Category Archives: FDA Stem Cell Trials

MOUNTAIN VIEW, Calif., March 6, 2013 /PRNewswire/ --Based on its recent analysis of the regenerative therapies market, Frost & Sullivan recognizes Cytomedix, Inc. with the 2012 North American Frost & Sullivan New Product Innovation Award for its Angel concentrated platelet-rich plasma (cPRP) system that takes significant strides forward for the emerging tissue regeneration applications market. This highly efficient and innovative platelet concentration system is capable of having a far-reaching effect on a large number of orthopedic procedures. The idea behind applying platelet-rich plasma to wounds is to use the patient's own natural healing process to re-establish equilibrium in the wound environment and alter a non-healing wound or injury to one that heals naturally. However, the development of commercially viable solutions has proven to be a challenge until now. Mounting supportive clinical evidence has Cytomedix poised to deliver on the growing market need. The Angel cPRP system recently received FDA 510K clearance to process bone marrow aspirate to produce platelet concentrates. This is the second indication it has received clearance for; the first was for whole blood processing. Most PRP systems are open systems, making them susceptible to contamination. The Angel cPRP system is a closed system, and its disposable processing … Continue reading →

NEW YORK, March 4, 2013 Reportlinker.com announces that a new market research report is available in its catalogue: Epigenetic Therapies and Technologies: World Market Prospects 2013-2023 http://www.reportlinker.com/p0692157/Epigenetic-Therapies-and-Technologies-World-Market-Prospects-2013-2023.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Therapy Report Details How to find trends and revenue predictions for epigenetics That analysis lets you assess forecasted sales at overall world market, submarket, product, regional and national level. You discover the potential of the industry and market for epigenetics, seeing where that field is heading. Forecasts and other analyses to help you find the best opportunities In our study you find revenue forecasting to 2023, historical data, growth rates and market shares. Also, you see qualitative analysis (SWOT and STEP), business news, outlooks and developmental trends (R&D). You gain 70 tables, 47 charts and two research interviews. Our work lets you investigate the most lucrative areas in that industry and market. Those technologies hold great promise. The following sections show what you see in our updated report. View post: Epigenetic Therapies and Technologies: World Market Prospects 2013-2023 … Continue reading →

SEATTLE, Feb. 28, 2013 /PRNewswire/ -- Cell Therapeutics, Inc.(CTI) (NASDAQ and MTA: CTIC) today reported financial results for the fourth quarter and full year ended December 31, 2012. "During the fourth quarter 2012, we began making PIXUVRI available to healthcare providers in the European Union and initiated commercial operations on a country-by-country basis," said James Bianco, M.D., President and CEO of CTI. "PIXUVRI is now available in eight countries in the E.U., and we are engaged in activities to increase awareness in the physician community of PIXUVRI's benefits for patients with multiply relapsed or refractory aggressive non-Hodgkin lymphoma. Separately, we have recently begun enrollment in the Phase 3 PERSIST-1 clinical trial of pacritinib for the treatment of patients with myelofibrosis. We believe that pacritinib, an oral, once-daily JAK2/FLT3 inhibitor, may offer patients an effective therapy with a safety profile that could allow for longer-term management of their disease. For 2013, we are focused on increasing use and adoption of PIXUVRI, while obtaining favorable reimbursement in major markets in the E.U.; building value through development of our late-stage product pipeline, with emphasis on pacritinib; and securing non-equity based operating capital through strategic partnerships, while managing our expenses." 2012 and Recent Key … Continue reading →

SILVER SPRING, MD--(Marketwire - Feb 22, 2013) - Nuvilex Inc., ( OTCQB : NVLX ) an international biotechnology provider of live, therapeutically valuable, encapsulated cells and services for research and medicine is pleased to announce that its Chief Operating Officer, Dr. Gerald Crabtree sat for an interview with Stock House Group, a research and content development investor relations firm. The interview can be heard at http://www.stockhousegroup.com/media. As part of Stock House Group's CEO interview series, Dr. Crabtree described Nuvilex's unique living cell encapsulation technology and the advantages that the technology has over other methods of cell encapsulation. He also described the technology as a "platform" upon which treatments for many serious diseases, including cancer, diabetes, and those that may be treatable using stem cells, may be built. Dr. Crabtree covered such topics as the Company's completed mid-phase clinical trials for the treatment of advanced, inoperable, pancreatic cancer. In these trials, Nuvilex's living cell encapsulation technology was used together with the well-known anticancer drug, ifosfamide. Results showed that the median survival time and one-year survival rate were almost double that seen in historical data for Gemzar, the only drug approved by the FDA as a single agent for the treatment of … Continue reading →

HAIFA, Israel, Feb. 21, 2013 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, announced today that the U.S. Food and Drug Administration (FDA) has designated Pluristem's PLacental eXpanded (PLX) cells orphan drug status for the treatment of aplastic anemia. Orphan drug designation qualifies a company for several benefits under the Orphan Drug Act of 1983 (ODA), as amended. These benefits include a 7-year period of orphan drug exclusivity upon product approval, a tax credit for certain clinical testing expenses for the orphan drug, written guidance on the non-clinical and clinical studies needed to obtain marketing approval of an orphan drug, and orphan drug grants. This is Pluristem's second orphan drug designation from the FDA. The company also received orphan drug status from the FDA for its PLX cells for the treatment of Buerger's disease in August of 2011. Aplastic anemia is a rare but serious disorder with a prevalence of less than 200,000 in the U.S. The disease is caused by the failure of hematopoietic stem cells (HSCs) contained within the bone marrow to produce red blood cells, white blood cells and platelets. The disease is considered an emergency and patients are supported … Continue reading →

