Category Archives: FDA Stem Cell Trials

BOONTON, N.J. and CAMBRIDGE, Mass., Sept. 19, 2012 /PRNewswire/ --Unigene Laboratories, Inc. (UGNE) and Tarix Pharmaceuticals today announced the successful completion of a feasibility study of an oral formulation of TXA127, Tarix's lead peptide drug candidate. Data from the feasibility study demonstrated that the oral formulation of TXA127 produced extremely high exposure in the blood that resulted in a several-fold increase in bioavailability as compared to the oral delivery of the unformulated drug, and was equal to or greater than that achieved by the current subcutaneous formulation. The oral formulation, developed jointly by Unigene and Tarix under a previously agreed upon feasibility program, leverages Unigene's Peptelligence technology platform to enable enhanced oral delivery of TXA127. Tarix is developing TXA127 for multiple therapeutic indications, including enhancement of engraftment following peripheral blood and cord blood stem cell transplantation, reduction in GVHD and mucositis following allogeneic stem cell transplantation, and peripheral vascular disease. In September 2011, TXA127 was granted orphan drug status by the U.S. Food and Drug Administration (FDA) for the treatment of pulmonary arterial hypertension (PAH), a rare disease resulting from insufficient cardiac output. Unigene's Peptelligence platform comprises peptide oral drug delivery and manufacturing assets, expertise and capabilities. Ashleigh Palmer, Unigene's … Continue reading →

MedImmune is teaming up with a Chinese company to launch a joint venture designed to develop and commercialize in China a new biologic therapy for rheumatoid arthritis and other autoimmune and inflammatory diseases. Under the venture, the Gaithersburg biotech will provide technical and development expertise and WuXi AppTec will provide local regulatory, manufacturing, pre-clinical and clinical trial support. Chinese law requires companies that conduct clinical trials to manufacture the experimental treatments locally when they haven't yet been approved in other markets, according to a MedImmune statement. MEDI5117, as the new treatment is called, is in phase 1 clinical trials in the U.S. and Europe. "This strategic partnership will enable us to establish a leadership presence in developing novel biologics in China, complementing AstraZeneca's investment in this important emerging market," Bahija Jallal, MedImmune's executive vice president for research and development, said in the statement. MedImmune is the global biologics division of British pharma giant AstraZeneca. The two companies will have equal ownership of the joint venture; AstraZeneca has the option to acquire full commercialization rights for MEDI5117. WuXi AppTec will earn revenue based on services provided to the joint venture, and MedImmune will receive milestone payments as the program progresses. "WuXi … Continue reading →

SAN DIEGO, CA--(Marketwire - Sep 12, 2012) - Medistem Inc. ( PINKSHEETS : MEDS ) announced today completion of the first phase of a joint project with the Shumakov Research Center of Transplantology and Artificial Organs of the Russian Federation and its Russian and CIS licensee ERCell.The collaboration is based on using Endometrial Regenerative Cell (ERC) technology licensed from Yale University to treat type 1 diabetes. Dr. Viktor Sevastianov, Head and Professor of the Institute of Biomedical Research and Technology, within the Shumakov Center, demonstrated safety and feasibility of ERC injection in experimental animal models of diabetes.Additionally, the studies demonstrated that the cell delivery technology developed by Dr. Sevastianov's laboratory can be used to enhance growth of ERC.These experiments are part of the process for registration of "new pharmacological substances," which is the first step towards drug approval in Russia. "Type 1 diabetes is a significant problem in the Russian Federation. Our laboratory has been working developing various delivery formulations for cell therapy, such as SpheroGel, which is registered in Russia," said Dr. Sevastianov. "Given that the ERC can be produced in large quantities, is a universal donor cell, and already is approved for clinical trials in both the USA … Continue reading →

