred Hutch physician-scientists are taking a closer look to understand how patients respond to the therapy and what could be done to make the treatment work better.

Impact of Lisocabtagene Maraleucel (liso-cel) treatment on health-related quality of life and health utility in patients (pts) with relapsed/refractory (R/R) aggressive B-cell non-Hodgkin lymphoma (NHL): TRANSCEND NHL 001Physician-scientist Dr. David Maloney will present findings from the TRANSCEND trial for CD19 CAR T that show how patients had improved quality-of-life measures (reduced fatigue and pain symptoms) starting six months after receiving CAR T-cell therapy. As medical director of the Cellular Immunotherapy Integrated Research Center at Fred Hutch, Maloney is at the forefront of clinical trials to develop cell therapies for blood and other cancers, including understanding side effects of CAR Ts and how to deliver them in outpatient settings. He cares for patients at the Bezos Family Immunotherapy Clinic at Seattle Cancer Care Alliance, the Hutchs clinical-care partner.Abstract No. 66 (poster presentation)Saturday, Dec. 7, 8:45 a.m.W308, Level 3

Factors associated with response, CAR T cell in vivo expansion, and progression-free survival after repeat infusions of CD19 CAR T cellsDoes a second dose of CAR T cells help if the first doesnt lead to a lasting remission? A team of Fred Hutch physician-scientists led by Dr. Cameron Turtleexamined outcomes of 44 patients who received a second cycle of CD19 CAR T-cell immunotherapy for acute lymphoblastic leukemia, chronic lymphocytic leukemia or non-Hodgkin lymphoma. The type of chemotherapy given before the first infusion of CAR T cells and a higher dose of CAR T cells for the second infusion were associated with better outcomes.Abstract No. 201 (oral presentation)Saturday, Dec. 7, 12:30 p.m.Valencia A (W415A), Level 4

Severe cytokine release syndrome is associated with impaired hematopoietic recovery after CD19-targeted CART-cell therapyDr. Krishna Juluri, a hematology-oncology fellow at Fred Hutch, will discuss how blood cells recover following CAR T treatment. The researchers found patients who experienced more severe cytokine release syndrome had slower recovery of blood counts. Since CRS can be treated, the Fred Hutch team concludes preventing it might improve blood-cell recovery.Abstract No. 3229 (poster presentation)Sunday, Dec. 8, 68 p.m.Hall B, Level 2

Combination of NKTR-255, a polymer-conjugated human IL-15, with CD19 CAR T-cell immunotherapy in a preclinical lymphoma modelDr. Cassie Chou will present preclinical studies that show how a novel IL-15 receptor agonist activates the interleukin 15 immune system pathway to enhance growth and anti-tumor efficacy of human CD19 CAR T cells in immunodeficient mice bearing human lymphoma. Future clinical trials will explore whether the compound can improve responses to CAR T-cell therapy. Chou is a research fellow and clinician who works in the lab ofDr. Cameron Turtle. Abstract No. 2866 (poster presentation)Sunday, Dec. 8, 68 p.m.Hall B, Level 2

Relapsed or refractory CLL after CD19-specific CART therapy: Treatment patterns and clinical outcomesTreating high-risk chronic lymphocytic leukemia remains challenging with a 65% relapse rate following CAR T-cell therapy. Looking at outcomes of patients with progressive disease after CAR-T, Dr. Mazyar Shadman reports that CAR T-cell therapy did not work as well for patients who had already been treated with more than one other therapy for CLL. This study defines a benchmark for future trials that target relapsed CLL after CAR-T, and it also argues for referring patients to CAR T before they have exhausted other therapeutic options.Abstract No. 4294 (poster presentation)Monday, Dec. 9, 68 p.m.Hall B, Level 2

CD20 CAR T-CELL THERAPY

CD20 targeted chimeric antigen receptor T cells for treatment of high-risk B-cell non-Hodgkin lymphomasMost CAR T-cell therapies for blood cancers target a cancer-specific protein marker called CD19. But more targets are needed. Another CAR T-cell therapy that targets the CD20 protein on cancer cells is being developed by Fred Hutch scientists. Dr. Mazyar Shadman will give an overview of the trial, which is recruiting patients at the Hutchs clinical-care partner, Seattle Cancer Care Alliance. Results of the trial are not ready and will not be reported at ASH.Abstract No. 3235 (poster presentation)Sunday, Dec. 8, 68 p.m.Hall B, Level 2

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TRANSPLANTATION

Extending the benefit of transplantation to more patientsSirolimus combined with Cyclosporine (CSP) and Mycophenolate Mofetil (MMF) As graft-vs-host disease (GVHD) prophylaxis after nonmyeloablative (NMA) hematopoietic cell transplantation (HCT) using HLA Class I or Class II antigen mismatched donors: Results from a Phase II multicenter trialStem cell transplants can save lives, but their success depends on the availability of compatible donors. Unfortunately, depending upon ethnicity, fully HLA-matched donors cannot be found for 25-84% of patients. Dr. Brenda Sandmaier is presenting results from a Phase 2 trial that shows how a triple-drug combination improves outcomes for patients treated with mismatched donors. Abstract No. 369 (oral presentation)Sunday, Dec. 8, 8 a.m.W230, Level 2

Cord blood transplantationTransplantation of blood stem cells from umbilical cord blood can treat blood disorders in patients who have been unable to find a suitable match among other donor sources. This is particularly true for patients of mixed ethnicities. Dr. Filippo Milano, associate director of Fred Hutchs Cord Blood Program, is involved in the following presentations.

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GENE THERAPY

Scientists in the lab of Dr. Hans-Peter Kiem, director of Fred Hutchs Stem Cell and Gene Therapy Program, are pioneering a variety of gene therapy approaches for HIV/AIDS, sickle cell anemia, blood cancers and other diseases. Below are their presentation abstracts.

Fully closed, large-scale, and clinical grade cell sorting of hematopoietic stem cell (HSC)-enriched CD90+ cells for transplantation and gene therapyDr. Stefan Radtke, a Fred Hutch staff scientist, will show for the first time in human blood samples how to isolate a rare stem cell subset that Fred Hutch researchers identified as capable of repopulating the entire blood and immune system. He used commercially available cell-sorting equipment to isolate the cells, an approach that has the potential to make gene therapy more efficient and affordable.Abstract No. 3246 (poster presentation)Sunday, Dec. 8, 68 p.m.Hall B, Level 2

CRISPR/Cas9-mediated protection of normal hematopoiesis combined with the CD33/CD3 bispecific T-cell engager (BiTE) antibody AMG330 for improved AML therapyCD33, a protein marker of cancerous cells in acute myeloid leukemia, is also found on healthy blood stem cells, which makes targeting CD33 toxic, as it kills both healthy cells and cancerous ones. Dr. Olivier Humbert, a staff scientist, used CRISPR to remove the CD33 target from healthy cells. Then, in a mouse model of acute myeloid leukemia, he found that T cells effectively use the CD33 bispecific T-cell engager (BiTE) antibody to attack cancer while sparing CRISPR-edited healthy cells.Abstract No. 4427 (poster presentation)Monday, Dec. 9, 68 p.m.Hall B, Level 2 _______________________________________________________________________________________________________________________

PRECISION MEDICINE / PEDIATRIC AML

Researchers from the lab of Dr. Soheil Meshinchi, a pediatric oncologist and acute myeloid leukemia specialist, will present oral presentations that map genetic mutations to patient outcomes. He says the ongoing genomic profiling work can help guide targeted treatments for patients with AML, the deadliest leukemia among children and young adults.

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ASH NOTABLES

ASH E. Donnall Thomas Lecture and PrizeThe long road to develop adoptive therapy for T cells that can effectively target acute myeloid leukemia and other malignanciesAt the annual E. Donnall Thomas Lecture, Dr. Philip Greenberg, head of the Program in Immunology at Fred Hutch, will talk about how T cells have been engineered to target acute myeloid leukemia and our latest understanding of why cell therapies like CAR T-cell therapy work for some patients and not others, but can potentially be engineered to overcome these obstacles. ASHs E. Donnall Thomas Lecture and Prize recognizes pioneering research achievements in hematology that have changed the field and is named for the Hutchs Dr. E. Donnall Thomas, who received a Nobel Prize for his pioneering efforts in bone marrow transplantation. Thomas was also a colleague and mentor to Greenberg. Learn more about the lecture in an ASH news release.Monday, Dec. 9, 910 a.m.Hall D, Level 2

Incoming ASH President Dr. Stephanie LeeASH will recognize Dr. Stephanie Lee, a hematologist and transplant physician-scientist at Fred Hutch, as its new president at the societys business meeting. Lee cares for stem cell transplant patients at the Hutchs clinical-care partner, Seattle Cancer Care Alliance, and at UW Medicine. Her research aims to improve the lives of transplant recipients. Lee directs the Hutchs Long-Term Follow-Up Research Program, which tracks the outcomes of more than 5,000 transplant survivors.Tuesday, Dec. 10, 11:1511:30 a.mHall D, Level 2

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ON THE HORIZON / OTHER ABSTRACTS

Other notable experts and newsy topics at ASH:

Chronic myeloid leukemia: Meeting global need with better molecular testingDr. Jerald Radich is a medical oncologist who specializes in chronic myeloid leukemia, a relatively rare, slow-growing cancer that is fatal if left untreated. His Fred Hutch research lab examines the molecular genetics of leukemias in an effort to develop methods to improve the detection and treatment of the disease. At an ASH education session, Radich will talk about his award-winning collaboration with The Max Foundation, a Seattle-area nonprofit, which has led to more people in under-resourced areas being tested for CML. He will also give an oral presentation about a molecular test he developed that can predict which CML patients will have a sustained, deep molecular response to treatment.

