Category Archives: Cell Medicine

In the middle of November, Editas Medicine (NASDAQ:EDIT) and Celgene (NASDAQ:CELG) announced changes to a development pact originally formed in 2015 with Juno Therapeutics, which is now part of Celgene. The agreement was amended in 2018, too, so the fact that changes were made wasn't necessarily big news. Editas received a $70 million upfront payment for executing the amended agreement, which was interpreted as the main takeaway from the announcement.

The announcement barely registered with investors and few gave it much thought for too long, especially after promising early results from the first clinical trials using a CRISPR-based medicine were announced by CRISPR Therapeutics days later.

But revisiting the amended collaboration agreement, and specifically what changes were made, hints at the long-term development plans of Editas Medicine. In short, it now has full control over an important class of immune cells. Whether that means the gene-editing pioneer lands another major development partner or goes full-steam ahead alone, investors can't overlook the significance.

Image source: Getty Images.

The basic scientific goal of the collaboration hasn't changed. Editas Medicine will use its gene-editing technology platform to engineer T cell receptors (TCR), while Juno Therapeutics will leverage its immunotherapy leadership to develop the engineered cellular medicines in clinical trials.

Why engineer TCRs? Immune cells rely on their receptors to identify targets, such as pathogenic bacteria and cancer cells. But immune cell receptors can be confused by molecules secreted within the tumor microenvironment, forcing them to halt their attack. They can also incorrectly attack an individual's own cells to trigger an autoimmune disease. A more recent concern stems from cellular medicines derived from a donor. Since the donor cells present different receptors compared to what the recipient's native T cells carry, the recipient's immune system (correctly) identifies the immunotherapy as a foreign substance, attacks it, and renders it less effective and less safe.

Therefore, it makes sense to engineer TCRs to create more potent and stealthier immunotherapies that are less likely to be tricked. Editas Medicine and Celgene still intend to do just that, albeit with subtle, yet important, differences to their development agreement.

Consideration

Previous Agreement (2015, 2018)

Amended Agreement (2019)

Focus

Cancer

Cancer and autoimmune diseases

Types of cells

CAR-T cells, alpha-beta T cells, gamma-delta T cells

Alpha-beta T cells

Juno Therapeutics exclusivity

Editas Medicine prohibited from all other work with CAR-T and TCRs in oncology

Editas Medicine prohibited from all other work on alpha-beta T cells and T cells derived from pluripotent stem cells

Upfront payment

$57.7 million (includes milestones collected under agreement)

$70 million

Milestone potential

$920 million plus tiered royalties

$195 million plus tiered royalties

Data source: SEC filings.

Essentially, Editas Medicine and Celgene have scaled back their original agreement in cancer and expanded their work to include autoimmune diseases. The most important detail is that the amended agreement allows the gene-editing pioneer to pursue the development of gamma-delta T cells, which were previously under the exclusive control of Juno Therapeutics. What does that mean?

Image source: Getty Images.

Without getting too far into the weeds, there are two main types of TCRs: alpha-beta and gamma-delta. The name refers to the molecular structure of the receptor, but that's not the important part.

Gamma-delta T cells, which comprise only about 5% of the T cells in your body, are thought to be one of the missing links in our understanding of the immune system. They're a mysterious bunch, but there could be significant value residing in the knowledge gaps.

These unique immune cells are governed by their own unique set of rules (relative to their alpha-beta peers) and straddle the innate immune system (what we're programmed with at birth) and adaptive immune systems (what's programmed as we encounter new environments throughout life). Gamma-delta T cells could be tinkered with in gut microbiome applications, to treat cardiovascular diseases, and to neutralize antibiotic-resistant infections. But the nearest commercial target of the mysterious immune cells is likely to be treating solid tumor cancers.

They possess potent anti-tumor activity where current immunotherapies fail, such as attacking cancer cells that lack tumor-specific antigens to target or that have become immune to checkpoint inhibitors. In fact, there's a link between certain cancer outcomes and the activity of specific gamma-delta T cells.

Given that, why would Celgene amend the agreement to ditch the rare subset of immune cells? Well, in August 2019, Celgene inked with a start-up called Immatics to develop engineered TCRs. The start-up's platform is based on gamma-delta tech.

Don't feel too bad for Editas Medicine, though. SEC filings reveal that the gene-editing pioneer didn't receive any money from the original collaboration deal with Celgene in the first nine months of 2019. That suggests the work had stalled or that the amendment was being hammered out for some time. The gene-editing pioneer wrestled back control of the tech and took a $70 million upfront payment to boot. While the potential milestone payments in the amended agreement are significantly lower than the originally promised bounty, Editas Medicine can offset that by signing a lucrative collaboration deal with a new partner.

There should be plenty of interest. Fellow gamma-delta T cell developer Adicet Bio recently landed an $80 million series B round funded in part by Johnson & Johnson, Regeneron,Samsung Biologics(not the same company as the electronics powerhouse), and Novartis. There's also Immatics, GammaDelta Therapeutics, and a handful of other start-ups making noise in the space.

Some competitors are directly engineering gamma-delta cells, and others are developing molecules to trigger the immune cells into action. Editas Medicine believes it has the edge, as it has a relatively precise and efficient method for engineering immune cells: gene editing.

The amended collaboration deal between Editas Medicine and Celgene received relatively little attention from investors. Perhaps that was a good thing, as Wall Street likely would have overreacted to the reduced scope of development and milestones. But investors that take the time to understand the details might be intrigued by the new research avenue for the gene-editing stock.

Can Editas Medicine become a leading force in gamma-delta T cell development? Perhaps. While it isn't the only company wielding a gene-editing platform, and CRISPR gene editing isn't the only type of gene editing, the company is well-positioned to take advantage of the opportunity. Investors will have to wait to see how (or if) the development strategy evolves around the new tech.

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Celgene Gave This Tech Back to Editas Medicine, but It Could Prove Valuable - The Motley Fool

ORLANDO, Florida Chimeric antigen receptor (CAR) T-cell therapy has been hailed as a major advance and a game changer, but their cost has redefined the meaning of "expensive."

However, new "real-world" data now suggests that CAR-T cell therapy may actually be cost effective, as it may lower other expenses related to the illness.

