Rhode Island Expands Stem Cell Therapy For Cancer Patients With New Approval – Kaiser Health News

The state Health Services Council voted to allow patients from the Lifespan Cancer Institute at the Rhode Island Hospital to take part in an autologous stem-cell therapy program. Meanwhile, Reuters reports on ongoing, controversial investments into adult stem cell research directed at heart disease.

The Boston Globe: Lifespan Cancer Institute Secures Key Approval For Stem-Cell Therapy For Cancer Patients The states largest health care system received approval to operate an autologous stem-cell therapy program at the Lifespan Cancer Institute at Rhode Island Hospital. The approval, which was granted by the state Health Services Council in an unanimous vote on June 16, will allow patients from the institute who need cancer treatments, such as stem-cell therapy which provides bone marrow transplants for patients undergoing chemotherapy, to receive care with their regular medical team. Rhode Island Hospital is only the second in the state to offer stem-cell therapy. The only other facility providing this treatment is at Roger Williams Medical Center in Providence. Rhode Islanders were often also referred to the Dana-Farber Cancer Institute in Boston. (Gagosz, 6/21)

More on stem cell research

Reuters: Years After Harvard Scandal, U.S. Pours Millions Into Tainted Field Mario Ricciardi, a young Italianmolecular biologist,was thrilledwhen he was selected to work with one of Harvard Medical Schools most successful stem cell researchers. His new boss, Dr. Piero Anversa, had become famous within the field for his bold findings in 2001 that adult stem cells had special abilities to regenerate hearts or even cure heart disease, the leading cause of U.S. deaths. Millions in U.S. government grants poured into Anversas lab at Brigham and Womens Hospital in Boston. Top journals published his papers. And the American Heart Association (AHA) proclaimed him a research pioneer. He was like a god, recalled Ricciardi, now 39, one of several scientists to speak out for the first time about their experiences in Anversas lab. Within a year of Ricciardis arrival in 2011, they grew suspicious, the scientists recalled. (Taylor and Heath, 6/21)

In other pharmaceutical and research news

Axios: Cancer Treatment Tool Gets Major Boost In Funding A tool used to analyze cancerous tumors based on algorithms built to map distant galaxies is getting a major influx of funding. The imaging platform called AstroPath is able to pinpoint how certain tumor cells interact with the body's tissues, allowing doctors to potentially learn more about who might respond well to various treatments. (Kramer and Snyder, 6/21)

The Boston Globe: Startup Will Target Cystic Fibrosis With A New Twist On Gene Therapy Gene therapy developers rely on hollowed-out viruses to shuttle DNA into the body, where it can treat or potentially even cure a genetic disease. But most of the dozens of companies in the field use just two kinds of viruses for their DNA delivery. Carbon Biosciences hopes to expand that toolbox. The Lexington, Mass., startup launched Tuesday with $38 million in series A financing to create a new class of gene therapies based on parvoviruses a large family of viruses best known for infecting dogs, but comprised of many little-studied viruses that can infect humans and other animals, too. (Cross, 6/21)

Axios: What Scientists Can Learn From Tracking Disease Outbreaks From Space Scientists are tracking diseases from space and getting a new view of human health. The proliferation of easy-to-use, relatively cheap and more comprehensive satellite data is allowing researchers to get a holistic view of what's happening on Earth during disease outbreaks and possibly learn how to predict the next one. By keeping an eye from above on changes to vegetation and other ecosystem factors that can lead to outbreaks, researchers are starting to piece together correlations between habitat loss and urbanization, among other factors, and infectious disease. (Kramer, 6/21)

Louisville Courier Journal: Louisville Researchers Study Prenatal Care. Here's What They Found One mother, worried about being perceived as "an angry Black woman," felt she had to "watch my tone," even while in the pain of giving birth.Another, under anesthesia at the time of birth, didn't know who delivered her baby.One woman asked for help after suffering with a cesarean section incision. She was told nothing was wrong and accused of just seeking pain medication. Later, once it got bad enough that she couldn't walk or hold her child,it was discovered her incision was very infected.Louisville researchers were toldthese and other stories while speaking with recent parents who accessed prenatal care or gave birth in the city. (Ladd, 6/22)