Repairing immune function

Underappreciated by most, the thymus is a gland in the chest that acts like a boot camp for T cells, training them to identify and kill foreign invaders. The gland wears out with stress, infection and age, and finding ways to boost its productivity could help sustain human health. Researchers in the lab of Dr. Jarrod Dudakov, a Fred Hutch immunologist, will present the latest in understanding the signaling pathways of the thymus. Discovering master regulators could be targets for helping the thymus to repair itself. Below are their presentation abstracts.

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Note: Fred Hutch and its scientists who contributed to these discoveries may stand to benefit from their commercialization. See links above to ASH abstracts for more details on individual researchers disclosures.

The clinical trials referenced above involve investigational products and/or therapies that have not been approved for commercial marketing by the U.S. Food and Drug Administration or any other regulatory authority. Results may vary, and encouraging results from early-stage clinical trials may not be supported in later-stage clinical trials. No conclusions should be drawn from the information in this report about the safety, efficacy or likelihood of regulatory approval of these investigational products and/or therapies.

# # #

Media Contact:Molly McElroyO: 206.667.2210M: 206.941.8146mwmcelro@fredhutch.org

At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutchs pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nations first National Cancer Institute-funded cancer prevention research program, as well as the clinical coordinating center of the Womens Health Initiative and the international headquarters of the HIV Vaccine Trials Network.

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Fred Hutch at ASH: Latest CAR T data BCMA, CD19, CD20 plus new insights on transplantation, gene therapy and more - Newswise

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November 22nd, 2019

Brainstorm Cell Therapeutics (BCLI) Gets a Buy Rating from Maxim Group – Smarter Analyst

By daniellenierenberg

Maxim Group analyst Jason McCarthy maintained a Buy rating on Brainstorm Cell Therapeutics (BCLI) yesterday and set a price target of $9.00. The companys shares closed last Monday at $3.92.

According to TipRanks.com, McCarthy s ranking currently consits of no stars on a 0-5 ranking scale, with an average return of -22.1% and a 25.6% success rate. McCarthy covers the Healthcare sector, focusing on stocks such as SELLAS Life Sciences Group, Hancock Jaffe Laboratories, and Lineage Cell Therapeutics.

Brainstorm Cell Therapeutics has an analyst consensus of Moderate Buy, with a price target consensus of $9.00.

See todays analyst top recommended stocks >>

Based on Brainstorm Cell Therapeutics latest earnings release for the quarter ending September 30, the company reported a quarterly GAAP net loss of $5.63 million. In comparison, last year the company had a GAAP net loss of $3.18 million.

Based on the recent corporate insider activity of 12 insiders, corporate insider sentiment is negative on the stock. This means that over the past quarter there has been an increase of insiders selling their shares of BCLI in relation to earlier this year. Most recently, in August 2019, Irit Arbel, a Director at BCLI sold 13,332 shares for a total of $48,795.

TipRanks has tracked 36,000 company insiders and found that a few of them are better than others when it comes to timing their transactions. See which 3 stocks are most likely to make moves following their insider activities.

Brainstorm Cell Therapeutics, Inc. operates as a biotechnology company, which develops and commercializes adult stem cell therapeutic products. It focuses on utilizing the patients own bone marrow stem cells to generate neuron-like cells that may provide an effective treatment initially for amyotrophic lateral sclerosis, Parkinsons disease, multiple sclerosis and spinal cord injury. The company was founded on September 22, 2000 and is headquartered in New York, NJ.

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Brainstorm Cell Therapeutics (BCLI) Gets a Buy Rating from Maxim Group - Smarter Analyst

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November 22nd, 2019

1st SCD Trial Patient Shows CTX001 Gene Editing to be Safe, Effective – Sickle Cell Anemia News

By daniellenierenberg

CTX001 safely and effectively increased the levels of fetal hemoglobin and prevented vaso-occlusive crisesin the first severesickle cell disease(SCD) patient receiving the therapy, according to preliminary data from a Phase 1/2 clinical trial.

CTX001 is a CRISPR-based gene editing therapy developed byCRISPR TherapeuticsandVertex Pharmaceuticals as a potential treatment for hemoglobin-associated diseases, includingSCD and beta-thalassemia.

It uses the CRISPR-Cas9 gene editing system to genetically modify a patients hematopoietic (bone marrow) stem cellsto produce high levels of fetal hemoglobin in red blood cells, which are then delivered back to the patient as part of a stem cell transplant.

The CRISPR-Cas9 system, which is similar to the editing system used by bacteria as a defense mechanism, allows researchers to edit parts of the genome by adding, removing, or changing specific sections of DNA.

Fetal hemoglobin, the main form of oxygen-carrying hemoglobin in the human fetus and newborn, largely disappears between six months to one year after birth, being replaced by its adult form.

Since the adult form is the one containing the defective component of hemoglobin in people with SCD and beta-thalassemia, an artificial increase of fetal hemoglobin has the potential to compensatefor the defective hemoglobin produced by these patients and reduce or prevent theirsymptoms.

The open-label, multi-center Phase 1/2 CLIMB-SCD-121 study (NCT03745287) is currently evaluating the safety and effectiveness of a single administration of CTX001 in people ages 18 to 35 with severe SCD.

The trial, which is expected to enroll up to 45 people, is stillrecruiting at 12 clinical sites in the United States, Canada, and Europe. Participants will be followed for approximately two years after treatment, and have the opportunity to enter a long-term follow-up study.

Before receiving CTX001, participants will undergo myeloablativechemotherapy, a strategy that kills cells in the bone marrow, thereby lowering the number of blood-forming cells. This way, the stem cell transplant will have more chances to rebuild a healthy bone marrow.

Researchers will first determine when the transplanted modified cells begin to produce mature blood cells in the patients, a process known as engraftment. After confirmation of engraftment, safety and effectiveness will be assessed as part of the trials primary and secondary goals.

One primary goal is to assess the proportion of people with an increase of at least 20% in the production of fetal hemoglobin, starting six months after CTX001 treatment. This increase must be sustained for more than three months at the time of analysis.

Among secondary goals is determining whether CTX001 reduces the annualized rate of vaso-occlusive crises.

In February, CRISPR Therapeutics and Vertex announced the enrollment of the first patient in the CLIMB-SCD-121 study, who was recruited in the U.S. and received CTX001 in mid-2019.

Now, the companies have shared the preliminary four-month data of this patient, a 33-year-old woman who had experienced seven vaso-occlusive crises per year the annualized rate of the two years before her enrollment in the trial.

Results showed that she had a confirmed engraftment 30 days after receiving CTX001 treatment. Four months after treatment, no vaso-occlusive crises were reported and she had stopped blood transfusion treatments.

After four months, her total hemoglobin levels were 11.3 g/dL, fetal hemoglobin levels had increased from 9.1% to 46.6%, and the percentage of fetal hemoglobin-producing red blood cells had increased from 33.9% to 94.7%.

CTX001s early safety profile was consistent with that previously reported for myeloablative chemotherapy followed by stem cell transplant. The woman experienced three serious adverse events, all of them resolved and considered to be unrelated to treatment.

Positive preliminary data were also announced for the first patient with beta-thalassemia receiving CTX001 in the Phase 1/2 CLIMB-Thal-111 study (NCT03655678).

We are very encouraged by these preliminary data [which] support our belief in the potential of our therapies to have meaningful benefit for patients following a one-time intervention, Samarth Kulkarni, PhD, CRISPR Therapeutics CEO, said in a press release.

A webcast and presentation about these preliminary results are available on the companys website.

The data are remarkable and demonstrate that CTX001 has the potential to be a curative CRISPR/Cas9-based gene-editing therapy for people with sickle cell disease and beta thalassemia, said Jeffrey Leiden, MD, PhD, Vertexs chairman, president, and CEO.

Leiden added that the trial is still in its early phase and that he looks forward to its final results.

Early this year, CTX001 receivedfast track statusfor the treatment of sickle cell disease by theU.S. Food and Drug Administration, which is expected to accelerate CTX001s development and regulatory approval process.

