Category Archives: FDA Stem Cell Trials

MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Advanced Cell Technology, Inc.s (ACT; OTCBB: ACTC or the Company), clinical partner, the University of California, Los Angeles (UCLA), has received approval of its Investigator Investigational New Drug (IND) Application with the US Food and Drug Administration (FDA), led by Steven Schwartz, M.D., Ahmanson Professor of Ophthalmology at the David Geffen School of Medicine at UCLA and retina division chief at UCLA's Jules Stein Eye Institute, to initiate a Phase I/II study using ACTs retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs) to treat myopic macular degeneration (MMD, or myopia), commonly known as nearsightedness. The primary focus of the study will be to evaluate the safety in patients with severe myopia of the type that causes fissures in the RPE layer of the eye. Dr. Schwartz is the principal investigator in each of ACTs two Phase I/II clinical trials for Stargardt's macular dystrophy and dry age-related macular degeneration (dry AMD) using RPE cells derived from hESCs. The approval was announced by Dr. Schwartz in his presentation at Bascom Palmer Eye Institutes tenth annual angiogenesis meeting, Angiogenesis, Exudation, and Degeneration 2013, on Saturday, February 9 in Miami, Fla. We are encouraged by Dr. Schwartzs … Continue reading →

NORTH HOLLYWOOD, Calif.--(BUSINESS WIRE)-- The International Myeloma Foundation (IMF) the oldest and largest foundation dedicated to improving the life and care of myeloma patients said POMALYST (pomalidomide) approval by the U.S. Food and Drug Administration will provide an important new option for patients who have exhausted all other treatments. POMALYST is an IMiDs compound, an immunomodulatory agent taken as an oral medication. It attacks the cancer in multiple ways, fighting the cells directly, as well as stimulating the immune system to aid cancer cell destruction. POMALYST is the first new oral cancer therapeutic approved for patients with multiple myeloma since REVLIMID was approved by the FDA in June 2006. The FDA decision follows the recent approval of KYPROLIS, a second-generation proteasome inhibitor for myeloma patients who have relapsed after previous therapies. In clinical trials, POMALYST and KYPROLIS also work together as a powerful new combination regimen. Brian G.M. Durie, M.D., Chairman and Co-founder of the IMF, states, With the novel therapies, many patients can experience long-term remissions. Since their introduction more than ten years ago, the median survival rate has increased from three years to nearly ten years because of these advances produced through medical innovation. However, when current drugs … Continue reading →

LEXINGTON, Mass.--(BUSINESS WIRE)-- Synageva BioPharma Corp. (Synageva) (GEVA), a clinical stage biopharmaceutical company developing therapeutic products for rare disorders, today announced its presentation at the upcoming Leerink Swann Global Healthcare Conference 2013. Mark Goldberg, MD, Senior Vice President, Medical and Regulatory Affairs, is scheduled to present on Wednesday, February 13, 2013, at 9:00 AM EST. The presentation will be webcast live and may be accessed from the Webcasts & Presentations section of the Investor Relations tab on the home page of Synagevas website at http://www.synageva.com. About Synagevas Lead Program Sebelipase alfa (formerly referred to as SBC-102) is a recombinant form of the human LAL enzyme under development by Synageva as an enzyme replacement therapy for LAL Deficiency, a lysosomal storage disorder (LSD). Synageva is currently evaluating sebelipase alfa in global clinical trials for both early and late onset LAL Deficiency. Sebelipase alfa has been granted orphan designations by the U.S. Food and Drug Administration (FDA), the European Medicines Agency, and the Japanese Ministry of Health, Labour and Welfare. Additionally, sebelipase alfa received fast track designation by the FDA. About LAL Deficiency LAL Deficiency is a rare autosomal recessive LSD caused by a marked decrease in LAL enzyme activity. Late onset … Continue reading →