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Rhode Island Expands Stem Cell Therapy For Cancer Patients With New Approval - Kaiser Health News

Hotels Are Taking Wellness to Extremes, From IV Drips to MRIs – The Wall Street Journal

Soaking in a porcelain tub with petal-thin lime slices fluttering around my limbs, I cant shake the feeling that Im stuck inside one of those fruit water dispensers that used to proliferate at co-working spaces. Im actually taking the waters, by way of an elaborate DIY Ayurvedic bath ritual now on offer at the Peninsula Hotels. Minutes earlier, the disembodied wellness concierge on the other end of my wellness portal (a text chat with a real live human, just a QR code away) dispatched a spa attendant to bring a flight of lovely-smelling bath-time products to my door. The bath-time accoutrements arrived in tiny ceramic bowls on a wooden tray, like so many banchan dishes at a Korean restaurant, with an instruction card for the bathing and slathering and self-massaging that was to follow. A few hours later, my portal pal is back, this time to check in about my pillow plansfeather, buckwheat or memory foam? The latter,my chatty caretakersays, might be a good option for you to have a restful night with proper neck support to start your day tomorrow with the Physique 57 class!

Ive traveled the 5.8 miles from my apartment to the Peninsula New York to avail myself of the hotel brands Life Lived Best initiative, whose health-oriented offerings are as manifold as its title is ambitious (if vague). The aim is to imbue every corner of the luxury chains 10 properties around the globe with micro-upgrades geared toward the pursuit of well-being. Wellness shouldnt be something you only address when you cross the threshold into the spa, says Gareth Roberts, the hotel groups director of brand and operations support. That outdated concept of Now youre in the World of Wellness? Thats not authentic.

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Hotels Are Taking Wellness to Extremes, From IV Drips to MRIs - The Wall Street Journal

Ambys Medicines Announces Formation of Clinical and Scientific Advisory Boards with Leading Liver Disease and Cell and Gene Therapy Experts – Business…

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Ambys Medicines, a company pioneering cell-replacement therapies for patients with liver disease, today announced the formation of its clinical and scientific advisory boards comprising leading clinical experts in liver disease and hepatocyte transplantation, and world-class scientists pioneering cell and gene technologies.

The clinical advisory board provides guidance on advancing Ambyss lead program, AMI-918, through the clinic and provides critical input on clinical trial design and patient selection. The scientific advisory board will provide a cross-discipline perspective on applying cutting-edge technology to Ambyss cell therapy platform to progress its discovery pipeline of next generation cell therapies.

Were honored to work with such an esteemed and diverse group of experts in liver disease, hepatocyte transplantation, and cell and gene therapies whose collective experience will be highly valuable as we finalize our clinical development strategy for AMI-918 and progress our genetically engineered hepatocyte follow-on programs, said Ronald Park, M.D., Chief Executive Officer of Ambys Medicines. Were grateful for the engagement and support from our advisors as we work to bring first-in-class hepatocyte replacement therapies to liver failure patients who currently lack treatment options.

Each of our advisors brings incredible knowledge and expertise in their respective fields that will be instrumental to Ambys as we continue to broaden our pipeline and move closer to becoming a clinical-stage company, said Markus Grompe, M.D., Founder and Chief Scientific Officer of Ambys Medicines. Were excited to partner together to realize the potential of our novel replacement cell therapy platform in restoring lost hepatic function to patients with acute or chronic liver failure and genetic liver diseases.

Clinical Advisory Board

Scientific Advisory Board

About Ambys Medicines Ambys Medicines is focused on pioneering cell replacement therapies for patients with liver failure. Ambyss proprietary platform enables the company to be the first and only company able to develop and manufacture functional human hepatocytes at scale. Our scientific approach has the potential to fundamentally transform the treatment paradigm for patients with acute and chronic liver failure and genetic diseases of the liver. Our lead program, AMI-918, is a hepatocyte replacement cell therapy in development to restore lost hepatic function. Beyond AMI-918, we are building a pipeline of next-generation modified hepatocytes that will rapidly expand the range of treatable patient populations. Learn more at ambys.com and follow us on Twitter, LinkedIn and Instagram.