Marta Figueiredo holds a BSc in Biology and a MSc in Evolutionary and Developmental Biology from the University of Lisbon, Portugal. She is currently finishing her PhD in Biomedical Sciences at the University of Lisbon, where she focused her research on the role of several signalling pathways in thymus and parathyroid glands embryonic development.

Total Posts: 94

Margarida graduated with a BS in Health Sciences from the University of Lisbon and a MSc in Biotechnology from Instituto Superior Tcnico (IST-UL). She worked as a molecular biologist research associate at a Cambridge UK-based biotech company that discovers and develops therapeutic, fully human monoclonal antibodies.

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1st SCD Trial Patient Shows CTX001 Gene Editing to be Safe, Effective - Sickle Cell Anemia News

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November 20th, 2019

Arthritis drugs could be repurposed to help prevent breast cancer spreading to the bone, study suggests – The University of Manchester

By daniellenierenberg

Drugs commonly used to treat arthritis may help to prevent breast cancer spreading to the bone, where it is incurable, new research suggests.

In a major new study published in Nature Communications, scientists propose that NHS arthritis drugs anakinra, canakinumab and sulfasalazine could in future be repurposed to help treat breast cancer, following the discovery of the role of bone marrow in the spread of the disease to the bone.

The study, largely funded by Breast Cancer Now, found that bone marrow releases a protein called interleukin 1-beta (IL-1) which encourages breast cancer cells to form secondary tumours once they reach the bone.

Crucially, the scientists at The University of Manchester and The University of Sheffield established that the process started by this molecule can be blocked by drugs already used in treating arthritis, with anakinra found to be able to prevent breast cancer forming secondary tumours in the bone in a study in mice.

While further research is needed to understand how these drugs may interact with the immune system or work together with other cancer therapies, it is hoped the findings could be quickly advanced into trials in women with breast cancer to try to prevent the disease spreading to the bone.

Research and care charity Breast Cancer Now said the findings offered another promising step in repurposing existing drugs to try to prevent the spread of breast cancer, following the recent addition of osteoporosis drugs bisphosphonates to NHS breast cancer treatment for certain patients.

Breast cancer is the UKs most common cancer, with around 55,000 women and 370 men being diagnosed each year and around 11,500 women still losing their lives each year in the UK.

Almost all of these deaths are attributable to secondary breast cancer, where breast cancer has spread to form tumours in other parts of the body. While secondary breast cancer (also known as metastatic breast cancer) can be controlled for some time, it currently cannot be cured.

One of the most common parts of the body for breast cancer to spread to is the bone, which can cause debilitating symptoms such as joint pain or fractures that often require surgery.

Special types of cells, called breast cancer stem cells, are thought to be responsible for the disease spreading around the body with previous research suggesting that healthy cells in different parts of the body can release certain molecules that help cancer stem cells settle and grow in new locations.

In a new study, research teams led by Dr Rachel Eyre and Professor Rob Clarke at The University of Manchester and Dr Penelope Ottewell from the Department of Oncology and Metabolism at The University of Sheffield investigated the growth of breast cancer cells in the lab and in mice to establish what helps the disease settle and grow in this location. They discovered the importance of certain factors released by the bone, and these findings were supported using data from patients with secondary breast cancer1.

The researchers first grew human breast cancer cells using liquid that human bone marrow had previously been grown in. They found that these cancer cells grew into tumours more easily than breast cancer cells that werent exposed to bone marrow liquid, suggesting bone marrow releases a molecule that helps cancer growth.

By tracking which signalling pathways2 became active in breast cancer cells after they had been exposed to bone marrow, the researchers discovered that the molecule IL-1 (which is released by bone marrow) was responsible for helping breast cancer stem cells grow into tumours.

They found that IL-1 activates a signalling pathway called NFKB/CREB-Wnt, which promotes the formation of secondary tumours a discovery that identifies multiple new targets (IL-1 receptor, NFKB, Wnt) for drugs to try to prevent the growth of breast cancer tumours in the bone.

Drugs that can inhibit the action of IL-1 already exist and are used in treating other conditions on the NHS. The researchers tested whether blocking the effect of IL-1 with clinically available arthritis drugs such as anakinra, as well as another drug, currently in trials for treating cancer, called vantictumab, could prevent the formation and growth of secondary breast cancer in the bone in mice.

They found that blocking the role of IL-1 using these drugs significantly reduced the ability of breast cancer cells to form secondary tumours in the bone in mice. For example, following treatment with anakinra, only 14% of mice developed secondary tumours in the bone, compared to 42% of controls.

Research is ongoing to understand how blocking the action of IL-1 to stop breast cancer spreading may affect the immune system, and whether drugs such as anakinra, canakinumab and sulfalazine could work with existing therapies including bisphosphonates to prevent the spread of the disease to the bone. With these drugs being well-tolerated and already in use in treating arthritis, the authors hope the findings could be quickly progressed into clinical trials for breast cancer in the future.

The researchers are also now working to understand whether the same signalling pathway (NFKB/CREB-Wnt) may be important in the spread of breast cancer to other parts of the body such as the liver or lungs.

The study was largely funded by Breast Cancer Now, with additional support from Weston Park Cancer Charity and the Medical Research Council.

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Arthritis drugs could be repurposed to help prevent breast cancer spreading to the bone, study suggests - The University of Manchester

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November 20th, 2019

Decoding the building blocks of life: bit bio races toward a sustainable source of human cells – Proactive Investors UK

By daniellenierenberg

The ability to turn human cells into anything we want sounds like the stuff of science fiction. But one Cambridge biotech says it's cracked the code

A sustainable source of human stem cells is one of the holy grails of modern medicine.

With applications as broad as re-growing failed organs, fighting cancer, and stopping animal testing, stem cell therapy is predicted to be worth US$35bn by 2023.

Now, Cambridge startup bit bio, has a new approach to re-coding skin cells from adult humans, and rewinding the clock to give them the power of stem cells, and then turn them into whatever we want them to be all without the controversial involvement of human embryos.

This, says neurosurgeon and founder Dr Mark Kotter, will democratise stem cells, so that anyone can use them, at any time.

The private sector is already placing big bets on the technology, with start-ups in the space raising as much as US$16mln in recent funding rounds.

Kotter says that our inability to produce enough human stem cells to match our need puts troubling limits on research and drug development.

In drug discovery, the biggest bottleneck is the mismatch between animal models and animal cell lines used for drug discovery, and then human setting used in the clinical trial, he explains.

Around 3% of new drugs make it all the way through trials and to market, he says, and the biggest reasons treatments tend to fail in clinical study is that they are either toxic to humans, or they dont work.

The only solution is to bring the human element back to the early stages, says Kotter.

If new therapies were tested on human tissue first, it would reduce or even bypass the need to test on animals, as well as speeding up development.

Kotter founded bit bio, formerly known as Elpis BioMed, in 2016, in addition to startup Meatable, which produces meat by growing cultures in the lab, rather than rearing animals for the table.

The time is now for bit bio, because what it is doing has only been possible since a Nobel Prize-winning discovery twelve years ago, which turned the world of stem cell research upside down.

Kyoto University researcher Shinya Yamanaka proved that it was possible to take a mature human skin cell and reprogram it to be like the stem cell of an embryo.

Until this revelation, stem cell research had been dogged by controversy and expense, as scientists had to use human embryos and umbilical cords as a source of stem cells, and then simulate complex conditions inside the womb in order to make them develop into the cells they desired.

One big problem in early cell reprogramming was that stem cells are incredibly alert to invading DNA and silences any foreign material it detects.

This meant that past attempts run a different program inside a cell often failed, because the cell destroyed it.

What happened next was a moment of "serendipity" in the lab, says Kotter.

Through trial and error, bit bio found they could use certain safe harbours where information is protected within cells, to stop theinterference.

By taking the genetic switch for gene silencing and placing it inside a safe harbour, and then separately running the new cell program inside another safe harbour, scientists found they could override gene silencing in order to change the cell type.

This approach is what Kotter says makes bit bio unique.

The lab can produce up to a kilogram of human cells now, and its tech platform OptiOx has also proved that it can generate two human cell types with 100% accuracy.

Kotter says that now the range of cells able to be produced matters more than the quantity.

The company is now focused on discovering what separates one type of cell from another, which Kotter says will allow the firm to decode the building blocks of life.

To this end, bit bio is using machine learning to analyse the differences between every type of human cell, from bone marrow cells to liver cells, and create a reference map for all the different types.

Once the research is complete, the company hopes it willbe able to generate any type of human cell, at scale, and with ultimate precision.

Preparations are underway for a Series A funding round, and Kotter says that he is determined not to sell the business, having already rejected offers from would-be buyers.

Bit bio though is in an area hot with competition, which moves quickly.

A US$16mln Series A mega funding round was recently announced in October by another Cambridge start-up, Mogrify, which is hoping to master direct cell reprogramming and turn blood cells straight into brain cells, or any other type.