When used in a population of older adults with non-Hodgkin's lymphoma, these new data show that CAR-T cell therapy cut related expenditures compared with healthcare costs prior to receiving this treatment.

"CAR-T therapy was associated with fewer hospitalizations, shorter time in the hospital, fewer ED visits, and lower total healthcare costs," said lead study author Karl M. Kilgore, PhD, of Avalere Health in Washington, DC.

He presented the findings here at the 2019 annual meeting of the American Society of Hematology (abstract 793).

CAR-T cell therapies were approved in the United States in 2017. First came tisagenlecleucel (Kymriah, Novartis), for the treatment of pediatric and young adult patients with acute lymphoblastic leukemia, with a price tag of $475,000. Closely following it was axicabtagene ciloleucel (Yescarta, Kite/Gliead), indicated for adult patients with relapsed/refractory aggressive B-cell non-Hodgkin's lymphoma who are ineligible for autologous stem cell transplant, with a price tag of $373,000.

The formidable price tags sent shock waves through the blood cancers community, which is struggling to incorporate this novel approach because of the remarkable responses that have been seen.

In the current study, Kilgore and colleagues evaluated the demographic and clinical characteristics of Medicare patients who received CAR-T therapy (axicabtagene ciloleucel or tisagenlecleucel) and then compared healthcare utilization, costs, and outcomes pre- and post-CAR T therapy.

"The goal of this study was to look at the real use of CAR-T cell therapy and real-world data on the use of these therapies," said Kilgore. "And to look at healthcare utilization."

Data was obtained from the Centers for Medicare & Medicaid Services 100% Medicare Fee-for-Service Part A and B claims data, and patients were included in the study if they had been diagnosed with lymphoma and received CAR T therapy between October 1, 2017, and September 30, 2018.

A total of 177 patients met all of the inclusion criteria and were included in the analysis.

The average age was 70 years, more than half (58.8%) were male, and they were primarily white (87.6%). Nearly all patients (91.5%) had a primary diagnosis of diffuse large B-cell lymphoma (DLBCL), as well as multiple co-morbidities with 74.6% having a Charlson Comorbidity Index score 3. Fewer than 5% of patients had undergone a previous autologous stem cell transplant, and 51% had one or more comorbidities that would have disqualified them from participating in CAR-T clinical trials (eg, renal failure, heart failure, recent history of DVT/PE).

Just over half of participants (52%) had been treated with intravenous chemotherapy in the 6 months prior to receiving CAR-T cell therapy, and 60% received outpatient lymphodepletion.

During their index episode of care for CAR-T infusion, the patients spent a median of 16 days (interquartile range, 10) in the hospital during and 45.5% required ICU care after infusion. In the 6-month period prior to CAR-T cell therapy (pre-index), 51.2% had been hospitalized at least once, and almost 20% had three or more periods of hospitalization. Of that group, 27.1% were readmitted during the post-index period.

Among patients who required hospitalization, the median length of stay pre-index was 7 days and 5 days post-index. The number of ED visits was also lower in the post- vs pre-index (15.8% vs 29.9%).

"Patients spent 17% less time in the hospital 6 months after CAR-T cell therapy than before," he said.

While there were no deaths during the post-index period, a small percentage (< 5%) were admitted to hospice care. It is unclear if any patients received chemotherapy during the 100-day post-index period, which would suggest disease progression. However, the authors note that claims for the period might be lagging behind for some patients.

Kilgore pointed out that half of the patients had one or more chronic conditions that, in some cases, would have excluded them from clinical trials. "But 73% remain alive at 6 months," he said. "We have data that goes out to 21 months, and over 50% are still alive at almost 2 years."

As for cost, the median total healthcare costs during the pre-index period were $51,999 (mean, 58,820; standard deviation [SD], 45,701) and $14,014 post-index (mean, 23,738; SD, 29,698). This extrapolates into $9,749 pre- vs $7,121 post-index for each patient per month, which is a 27% decrease in expenditures.

Kilgore explained that the total paid amounts for CAR-T from all sources (Medicare and patient) varied significantly, depending on whether patients were treated in a clinical trial and whether the hospital was reimbursed under standard Medicare prospective payment system (PPS) for inpatient facilities or through the PPS-exempt payment system.

Commenting on the study, Sarah Rutherford, MD, a hematologist at Weill Cornell Medicine and New York-Presbyterian in New York City, believes that the key takeaway from this study is that the majority of participants who were older and sicker than many enrolled on CAR T-cell clinical trials did quite well.

"Diffuse large B-cell lymphoma is a disease that usually causes people to die quickly if they are refractory to multiple lines of therapy, so the 6-month survival of 75% in this patient population is impressive," she said. "A large proportion of these patients are likely to have died had they not received CAR T-cell therapy."

Rutherford noted that the study authors analyzed the costs associated with patients in the pre- and post- CAR T-cell setting, finding that healthcare costs were lower following CAR T-cell therapy in this Medicare patient subset compared with costs prior to the therapy.

"I think CAR T-cell use is certainly justified given the lack of efficacious therapies in relapsed and refractory DLBCL patients, and this study indicates that there may be a financial benefit as well, though the actual costs associated with CAR T-cell therapy were not included in the analysis," she told Medscape Medical News.

Kilgore has disclosed research funding from Kite Pharma. Several of the other co-authors have disclosed relationships with industry, which are noted in the abstract.

2019 Annual Meeting of the American Society of Hematology: Abstract 793. Presented December 9, 2019.

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'Real-World' Data Show CAR-T Therapies Are Cost Effective - Medscape

Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, today announced that it has discovered and validated a novel fetal hemoglobin repressor, Nuclear Factor I X (NFIX), using its gene control platform. The finding sheds light on how the gamma-globin gene, which leads to the production of fetal hemoglobin, is controlled and points to new potential targets for therapeutic intervention in sickle cell disease. These data will be presented in an oral presentation tomorrow at the 61st American Society of Hematology (ASH) Annual Meeting and were highlighted today in an ASH press briefing.

"This discovery highlights the power of our platform to elucidate regulatory regions of the genome to control the expression of a single gene for therapeutic benefit," said Eric R. Olson, Ph.D., Syross Chief Scientific Officer. "Based on real-world genetic and clinical data from patients, we believe it is possible to provide a functional cure for sickle cell disease by switching on the gamma-globin gene, which is typically turned off at birth, to make healthy red blood cells. Our discovery of NFIX as a critical player in silencing the gamma-globin gene opens up new potential therapeutic approaches as we advance our effort to discover an oral medicine that addresses the root cause of disease in sickle cell patients."