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Ambys Medicines Announces Formation of Clinical and Scientific Advisory Boards with Leading Liver Disease and Cell and Gene Therapy Experts - Business...

NYU Langone Health Continues to Rapidly Expand Its Outpatient Network – NYU Langone Health

NYU Langone Health continues to broaden access to high-quality primary and specialty care with recent expansions on Long Island and in Brooklyn and southeast Florida.

Were continually evolving our network to better meet our patients needs, says Andrew Rubin, senior vice president for clinical affairs and ambulatory care at NYU Langone. Whether were adding new services or opening up new practices, our goal is to make it easier for patients to access integrated, comprehensive, patient-centered care in the communities we serve.

Expanding the breadth and depth of services on Long Island, NYU Langone recently added the following practices and providers.

Three new practices at 100 Hospital Road in Patchogue offer multispecialty and surgical care as part of a broader expansion to bring more healthcare services to Suffolk County. The care team at NYU Langone Long Island Surgical AssociatesPatchogue, 100 Hospital Road specializes in breast, colorectal, general, and urologic surgery consultations. Radiation oncology consultations are also available on-site at Perlmutter Cancer Center Radiation Oncology at NYU LangonePatchogue. At NYU Langone Medical AssociatesPatchogue, 100 Hospital Road, the team offers family medicine care for patients age 16 and older, and gastroenterology, podiatry, and urology services.

Vascular surgeon Jonathon A. Rubin, MD, is now seeing patients at NYU Langone Cardiology AssociatesEast Patchogue.

Neurosurgeons Richard W. Johnson, MD, Ricky Madhok, MD, and David Chen, DO, recently joined NYU Langones neurosurgery department at NYU Langone HospitalLong Island, and see patients at NYU Langone Ambulatory Care East Meadow, NYU Langone Huntington Medical Group, and NYU Langone Neurosurgery AssociatesKew Gardens.

At NYU Langone Ambulatory Care East Meadow, occupational and physical therapy and speechlanguage pathology experts at NYU Langones Rusk Rehabilitation now provide specialized care for people with neurologic conditions.

NYU Langone also continues to extend its reach in Brooklyn with the opening of a new location and expanded services.

NYU Langone opened a second care center in Greenpoint, NYU Langone Brooklyn Medical AssociatesKent Street, located in the historic Eberhard Faber Pencil Factory. This new practice offers bariatric and orthopedic surgery consultations, gastroenterology and endoscopy services, on-site diagnostic imaging at NYU Langone RadiologyGreenpoint, and physical therapy through NYU Langones Rusk Rehabilitation.

New clinical services available at NYU Langone Brooklyn Medical AssociatesDyker Heights include bariatric and general surgery consultations, gastroenterology, endocrinology, and pulmonology.

Swapna Ghanta, MD, a breast surgeon and oncologist at Perlmutter Cancer CenterSunset Park who specializes in advanced breast surgery and reconstruction techniques, has joined the medical team at NYU Langone Brooklyn Medical Associates902 Quentin Road. Dr. Ghanta also sees patients at high risk of developing breast cancer.

In Palm Beach County, Florida, NYU Langone recently introduced orthopedics and womens health services and expanded its medical weight loss program to enhance access to comprehensive care at NYU Langone Medical AssociatesWest Palm Beach.

The team here welcomes Dennis A. Cardone, DO, and John G. Kennedy, MD, two of New Yorks leading sports medicine and orthopedic surgery physicians, who are now seeing patients in West Palm Beach. They treat injuries with the goal of optimizing performance, and a rapid and safe return to play. They specialize in sports regenerative medicine techniques for soft tissue and joint conditions, including platelet-rich plasma (PRP), concentrated bone marrow aspirate (CBMA), and fat stem cell transplant treatments. Dr. Kennedy also performs in-office needle arthroscopy (IONA) in Floridas first fully equipped IONA facility. IONA is a minimally invasive procedure performed on joints and tendons in the office, leading to significant pain reduction, a low complication rate, and excellent patient-reported outcomes.