Mogrify uses big data to identify the small molecules needed to convert, maintain and culture a target cell type.

While both companies were finalists in the 2018 Cambridge Startup of the Year award, bit bio was the one to scoop the prize.

One aspect that separates the two companies is that Mogrify uses its technology to turn cells directly into other cell types, rather than using it to rewindto the stem cell phase, which is when cells can reproduce very quickly,

Kotter says that this stem cell phase focusis whatallows bit bio to havea stable supply of human cells.

If bit bio completes a similar, or even bigger, fundraise, it could advance the fledgling firm from seed to stem, in its attempt to stabilise a production line for essential cell technology.

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Decoding the building blocks of life: bit bio races toward a sustainable source of human cells - Proactive Investors UK

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November 20th, 2019

Arthritis drugs could halt the spread of breast cancer, study suggests – sciencefocus.com

By daniellenierenberg

Simple arthritis drugs used on the NHS could help stop breast cancer spreading, research suggests.

Scientists propose that arthritis drugs anakinra, canakinumab and sulfasalazine could be re-purposed to help block cancer reaching bones.

Research teams from the University of Manchester and the University of Sheffield discovered that a protein released by bone marrow, called interleukin 1-beta encouraged breast cancer cells to form secondary tumours once they reach the bone.

Tests on mice found that this molecule can be blocked by drugs already used to treat arthritis.

Cellect Biotechnology Reports Third Quarter 2019 Financial and Operating Results – Yahoo Finance

By daniellenierenberg

TEL AVIV, Israel, Nov. 19, 2019 /PRNewswire/ --Cellect Biotechnology Ltd. (APOP), a developer of innovative technology which enables the functional selection of stem cells, today reported financial and operating results for the third quarter ended September 30, 2019 and provided a corporate update.

Recent Highlights

"Our clinical and regulatory teams remained focused during the third quarter and the more recent positive developments position us to achieve our goals, both in the U.S. and Israel," commented Dr. Shai Yarkoni, Chief Executive Officer. "In the U.S., the IND approval is a significant achievement and represents our first-ever FDA IND in the U.S., with Washington University School of Medicine. In Israel, our Phase 1/2 clinical study of ApoGraft is progressing slowly and we expect to complete the recruitment around the end of the year."

"With our prudent use of cash during the third quarter and the anticipated cash usage needs over the coming quarters, we continue to believe we have the resources to execute our clinical and regulatory plans for the foreseeable future," said Eyal Leibovitz, Chief Financial Officer.

ThirdQuarter 2019 Financial Results:

*For the convenience of the reader, the amounts above have been translated from NIS into U.S. dollars, at the representative rate of exchange on September 30, 2019 (U.S. $1 = NIS 3.482).

Strategic Review Progress Update

On May 16, 2019, the Company disclosed that it commenced plans to explore strategic alternatives to maximize shareholder value. Potential strategic alternatives that may be evaluated include, but are not limited to, an acquisition, merger, business combination, including in other business fields than the Company's in-licensing, or other strategic transaction involving the Company or its assets. The Company continues to evaluate business development opportunities and will keep investors informed as they mature or warrant investor disclosure.

About Cellect Biotechnology Ltd.

Cellect Biotechnology (APOP) has developed a breakthrough technology, for the selection of stem cells from any given tissue, that aims to improve a variety of stem cell-based therapies.

The Company's technology is expected to provide researchers, clinical community and pharma companies with the tools to rapidly isolate stem cells in quantity and quality allowing stem cell-based treatments and procedures in a wide variety of applications in regenerative medicine. The Company's current clinical trial is aimed at bone marrow transplantations in cancer treatment.

Forward Looking Statements

This press release contains forward-looking statements about the Company's expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as "believe", "expect", "intend", "plan", "may", "should", "could", "might", "seek", "target", "will", "project", "forecast", "continue" or "anticipate" or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: the Company's history of losses and needs for additional capital to fund its operations and its inability to obtain additional capital on acceptable terms, or at all; the Company's ability to continue as a going concern; or maintain its current operations; uncertainties involving any strategic transaction the Company may decide to enter into as the result of its current efforts to explore new strategic alternatives; uncertainties of cash flows and inability to meet working capital needs; the Company's ability to obtain regulatory approvals; the Company's ability to obtain favorable pre-clinical and clinical trial results; the Company's technology may not be validated and its methods may not be accepted by the scientific community; difficulties enrolling patients in the Company's clinical trials; the ability to timely source adequate supply of FasL; risks resulting from unforeseen side effects; the Company's ability to establish and maintain strategic partnerships and other corporate collaborations; the scope of protection the Company is able to establish and maintain for intellectual property rights and its ability to operate its business without infringing the intellectual property rights of others; competitive companies, technologies and the Company's industry; unforeseen scientific difficulties may develop with the Company's technology; and the Company's ability to retain or attract key employees whose knowledge is essential to the development of its products. Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in Cellect Biotechnology Ltd.'s Annual Report on Form 20-F for the fiscal year ended December 31, 2018 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, http://www.sec.gov, and in the Company's periodic filings with the SEC.

Story continues

Cellect Biotechnology Ltd

Consolidated Statement of Operation

Convenience

translation

Nine months

ended

Nine months ended

Three months ended

September 30,

2019

2018

2019

2018

Unaudited

U.S. dollars

NIS

(In thousands, except share and per

share data)

Research and development expenses

2,743

9,551

9,473

2,465

4,125

General and administrative expenses

2,249

7,832

11,001

2,768

3,929

Operating loss

4,992

17,383

20,474

5,233

8,054

Financial expenses (income) due to warrants exercisable into shares

(2,303)

(8,020)

(2,935)

(910)

(1,320)

Other financial expenses (income), net

393

1,369

(1,177)

489

Total comprehensive loss

3,082

10,732

16,362

4,812

6,798

Loss per share:

Basic and diluted loss per share

0.015

0.051

0.127

0.021

0.052

Basic and diluted loss per ADS

0.30

1.02

2.54

0.42

1.04

Weighted average number of shares outstanding used to compute basic and diluted loss per share

208,771,303

129,139,278

224,087,799

130,192,799

Cellect Biotechnology Ltd.

Consolidated Balance Sheet Data

ASSETS

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Cellect Biotechnology Reports Third Quarter 2019 Financial and Operating Results - Yahoo Finance

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November 20th, 2019

Bone Marrow Processing Systems Market With Industry Overview, Supply Chain, Key Players, & Analysis To 2025 – Guru Online News

By daniellenierenberg

Bone marrow aspirationand trephine biopsy are usually performed on the back of the hipbone, or posterior iliac crest. An aspirate can also be obtained from the sternum (breastbone). For the sternal aspirate, the patient lies on their back, with a pillow under the shoulder to raise the chest. A trephine biopsy should never be performed on the sternum, due to the risk of injury to blood vessels, lungs or the heart.

The need to selectively isolate and concentrate selective cells, such as mononuclear cells, allogeneic cancer cells, T cells and others, is driving the market. Over 30,000 bone marrow transplants occur every year. The explosive growth of stem cells therapies represents the largest growth opportunity for bone marrow processing systems.

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Europe and North America spearheaded the market as of 2018, by contributing over 74.0% to the overall revenue. Majority of stem cell transplants areconducted in Europe, and it is oneof the major factors contributing to the lucrative share in the cell harvesting system market.

In 2018, North America dominated the research landscape as more than 54.0% of stem cell clinical trials were conducted in this region. The region also accounts for the second largest number of stem cell transplantation, which is further driving the demand for harvesting in the region.

Asia Pacific is anticipated to witness lucrative growth over the forecast period, owing to rising incidence of chronic diseases and increasing demand for stem cell transplantation along with stem cell-based therapy.

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Japan and China are the biggest markets for harvesting systems in Asia Pacific. Emerging countries such as Mexico, South Korea, and South Africa are also expected to report lucrative growth over the forecast period. Growing investment by government bodies on stem cell-based research and increase in aging population can be attributed to the increasing demand for these therapies in these countries.

Major players operating in the global bone marrow processing systems market are ThermoGenesis (Cesca Therapeutics inc.), RegenMed Systems Inc., MK Alliance Inc., Fresenius Kabi AG, Harvest Technologies (Terumo BCT), Arthrex, Inc. and others.

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November 20th, 2019

Arthritis drugs available on the NHS help stop the spread of breast cancer to bones – The Sun

By daniellenierenberg

ARTHRITIS drugs available on the NHS help stop the spread of breast cancer, a study suggests.

They blocked secondary tumours fuelled by a bone marrow protein called interleukin 1-beta, researchers found.

In tests, just 14 per cent of mice treated with arthritis drug anakinra developed secondary tumours in the bone, compared with 42 per cent in a control group.

Other arthritis drugs canakinumab and sulfasalazine had similar effects, the Manchester University and Sheffield University researchers found.

