Category Archives: FDA Stem Cell Trials

A company with the first FDA-approved personalized cell therapy for reducing wrinkles has raised $45 million in a private stock sale. The financing was sought to improve manufacturing capacity for the therapy and advance other uses for it such as treating burn victims, according to a company statement. Fibrocell Sciences aesthetic therapeutic, Laviv, secured got the green light from the U.S. Food and Drug Administration last year. Laviv uses individuals fibroblast cells to reduce nasolabial fold wrinkles, creases on the face that start from the outer corners of the nose and go down to the corners of the mouth. It also has an acne therapy in phase 3 clinical trials and a burn scar therapy in phase 2 trials. The Exton, Pennsylvania biopharmaceutical companys personalized cell development platform technology isolates, purifies and multiplies a patients fibroblast cells, connective skin cells that make collagen. Additionally, Fibrocell agreed to a strategic collaboration with biotechnology firm Intrexon which can provide genome engineering, cell processing, and cell system engineering, among other services, to help advance Fibrocells personalized cell therapy program. As part of the financing deal, Third Security LLC will get two seats on Fibrocells board. Personalized stem cell development fits into the broader … Continue reading →

REDWOOD CITY, Calif.--(BUSINESS WIRE)-- OncoMed Pharmaceuticals, Inc., a clinical stage, research and discovery company developing novel therapeutics that target cancer stem cells, today announced clinical progress with two of its Notch pathway product candidates, resulting in $8 million in milestone payments from the companys strategic collaborator GlaxoSmithKline (GSK). Anti-Notch2/3 (OMP-59R5) OncoMed has initiated a Phase 1b/2 clinical trial in its anti-Notch2/3 antibody (OMP-59R5) program. In the Phase 1b/2 ALPINE trial (Antibody therapy in first-Line Pancreatic cancer Investigating anti-Notch Efficacy and safety), Anti-Notch2/3 is being tested in combination with gemcitabine in first-line advanced pancreatic cancer patients. Following a Phase 1b safety run-in, a randomized Phase 2 clinical trial will proceed in these patients to compare the efficacy of standard-of-care gemcitabine either with Anti-Notch2/3 or with placebo. The two primary endpoints of the Phase 2 part of the trial will be progression-free survival (PFS) in the Anti-Notch2/3 arm compared to a placebo arm in all patients, as well as in patients who have a particular biomarker. Key secondary and exploratory endpoints include overall survival, response rate, and safety, and these endpoints will be assessed in all patients, as well as in the biomarker positive subset of patients. Dr. Lon Smith, from the … Continue reading →

MADISON, Wis., Oct. 3, 2012 /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 Jamey Weichert, Ph.D., Lance Hall, M.D., Anne M. Traynor, M.D., Glenn Liu, M.D. and their colleagues is being made by Dr. Weichert at the Imaging in 2020 Conference taking place September 30 to October 4, 2012 in Jackson Hole, Wyoming. This presentation describes the mechanistic foundation for Novelos' diapeutic (diagnostic + therapeutic) technology platform together with animal data and initial findings in advanced cancer patients that demonstrate selective and prolonged uptake 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. Weichert is Associate Professor of Radiology, Dr. Hall is Assistant Professor of Radiology, Dr. Traynor is Associate Professor of Medicine and Dr. Liu is Associate Professor of Medicine, 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. "LIGHT, HOT and GLOW2 were … Continue reading →

NEW YORK, Oct. 1, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue: Translational Regenerative Medicine: Market Prospects 2012-2022 http://www.reportlinker.com/p0595030/Translational-Regenerative-Medicine-Market-Prospects-2012-2022.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Blood_Supply,_Tissue_Banking_and_Transplantation Report Details New study shows you commercial potential of regenerative treatments See what the future holds for translational regenerative medicine. Visiongain's updated report lets you assess forecasted sales at overall world market, submarket, product and regional level to 2022. There you investigate the most lucrative areas in that research field, industry and market. Discover prospects for tissue-engineered products, stem cell treatments and gene therapy. We pack our study with information and analysis to help your work and save you time: Access to present and predicted trends, with commercial opportunities and prospects revealed Data and discussions - including our revenue forecasts to 2022 - for your research, analyses and decision making Read this article: Translational Regenerative Medicine: Market Prospects 2012-2022 … Continue reading →

SAN DIEGO--(BUSINESS WIRE)-- Medistem Inc (Pink Sheets:MEDS) announced today the initiation of a collaboration with Superview Biotechnology Co. Ltd, a subsidiary of Yinhuan Holding Co from Yixing, China. The joint work will be aimed at using proprietary stem cell lines developed by Medistem for screening of monoclonal antibodies for therapeutic activity in the area of regenerative medicine. As part of the collaboration, the two companies will evaluate various candidates jointly, as well as apply for grants and share research data. To date, the majority of stem cell companies are focusing on the stem cell itself being a product. By collaborating with Superview Biotechnology, we aim to assess the feasibility of developing antibodies that can modulate the activity of stem cells that already exist in the body, said Thomas Ichim, CEO of Medistem. This approach not only provides methods of activating stem cells but also allows for the development of stem cell adjuvant therapies that could be used to resurrect stem cell candidates that failed in clinical trials. Superview Biotechnology has developed proprietary methods of rapidly generating monoclonal antibodies to esoteric protein targets. Medistem has a history of success in the area of stem cells, being the only company to take … Continue reading →