The team also welcomes gynecologist Raquel B. Dardik, MD, who provides preventive care and management of conditions affecting the female reproductive system from puberty through menopause and beyond.

In addition, social worker Deborah Lifschitz, LCSW, helps support the emotional needs of patients enrolled in the medical weight loss program at NYU Langone Medical AssociatesWest Palm Beach and offers general mental health counseling services. Lifschitz also sees patients at NYU Langone Medical AssociatesDelray Beach.

We invest in the health of our communities by bringing more physicians into newer facilities with the latest technology and equipment, which we believe leads to better patient outcomes, says Rubin. No matter where they are seen, patients can expect the highest level of care across NYU Langone.

Deborah DJ Haffeman Phone: 646-284-5630 deborah.haffeman@nyulangone.org

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NYU Langone Health Continues to Rapidly Expand Its Outpatient Network - NYU Langone Health

Calidi Biotherapeutics Announces Appointment of W.K. Alfred Yung, M.D., to its Medical Advisory Board – Business Wire

LA JOLLA, Calif.--(BUSINESS WIRE)--Calidi Biotherapeutics, Inc., a clinical-stage biotechnology company that is pioneering the development of stem cell-based delivery of oncolytic viruses, today announced the appointment of W.K. Alfred Yung, M.D., Professor, Neuro-Oncology at the MD Anderson Cancer Center, to its Medical Advisory Board.

We are inspired by clinician-scientists like Dr. Yung who have dedicated their careers to advancing care for patients with deadly cancers, such as glioblastoma, for which there are few effective treatments, said Allan J. Camaisa, Chief Executive Officer and Chairman of Calidi. As clinical trials studying the safety and efficacy of Calidis oncolytic virus-based therapies progress, the expertise of seasoned clinicians like Dr. Yung will help us further our understanding of the benefits of these drugs to patients.

Dr. Yung is a fixture in the treatment of brain cancers with extensive experience studying glioblastoma, the deadliest form of brain cancer. He built the neuro-oncology department at MD Anderson Cancer Center, served as co-chair of the National Cancer Institute Brain Malignancy Steering Committee, and advised President Bidens Cancer Moonshot Initiative. Dr. Yung has published more than 350 peer-reviewed articles and served as the editor-in-chief of Neuro-Oncology.

Despite many promising new advancements in precision medicine for many cancers, glioblastoma remains one of the deadliest cancers with limited treatment successes and poor patient quality of life, said W. K. Alfred Yung, M.D. I see great promise in the potential of Calidi Biotherapeutics therapeutic vaccine which shields cancer-fighting oncolytic viruses in stem cells, helping protect the virus from a patients immune system until it reaches the cancer cell. If this approach proves successful in human trials, it could be a game changer not just for the treatment of brain cancers, but for other solid tumor cancers too.

About Calidi Biotherapeutics

Calidi Biotherapeutics is a clinical-stage immuno-oncology company with proprietary technology that is revolutionizing the effective delivery of oncolytic viruses for targeted therapy against difficult-to-treat cancers. Calidi Biotherapeutics is advancing through the FDA approval process a potent allogeneic stem cell and oncolytic virus combination for use in multiple oncology indications. Calidis off-the-shelf, universal cell-based delivery platform is designed to protect, amplify, and potentiate oncolytic viruses currently in development leading to enhanced efficacy and improved patient safety. Calidi Biotherapeutics is headquartered in La Jolla, California. For more information, please visit http://www.calidibio.com.