Four months after the Food and Drug Administration shot down United Therapeutics application to market a tablet version of its drug for pulmonary arterial hypertension, the Silver Spring company has reapplied to the regulatory agency. United Therapeutics, which already sells intravenous, subcutaneous and inhaled versions of its major money-maker, has been working for years to gain regulatory approval for an oral version. United Therapeutics stock rose 5.5 percent Thursday morning on the news; it had tumbled 15.3 percent following the FDAs rejection in October. At the time, the FDA said it had concerns that the drug, called oral trepostinil, didnt show enough improvement in patients who took it in clinical trials, as measured by how far they could walk in six minutes. The agency suggested that another phase 3 trial should possibly involve fixed and more frequent dosing, such as three times a day versus twice daily, COO Roger Jeffs said in a conference call then. Some of the agencys concerns came as a surprise, Jeffs said, as they hadnt been raised in regulators discussions with the company. Since then, company officials have met with regulators to gain a better understanding of their concerns, and the resubmitted application addresses those … Continue reading →

Second Sight Medical Products / AP This undated product image provided by Second Sight Medical Products shows a new implantable device that takes the place of damaged cells inside the eye. It wont restore sight completely, but allows sight-impaired individuals to detect light and dark. On Thursday, the U.S. Food and Drug Administration (FDA) approved a device created by Second Sight Medical Products that can be used to treat a rare type of blindness calledretinitis pigmentosa (RP). Retinitis pigmentosa isa genetic eye condition in which cells of the retina, which are responsible for translating light rays into images in the brain, gradually deteriorate. People with the condition start to lose peripheral vision first, then find it harder to see at night until eventually their central vision is lost as well. According to the national statistics, about one in 4000 people in the U.S. are affected by RP. (MAGAZINE: The High-Tech Future of the Human Body) The artificial retina, called the Argus II Retinal Prosthesis System, is the first implantable device to treat the condition and is approved for people over age 25 with advanced RP who can see some light. The device consists of a panel of electrodes that are … Continue reading →

LEXINGTON, Mass.--(BUSINESS WIRE)-- Synageva BioPharma Corp. (Synageva) (GEVA), a clinical stage biopharmaceutical company developing therapeutic products for rare diseases, today announced that the first patient initiated treatment in the ARISE trial (Acid Lipase Replacement Investigating Safety and Efficacy), a global, Phase 3, randomized, double-blind, placebo-controlled study of sebelipase alfa in children and adults with late onset lysosomal acid lipase deficiency (LAL Deficiency). The buildup of abnormal fats in LAL Deficiency can cause progressive and severe liver damage including cirrhosis in children and adults, as well as accelerated atherosclerosis, said Anthony Quinn, MBChB, PhD, FRCP, Senior Vice President and Chief Medical Officer at Synageva. By replacing the deficient enzyme that causes the accumulation of these abnormal fats, sebelipase alfa addresses the root cause of LAL Deficiency. Based on data from the previously conducted preclinical and clinical studies with sebelipase alfa, the Phase 3 ARISE trial was designed to assess the effects of sebelipase alfa on a broad range of abnormalities associated with LAL Deficiency. About ARISE: A global Phase 3 trial of sebelipase alfa in children and adults with late onset LAL Deficiency The ARISE trial will enroll 50 patients (children and adults) with late onset LAL Deficiency. Patients enrolled in … Continue reading →

NEEDHAM, Mass., Feb. 11, 2013 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (CLDX) today announced that Michael Yellin, MD, Vice President of Clinical Science, will present final results from a Phase 1 trial of CDX-301 (rhuFlt3L) in healthy volunteers in an oral presentation at the American Society for Blood and Marrow Transplantation 2013 BMT Tandem Meetings. The presentation will be held on Wednesday, February 13, 2013 at 4:45 pm MST (6:45 pm EST) at the Salt Palace Convention Center in Salt Lake City, Utah. The Company will issue a press release outlining the results of the presentation before market open on Thursday, February 14, 2013. The Company previously announced that it plans to initiate a pilot study in hematopoietic stem cell transplant by year end 2013. CDX-301 or Flt3L is a potent cytokine that stimulates the expansion and differentiation of hematopoietic progenitor and stem cells. Flt3L has demonstrated a unique capacity to increase the number of circulating dendritic cells in both laboratory and clinical studies. In addition, Flt3L has shown impressive results in models of cancer, infectious diseases and inflammatory/autoimmune diseases. Celldex believes this ligand may hold significant opportunity for synergistic development in combination with other molecules. About Celldex Therapeutics, Inc. … Continue reading →

NEW YORK, Feb. 11, 2013 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue: Plunkett's Biotech & Genetics Industry Trends & Statistics 2013: A Summary Version of Plunkett's Biotech & Genetics Industry Almanac 2013 http://www.reportlinker.com/p01054189/Plunketts-Biotech--Genetics-Industry-Trends--Statistics-2013-A-Summary-Version-of-Plunketts-Biotech--Genetics-Industry-Almanac-2013.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Genomics Key Features: -Industry trends analysis, market data and competitive intelligence-Market forecasts and Industry Statistics-Buyer may register for access to search and export data at Plunkett Research Online Pages: 77 Statistical Tables Provided: 18 Geographic Focus: Global A condensed market research report excerpted from Plunkett's Biotech & Genetics Industry Almanac 2013, including forecasts and market estimates, technologies analysis and vital statistical tables. You will gain significant insights that can help you shape your own strategy for business development, product development and investments. -How is the industry evolving? -How is the industry being shaped by new technologies? -How is demand growing in emerging markets and mature economies?-What is the size of the market now and in the future? Contents, Statistics, Forecasts and Analysis Include: Follow this link: Plunkett's Biotech & Genetics Industry Trends & Statistics 2013: A Summary Version of Plunkett's Biotech & Genetics ... … Continue reading →