Category Archives: FDA Stem Cell Trials

JUPITER, Fla., June 21, 2012 /PRNewswire/ --BioRestorative Therapies, Inc. ("BRT" or the "Company") (BRTX), a life sciences company focused on cellular therapies for various personal medical applications, announced today that it has entered into a Research Agreement with the University of Utah ("University"). Pursuant to the agreement, the University is to provide research services relating to the identification of brown fat tissue and the development and characterization of brown fat cell lines. Pursuant to the terms of the Research Agreement, all inventions, discoveries, patent rights, information, data, methods and techniques, including all cell lines, cell culture media and derivatives thereof, shall be owned by BRT. The research and development that will be performed at the University, under the supervision of Dr. Amit Patel, will be used for the eventual filing of an IND with the FDA for a Phase 1 clinical trial. The agreement was entered into in connection with the Company's ThermoStem Program, which focuses on treatments for metabolic disorders, such as diabetes and heart disease, and obesity. The ThermoStem Program employs the use of brown fat, which initial research indicates has a role in maintaining metabolism and provides the potential for a cell based therapeutic for the treatment … Continue reading →

QUBEC CITY, June 21, 2012 /CNW Telbec/ - Aeterna Zentaris Inc. (AEZS) (TSX:AEZ) (the"Company") today announced that Phase 1 trial results for its oral PI3K/Akt inhibitor, perifosine, showed the drug's activity against chemo-resistant and radio-resistant neuroblastoma, while allowing good quality of life and sparing vital organs. Neuroblastoma is a type of childhood cancer which usually begins in nerve tissues. Data were presented yesterday by Brian H. Kushner, MD, of the Memorial Sloan-Kettering Cancer Center in New York, during a poster session at the Advances in Neuroblastoma Research Conference which is being held in Toronto , Canada . The Study This was an open-label dose-escalating Phase 1 trial to assess toxicity and efficacy of perifosine, given in monotherapy to patients with neuroblastoma (clinicaltrials.gov NCT00776867). Patients were dosed using 50mg tablets and received a loading dose (100-200mg/m2) of perifosine on day1, followed by daily maintenance doses (50-75mg/m2) until progressive disease or dose-limiting toxicity. Disease evaluation was every 8 weeks. The poster reported on the outcome of 24 patients treated to date; patients had a median age of8.7 years (range 4.7 to 33.5) and a median disease duration of 4.6 years (range 2.5 to 8.0). Three patients were treated for neuroblastoma refractory to … Continue reading →

More Topics: Choose a Sector Accounting Firms Advertising/Media/Communications Capital CEO/Board General Business Health/Biotech Internet/Technology Investment Firms Law Firms Mergers & Acquisitions Money Managers People Private Companies Public Companies Venture Capital Posted June 21, 2012 Application for new indication for REVLIMID (lenalidomide) in newly-diagnosed and maintenance multiple myeloma has been withdrawn from CHMP; Plans to re-submit with more mature data Pomalidomide NDA for patients with relapsed and refractory multiple myeloma accepted for standard review by U.S. FDA, PDUFA date set for Feb. 10, 2013; MAA for patients with relapsed and refractory multiple myeloma submitted to the EMA 2012 guidance and 2015 financial targets reaffirmed Conference call to be held at 8:30 a.m. EDT, available by webcast BOUDRY, Switzerland--(BUSINESS WIRE)--Celgene International Srl, a subsidiary of Celgene Corporation (NASDAQ: CELG), is providing a regulatory update for REVLIMID (lenalidomide) and pomalidomide as treatments for multiple myeloma. We have decided to withdraw the new indication submission to the Committee for Medicinal Products for Human Use (CHMP) for REVLIMID (lenalidomide), which was intended for the maintenance treatment of newly diagnosed multiple myeloma patients who have not progressed following initial treatment with melphalan, prednisone and REVLIMID (lenalidomide), or maintenance therapy following autologous stem cell transplantation. In response … Continue reading →

FRANKLIN, Tenn.--(BUSINESS WIRE)-- Numerous presentations were made today during the Regenerative Strategies Forum at the 2012 American Orthopaedic Foot and Ankle Society (AOFAS) annual meeting in San Diego, CA which supported the safety, effectiveness, clinical need, biologic rationale and cost effectiveness of Augment Bone Graft from BioMimetic Therapeutics, Inc. (BMTI). Regenerative Strategies and Emerging Technologies Pre-meeting Presentations The forum included lectures by numerous leading foot and ankle surgeons covering regenerative strategies related to foot and ankle surgery. The following presentations highlighted the clinical and pharmaco-economic need and biologic rationale for Augment Bone Graft as an alternative to autograft. AOFAS Annual Meeting Presentations and Poster In addition to the above presentations given today at the regenerative forum, the following presentations related to the clinical need for Augment or Augment Injectable Bone Graft will be presented later during the AOFAS annual meeting. Exhibit Booth In addition to these surgeon presentations at the AOFAS annual meeting, BioMimetic will host a commercial exhibit booth #401 in the Sapphire Ballroom at the Hilton Bayfront Hotel from June 21 23. About BioMimetic Therapeutics BioMimetic Therapeutics (BMTI) is a biotechnology company specializing in the development and commercialization of clinically proven products to promote the healing of musculoskeletal … Continue reading →