CAMBRIDGE, Mass. & BOTHELL, Wash.--(BUSINESS WIRE)-- Seattle Genetics, Inc. (SGEN) and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502), today announced the completion of patient enrollment in a phase III clinical trial of ADCETRIS (brentuximab vedotin) for post-transplant Hodgkin lymphoma (HL) patients. The phase III trial, also known as the AETHERA trial, is evaluating ADCETRIS versus placebo for the treatment of patients at high risk of residual Hodgkin lymphoma following autologous stem cell transplant (ASCT). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL. We are pleased to complete the enrollment of this important phase III trial, evaluating the use of ADCETRIS for Hodgkin lymphoma patients who are at high risk of residual disease following an ASCT, said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer of Seattle Genetics. The AETHERA trial is designed to provide the medical community with valuable insight into the potential for ADCETRIS to consolidate responses in Hodgkin lymphoma patients following a transplant, and will be the first data on the use of ADCETRIS in a maintenance-type setting. We anticipate data from this trial will be available in late 2013 or early 2014. … Continue reading →

RESEARCH TRIANGLE PARK, N.C., Sept. 21, 2012 /PRNewswire/ -- Chimerix, Inc., a biotechnology company developing orally-available antiviral therapeutics, today announced data highlighting the significant morbidity and resource utilization associated with the current standard of care for the management of cytomegalovirus (CMV) infection in hematopoietic stem cell transplant (HSCT) recipients. This analysis, entitled "Preemptive Therapy (PrT) for Cytomegalovirus (CMV) Post-hematopoietic Cell Transplantation (HCT) is Associated with Significant Morbidity and Resource Utilization," was presented at the 52nd Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC, September 9-12, San Francisco). Morbidity and Resource Utilization Associated with Preemptive Therapy Preemptive therapy is the initiation of antiviral therapy in the presence of viral infection. Chimerix's presentation highlighted adverse effects (AEs) experienced by patients who received preemptive therapy and were treated with currently available antiviral agents, including valganciclovir, ganciclovir, foscarnet and cidofovir. A retrospective analysis of data from 71 patients who received preemptive treatment of CMV infection showed that the majority experienced at least one significant AE. These AEs included: Of these patients, 18% had life-threatening AEs, including bacterial infections, cytopenias, and hemorrhages, and 23% had an AE that required hospitalization. While the currently available antiviral agents are associated with significant adverse events, including cytopenias, … Continue reading →

67 WALL STREET, New York - September 20, 2012 - The Wall Street Transcript has just published its Biotechnology and Pharmaceuticals Report offering a timely review of the sector to serious investors and industry executives. This special feature contains expert industry commentary through in-depth interviews with public company CEOs, Equity Analysts and Money Managers. The full issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online. Topics covered: Biotechnology and Pharmaceutical Valuations - Oncology Drug Development - Orphan Drugs - FDA Approval Process - Reimbursement Trends Companies include: Hadasit Bio-Holdings Ltd. (HADSY) and many others. In the following excerpt from the Biotechnology and Pharmaceuticals Report, the CEO of Hadasit Bio-Holdings discusses the outlook for his company for investors: TWST: Please tell us about Hadasit Bio-Holdings. Mr. Shahaf: Hadasit Bio-Holdings is a subsidiary of the Hadassah Hospital, which is one of the leading medical and scientific research institutes in Israel. It also operates two large hospitals in the city of Jerusalem and employs around 1,200 physicians and researchers. Some of them are very creative, very entrepreneurial, and we were set up with the mandate to commercialize the I.P. coming out of this extremely bright group of physicians. … Continue reading →

67 WALL STREET, New York - September 20, 2012 - The Wall Street Transcript has just published its Biotechnology and Pharmaceuticals Report offering a timely review of the sector to serious investors and industry executives. This special feature contains expert industry commentary through in-depth interviews with public company CEOs, Equity Analysts and Money Managers. The full issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online. Topics covered: Biotechnology and Pharmaceutical Valuations - Oncology Drug Development - Orphan Drugs - FDA Approval Process - Reimbursement Trends Companies include: Hadasit Bio-Holdings Ltd. (HADSY) and many others. In the following excerpt from the Biotechnology and Pharmaceuticals Report, the CEO of Hadasit Bio-Holdings discusses the outlook for his company for investors: TWST: Please tell us about Hadasit Bio-Holdings. Mr. Shahaf: Hadasit Bio-Holdings is a subsidiary of the Hadassah Hospital, which is one of the leading medical and scientific research institutes in Israel. It also operates two large hospitals in the city of Jerusalem and employs around 1,200 physicians and researchers. Some of them are very creative, very entrepreneurial, and we were set up with the mandate to commercialize the I.P. coming out of this extremely bright group of physicians. … Continue reading →

GAITHERSBURG, MD--(Marketwire - Sep 19, 2012) - Cytomedix, Inc. ( OTCQX : CMXI ), a fully integrated regenerative medicine company commercializing and developing innovative platelet and adult stem cell technologies, today announced that Martin P. Rosendale, Chief Executive Officer of Cytomedix, will present a corporate update at BIOX; Noble Financial Capital Markets' Life Sciences Exposition to be held at the University of Connecticut, Stamford Campus on September, 24-25, 2012.Mr. Rosendale's presentation will take place on Monday, September 24th at 8:00 a.m. Eastern time. In addition to the corporate presentation, Mr. Rosendale will be a participant on the panel presentation titled "Advancements in Cell Therapy & Regenerative Medicine," on September 24th at 11:45 a.m. Following the event, a high-definition video webcast of the Company's presentation and a copy of the presentation materials will be available on the Company's web site at http://www.cytomedix.com, or through the Noble Financial websites: http://www.noblefcm.com, or http://www.nobleresearch.com/BioExposition.htm. Microsoft SilverLight viewer (a free download from the presentation link) is required to participate. The webcast will be archived on Cytomedix's website for 90 days following the event. About Noble Financial Noble Financial Capital Markets was established in 1984 and is an equity research driven, full-service, investment banking boutique focused … Continue reading →