Dr Rachel Eyre told journal Nature Communications: We will now look to see if similar processes are also involved in breast cancer growing in organs such as the liver and lungs.

The study was largely funded by charity Breast Cancer Now.

According to Breast Cancer Now, around 55,000 women and 370 men are diagnosed with breast cancer each year, making it the UK's most common cancer.

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About 11,500 women die from the disease each year, almost all from tumours that have spread to other parts of the body.

Breast cancer most commonly spreads to the bones, brain, lungs or liver.

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Arthritis drugs available on the NHS help stop the spread of breast cancer to bones - The Sun

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November 20th, 2019

Cellect Biotechnology Reports Third Quarter 2019 Financial and Operating Results – BioSpace

By daniellenierenberg

TEL AVIV, Israel, Nov. 19, 2019 /PRNewswire/ --Cellect Biotechnology Ltd. (NASDAQ: APOP), a developer of innovative technology which enables the functional selection of stem cells, today reported financial and operating results for the third quarter ended September 30, 2019 and provided a corporate update.

Recent Highlights

ThirdQuarter 2019 Financial Results:

*For the convenience of the reader, the amounts above have been translated from NIS into U.S. dollars, at the representative rate of exchange on September 30, 2019 (U.S. $1 = NIS 3.482).

Strategic Review Progress Update

About Cellect Biotechnology Ltd.

Cellect Biotechnology (APOP) has developed a breakthrough technology, for the selection of stem cells from any given tissue, that aims to improve a variety of stem cell-based therapies.

Forward Looking Statements

Cellect Biotechnology Ltd

Consolidated Statement of Operation

Convenience

translation

Nine months

ended

Nine months ended

Three months ended

September 30,

2019

2018

2019

2018

Unaudited

U.S. dollars

NIS

(In thousands, except share and per

share data)

Research and development expenses

2,743

9,551

9,473

2,465

4,125

General and administrative expenses

2,249

7,832

11,001

2,768

3,929

Operating loss

4,992

17,383

20,474

5,233

8,054

Financial expenses (income) due towarrants exercisable into shares

(2,303)

(8,020)

(2,935)

(910)

(1,320)

Other financial expenses (income), net

393

1,369

(1,177)

489

Total comprehensive loss

3,082

10,732

16,362

4,812

6,798

Loss per share:

Basic and diluted loss per share

0.015

0.051

0.127

0.021

0.052

Basic and diluted loss per ADS

0.30

1.02

2.54

0.42

1.04

Weighted average number of sharesoutstanding used to compute basic anddiluted loss per share

208,771,303

129,139,278

224,087,799

130,192,799

Cellect Biotechnology Ltd.

Consolidated Balance Sheet Data

ASSETS

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Cellect Biotechnology Reports Third Quarter 2019 Financial and Operating Results - BioSpace

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November 20th, 2019

These Scientists May Have Found a Cure for ‘Bubble Boy’ Disease – Smithsonian.com

By daniellenierenberg

On the morning of April 25, 2018, in Fort Wayne, Indiana, Omarion Jordan came into the world ten-fingers-and-toes perfect. His mother, Kristin Simpson, brought her dark-haired newborn home to a mostly empty apartment in Kendallville, about 30 miles to the north. Shed just moved in and hadnt had time to decorate. Her son, however, had everything he needed: a nursery full of toys, a crib, a bassinet and a blue octopus blanket.

Still, within his first couple of months, he was plagued by three different infections that required intravenous treatments. Doctors thought he had eczema and cradle cap. They said he was allergic to his mothers milk and told her to stop breastfeeding. Then, not long after he received a round of standard infant vaccinations, his scalp was bleeding and covered with green goop, recalled the first-time mother, who was then in her late teens. She took him to the hospital emergency room, where, again, caregivers seemed puzzled by the babys bizarre symptoms, which didnt make any sense until physicians, finally, ordered the right blood test.

What they learned was that Omarion was born with a rare genetic disorder called X-linked severe combined immunodeficiency (SCID), better known as the bubble boy disease. Caused by a mutated gene on the X chromosome, and almost always limited to males, a baby born with X-linked SCID, or SCID-X1, lacks a working immune system (hence the unusual reaction to vaccination). The bubble boy name is a reference to David Vetter, a Texas child born with SCID-X1 in 1971, who lived in a plastic bubble and ventured out in a NASA-designed suit. He died at 12, but his highly publicized life inspired a 1976 TV movie starring John Travolta.

Today, technological advances in hospitals provide a kind of bubble, protecting SCID-X1 patients with controlled circulation of filtered air. Such safeguards are necessary because a patient exposed to even the most innocuous germs can acquire infections that turn deadly. As soon as Omarion tested positive for the disorder, an ambulance carried him to Cincinnati Childrens Hospital in nearby Ohio and placed him in isolation, where he remained for the next few months. I had no idea what would happen to him, his mother recalled.

Approximately one in 40,000 to 100,000 infants is born with SCID, according to the Centers for Disease Control and Prevention. Only about 20 to 50 new cases of the SCID-X1 mutationwhich accounts for about half of all SCID casesappear in the United States each year. For years, the best treatments for SCID-X1 have been bone marrow or blood stem cell transplantations from a matched sibling donor. But fewer than 20 percent of patients have had this option. And Omarion, an only child, was not among them.

As it happened, medical scientists at St. Jude Childrens Research Hospital in Memphis, Tennessee, were then developing a bold new procedure. The strategy: introduce a normal copy of the faulty gene, designated IL2RG, into a patients own stem cells, which then go on to produce the immune system components needed to fight infection. Simpson enrolled Omarion in the clinical study and Cincinnati Childrens Hospital arranged a private jet to transport her and her son to the research hospital, where they stayed for five months.

St. Jude wasnt the first to try gene therapy for SCID-X1. Nearly 20 years ago, researchers in France reported successfully reconditioning immune systems in SCID-X1 patients using a particular virus to deliver the correct gene to cells. But when a quarter of the patients in that study developed leukemia, because the modified virus also disrupted the functioning of normal genes, the study was halted and scientists interested in gene therapy for the disorder hit the brakes.

At St. Jude, experts led by the late Brian Sorrentino, a hematologist and gene therapy researcher, set out to engineer a virus delivery vehicle that wouldnt have side effects. They started with a modified HIV vector emptied of the virus and its original contents, and filled it with a normal copy of the IL2RG gene. They engineered this vector to include insulators to prevent the vector from disturbing other genes once it integrated into the human genome. The goal was to insert the gene into stem cells that had come from the patients own bone marrow, and those cells would then go on to produce working immune system cells. It was crucial for the viral vector to not deliver the gene to other kinds of cellsand thats what the researchers observed. After gene therapy, for example, brain cells do not have a correct copy of the gene, explained Stephen Gottschalk, who chairs St. Judes Department of Bone Marrow Transplantation and Cellular Therapy.

In the experimental treatment, infants received their re-engineered stem cells just 12 days after some of their bone marrow was obtained. They went through a two-day, low-dose course of chemotherapy, which made room for the engineered cells to grow. Within four months, some of the babies were able to fight infections on their own. All eight of the initial research subjects left the hospital with a healthy immune system. The remarkably positive results made news headlines after being published this past April in the New England Journal of Medicine. Experimental gene therapy frees bubble boy babies from life of isolation, the journal Nature trumpeted.

So far, the children who participated in that study are thriving, and so are several other babies who received the treatmentincluding Omarion. As a physician and a mom, I couldnt ask for anything better, said Ewelina Mamcarz, lead author of the journal article and first-time mother to a toddler nearly the same age as Omarion. The children in the study are now playing outside and attending day care, reaching milestones just like my daughter, Mamcarz says. Theyre no different. Mamcarz, who is from Poland, came to the United States to train as a pediatric hematologist-oncologist and joined St. Jude six years ago.

Other medical centers are pursuing the treatment. The University of California, San Francisco Benioff Childrens Hospital is currently treating infant patients, and Seattle Childrens Hospital is poised to do the same. Moreover, the National Institutes of Health has seen success in applying the gene therapy to older patients, ages 3 to 37. Those participants had previously received bone marrow transplants from partially matched donors, but theyd been living with complications.

In the highly technical world of medicine today, it takes teamwork to achieve a breakthrough, and as many as 150 peoplephysicians, nurses, regulators, researchers, transplant coordinators and othersplayed a role in this one.

Sorrentino died in November 2018, but hed lived long enough to celebrate the trial results. In the early 90s, we thought gene therapy would revolutionize medicine, but it was kind of too early, said Gottschalk, who began his career in Germany. Now, nearly 30 years later, we understand the technology better, and its really starting to have a great impact. We can now develop very precise medicine, with very limited side effects. Gottschalk, who arrived at St. Jude a month before Sorrentinos diagnosis, now oversees the hospitals SCID-X1 research. Its very, very gratifying to be involved, he said.