The focus of Syros drug discovery program in sickle cell disease is to develop an oral medicine to mimic a condition found in a subset of patients, who also inherit a hereditary persistence of fetal hemoglobin (HPFH) mutation, in which the gamma-globin gene remains activated after birth. Despite having the mutated adult beta-globin gene that causes sickled cells, these patients are largely asymptomatic because the activated gamma-globin gene leads to the production of enough fetal hemoglobin for red blood cells to function normally.

Using its gene control platform, Syros scientists analyzed and compared regulatory regions of the genome in red blood cell precursors, known as erythroblasts, at various stages of maturity from fetal and adult sources to identify novel drug targets involved in the switch from fetal to adult hemoglobin expression. The genome-wide analysis pointed to NFIX as a potential fetal hemoglobin repressor. The scientists then validated the role of NFIX in silencing fetal hemoglobin by knocking down the NFIX gene in primary cells and an erythroid cell line that expresses adult hemoglobin. The data showed:

The oral presentation will take place tomorrow during the Thalassemia and Globin Gene Regulation: Hemoglobin Regulation and Beta Thalassemia Research session from 4:30-6:30 p.m. ET in Valencia A (W415A) at the Orange County Convention Center, Valencia A (W415A). The ASH presentation is also now available on the Publications and Abstracts section of the Syros website at http://www.syros.com.

About Syros Pharmaceuticals:

Syros is redefining the power of small molecules to control the expression of genes. Based on its unique ability to elucidate regulatory regions of the genome, Syros aims to develop medicines that provide a profound benefit for patients with diseases that have eluded other genomics-based approaches. Syros is advancing a robust pipeline of development candidates, including SY-1425, a first-in-class oral selective RAR agonist in a Phase 2 trial in a genomically defined subset of acute myeloid leukemia patients, and SY-5609, a highly selective and potent oral CDK7 inhibitor in investigational new drug application-enabling studies in cancer. Syros also has multiple preclinical and discovery programs in oncology and monogenic diseases, including sickle cell disease. For more information, visit http://www.syros.com and follow us on Twitter (@SyrosPharma) and LinkedIn.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the power of the Companys gene control platform and the Companys ability to discover an oral medicine that can restore healthy blood function in sickle cell patients and provide a functional cure for sickle cell disease. The words anticipate, believe, continue, could, estimate, expect, "hope," intend, may, plan, potential, predict, project, target, should, would, and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including Syros ability to: successfully advance the development of its programs; demonstrate in any current and future clinical trials the requisite safety, efficacy and combinability of its drug candidates; replicate scientific and non-clinical data in clinical trials; obtain and maintain patent protection for its drug candidates and the freedom to operate under third party intellectual property; obtain and maintain necessary regulatory approvals; identify, enter into and maintain collaboration agreements with third parties; manage competition; manage expenses; raise the substantial additional capital needed to achieve its business objectives; attract and retain qualified personnel; and successfully execute on its business strategies; risks described under the caption "Risk Factors" in Syros Annual Report on Form 10-K for the year ended December 31, 2018 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, each of which is on file with the Securities and Exchange Commission; and risks described in other filings that Syros makes with the Securities and Exchange Commission in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Syros expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20191208005032/en/

Contacts

Media: Naomi AokiSyros Pharmaceuticals, Inc.617-283-4298naoki@syros.com

Investors: Hannah DeresiewiczStern Investor Relations, Inc.212-362-1200hannah.deresiewicz@sternir.com

Link:
Syros Presents on Identification of Novel Fetal Hemoglobin Repressor as Part of Broader Drug Discovery Program in Sickle Cell Disease at 61st Annual...

DetailsCategory: AntibodiesPublished on Sunday, 08 December 2019 13:21Hits: 143

Mosunetuzumab data to be presented at the American Society of Hematology 2019 Annual Meeting Plenary Scientific Session demonstrate durable complete responses in people with relapsed or refractory non-Hodgkins lymphoma

Preliminary safety and efficacy data for CD20-TCB support potential of combination approaches with anti-CD20 therapies

SOUTH SAN FRANCISCO, CA, USA I December 07, 2019 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced new data on two investigational CD20-CD3 T-cell engaging bispecific antibodies, mosunetuzumab and CD20-TCB, in people with relapsed or refractory (R/R) B-cell non-Hodgkins lymphoma (NHL). Results from the Phase I/Ib GO29781 study of mosunetuzumab, including data from people previously treated with chimeric antigen receptor (CAR) T-cell therapy, will be presented at the 61st American Society of Hematology (ASH) 2019 Annual Meeting during the Plenary Scientific Session. The Plenary Scientific Session highlights the top six abstracts submitted to the meeting, as determined by the ASH Program Committee. Additionally, results from the Phase I/Ib NP30179 study evaluating CD20-TCB as a combination therapy with Gazyva (obinutuzumab) for people with R/R NHL, will be presented.

Despite recent treatment advancements, slow-growing and aggressive non-Hodgkins lymphomas present increasingly difficult management challenges with each subsequent relapse, said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. Were encouraged by these early results, which suggest that our novel bispecific cancer immunotherapies may help people with relapsed or treatment-refractory disease who need more options.

The GO29781 study evaluated mosunetuzumab in patients with R/R NHL, including patients who have relapsed following, or are resistant to, CAR T-cell therapy a patient population with limited treatment options. Results from this dose-escalation study showed encouraging efficacy with an objective response rate (ORR) of 62.7 percent (n=42/67) in slow-growing NHL and 37.1 percent (n=46/124) in aggressive NHL. Additionally, data demonstrated a complete response (CR) rate of 43.3 percent (n=29/67) in slow-growing NHL and 19.4 percent (n=24/124) in aggressive NHL. CRs showed durability, with 82.8 percent (n=24/29) of patients with slow-growing NHL remaining in remission up to 26 months off initial treatment and 70.8 percent (n=17/24) of patients with aggressive NHL, remaining in remission up to 16 months off initial treatment. Of the participants who received prior CAR T-cell therapy, the ORR was 38.9 percent (n=7/18), and 22.2 percent (n=4/18) achieved a CR. Adverse reactions included cytokine release syndrome (CRS) in 28.9 percent of patients with 20.0 percent at Grade 1 and 1.1 percent at Grade 3. Grade 3 neurological adverse events occurred in 3.7 percent of patients.