Forward-Looking Statement

This press release contains forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Terms such as anticipates, believe, continue, could, estimate, expect, intends, may, might, plan, possible, potential, predicts, project, should, would as well as similar terms, are forward-looking in nature. The forward-looking statements contained in this discussion are based on the Calidis current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Calidi will be those that it has anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Calidis control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: the occurrence of any event, change or other circumstances that could give rise to the termination of negotiations and any subsequent definitive agreements with respect to the business combination (the Business Combination) with Edoc Acquisition Corp. (Edoc); the outcome of any legal proceedings that may be instituted against Edoc, Calidi, the combined company or others following the announcement of the Business Combination, the private placement financing proposed to be consummated concurrently with the Business Combination (the PIPE), and any definitive agreements with respect thereto; the inability to complete the Business Combination due to the failure to obtain approval of the shareholders of Edoc, the possibility that due diligence completed following execution of the principal definitive transaction documents for the Business Combination and PIPE will not be satisfactorily concluded, the inability to complete the PIPE or other financing needed to complete the Business Combination, or to satisfy other conditions to closing; changes to the proposed structure of the Business Combination that may be required or appropriate as a result of applicable laws or regulations or as a condition to obtaining regulatory approval of the Business Combination; the ability to meet stock exchange listing standards following the consummation of the Business Combination; the risk that the Business Combination disrupts current plans and operations of Calidi as a result of the announcement and consummation of the Business Combination; the ability to recognize the anticipated benefits of the Business Combination or to realize estimated pro forma results and underlying assumptions, including with respect to estimated shareholder redemptions; costs related to the Business Combination; changes in applicable laws or regulations; the evolution of the markets in which Calidi competes; the inability of Calidi to defend its intellectual property and satisfy regulatory requirements; the ability to implement business plans, forecasts, and other expectations after the completion of the proposed Business Combination, and identify and realize additional opportunities; the risk of downturns and a changing regulatory landscape in the highly competitive pharmaceutical industry; the impact of the COVID-19 pandemic on Calidis business; and other risks and uncertainties set forth in the section entitled Risk Factors and Cautionary Note Regarding Forward-Looking Statements in Edocs preliminary prospectus dated March 16, 2022, in the Registration Statement on Form S-4 filed with the Securities and Exchange Commission (SEC) on March 16, 2022.

Important Information About the Business Combination Transaction and Where to Find It

This press release relates to a proposed business combination between Edoc Acquisition Corp. a Cayman Islands exempted company, EDOC Merger Sub Inc., a Nevada corporation and Calidi Biotherapeutics, Inc., a Nevada corporation. A full description of the terms and conditions Agreement and Plan of Merger constituting the business combination is provided in the registration statement on Form S-4 filed with the U.S. Securities and Exchange Commission (SEC) by Edoc Acquisition Corp., that includes a prospectus with respect to the securities to be issued in connection with the merger, and information with respect to an extraordinary meeting of Edoc Acquisition Corp. shareholders to vote on the merger and related transactions. Edoc Acquisition Corp. and Calidi Biotherapeutics, Inc. urges its investors, shareholders and other interested persons to read the proxy statement and prospectus as well as other documents filed with the SEC because these documents will contain important information about Calidi Biotherapeutics, Inc., Edoc Acquisition Corp., and the business combination transaction. After the registration statement is declared effective, the definitive proxy statement and prospectus to be included in the registration statement will be distributed to shareholders of Edoc Acquisition Corp. and Calidi Biotherapeutics, Inc., as of a record date to be established for voting on the proposed merger and related transactions. Shareholders may obtain a copy of the Form S-4 registration statement, including the proxy statement and prospectus, and other documents filed with the SEC without charge, by directing a request to: Edoc Acquisition Corp. at 7612 Main Street Fishers, Suite 200, Victor, New York 14564. The preliminary and definitive proxy statement and prospectus included in the registration statement can also be obtained, without charge, at the SECs website (www.sec.gov).

Participation in the Solicitation

Edoc Acquisition Corp., Calidi Biotherapeutics, Inc., and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies or consents from Edoc Acquisition Corp. and Calidi Biotherapeutics, Inc. shareholders in connection with the proposed transaction. A list of the names of the directors and executive officers of Edoc Acquisition Corp. and Calidi Biotherapeutics, Inc. and information regarding their interests in the business combination transaction is contained in the proxy statement and prospectus. You may obtain free copies of these documents as described in the preceding paragraph.