MADISON, Wis., Sept. 11, 2012 /PRNewswire/ -- Novelos Therapeutics, Inc. (NVLT), a pharmaceutical company developing novel drugs for the treatment and diagnosis of cancer, today announced that it has successfully completed the second cohort in a U.S. multi-center Phase 1b dose-escalation trial of its cancer-targeted molecular radiotherapeutic compound I-131-CLR1404 (HOT) in cancer patients with advanced solid tumors. The second two-patient cohort was successfully dosed with approximately 40 mCi of HOT, triggering enrollment into the third cohort at approximately 60 mCi. Details of the trial design are available on http://www.clinicaltrials.gov ID: NCT01495663, or at http://www.novelos.com in the 'Clinical Trials' section. Glenn Liu, M.D., Associate Professor of Medicine and Director of the Cancer Therapy Discovery and Development (Phase I) Program at the University of Wisconsin Carbone Cancer Center, is the trial's principal investigator. Detailed trial results are expected to be presented at a scientific venue at a later date. "Data from this second cohort indicates that HOT was well-tolerated, without any dose-limiting or sub-dose-limiting toxicities, enabling enrollment of the third cohort as planned," said Dr. Liu. "We continue to observe selective uptake of HOT in cancerous tumors where it persists for at least 21 days." "We are pleased with HOT's safety profile … Continue reading →

ROCKVILLE, Md., Sept. 10, 2012 /PRNewswire/ --Neuralstem, Inc. (NYSE MKT: CUR) announced that President and CEO Richard Garr will present at the 2012 Rodman & Renshaw Annual Healthcare Conference on Tuesday, September 11 at 2:00 p.m. EDT, at The Waldorf=Astoria, Starlight South. Garr will discuss the company's opportunities and advancements in neural stem cell therapy and pharmaceuticals. He will be providing an update on ongoing clinical trials, including the recently completed ALS Phase I, and an overview on future trials. To view the live webcast, visit Neuralstem's Investor Center at http://www.neuralstem.com , or: http://www.wsw.com/webcast/rrshq22/cur . (Logo: http://photos.prnewswire.com/prnh/20061221/DCTH007LOGO ) The 2012 Rodman & Renshaw Annual Healthcare Conference is being held at The Waldorf=Astoria in New York City, September 9-11. For more information, see: http://www.rodm.com/conferences?id=176 . About Neuralstem Neuralstem's patented technology enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells constitutively into mature, physiologically relevant human neurons and glia. Neuralstem has recently completed an FDA-approved Phase I safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease, and has been awarded orphan status designation by the FDA. In … Continue reading →

MADISON, Wis., Sept. 7, 2012 /PRNewswire/ -- Novelos Therapeutics, Inc. (NVLT), a pharmaceutical company developing novel drugs for the treatment and diagnosis of cancer, today announced that three clinical imaging posters based on research conducted by Lance Hall, M.D., Anne M. Traynor, M.D., Glenn Liu, M.D., Jamey Weichert, Ph.D. and their colleagues are being presented at the World Molecular Imaging Congress taking place September 5-8, 2012 in Dublin, Ireland. These presentations describe initial findings in advanced cancer patients that demonstrate selective and prolonged uptake of Novelos' PET imaging and therapeutic compounds in a range of tumor types. Dr. Hall is Assistant Professor of Radiology, Dr. Traynor is Associate Professor of Medicine, Dr. Liu is Associate Professor of Medicine and Dr. Weichert is Associate Professor of Radiology, all in the School of Medicine and Public Health at the University of Wisconsin, Madison and all are members of the UW Carbone Cancer Center. Dr. Weichert is also the Chief Scientific Officer of Novelos and the founder of Novelos' technology. "We are consistently seeing cancer-selective tumor uptake and prolonged retention across multiple tumor types with I-124-CLR1404 (LIGHT) and I-131-CLR1404 (HOT)," said Dr. Hall. "LIGHT has potential as a stand-alone PET imaging agent for … Continue reading →