Results from the Phase I/Ib dose-escalation NP30179 study, evaluating CD20-TCB at doses ranging from 0.6 mg to 16 mg plus Gazyva in people with R/R B-cell NHL, showed an ORR of 54 percent (n=15/28) and a CR rate of 46 percent (n=13/28). This included an ORR and CR of 66.7 percent (n=4/6) in people with follicular lymphoma and an ORR of 50.0 percent (n=11/22) and a CR of 40.9 percent (n=9/22) in aggressive NHL. The most frequently observed adverse event across all treatment doses was CRS, occurring in 67.9 percent of patients (n=19/28), with the majority of events being low grade (Grade 1-2).

Both mosunetuzumab and CD20-TCB continue to be evaluated in a robust clinical development program, investigating the treatments as monotherapies and in combination with other therapies, in people with slow-growing and aggressive forms of NHL.

About Genentechs Investigational Bispecifics

Genentech is currently developing two T-cell engaging bispecific antibodies, mosunetuzumab and CD20-TCB, designed to target CD20 on the surface of B-cells and CD3 on the surface of T-cells. This dual targeting activates and redirects a patients existing T-cells to engage and eliminate target B-cells by releasing cytotoxic proteins into the B-cells. Mosunetuzumab and CD20-TCB differ in their structures, and both are being developed by Genentech as part of our ongoing strategy to explore multiple bispecific formats, to identify those that maximize potential clinical benefits for patients. The clinical development programs for mosunetuzumab and CD20-TCB include ongoing investigations of these molecules as monotherapies and in combination with other medicines, for the treatment of people with CD20-positive B-cell non-Hodgkins lymphomas, including diffuse large B-cell lymphoma and follicular lymphoma.

About the GO29781 study

The GO29781 study [NCT02500407] is a Phase I/Ib, multicenter, open-label, dose-escalation study evaluating the safety and pharmacokinetics of mosunetuzumab in people with relapsed or refractory B-cell non-Hodgkins lymphoma. Outcome measures include best objective response rate by revised International Working Group criteria, maximum tolerated dose, and tolerability.

About the NP30179 study

The NP30179 study [NCT03075696] is a Phase I/Ib, multicenter, open-label, dose-escalation study, evaluating the efficacy, safety, tolerability and pharmacokinetics of CD20-TCB. In this study, CD20-TCB is assessed as a single agent and in combination with Gazyva, following pre-treatment with a one-time, fixed dose of Gazyva, in people with relapsed or refractory B-cell non-Hodgkins lymphoma. Outcome measures include overall response rate, complete response rate per Lugano 2014 criteria, maximum tolerated dose, and tolerability.

About Non-Hodgkins Lymphoma

There are two main types of lymphoma: Hodgkins lymphoma and non-Hodgkins lymphoma (NHL). NHL has two subsets, aggressive and indolent (slow-growing).

NHL represents approximately 85 percent of all lymphomas diagnosed. According to the American Cancer Society, it is expected that nearly 74,000 people will be diagnosed with NHL in the United States in 2019, and nearly 20,000 will die from the disease.

Most cases of NHL start in B-lymphocytes, cells that are part of the bodys immune system and help to defend the body against infections. B-cell lymphoma develops when these cells become cancerous and begin to multiply and collect in the lymph nodes or lymphatic tissues such as the spleen.

Gazyva Indications

Gazyva (obinutuzumab) is a prescription medicine used:

About Genentech in Hematology

For more than 20 years, Genentech has been developing medicines with the goal to redefine treatment in hematology. Today, were investing more than ever in our effort to bring innovative treatment options to people with diseases of the blood. For more information visit http://www.gene.com/hematology.

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

SOURCE: Genentech

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Genentech Announces New Data on Novel Cd20-cd3 Bispecific Cancer Immunotherapies in People With Difficult-to-Treat Lymphomas | Antibodies | News...

Long Islanders who live the salt life probably have packed their sunscreen away with the summer beach towels and chairs.

But health experts warn that sun protection is key even when its too cold to catch rays while lounging on the sand or on a boat.

Applying sunscreen before skiing, winter surfing and shoveling snow can go a long way toward helping ward off skin cancer.

Theres this misconception that because its colder that the sun is less strong its really not true, said Dr. Adam C. Berger, chief of Melanoma and Soft Tissue Oncology at Rutgers Cancer Institute of New Jersey. We dont feel the direct heat as much, but we are still getting the direct sunlight.

The sun is actually closer to the Earth during the winter months, but its rays hit at a steeper angle in the summer.

Ultraviolet A (UVA) and Ultraviolet B (UVB) rays, which damage the skin, are present throughout the year. Most skin cancers are caused by overexposure to UV light.

The risk of sun exposure is just as great in the wintertime as it is in the summertime, Berger said.

The U.S. Centers for Disease Control and Prevention lists skin cancer as the most common form of cancer in the nation.

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The majority of those cases are basal cell and squamous cell carcinomas, described by the CDC as highly curable, but can be disfiguring.

However, one type of skin cancer, known as melanoma, can be fatal. In 2016, more than8,000 people died from melanomas of the skin in the United States, according to the CDC, and 82,000 new cases were reported.

People should be aware of the cumulative impact of sun exposure, said Dr. Raman Madan, director of cosmetic dermatology and assistant clinical professor at Northwell Health/Hofstra School of Medicine.

One of the things people dont realize is its not one particular sunburn or one particular sun exposure, Madan said. Its like adding sand to a box, and at some point that box fills up and you get skin cancer. If you are not wearing sunscreen, the box is still filling up. You dont get a break in the winter.

The strength of ultraviolet rays intensify as they reflect off snow and water.

A lot of people dont think about how the sun is reflected off the snow, Berger said. I see people come back from ski trips all the time with horrible sunburn on their face.

Winter surfers, covered head to toe in wet suits, are a common sight along Long Islands shoreline. Skudin Surf, a school in Long Beach, even holds a class called Winter Warriors focused on cold weather surfing, and students are encouraged to use sunscreen.