No Offer or Solicitation

This press release will not constitute a solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed business combination. This press release will also not constitute an offer to sell or the solicitation of an offer to buy any securities of Calidi Biotherapeutics, Inc., nor will there be any sale of securities in any states or jurisdictions in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities will be made except by means of a prospectus meeting the requirements of section 10 of the Securities Act of 1933, as amended, or an exemption therefrom.

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Calidi Biotherapeutics Announces Appointment of W.K. Alfred Yung, M.D., to its Medical Advisory Board - Business Wire

Veloxis Pharmaceuticals Announces Dosing of the First Patient by partner Xenikos in the Global Phase 3 Study Evaluating T-Guard in Patients with…

T-Guard, under development by Xenikos B.V., is being studied in comparison to ruxolitinib in patients with Grade III or IV SR-aGHVD

CARY, N.C., June 28, 2022 /PRNewswire/ -- Veloxis Pharmaceuticals, an Ashai Kasei company, today announced dosing of the first patient by its partner, Xenikos, in a global pivotal Phase 3 clinical study [NCT04934670] designed to evaluate T-Guard versus ruxolitinib for the treatment of patients with Grade III or IV steroid-refractory acute graft-versus-host disease (SR-aGVHD) following allogeneic hematopoietic stem cell transplant (allo-HSCT). T-Guard is currently being developed by Xenikos B.V., a privately-held biotechnology company that develops innovative immunotherapies for treating patients with severe immune disease and post-transplant rejection.

(PRNewsfoto/Veloxis Pharmaceuticals)

This study comparing T-Guard to ruxolitinib, if successful, can help bring a new treatment option to patients.

In September 2021, Xenikos secured40 million in convertible debt consisting of two equal tranches of 20 million, led by Veloxis Pharmaceuticals with participation from existing investors, Medicxi, RA Capital Management, Oost NL and Sanquinnovate. In connection with the financing, Veloxis has obtained two sequential call options to acquire the company.

"Patients who experience SR-aGVHD have limited treatment options and sadly, their condition is often fatal" said Ulf Meier-Kriesche, chief scientific officer of Veloxis. "This Phase 3 study comparing T-Guard, with its novel mechanism of action, to ruxolitinib, if successful, can help bring a new treatment option to patients who urgently need it."

"Veloxis is looking forward to the potential addition of T-Guard to its pipeline as we develop a broad portfolio of novel drugs to meet the needs of different groups of transplant patients," says Mark Hensley, CEO of Veloxis.

Xenikos reached agreement with the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) on the design of this global, pivotal, randomized Phase 3 study, which is planned to enroll 246 patients and has been designed to test for superiority of T-Guard compared to ruxolitinib for the treatment of Grade III or IV SR-aGVHD. The study will be conducted at 75 transplant centers across the U.S. and Europe and will be executed in collaboration with the Blood and Marrow Transplant Clinical Trials Network (BMT CTN). Patients will be randomized 1:1 to receive either T-Guard or ruxolitinib. Participants in the T-Guard arm will receive a one-week course of treatment with T-Guard as a four-hour infusion every other day. Each dose consists of 4mg/m2 body surface area (BSA). Participants in the ruxolitinib arm will receive 10mg of ruxolitinib twice daily for a minimum of 56 days.

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The primary endpoint of the study is complete response (CR) rate at Day 28, which is an important surrogate for long-term survival in patients with SR-aGVHD. Key secondary objectives include overall survival at Days 60, 90, 180 and 365, duration of complete response (CR), time to CR, overall response rate at Days 14, 28 and 56, GVHD-free survival, incidence of infections and safety.

There will be a safety run-in phase at the beginning of the study whereby the Data and Safety Monitoring Board (DSMB) will evaluate the first 24 patients. Xenikos expects to report results from the safety run-in phase during the first half of 2023. The trial will also include an interim analysis for futility after 46 patients become evaluable for the primary endpoint. A second interim analysis will be performed once 150 participants have reached Day 28.

Xenikos expects the data from this study to support the submission of a Biologics License Application (BLA) in the U.S. based on Day 28 data from the first 150 patients. Data from the full 246 patients is expected to support the submission of a Marketing Authorization Application (MAA) in the EU.