By RTT News, February 05, 2013, 10:59:00 AM EDT (RTTNews.com) - Regen BioPharma, a wholly-owned subsidiary of Bio-Matrix Scientific Group Inc. (BMSN.PK), on Tuesday announced filing of an Investigational New Drug application with the FDA to initiate clinical trials assessing the company's HemaXellerate I stem cell drug in patients with drug-refractory aplastic anemia. HemaXellerate I is a patient-specific composition of cells that have previously been demonstrated to repair damaged bone marrow and stimulate production of blood cells based on previous animal studies. If the clinical trial is successful, the company plans to expand use of HemaXellerate I to other conditions associated with bone marrow dysfunction, with the overall goal of entering the hematopoietic growth factor market, which is substantial in size and currently includes drugs such as Neupogen, Neulasta, Leukine and Revolade. The planned clinical trial anticipates recruiting 10 patients who have failed standard of care, which will be treated with HemaXellerate I and followed for safety parameters and signals of efficacy. Therapeutic effects will be quantified based on immunological measurements, as well as improvement in blood counts. Patients in the trial will be assessed for one year, however, because the trial is unblinded, data will be available as the … Continue reading →

LENEXA, KS--(Marketwire - Feb 4, 2013) - TVAX Biomedical, a clinical stage development company advancing its proprietary T cell-based immunotherapy for the treatment of cancer, today announced that the company will present at the 15th Annual BIO CEO & Investor Conference.The conference will take place February 11-12, 2013 at the Waldorf Astoria Hotel in New York City.Phil Haworth, Ph.D., chief executive officer of TVAX, will present a corporate update on Monday, February 11, 2013 at 1:45 p.m. (Eastern) in the Park South presentation room. Dr. Haworth will also be available for one-on-one meetings with investors during the conference.If you are interested in meeting with Dr. Haworth, please contact Stephanie Diaz of Vida Strategic Partners at 415-675-7401 or sdiaz@vidasp.com. About TVAX Biomedical TVAX Biomedical is a clinical stage development company advancing its targeted T cell-based immunotherapy for the treatment of cancer. The company's proprietary therapeutic approach offers the promise of improved clinical outcomes, low toxicity and the potential for fundamentally changing the way cancer is treated. TVAX Immunotherapy is a unique personalized "killer" T cell treatment. This treatment has demonstrated the potential to effectively treat numerous cancers without many of the undesirable side effects associated with radiation and chemotherapy. A key … Continue reading →

MADISON, Wis., Feb.4, 2013 /PRNewswire/ --Novelos Therapeutics, Inc. (NVLT), a pharmaceutical company developing novel drugs for the treatment and diagnosis of cancer, today announced that Harry S. Palmin, President and CEO of Novelos, will present a corporate update at the 15th Annual BIO CEO & Investor Conference on Monday, February 11, 2013. Mr. Palmin is scheduled to present at 2pm ET in the Duke of Windsor Suite on the 4th floor. The event will be held February 11-12 at The Waldorf Astoria in New York City. A live webcast of the Novelos presentation may be accessed via http://www.novelos.com The webcast will be archived for 90 days following the presentation. The BIO CEO & Investor Conference is the largest investor conference focused on established and emerging publicly traded biotech companies. Information about the conference is available at http://www.bio.org/events/conferences/bio-ceo-investor-conference About Novelos Therapeutics, Inc.We are a pharmaceutical company developing novel drugs for the treatment and diagnosis of cancer. Our cancer-targeted compounds are selectively taken up and retained in cancer cells, including cancer stem cells, versus normal cells. Thus, our therapeutic compounds appear to directly kill cancer cells while minimizing harm to normal cells. This offers the potential for a paradigm shift in cancer … Continue reading →

Seattle Genetics Inc. (SGEN) recently received approval from Health Canada for its oncology drug, Adcetris (brentuximab vedotin). Adcetris has been approved under Health Canada's Notice of Compliance with conditions (NOC/c) for the treatment of patients with Hodgkins lymphoma (HL) after failure of autologous stem cell transplant (:ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not suitable for ASCT. Adcetris was also approved for the treatment of systemic anaplastic large cell lymphoma (sALCL) after failure of at least one multi-agent chemotherapy regimen. For similar indications, Adcetris was approved by the US Food and Drug Administration (:FDA) in Aug 2011 and in the EU in Oct 2012. The NOC/c requires Seattle Genetics to conduct clinical trials to confirm the anticipated clinical benefit of Adcetris. Seattle Genetics is currently enrolling patients for two confirmatory phase III studies evaluating the drug for the front-line treatment of HL and mature T-cell lymphoma (:MTCL), including sALCL. Meanwhile, in Jan 2013, a global phase III study (ECHELON-2) was initiated on Adcetris. In this study, Adcetris plus chemotherapy will be evaluated for the front-line treatment of CD30-positive MTCL including patients with sALCL and other types of peripheral T-cell lymphomas. Our … Continue reading →