For now the SCID-X1 gene therapy remains experimental. But with additional trials and continued monitoring of patients, St. Jude hopes that the therapy will earn Food and Drug Administration approval as a treatment within five years.

Simpson, for her part, is already convinced that the therapy can work wonders: Her son doesnt live in a bubble or, for that matter, in a hospital. He can play barefoot in the dirt with other kids, whatever he wants, because his immune system is normal like any other kid, she said. I wish there were better words than thank you.

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These Scientists May Have Found a Cure for 'Bubble Boy' Disease - Smithsonian.com

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November 20th, 2019

Call for better drug to be approved for sufferers of rare blood cancer – The Age

By daniellenierenberg

I could barely think, because all the small blood vessels in my head were getting this thick blood pumping through.

In addition to bad headaches and crippling fatigue, PV sufferers are also prone to blood clots, which can pose a separate health risk.

According to the Leukaemia Foundation, PV is diagnosed in an estimated 250 Australians each year, and is one of three types of blood cancers called MPNs.

Associate Professor Steven Lane says the longer-lasting the version of interferon, the greater the effect it appears to have on PV.

Standard treatment for the condition is old-fashioned bloodletting to help thin the blood, combined with drugs that target the bone marrow, where the cancers stem cells are located.

Associate Professor Steven Lane, who is the head of QIMR Berghofers Cancer Program and a Royal Brisbane and Womens Hospital clinical haematologist, said the current most effective drug on the market in Australia was a form of interferon, a protein-based anti-cancer drug.

However, the form used most widely had to be taken up to three times a week, which, given the drug will often have to be used for the rest of the patients life, was not ideal.

A long-acting version of the drug has now been approved for use in Australia that only needs to be given once a week we call it the long-acting version of the drug, Dr Lane said.

Theres actually an even longer-acting version of the drug, an ultra-long-acting version, which has been approved in Europe but not Australia, and wed like to see that approved here.

Thats because Dr Lanes recent research into PVs response to drug therapy found that, in mice, the longer-acting the version of interferon, the better the effect on reducing the cancer symptoms.

People need to remain on this drug for a long time, and it actually doesnt usually start having an effect for six months, he said.

And as you increase the duration of action of the drug, not only is it more convenient for the people who need to inject themselves with it, it appears to be more effective as well.

Ms Chapman switched to the long-acting version of interferon around a year ago, and said she finally felt a sudden improvement in her condition just three months ago, just ahead of her 50th birthday in December, and her daughters 21st.

When youve been living with this for 12 or 13 years, you sometimes forget what its like to feel normal, she said.

I would love to get access to the ultra-long-acting version it would be wonderful to have even fewer injections, and better control over the disease as well.

The QIMR research has been published in the journal Leukemia.

Our journalists abide by a set of reporting guidelines when writing about medical research. If you would like to read them click here.

Stuart Layt covers health, science and technology for the Brisbane Times. He was formerly the Queensland political reporter for AAP.

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November 20th, 2019

Autologous Stem Cell And Non Stem Cell Based Therapies Market Opportunity Analysis and Industry Forecast up to 2026 – Guru Online News

By daniellenierenberg

Autologous stem cell and non-stem cell based therapiesinvolve an individuals cell to be cultured and then re-introduced to the donors body. These therapies do not use foreign organism cells and are therefore free from HLA incompatibility, disease transmission, and immune reactions.Increasing demand for the new therapies in the field of regenerative medicine is directly facilitating the growth of autologous stem cell and non-stem cell based therapies market. Furthermore, since the risk to transplantation surgeries is significantly reduced in these therapies, they are increasingly being preferred for treatment of bone marrow diseases, aplastic anemia, multiple myeloma, non-Hodgkins lymphoma, Hodgkins lymphoma, Parkinsons disease, thalassemia, and diabetes.

Moreover, rising incidents of cancer, diabetes and cardiovascular diseases along with growing geriatric population is another factor attributed for its high growth. However, side-effects of autologous stem cell and non-stem cell based therapies such as nausea, infection, hair loss, vomiting, diarrhea, etc. are expected to affect the market to an extent. High cost is another factor that can act as challenge to autologous stem cell and non-stem cell based therapies market. In spite of this, less risk post transplantation surgeries and favorable tax reimbursement policies are anticipated to reduce the impact of these limitation during the forecast period.Autologous stem cell and non-stem cell based therapies market can be segmented on the basis of application, end-user, and region.

In terms of application, the autologous stem cell and non-stem cell based therapies market can be segmented into blood pressure (BP) monitoring devices, intracranial pressure (ICP) monitoring devices, and pulmonary pressure monitoring devices.

In terms of end-user, the market can be segmented into ambulatory surgical center and hospitals. By region, the market can be segmented into North America, Europe, Asia Pacific, Middle East and Africa and South America. Amongst all, Asia Pacific is anticipated to be the most attractive market owing to favorable reimbursement policies in the region.The players operating in autologous stem cell and non-stem cell based therapies market are limited. They are consistently involved in research and development activities for product development to keep up with the growing competition, thereby aiding the growth of autologous stem cell and non-stem cell based therapies market across the world.

The major players operating in autologous stem cell and non-stem cell based therapies market are Regennex, Antria(Cro), Bioheart, Orgenesis Inc., Virxys corporation , Dendreon Corporation, Tigenix, Georgia Health Sciences University, Neostem Inc, Genesis Biopharma, Brainstorm Cell Therapeutics, Tengion Inc., Fibrocell Science Inc., Opexa Therapeutics Inc, Regeneus Ltd, and Cytori Inc., among others.

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Autologous Stem Cell And Non Stem Cell Based Therapies Market Opportunity Analysis and Industry Forecast up to 2026 - Guru Online News

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November 20th, 2019

Adipose Derived Stem Cell Therapy Market New Business Opportunities and Investment Research Report – Bishop’s Cleeve Bulletin

By daniellenierenberg

Adipose Derived Stem Cell Therapy Market Report 2018-2026includes a comprehensive analysis of the present Market. The report starts with the basic Adipose Derived Stem Cell Therapy industry overview and then goes into each and every detail.

Adipose Derived Stem Cell Therapy Market Report contains in depth information major manufacturers, opportunities, challenges, and industry trends and their impact on the market forecast. Adipose Derived Stem Cell Therapy also provides data about the company and its operations. This report also provides information on the Pricing Strategy, Brand Strategy, Target Client, Distributors/Traders List offered by the company.

Description:

Adipose derived stem cells (ADSCs) are stem cells derived from adipocytes, and can differentiate into variety of cell types. ADSCs have multipotency similar to bone marrow mesenchymal stem cells, thus ADSCs substitute for bone marrow as a source of stem cells. Numerous manual and automatic stem cell separation procedures are adopted in order to separate adipose stem cells (ASCs) from adipose tissue. Flow cytometry can also be used to isolate ADSCs from other stem cells within a cell solution.

Get Request Sample Copy of Research Report @ https://www.coherentmarketinsights.com/insight/request-sample/2357

Important Features that are under offer & key highlights of the report:

1) What all regional segmentation covered? Can the specific country of interest be added?Currently, the research report gives special attention and focus on the following regions:North America (U.S., Canada, Mexico), Europe (Germany, U.K., France, Italy, Russia, Spain etc), South America (Brazil, Argentina etc) & Middle East & Africa (Saudi Arabia, South Africa etc)** One country of specific interest can be included at no added cost. For inclusion of more regional segment quote may vary.

2) What all companies are currently profiled in the report?The report Contain the Major Key Players currently profiled in this market.** List of companies mentioned may vary in the final report subject to Name Change / Merger etc.

3) Can we add or profiled new company as per our need?Yes, we can add or profile new company as per client need in the report. Final confirmation to be provided by the research team depending upon the difficulty of the survey.** Data availability will be confirmed by research in case of a privately held company. Up to 3 players can be added at no added cost.

4) Can the inclusion of additional Segmentation / Market breakdown is possible?Yes, the inclusion of additional segmentation / Market breakdown is possible to subject to data availability and difficulty of the survey. However, a detailed requirement needs to be shared with our research before giving final confirmation to the client.** Depending upon the requirement the deliverable time and quote will vary.

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Keyplayers :

Adipose Derived Stem Cell Therapy Market competition by top manufacturers/players, with Adipose Derived Stem Cell Therapy sales volume, Price (USD/Unit), Revenue (Million USD) and Market Share for each manufacturer/player; the top players including: BioRestorative Therapies, Inc., Celltex Therapeutics Corporation, Antria, Inc., Cytori Therapeutics Inc., Intrexon Corporation, Mesoblast Ltd., iXCells Biotechnologies, Pluristem Therapeutics, Inc., Thermo Fisher Scientific, Inc., Tissue Genesis, Inc., Cyagen US Inc., Celprogen, Inc., and Lonza Group, among others.