Acute Graft-Versus-Host Disease

Following allogeneic stem cell transplantation, most patients have a high risk of developing graft-versus-host disease (GVHD). With GVHD, the donor's immune cells attack the patient's cells. Acute GVHD occurs early after transplantation and can be relatively mild or quite severe, even life-threatening, if not treated. Although GVHD can often be treated successfully with steroids, few options are available if the disease progresses or becomes resistant to steroid treatment, and the long-term survival of patients with steroid-refractory acute GVHD (SR-aGVHD) is less than 20%, highlighting the urgent need for effective new therapies.

T-Guard: Helping Reset the Body's Immune System

T-Guard is designed to reset the body's immune system in life-threatening T cellmediated conditions, potentially including prevention of transplant-related rejection, treatment of acute solid-organ rejection, and severe autoimmune disease. T-Guard consists of a unique combination of toxin-conjugated monoclonal antibodies that target CD3 and CD7 molecules on immune cells. Preclinical and early clinical testing have shown that T-Guard can specifically identify and eliminate mature T cells and NK cells with tolerable treatment-related side effects. T-Guard's action is believed to be short-lived, which may alter a patient's vulnerability to opportunistic infections compared to currently available therapies. T-Guard has been previously studied in a Phase 1/2 study in comparison to institutional historical controls in patients being treated second-line for SR-aGVHD following hematopoietic stem cell transplantation (HSCT). To learn more about that study, please find it here (link). T-Guard has been granted Orphan Drug Designation in both the EU and the U.S.

About the Blood and Marrow Transplant Clinical Trials Network (BMT CTN)

The BMT CTN conducts rigorous multi-institutional clinical trials of high scientific merit, focused on improving survival for patients undergoing hematopoietic cell transplantation and/or receiving other cellular therapies. The BMT CTN has completed accrual to more than 50 Phase II and III trials at more than 100 transplant centers and enrolled over 16,000 study participants.

BMT CTN is funded by the National Heart, Lung, and Blood Institute and the National Cancer Institute, both parts of the National Institutes of Health (NIH) and is a collaborative effort of 20 Core Transplant Centers/Consortia, the Center for International Blood and Marrow Transplant Research (CIBMTR), the National Marrow Donor Program (NMDP)/Be The Match and the Emmes Company, LLC, a clinical research organization. CIBMTR is a research collaboration between the NMDP/Be The Match and the Medical College of Wisconsin.

The BMT CTN 2002 study is being led by Drs. Mehdi Hamadani, Protocol Officer, Scientific Director of CIBMTR, Medical College of Wisconsin; John Levine, Protocol Co-chair, Director of BMT Clinical Research, Mt. Sinai School of Medicine; Grard Soci, Protocol Co-chair, Head of Hematology-Transplantation, Hpital Saint-Louis; and Gabrielle Meyers, Protocol Co-chair, Associate Professor of Medicine, Oregon Health and Science University. More information about the BMT CTN can be found at bmtctn.net.

About Xenikos

Xenikos develops innovative immunotherapies based on conjugated antibodies. This novel therapeutic approach helps reset the immune system in patients who have a severe immune disease or have developed post-transplantation rejection. A randomized Phase 3 registration trial evaluating the company's flagship product, T-Guard for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGVHD) is underway in the U.S. and Europe.

About Veloxis Pharmaceuticals

Veloxis Pharmaceuticals, Inc, an Asahi Kasei company, is a fully integrated specialty pharmaceutical company committed to improving the lives of transplant patients. Headquartered in Cary, North Carolina, USA, Veloxis is focused on the global development and commercialization of medications utilized by transplant patients and by patients with serious related diseases. For further information, please visitwww.veloxis.com.

About Asahi Kasei

The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber business, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 40,000 employees around the world, the company contributes to sustainable society by providing solutions to the world's challenges through its three business sectors of Material, Homes, and Healthcare. Its healthcare operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. For further information, please visitwww.asahi-kasei.com.

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Veloxis Pharmaceuticals Announces Dosing of the First Patient by partner Xenikos in the Global Phase 3 Study Evaluating T-Guard in Patients with...