NEW YORK, Sept. 5, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NBS) ("NeoStem" or the "Company"), a cell therapy company, today announced that Company management of a NeoStem company, Progenitor Cell Therapy ("PCT"), an internationally recognized contract development and manufacturing organization (CDMO), has been invited to present on its core expertise in development of commercial manufacturing processes for cell therapy at two cell therapy conferences in September. At each, PCT will offer its unique perspective as an industry leader in contract development and manufacturing of cell therapy products, with over 12 years of exclusive cell-therapy focused experience. Timothy Fong, Ph.D, M.B.A, PCT's Vice President, Technology and Product Development, will be sharing PCT's expertise in cell therapy manufacturing with a focus on commercialization. At IBC Life Sciences' Cell Therapy Bioprocessing Conference, he will chair a panel on quality assurance and controls and will give a presentation entitled "From Concept to Product: Considerations for Developing a Robust Commercial Manufacturing Process", which will include considerations for developing a robust commercial manufacturing process. He will also speak at the Stem Cells USA and Regenerative Medicine Congress on "Cell manufacturing considerations for first-in-world stem cell therapeutics". Dr. Fong stated, "As a cell therapeutic progresses from concept … Continue reading →

GAITHERSBURG, MD--(Marketwire -09/04/12)- Cytomedix, Inc. (CMXI) (CMXI), a fully integrated regenerative medicine company commercializing and developing innovative platelet and adult stem cell technologies, today announced that the Company's AutoloGel System was highlighted in a continuing education program at the Paralyzed Veterans of America Summit 2012 held August 28 to 30 at the Paris Las Vegas Hotel. The AutoloGel System is a device for the production of autologous platelet rich plasma ("PRP") gel, and is the only PRP device cleared by the U.S. Food and Drug Administration ("FDA") for use in wound management. The program, titled, "Platelet Rich Plasma (PRP) Gel for Wounds on Persons with SCI," was delivered by Laurie Rappl, PT, DPT, CWS, Clinical Development Liaison for Cytomedix. Ms. Rappl's discussion addressed the underlying mechanisms of action that allow the Company's physiologically relevant concentration of PRP in the AutoloGel System to accelerate healing in recalcitrant wounds in patients with Spinal Cord Injuries ("SCI"), and highlighted the clinical data demonstrating rapid reduction in wound area and volume, as well as reduction of undermining and sinus tracts/tunnels in non-healing wounds in patients with SCI. "The physiology of SCI -- such as decreased blood flow, blood pressure and blood supply -- causes … Continue reading →

HAIFA, Israel, Aug. 30, 2012 (GLOBE NEWSWIRE) -- Pluristem Therapeutics, Inc. (PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, today announced that it has filed the necessary documents requesting that the U.S. Food and Drug Administration (FDA) grant orphan drug status to its PLacental eXpanded (PLX) cells for the treatment of aplastic anemia. The filing marks Pluristem's second orphan drug application to the U.S. FDA. The company applied once before, and successfully received in August of 2011, orphan drug status from the FDA for its PLX cell therapy in the treatment of Buerger's disease. Aplastic anemia is a rare but serious disorder caused by destruction of blood-forming stem cells (Hematopoietic Stem Cells or HSCs) in the bone marrow. While normally HSCs develop into three types of blood cells, red blood cells, white blood cells and platelets, in aplastic anemia all blood types are deficient, a condition also known as pancytopenia. The disease is considered an emergency situation where patients are supported either with blood transfusions in anticipation of a bone marrow transplant (BMT) or with drugs that suppress the immune system. Aplastic anemia patients are included in the bone marrow transplant market estimated at $1.3 billion per year in … Continue reading →

Novartis International AG / Novartis drug Jakavi first medication to receive European Commission approval to treat patients with myelofibrosis . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement. * Jakavi() (INC424, ruxolitinib) approval based on results from the most extensive myelofibrosis clinical trial program to date * Myelofibrosis is a life-threatening blood cancer associated with progressive, debilitating symptoms that can severely impact quality of life and shorten survival * In Phase III studies, Jakavi reduced spleen size and debilitating manifestations of myelofibrosis by targeting the underlying mechanism of disease Basel, August 28, 2012 - Novartis received approval today from the European Commission for Jakavi() (INC424, ruxolitinib), a JAK 1 and JAK 2 inhibitor for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post- polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. The European Commissions decision was based on positive findings from the COMFORT (COntrolled MyeloFibrosis Study with ORal JAK Inhibitor Therapy) clinical trial program. "The approval of Jakavi by the European Commission brings an urgently needed new treatment option with the potential to make a real difference in patients lives, … Continue reading →