Adipose Derived Stem Cell Therapy Market Dynamics in the world mainly, the worldwide 2018-2026 Adipose Derived Stem Cell Therapy Market is analyzed across major global regions. CMI also provides customized specific regional and country-level reports for the following areas:

Region Segmentation:

North America (USA, Canada and Mexico)Europe (Germany, France, UK, Russia and Italy)Asia-Pacific (China, Japan, Korea, India and Southeast Asia)South America (Brazil, Argentina, Columbia etc.)Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa)

Key questions answered in the report:

1. What will the market growth rate of Adipose Derived Stem Cell Therapy market in 20262. What are the key factors driving the global Adipose Derived Stem Cell Therapy market3. Who are the key manufacturers in Adipose Derived Stem Cell Therapy market space?4. What are the market opportunities, market risk and market overview of the Adipose Derived Stem Cell Therapy market?5. What are sales, revenue, and price analysis by types and applications of Adipose Derived Stem Cell Therapy market?6. What are sales, revenue, and price analysis by regions of Adipose Derived Stem Cell Therapy industry?

Further in the report, the Adipose Derived Stem Cell Therapy market is examined for Sales, Revenue, Price and Gross Margin. These points are analyzed for companies, types, and regions. In continuation with this data, the sale price is for various types, applications and region is also included. The Adipose Derived Stem Cell Therapy industry consumption for major regions is given. Additionally, type wise and application wise figures are also provided in this report.

Ask Query for more details @ https://www.coherentmarketinsights.com/insight/talk-to-analyst/2357

In this study, the years considered to estimate the market size of 2018-2026 Adipose Derived Stem Cell Therapy Market are as follows:History Year: 2015-2017Base Year: 2017Estimated Year: 2018Forecast Year 2018 to 2026

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Coherent Market Insights is a prominent market research and consulting firm offering action-ready syndicated research reports, custom market analysis, consulting services, and competitive analysis through various recommendations related to emerging market trends, technologies, and potential absolute dollar opportunity.

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Adipose Derived Stem Cell Therapy Market New Business Opportunities and Investment Research Report - Bishop's Cleeve Bulletin

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November 20th, 2019

U.S. stem cell clinic offering unapproved therapies brings direct-to-consumer marketing to Ottawa – Ottawa Citizen

By daniellenierenberg

Just a few months after Health Canada began cracking down on private clinics offering unapproved stem cell therapies, at least one U.S. clinic has moved in to fill the vacuum with direct marketing to Canadian consumers.

The clinic from Burlington, Vermont, even offers shuttle buses to transport people from Ottawa to the clinic four hours away for treatment it suggests will end joint pain, among other things. Lunch and dinner are free, but each injection costs $6,880. Two for $10,880.

The treatments, using umbilical cord-derived mesenchymal stem cells, are not approved in either Canada or the United States. Health Canada warns that Canadians who travel abroad for stem cell treatments may put themselves at risk.

While stem cells, which were discovered at the University of Toronto in 1961 by James Till and Ernest McCulloch, promise to revolutionize many treatments and could offer breakthroughs for diseases, almost all are still considered experimental and have yet to be proven safe or effective. Clinical trials on numerous potential stem cell therapies are under way, including in Ottawa.

While research progresses, private stem cell clinics have popped up around the world making promises for treatments not yet proven safe or effective.

A 2018 study by Leigh Turner of the University of Minnesota Center for Bioethics found 43 clinics offering stem cell treatments in Canada and 750 in the U.S. Earlier this year, Health Canada sent Canadian clinics, including some in Ottawa, cease-and-desist letters.

Clinics in Vermont, near the Canadian border, appear to have ramped up marketing to Canadians since then. One clinic has been holding back-to-back seminars. Another says it stopped marketing in Canada after receiving a warning from Health Canada.

There have been cases of harm as a result of treatments, including two women who had permanent damage to their sight after stem cells were injected into their eyes at a Florida clinic. Other patients have been infected with unsterilized equipment and others have developed tumours at the site of stem cell injections.

A common harm, critics say, is exploitation.

Dr. Michael Rudnicki is director of the regenerative medicine program and Sprott Centre for Stem Cell Research at the Ottawa Hospital Research Institute, says of stem cell therapy claims: If it sounds too good to be true, it probably is too good to be true.jpg

Health officials say the clinics are misusing the promise of stem cell therapy to exploit vulnerable patients.

These patients are in pain and they are suffering and they are looking for help and they are being exploited, said Dr. Michael Rudnicki, director of the regenerative medicine program and Sprott Centre for Stem Cell Research at the Ottawa Hospital Research Institute.

If it sounds too good to be true, it probably is too good to be true.

At a recent seminar at a west-end Ottawa hotel meeting room, Roseanna Ammendolea of the Vermont Center for Regenerative Medicine told a packed room that her clinic and others like it had successfully treated people for pain related to arthritis, neuropathy and other ailments that affected joints using mesenchymal stem cells from umbilical cords. The stem cells, she claimed, are both effective and safe, saying there had been no issues with cell rejection.

We will not give injections if we feel that this injection will not be beneficial to our patients. This is why we are so successful.

Participants, including some who walked with canes and others who talked about being in pain and having mobility issues, were shown videos of people described as Canadian clients who claimed the treatments worked. One man said it was probably the best money I have spent in my life as far as my health. Another said she would do it again in a heartbeat and was able to do things she hadnt been able to do earlier.

They were also shown a slide showing long wait times for hip and knee replacements in Ontario, We are not a priority, she said. Where does that leave us? Participants werent told exactly how the stem cells were supposed to work, but claimed they had successfully improved pain and mobility issues in clients.

What the seminar goers werent told is that, even in the U.S., the treatment is not covered by health insurance because it remains unproven.

The U.S. Federal Drug Administration has issued a warning to consumers not to use cell therapies that are unapproved or unproven.

Stem cells have been called everything from cure-alls to miracle treatments. But dont believe the hype. Some unscrupulous providers offer stem cell products that are both unapproved and unproven. So beware of potentially dangerous procedures and confirm whats really being offered before you consider anytreatment, the FDA said in a statement.

The only stem-cell-based products that are FDA-approved for use in the United States are blood-forming stem cells derived from cord blood for limited use in patients with disorders affecting the body system that is involved in the production of blood. Bone marrow is also used for these treatments, but is generally not regulated by the FDA for that use.

Health Canada has granted market authorization for a stem cell therapy to treat graft-versus-host disease and two cell-based gene therapies to treat certain cancers. Most cell therapies are still experimental.

I totally understand the skepticism of it, Doug Argento, who works at the Vermont Center for Regenerative Medicine, said in a telephone interview, but the fact is that things that are approved now and medically paid for were seen as renegade 20 or 30 years ago.

The treatment employs technology developed by Neil Riordan, founder, chairman and chief science officer of the Stem Cell Institute in Panama, using human umbilical cord tissue-derived mesenchymal stem cells. There are 41 such clinics across the U.S. Riordan also played a role in the development of a nutritional product called Stem-Kine, which producers claim without scientific backing increases the number of stem cells circulating in a persons body.

The stem cells injected in the clinic, Argento said, are from umbilical cord tissue as a result of caesarean births to reduce risk of infection.

Rudnicki, of The Ottawa Hospital Research Institute, says there is no evidence that these sorts of cells are regenerative at all. It would not pass muster in Canada.

The public has to understand that there are people out to remove them from their money.

Rudnicki says he regularly receives inquiries from people desperate to get stem cell treatments. He says he tries to connect them with clinical trials that they might be able to participate in.

Rudnicki noted there were multiple clinical trials in Canada, including treatments of autoimmune diseases, trials involving treatment for Type 1 diabetes and others.

But the use of these inappropriate cell types for treating arthritis and joints and so on is certainly not approved by Health Canada and would not be allowed in Canada under the regulations.

There is some evidence that injections of some stem cell products might have a temporary positive impact on inflammation, he said, but it will not be regenerative and will not restore function to joints. They are being sold a bill of goods.

Leigh Turner of the University of Minnesota Center for Bioethics, meanwhile, says the explosion in clinics offering unproven stem cell therapies in the U.S. is a marketplace that traffics in misrepresentation. It is easy to see how people are taken advantage of and scammed.

It is also difficult to find out about physical harms being done to patients.

There are no safety studies. We dont have good data. But we do know there have been some serious harms.

Stem cell therapies have the potential to become standard treatment in some areas, but they are not there yet, Turner said.

Businesses are tapping into genuine human suffering, desperation and also hope.

Turner also noted there was an excellent chance that the vials of liquid being injected into patients did not actually contain stem cells.

Dr. Jonathan Fenton of another stem cell clinic in Burlington, the Vermont Regenerative Medicine, said he had complained about the new clinic, the Vermont Center for Regenerative Medicine, which has a similar name and employs hard-sell tactics, he said.

His clinic takes bone marrow from patients hips and injects it. The procedure is done the same day. He says he regularly sees Canadian patients for bone marrow aspiration therapy and platelet-rich plasma treatments, using their own blood. The treatments, he says, speed healing and are allowed in the U.S. The use of bone marrow aspiration is neither proven nor allowed in Canada.