Sunscreen is something we promote with all our campers, said Nancy Dennehy, office manager for Skudin Surf, which runs programs on Long Beach, Nickerson Beach and Rockaway, as well as in Puerto Rico.

When I go paddleboarding in the winter, I make sure I put sunscreen on my face, she said.

Madan, who is also a dermatologist at Huntington Hospital, recommends that everyone see a board-certified dermatologist physician for a skin check once a year.

He urges patients to be proactive and mindful of any skin changes that could signal a problem. Asymmetrical spots or moles, jagged borders and uneven colors are some of the warning signs of melanoma.

We want to catch that because it can spread and lead to death quickly, Madan said. Basal cell and squamous cell are much more common. With these types of skin cancers, you are looking for pink scaly plaques scabby areas that just dont seem to heal.

Avid outdoorsman Ed Moran of Smithtown said he keeps sunscreen in his backpack during the warm summer months, but takes it out after October.

Hes active year-round, leading people on cross-country skiing, snowshoe and hiking trips through his guide business Eastern Outdoor Experiences.

I know there are certain activities later in the winter where I am more prone to getting a sunburn like skiing, Moran said.

He admitted his own record of wearing sunscreen while skiing is a spotty one.

[I wear it]when Im good and I dont want my wife to yell at me, he said with a laugh.

HOW TO PROTECT YOURSELF IN WINTER MONTHS

SOURCE: U.S. Centers for Disease Control and Prevention

Lisa joined Newsday as a staff writer in 2019. She previously worked at amNewYork, the New York Daily News and the Asbury Park Press covering politics, government and general assignment.

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Medical warning: Sun protection needed even in winter - Newsday

Yaoyao Tong,1,2 Kun Tong,1,2 Qinghong Zhu,1 Yuqin Wu,3 Yi Yang,4 Jicai Zhang,1 Pei Hu,1,5 Shirong Yan2

1Department of Laboratory Medicine, Taihe Hospital, Hubei University of Medicine, Shiyan, Hubei, Peoples Republic of China; 2Hubei Key Laboratory of Wudang Local Chinese Medicine Research, School of Pharmaceutical Sciences, Hubei University of Medicine, Shiyan, Hubei, Peoples Republic of China; 3Department of Central Operating Room, Taihe Hospital, Hubei University of Medicine, Shiyan, Hubei, Peoples Republic of China; 4Reproductive Medicine Centre, Taihe Hospital, Hubei University of Medicine, Shiyan, Hubei, Peoples Republic of China; 5Hubei Key Laboratory of Embryonic Stem Cell Research, Hubei University of Medicine, Shiyan, Hubei, Peoples Republic of China

Correspondence: Shirong YanHubei Key Laboratory of Wudang Local Chinese Medicine Research, School of Pharmaceutical Sciences, Hubei University of Medicine, No. 30, South Renmin Road, Maojian District, Shiyan City, Hubei Province, Peoples Republic of ChinaEmail graceyan@163.comPei HuDepartment of Laboratory Medicine, Taihe Hospital, Hubei University of Medicine, No. 32, South Renmin Road, Maojian District, Shiyan City, Hubei Province, Peoples Republic of ChinaEmail hupei2018@taihehospital.com

Purpose: To investigate the role of glypican-3 (GPC3) in cobalt chloride (CoCl2)-induced cell apoptosis in hepatocellular carcinoma.Methods: HepG2 cells were treated with CoCl2 in the absence or presence of GPC3 plasmid transfection. Cell viability and apoptosis were assessed by MTT assay and flow cytometry, respectively. The expression of GPC3, hypoxia-inducible factor 1 (HIF-1), c-myc, sp1, poly-ADP-ribose polymerase (PARP) and caspase-3 was determined by real-time PCR, Western blotting, and immunofluorescence after the cells were treated with different concentrations of CoCl2 or siRNA targeting HIF-1.Results: CoCl2 significantly inhibited the proliferation of HepG2 cells and induced apoptosis. Additionally, the expression of GPC3 mRNA and protein was decreased, and overexpression of GPC3 attenuated the tumour inhibiting effects. Further studies showed that CoCl2 increased the expression of HIF-1 while reducing the expression of sp1 and c-myc; knockdown of HIF-1 elevated the expression of GPC3, sp1, and c-myc.Conclusion: CoCl2 inhibited the growth of HepG2 cells through downregulation of GPC3 expression via the HIF-1/c-myc axis.

Keywords: cobalt chloride, c-myc, glypican-3, hepatocellular carcinoma, hypoxia-inducible factor 1

This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License.By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

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Cobalt Chloride Induced Apoptosis by Inhibiting GPC3 Expression via th | OTT - Dove Medical Press

SAN FRANCISCO, Dec. 2, 2019 /PRNewswire/ -INTELLiSTEM Technologies, a pioneering research company revolutionizing stem cell medicine, is helping to create an affordable future for cancer therapies. Currentcancer cell therapies likeCAR T Cells cost between$350k (USD) and $500k (USD.)INTELLiSTEM expects its Super SentinelCells(SSCs) treatment to be priced between$30-$50k USD. This represents a massive difference in price for hospitals and patients paying or co-paying for their own treatments.

"Older generations of cell therapies require harvesting the cells from the patients, processing them, manufacturing them and then injecting them back into the patient," said Dr. Riam Shammaa, MD Founder and CEO of INTELLiSTEM."Most of those cells can't be grown in large quantities and are very difficult to manufacture, driving the cost way up. Our solution is based on genetically engineering 'off-the-shelf cells 'ready to inject directly into patients. Our cells are easy to grow into billions of cells to treat multiple patients and this drops the cost substantially."

According to Shammaa, the highcurrent cost of cell therapies likeCAR T Cells and dendriticcellsis not only unsustainable(causinga heavy financialburdenfor hospitals acrossNorth America) but is also making life-saving cancer therapies financially inaccessible to millions of patients.

INTELLiSTEM Researchers have created genetically engineered Super Sentinel Cells(SSC's) to effectively target Cancer cells.The SSC's are showing an unprecedented 80% success rate in animal models.The current success rate for existing Cancer cell therapy treatments is 20-40%.

INTELLiSTEM is currently moving into phase one of human trials with the SSC's within the next 12 months.