Director of Laboratory Operations & Research Explains Future Benefits... The Building Blocks of Regenerative Medicine Miami, Florida (PRWEB) January 31, 2013 "Adult stem cells can be found and isolated from several different adult tissue types including but not limited to: bone marrow, umbilical cord blood, dental pulp tissue, adipose (fat) tissue, menstrual blood, synovial fluid etc. The stem cells isolated from these adult tissues have the ability to differentiate (mature into) numerous other cell types giving them the potential to treat a variety of different disease states", said Dr. Todd Flower, Director of Laboratory Operations and Research to GeneCell International and former professor at Bentley University in Boston. Stem cells from bone marrow and umbilical cord blood have been used extensively in the clinical arena for more than 20 years to treat a variety of diseases, in fact today approximately 80 different diseases can be treated with umbilical cord blood, i.e. cancers, blood disorders like anemia, metabolic disorders etc. The clinical applications of umbilical cord blood has been growing by leaps and bounds considering 20 years ago it was thought that cord blood can be used to treat only a handful of different diseases. The other sources of these cells … Continue reading →

ALAMEDA, Calif.--(BUSINESS WIRE)-- BioTime, Inc. (NYSE MKT: BTX) and BioTimes subsidiary OncoCyte Corporation provided an update on the progress of development of PanC-DxTM, a novel blood-based diagnostic test utilizing molecular markers discovered at BioTime and OncoCyte designed to detect the presence of various human cancers, including cancers of the breast, lung, bladder, uterus, stomach, and colon. By facilitating early, non-invasive cancer detection, PanC-DxTM could lead to more successful therapeutic outcomes through earlier diagnosis and treatment. This diagnostic test could also reduce the cost of cancer monitoring and increase the availability of affordable cancer screening worldwide. OncoCyte first announced the development of PanC-DxTM during December 2011 and last provided a progress update in March 2012. In addition to this update, OncoCyte intends to release additional information regarding the progress of PanC-DxTM development throughout 2013. OncoCytes plans for 2013 include the initiation of a clinical study focused on breast cancer screening at a group of leading cancer research institutions. OncoCyte has been developing, characterizing, and manufacturing monoclonal antibodies in preparation for the initiation of the clinical study and is currently working with a select group of cancer researchers to design the trial and select the study sites. If its laboratory findings are … Continue reading →

MADISON, Wis., Jan. 31, 2013 /PRNewswire/ -- Novelos Therapeutics, Inc. (NVLT), a pharmaceutical company developing novel drugs for the treatment and diagnosis of cancer, today announced that an oral presentation on research conducted by Novelos and its collaborators is being made by Dr. Christopher Pazoles at the EMIT: Targeted Radiotherapy international conference taking place January 29 to 31, in Washington, D.C. This presentation by invitation from EMIT describes the mechanistic foundation for Novelos' diapeutic (diagnostic + therapeutic) technology platform together withanimal data and initial findings in advanced cancer patients that demonstrate selective and prolonged accumulation of Novelos' PET imaging I-124-CLR1404 (LIGHT), therapeutic I-131-CLR1404 (HOT) and optical imaging CLR1502 (GLOW2) compounds in a range of tumor types. Dr. Pazoles is the Senior Vice President of Research and Development for Novelos. "LIGHT, HOT and GLOW2 were designed to exploit a feature shared by most, if not all, cancer cells including cancer stem cells, which results in the selective uptake and prolonged accumulation of our proprietary, small-molecule delivery vehicle in a wide range of malignant tumors compared with normal tissues," said Dr. Pazoles. "By incorporating a unique functional property in each PET imaging, radiotherapy or optical imaging we have generated an array of … Continue reading →