Fenton, who is secretary-treasurer of the American Academy of Orthopedic Medicine, acknowledged many people offering stem cell treatments are not doing it to the highest ethical standards.

He has filed complaints with state officials over clinics selling unsafe or fraudulent treatments. I have asked the state and federal judiciary to close down this clinic for committing fraud.

He said his platelet and bone marrow treatments were covered by a major Vermont health insurer because they saw the cost of benefits were going down and patients were requiring fewer surgeries.

He said he was told by Health Canada that he could not market in Canada. Representatives of the Vermont Center for Regenerative Medicine, meanwhile, said they had discussions with Health Canada about what they could and could not say when marketing in Canada before holding seminars in Ottawa and Halifax.

We have looked at the information provided and have not identified any immediate non-compliance with advertising regulations pertaining to Canadian health products, a Health Canada spokesperson said, adding that the agency was continuing to assess.

Back at a west-end Ottawa hotel, some participants in the seminar, including a retired pharmacist, said they were considering getting the treatments. But its expensive.

Another participant said he was skeptical. They seemed very sketchy when I went online.

epayne@postmedia.com

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November 18th, 2019

CNST Stock Is Particularly Risky After Its Recent Run – Investorplace.com

By daniellenierenberg

In my view, few investment sectors are as frustrating as the pharmaceutical industry. One moment, you could be riding high on bullish momentum. The next, you could be staring at unfathomable losses. For stakeholders of Constellation Pharmaceuticals (NASDAQ:CNST), though, theyre enjoying the positive end of this dynamic. Year to date, CNST stock is up a blistering 846%.

Source: Shutterstock

Most of these bonkers gains came within the last two months. Since the beginning of October, Constellation Pharmaceuticals stock has jumped nearly 400%. And in this month alone, CNST is up over 68%. Seemingly, this company has no downside, inspiring others to jump aboard this extreme momentum name. Should you follow suit?

Unlike other speculative gambles, a fundamental case exists for the massive skyrocketing of CNST stock. Among the underlying companys therapies is an experimental drug called CPI-0610, a treatment for myelofibrosis. According to pharma giant Celgenes (NASDAQ:CELG) website, myelofibrosis is a rare blood cancer. Only 5,000 people in the U.S. are diagnosed with the illness each year.

Further, myelofibrosis starts in the stem cells of the bone marrow, leading to the production of faulty blood cells. Prior efforts in treating this illness have not produced substantive results. However, Constellations CPI-0610 has performed exceptionally well in a phase II study; hence, the massive surge in Constellation Pharmaceuticals stock.

In fact, all four patients that participated in the study responded positively to the drug. Because of the positive data that came from the clinical trial, Constellation will expand the study to include more patients. This, of course, suggests supreme confidence in the CPI-0610 therapy, and that could ultimately represent a paradigm-shifting breakthrough.

Still, I think you should consider the long road ahead before jumping aboard CNST stock.

By their very nature, rare diseases are difficult to address. And among this class of debilitating conditions, myelofibrosis is particularly nasty. According to Dr. Ruben Mesa, myelofibrosis is a variable disease. This means that medical doctors must apply custom-tailored treatments for different patients.

Thus, while Constellation may have won the initial round in its Phase II study, the real work is coming ahead. With many more test subjects, the chances that CPI-0610 could be considered ineffective or even adverse jump significantly.

In other words, the enthusiasm were seeing now with CNST stock could quickly go the other way.

Theres also the little matter of the economics and politics of addressing myelofibrosis. As you might imagine, combating rare diseases without financial incentives wouldnt make much economic sense. But the Orphan Drug Act, passed in 1983, encouraged pharmaceuticals to address rare diseases through various incentive programs.

Unfortunately, like anything involving government action, good intentions gave way to hellish results. Pharmaceuticals gamed the system the Orphan Drug Act created, pocketing massive profits for rare-disease therapies. Since the patients had no recourse in this monopolized environment, they (and their insurance companies) foot the bill.

Underlining the current bullish thesis for CNST stock is the idea that Constellation will become the only viable myelofibrosis player. Celgene is trying but is coming up short. Essentially, Constellation can charge what they want for their drug if theyre successful.

But even if they are successful and thats a huge if the political environment for price-gouging pharmaceuticals is extremely unfavorable.

No matter how great a scientific achievement Constellation has made, diving into Constellation Pharmaceuticals stock seems risky. With shares gaining 400% in the past month and a half, most of the good news is surely baked in.

Of course, we could hear even better results once the company expands its myelofibrosis study. But that too is a risky perspective.

For those who are not familiar with the pharmaceutical industry, I highly recommend reading Dr. Mario Beauregards book Brain Wars. Among the many topics that Dr. Beauregard covers, a central motif is the mysteries of the mind. Compelling evidence indicates that our mental state can generate healing.

But a flipside to this concept is that an alarming number of pharmaceuticals fail the placebo test; that is, many if not most drugs are no more effective than patients belief in their efficacy.

Soon, well see how good CPI-0610 really is. For those that cant handle extreme price swings, you should stay away from Constellation Pharmaceuticals stock.

As of this writing, Josh Enomoto did not hold a position in any of the aforementioned securities.

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November 18th, 2019

CytoDyn Announces Acceptance of Leronlimab (PRO 140) Data for Presentation at the Conference on Retroviruses and Opportunistic Infections (CROI) in…

By daniellenierenberg

Independent data from the PRESTIGIO Registry Study Group in Italy shows leronlimab inhibits multi-drug resistant HIV-1 viruses in Heavily Treatment-Experienced (HTE) patients

VANCOUVER, Washington, Nov. 18, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company), a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that an abstract from the PRESTIGIO Registry Study Group showing that leronlimab was effective at inhibiting multi-drug resistant HIV-1 isolates from HTE patients was accepted for presentation at CROI. The HTE HIV-1-infected patients harbored documented 4-class resistances and were enrolled in the Italian PRESTIGIO Registry Study Group. The authors conclude that, in HTE patients with multi-drug resistance to HIV-1, all CCR5 tropic strains were fully susceptible to PRO 140.

PRESTIGIO is an Italian registry (http://www.registroprestigio.com) involving 40 clinical centers throughout Italy, coordinated by the IRCCS San Raffaele Hospital (Milan). The registry is performing medical research in a study involving HTE HIV-1-infected patients with a documented 4-class drug resistance (multi-drug resistance MDR), including novel treatment approaches.

This completely independent research study on clinical isolates from patients with documented 4-class drug resistances demonstrates that leronlimab may play a key role in patients with very limited therapeutic options, stated CytoDyn President and CEO, Nader Pourhassan, Ph.D. This is further support for our belief that leronlimab is positioned to change the treatment paradigm in HIV therapy, Dr. Pourhassan concluded.

This data, co-authored by Stefano Rusconi, M.D., et al., University of Milan, on behalf of the PRESTIGIO Registry Study Group, will be presented at the March 8-11, 2020 CROI meeting at the Hynes Convention Center, Boston, MA.

About Leronlimab (PRO 140)The U.S. Food and Drug Administration (FDA) has granted a "Fast Track" designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with highly active antiretroviral therapy (HAART) for HIV-infected patients, and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including non-alcoholic steatohepatitis (NASH). Leronlimab has successfully completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab can significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 plays a vital role in tumor invasion and metastasis. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019. CytoDyn is conducting additional research with leronlimab in the setting of oncology and NASH with plans to conduct further clinical studies when appropriate.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be important in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD. Blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted "orphan drug" designation to leronlimab for the prevention of GvHD.

About CytoDynCytoDyn is a biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a crucial role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has completed a Phase 3 pivotal trial with leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in 2019 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication, which, if successful, could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, results from a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients. Some patients on leronlimab monotherapy have viral suppression for more than four years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and has received clearance to initiate a clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at http://www.cytodyn.com.

Forward-Looking StatementsThis press release contains certain forward-looking statements that involve risks, uncertainties, and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as "believes," "hopes," "intends," "estimates," "expects," "projects," "plans," "anticipates" and variations thereof, or the use of future tense, identify forward-looking statements but, their absence does not mean that a statement is not forward-looking. The Company's forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i)the sufficiency of the Companys cash position, (ii)the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv)the Companys ability to enter into partnership or licensing arrangements with third parties, (v)the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Companys ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Companys clinical trials, (viii)the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix)the market for, and marketability of, any product that is approved, (x)the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi)regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii)general economic and business conditions, (xiii)changes in foreign, political, and social conditions, and (xiv)various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CONTACTSInvestors: Nader Pourhassan, Ph.D.President & CEOnpourhassan@cytodyn.com

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CytoDyn Announces Acceptance of Leronlimab (PRO 140) Data for Presentation at the Conference on Retroviruses and Opportunistic Infections (CROI) in...

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