"We could see practical cures for specific Cancers in as little as 5-7 years," added Shammaa.

See animated video of SSC'shere high-resolution Images also available.

How does the treatment work?

Cancer cells are very good at hiding from the immune system. Essentially, the Super Sentinel Cells are the next generation of antigen-presentingcells, theyshow the immune system where the Cancer cells are hiding in a host and allow the immune system to kick in and attack/kill them.

What Cancers could this effectively treat?

Super Sentinel Cells have the capacity to targethematological and solid cancersdue to their ability to learn the signals and antigens of each cancer. Due to the massive task at hand and to accelerate the progression of multiple Cancer cures, INTELLiSTEM started collaborating with cancer centers across the United States and is also looking to collaborate with research institutions around the world to accelerate the accessibility of the therapy to patients. The SSC's are expected to be effective on solid tumors such as Breast Cancer,Lung Cancer, Melanoma, Prostate Cancer and Lymphomas.

How many treatments are required?

Animal models are showing that 80% of the tested animals survive after one treatment compared to 20% using availablecell therapiesand 0% without treatment, but Shammaa believes that 100% can be achieved with a second injection/treatment of Super Sentinel Cells.

SOURCE INTELLiSTEM Technologies

https://www.intellistemtech.com/

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New Stem Cell Research Could Make Cancer Treatments affordable and Effective for Hospitals and Patients - PRNewswire

GAITHERSBURG, Md. and CAMBRIDGE, Mass., Dec. 4, 2019 /PRNewswire/ -- MaxCyte, the global cell-based therapies and life sciences company, and KSQ Therapeutics, a biotechnology company using its proprietary CRISPRomics discovery platform to achieve higher probabilities of success in drug development, announced today that the companies have entered into a new development and commercialization agreement. Under the agreement, KSQ gains rights to use MaxCyte's Flow Electroporation technology and ExPERT instruments for the advancement of KSQ's engineered tumor-infiltrating lymphocyte (eTIL) programs, which the company is developing for the treatment of PD-1 refractory solid tumors.

Under the terms of the agreement, KSQ obtains non-exclusive clinical and commercial use rights to MaxCyte's cell engineering platform to develop multiple adoptive cell therapies. In return, MaxCyte is eligible to receive certain milestone payments in addition to other licensing fees.

"Adoptive cell therapies hold significant potential to improve outcomes for patients that are otherwise unresponsive to current treatments," said David Meeker, M.D., Chief Executive Officer of KSQ. "MaxCyte's technology will play an important role in enabling the further development of our eTIL programs as we work to bring best-in-class, cell-based medicines forward for difficult to treat solid tumors."

MaxCyte's 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 are delighted to have signed this agreement with KSQ Therapeutics, a company that's forging an exciting path in the field of adoptive cell therapies with the potential to deliver significant benefits to patients. This is the fifth commercial license we have signed this year, demonstrating that MaxCyte is the partner of choice for leading technology companies, like KSQ, that are at the cutting edge of cell therapy and gene editing," said Doug Doerfler, President & CEO of MaxCyte, Inc.

About KSQ TherapeuticsKSQ Therapeutics is advancing apipelineof tumor- and immune-focused drug candidates for the treatment of cancer, across multiple drug modalities including targeted therapies, adoptive cell therapies and immuno-therapies. KSQ's proprietaryCRISPRomicsdiscovery engine enables genome-scale,in vivovalidated, unbiased drug discovery across broad therapeutic areas. KSQ was founded by thought leaders in the field of functional genomics and pioneers of CRISPR screening technologies, and the company is located in Cambridge, Massachusetts. For more information, please visit the company's website atwww.ksqtx.com.

About MaxCyte MaxCyte 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 MaxCyte's 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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MaxCyte and KSQ Therapeutics Announce Development and Commercialization Agreement to Enable the Advancement of KSQ's Adoptive Cell Therapy Programs -...

Futurist Ray Hammond talks to Stephen Hyamsabout revolutions in healthcare, the future of work and cryptocurrencies

05 DECEMBER 2019 | STEPHEN HYAMS

Ray Hammond has a long record of accurate foresight about the future, such as identifying the coming importance of the internet shortly after its launch.

How did he become a futurist?

It happened by accident, he says. After finishing with journalism, I wanted to become a writer. During a small book tour in San Diego, I met the well-respected futurist Alvin Toffler. We kept in touch and he encouraged me to broaden out beyond technology, which was then my focus, to understand the way that todays trends may shape reality in 10 to 20 years time.

The future of health

Hammond is excited by the current revolutions in healthcare, of which he expects digital health to havethe earliest impact. Within 10 to 15 years, perhaps30% of hospital inpatients will be at home in bed but monitored so thoroughly that its almost as if they were in the hospital, he says. A team of mobile nurses will take care of their physical needs. Its also going to have a profound impact on the way drugs are developed, because drug companies can use the data that flows back from digital devices to learn how were responding. Eventually, it will be as if every patient is taking part in a real-time clinical experiment.

DNA-based and stem cell medicine will also play a significant role during the next five to 10 years. For privacy reasons, it will take a while for people to accept having their DNA stored., says Hammond. For many people, DNA stands for do not ask. Once the benefits of DNA analysis are understood fully, the word will spread and, with full consideration for privacy and data protection, DNA-based medicine will be an enormously powerful tool. He cites the detection of genetic abnormalities in the earliest stages of embryonic development during pregnancy as an example.

Its early days for stem cell medicine, but Hammond predicts that it will become very important within 10 years. It seems to have so many applications, a bit like penicillin, and promises to deal with lots of diseases that are currently intractable. Using stem cells from ones own body avoids the risk of rejection. Im certain that in 10 years time we will be taking organs off the shelf, or theyll be grown to order for us.

Hammond believes two other healthcare revolutions will have longer-term implications. The first is nanoscale medicine, which he believes will have a huge impact, but not for another 20 years. Manipulating molecules at the nanoscale level will enable the production of drugs designed to produce specific proteins that are tailored for certain illnesses. Nanoparticles are currently being developed for the targeted delivery of drugs, while there is some research involving nanoparticles that seeks to develop a vaccine for influenza. Hammond believes the other healthcare revolution will be in gene editing to enable removal of damaging pieces of DNA from a patients tissue but care is needed to avoid it affecting the germline, for fear of unintended consequences.

Healthcare outlook

What will be the collective impact of these developments? During the next 20 to 30 years they will transform healthcare, and I think it is likely we will see a return to higher rates of mortality improvements in the UK, following the period of lower rates seen during the past few years.

Hammond is excited by two recent pieces of research into anti-ageing, one of which removes senescent cells from the body. These cells are widely believed to contribute to ageing. The other work involves therapyto reprogram genes to reverse the ageing process.

In human trials, there have been some startling achievements in a single year, 70% to 80% of the patients had their biological clock reversed by two and a half years, he says. The results were so stunning that the researchers have easily been able to raise the money to carry out much wider trials. Until a year ago, I was highly sceptical about rejuvenation and life extension, but not any longer. By 2030 or 2040 I think we could see some patients extending their lives as healthy centenarians. Within the next 20-30 years, Hammond also thinks that most types of cancer will be controllable, as opposed to being cured.

How can we meet the cost of healthcare for an ageing population? During the next 10 years it will be a problem, but there are indications that things will improve significantly, mostly thanks to digital technology, says Hammond. The key is 5G networks, which will be super-fast and reliable, with instant, real-time responses and no bandwidth problems. This will facilitate distributed care, in which many patients are monitored from their homes, thereby taking the pressure off hospital space. The healthcare revolutions will mean fewer people in hospital, and for less time.

The collection and analysis of healthcare data is developing fast, and it must remain secure for people to remain comfortable in providing it. Could insurers seek to use the data for underwriting purposes? There are currently legal barriers to the discriminatory use by insurers of DNA information, while they are also no longer allowed to ask the catch-all question of whether there is any other information that would be relevant.

Digital monitoring devices will not be for everyone, while those who do use them will need clear instructions explaining that they are not fully accurate and no substitute for proper medical advice.

Robotics will have developed to the point where most of the non-medical tasks in a hospital are handled by machines, Hammond says. For example, a robot nurse in triage could perform standard tests before passing the patient to a doctor, if necessary. Remote robotic surgery will also become very efficient oneeye specialist in London might be treating people anywhere in the UK, or around the world. Another interesting development is the growing use of virtual reality as an alternative to conventional anaesthetic.

Technology and work

Will robotics and automation put jobs at risk? During the next 15 years, there will be a lot of disruption in the workplace, says Hammond. Peoples roles will change, and retraining will be needed, but there will still be a lot of demand for human employment. After that period, Im not so sure; by the mid-2030s I think robots will be so ubiquitous, powerful and capable that a lot of human endeavour will not be needed. Robots will be increasing productivity to such an extent that society will have enough money to give to people who are not employed.

Such a fundamental change brings challenges, though. For many people, work is part of their identity, and when theyre denied it an important part of their life disappears, Hammond says. I dont have the answerto that, but Im worried.

Part of the solution is to recognise and pay for carers in the family, and Hammond predicts there will still be plenty of demand here. Robots will empathise and form attachments, but when real help or comfort is needed,I think well want a human for the foreseeable future.

I ask about the impact of artificial intelligence (AI)on replacing human work. Today AI is, at best, as intelligent as a rodent. I think it will be at least 30 years before AI is a threat to humanity in terms of its decision-making capabilities.

Cryptocurrencies and cash

Hammond expects blockchain technology, invented for the cryptocurrency Bitcoin, to have a huge and wide-ranging impact. Blockchain will be everywhere for example, managing patients in hospitals, or the assets and policies of an insurance company. The biggest drawback is its high energy demand, but there have been recent breakthroughs in that respect.

Cryptocurrencies do not need an issuing bank or government to authenticate them, as they are self-authenticating, so this poses a threat to the conventional banking industry and national sovereignty over finance, he continues. I dont see it happening on a big scale within 10 years, but in the longer term, if political will allows, there is no doubt that cryptocurrencies will replace fiat currencies.

Does this signal the end of cash? In my 1983 book Computers and Your Child I predicted there would be no cash in society by the year 2000, Hammond says.I was looking at the technology, and in that respect my prediction could have been correct, but I was forgetting human psychology. People like to feel they hold cash.I think cash will still be around in 10-15 years, but very much reduced.

I conclude by asking Hammond what his biggest concern for the future is. Climate change, with the extreme weather events that are going to become more frequent and severe and continue for at least the next30-40 years.

What excites him the most? The continuing improvement in human health. I love the idea of looking to a future where most serious illness is eradicated, with far less human suffering.

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Interview: Shaping the future - The Actuary

London, UK, 4 December 2019:The first UK clinical trial site for the treatment of diabetic patients with chronic limb-threatening ischemia (CLI) using a novel patient-specific regenerative therapy has opened for patient recruitment at the University Hospital of Wales in Cardiff. The site will be evaluating Rexgeneros REX-001 in two Phase III trials, codenamed the SALAMANDER trials. The trials are being led by Mr Ian Williams, a Consultant Vascular Surgeon and the Principal Investigator at the site.

The University Hospital of Wales is participating in the trials through a consortium, the Midlands-Wales Advanced Therapy Treatment Centre (MW-ATTC), part of the Advanced Therapy Treatment Centre Network (ATTC) which aims to bring pioneering advanced therapy medicinal products (ATMPs) to patients. THE MW-ATTC has been working in collaboration with the Cardiff & Vale University Health Board to progress the initiation of the two SALAMANDER trials and is planning to activate new clinical trial sites in the Midlands in England shortly.

CLI is a chronic disease and the most serious form of peripheral arterial disease (PAD), a common condition in which a build-up of fatty deposits in the arteries reduces the blood flow to the legs and feet. CLI is characterized by chronic ischemic at-rest pain, ulcers or gangrene in one or both legs. CLI is a common condition in Europe and the United States affecting 1-1.5% of the population aged over 401. It represents an area of high unmet medical need as there are currently no approved therapies that successfully treat the CLI patient population. Patients with CLI have a very negative prognosis. A year after initial diagnosis, around 12% of patients have had an amputation. Five years after diagnosis the situation is even worse with mortality at 50%, rising to 70% after ten years2.

REX-001 represents a new class of regenerative medicines. It is an autologous cell therapy manufactured using the patients own bone marrow and consists of immune cells (lymphocytes, monocytes and granulocytes) and progenitor cells involved in immune modulation and tissue regeneration. It is administered as a single dose within 4 days after collection of bone marrow cells.

Ian Williams, Consultant Vascular Surgeon and Principal Investigator commented,Chronic limb-threatening ischemia is a serious disease with severe consequences and limited treatment options. There is a high unmet need for novel and innovative therapiessuch as REX-001that have the potential to be a highly effective treatment and to reduce amputation and mortality rates amongst the patient population.

Chris Fegan, Consultant Haematologist, Cardiff and Vale University Health Board said, We have brought together many highly specialized teams from diabetes, surgery, radiology and stem cell transplantation to participate in the pioneering SALAMANDER study here at Cardiff and Vale, which we hope will revolutionize treatment options for patients with chronic limb-threatening ischemia.

Rexgenero, the company pioneering the development of REX-001, says that the experimental product has already demonstrated efficacy in Phase I/II studies. In the Phase II clinical trial, 82% of patients with non-healing ischemic ulcers were healed within the first 12 months after a single administration dose of REX-001.

Joe Dupere, CEO of Rexgenero added, Treating our first patient with REX-001 in the UK will be an important milestone for our Phase III program in diabetic patients with chronic-limb threatening ischemia, a severe condition with high unmet need. With clinical trial sites and manufacturing bases now open across multiple countries in Europe, we are one step closer to completion of the Phase III studies and potential regulatory and market approval for an innovative and much-needed product.

Rexgenero is planning to treat a total of 60 patients with CLI and rest pain and 78 patients with CLI and non-healing ischemic ulcers in two independent Phase III SALAMANDER trials in approximately 25 hospitals across Europe.In addition to the trial sites in the UK, Rexgenero is also recruiting patients for both trials at sites inSpain, Austria, Portugal, Poland, Hungary, the Netherlands and the Czech Republic.

For more information about the REX-001 Phase III SALAMANDER trials, and how to participate, please visit theclinical trial website.

References

ENDS

For further information, please contact:

At Rexgenero

For media enquiries (Rexgenero)

Joe Dupere, CEO+44 (0)20 3700 7480info@rexgenero.com

Instinctif PartnersAshley Tapp+44 (0)20 7866 7923Rexgenero@instinctif.com

At the University Hospital of Wales

Cardiff and University Health BoardCommunications Team+44 (0)29 2074 6381news@wales.nhs.uk

About Rexgenero

Rexgenero is a clinical-stage regenerative medicine company developing innovative cell-based therapies targeting serious diseases with unmet medical needs.

The Companys lead candidate, REX-001, is a highly innovative autologous cell therapy that is being studied in a Phase III clinical programme in patients with chronic limb-threatening ischemia (CLI) with diabetes, a poorly treated disease with a high risk of amputation and death. REX-001 has been shown to be effective in Phase I/II and Phase II trials, alleviating CLI in the majority of patients, offering the potential to increase the quality of life of CLI patients by reducing pain, alleviating ulcers, increasing mobility, improving sleep and reducing the need for amputation. Rexgenero is developing REX-001 in a range of indications and, pending approval, intends to launch and market this specialty product in major territories.

Rexgenero is a privately-owned company, which draws on an exceptional understanding of the fundamental science of cell therapies developed by the Andalusian Health Authority (Servicio Andaluz de Salud) and Andalusian Initiative of Advanced Therapies.

The Company was founded in 2015 and is headquartered in London (UK) with R&D and manufacturing operations in Seville (Spain) and Frankfurt (Germany).

For more information, please visit:www.rexgenero.com

Connect with us: Twitter:@_Rexgenero; LinkedIn:https://www.linkedin.com/company/rexgenero-limited/

About the REX-001 Phase III SALAMANDER Trials

REX-001 has shown efficacy in 70% of patients in Phase I and I/II studies and is currently progressing through two Phase III SALAMANDER trials in Europe being conducted at approximately 30 sites, with plans to enrol a total of 138 patients. The trials are given the name SALAMANDER in reference to the amphibians ability to regenerate its tail and limbs.

ThePhase III studyin patients with Rutherford stage 4 CLI will assess the efficacy and safety of REX-001 with a primary endpoint of complete relief of ischemic rest pain.

ThePhase III studyin patients with Rutherford stage 5 CLI will assess the efficacy and safety with a primary endpoint of complete ulcer healing.

Amputation-free survival is included as a secondary endpoint in both studies. The trials are expected to produce interim analysis in early 2021 with full results expected later that year; all dependent on the speed of patient recruitment.

For more information about the REX-001 Phase III SALAMANDER trials, please visit:https://www.cli-treatment.com

About the Midlands and Wales Advanced Therapy Treatment Centre (MW-ATTC)

The Midlands and Wales Advanced Therapy Treatment Centre (MW-ATTC) consists of a large regional network with the necessary commercial and NHS infrastructure required to facilitate the delivery of advanced therapy treatments to patients. The centre includes a wide range of specialists in advanced therapy manufacturing including academic and commercial partners, logistics companies, specialists in clinical trial delivery and teams focussed on IT solutions and health economics.

For more information, please visit:https://www.theattcnetwork.co.uk/centres/midlands-wales

The ATTC Network Programme is a world-first, UK system of Advanced Therapy Treatment Centres (ATTC) operating within the NHS framework and coordinated by the Cell and Gene Therapy Catapult to address the unique and complex challenges of bringing pioneering advanced therapy medicinal products (ATMPs) to patients. The centres include Innovate Manchester Advanced Therapy Centre Hub (iMATCH), Midlands-Wales Advanced Therapy Treatment Centre (MW-ATTC, comprising Birmingham, Wales and Nottingham) and Northern Alliance Advanced Therapies Treatment Centre (NA-ATTC, comprising Scotland, Newcastle and Leeds).

The network is initially supported by the Industrial Challenge Strategy Fund with the aim to develop first-of-a-kind technologies for the manufacture of innovative medicines across areas including blindness, cancer, heart failure, liver disease, neurological conditions and rare paediatric diseases.

For more information, please visit:https://www.theattcnetwork.co.uk/

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First UK Clinical Trial Site Open for Recruitment of Diabetic Patients with Chronic Limb-Threatening Ischemia Using Novel Patient-Specific...