SAN BRUNO, Calif., June 20, 2012 /PRNewswire/ -- Twenty years ago this month, CBR (Cord Blood Registry) in partnership with the University of Arizona, processed the first cord blood stem cell sample in the world to be stored specifically for family use. Since 1992, the number of conditions treated with cord blood stem cells has greatly expanded, and so has CBR. Today, CBR is the largest family cord blood bank in the world with more than 425,000 samples in storage a population the size of a major city like Miami. What distinguishes the "city of individuals" with newborn stem cells banked at CBR is the exclusive opportunity to participate in a growing number of ground-breaking clinical trials. (Photo: http://photos.prnewswire.com/prnh/20120620/SF27549-INFO) (Logo: http://photos.prnewswire.com/prnh/20120216/AQ54476LOGO) "As the leader and innovator in family banking, we believe every newborn deserves a healthy future and that we have a responsibility to lead the way," said Heather Brown, vice president of scientific & medical affairs at CBR. "Looking back, the creation of our bank allowed families for the first time to preserve a genetically-related source of newborn stem cells, ready and available if needed for a lifesaving transplant to regenerate a person's immune system after radiation or chemotherapy. … Continue reading →

MADISON, Wis., June 19, 2012 /PRNewswire/ -- Novelos Therapeutics, Inc. (NVLT), a pharmaceutical company developing novel drugs for the treatment and diagnosis of cancer, today announced that the University of Wisconsin Carbone Cancer Center (UWCCC), a leading oncology research institution, has successfully dosed three patients in a Phase 1-2 positron emission tomography (PET) imaging trial of I-124-CLR1404 (LIGHT), a cancer-targeted PET imaging agent, in patients with primary or metastatic brain cancer. The three glioma patients were dosed with LIGHT at 5 mCi. Details of the trial design are available at http://www.clinicaltrials.gov ID: NCT01540513, or at http://www.novelos.com in the 'Clinical Trials' section. Lance Hall, M.D., is the trial's principal investigator. This trial is being funded by the UWCCC and the Institute for Clinical and Translational Research (ICTR). Detailed trial results are expected to be presented at a scientific venue at a later date. "Despite recent advances in diagnostic and therapeutic techniques, prognosis of patients with many brain tumors, and particularly malignant gliomas, remains dismal. This reflects in part the diagnostic uncertainty in identifying infiltrative tumor growth of malignant gliomas which in turn affects subsequent treatment strategies," said Dr. Hall. "The preliminary results from these three glioma patients are very encouraging. We … Continue reading →

HENDERSON, Nev.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals, Inc. (SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology and hematology, today announced new clinical data presented in an oral presentation for ZEVALIN (ibritumomab tiuxetan) Injection for intravenous use at the 17th Congress of the European Hematology Association (EHA). In one of only four abstracts accepted for oral presentation in the meetings clinical transplantation session (Abstract # 1118), Dr. Avichai Shimoni (Chaim Sheba Medical Center, Tel Hashomer, Israel) presented an update with longer follow-up time from a multi-center, prospective randomized study, for which he reported that ZEVALIN administered in combination with BCNU, etoposide, cytarabine (Ara-C), melphalan (BEAM) therapy Z-BEAM resulted in a 91% two-year overall survival (OS) rate in patients with refractory/relapsed aggressive lymphoma, versus a 62% OS rate in patients administered BEAM alone (p=0.03). Based on these findings, which were updated from results published January 2012 in the journal "CANCER", the Journal of the American Cancer Society, Spectrum's development program for ZEVALIN has been expanded to include support for a larger, randomized international study using the Z-BEAM regimen as a preparative regimen for patients with lymphoma who receive autologous stem cell transplantation (ASCT). This … Continue reading →

By Mike Volkin - June 15, 2012 | Tickers: AOL, MSFT, RAI, CIGX, TEVA | 0 Comments Mike is a member of The Motley Fool Blog Network -- entries represent the personal opinions of our bloggers and are not formally edited. 3 Biotech Stocks That Could Change The World By George S. Mack, The Life Sciences Report For more interviews with sector experts and analysts, please sign up for our newsletter at http://www.thelifesciencesreport.com. Every investor is in search of a breakthrough that will change the world. Patrick Cox has seen it all before as an insider at Netscape Communications before it was acquired by AOL Inc. (NYSE: AOL) at the end of 1998 and before Microsoft Corp. (NASDAQ: MSFT) ever noticed that that the world was shifting under its feet. The browser revolution began with the straightforward idea that all computer operating systems could be networked with seamless cross-platform ease. I recently interviewed Cox, now editor of Breakthrough Technology Alert and Technology Profits Confidential, for the story Biotech Ideas That Will Change the World in The Life Sciences Report. He sees a new revolution in progress as stem cell technologies and targeted therapies begin to change the entire paradigm of … Continue reading →

Diabetes currently afflicts approximately 285 million people worldwide, about 6.4 percent of the global population. The World Health Organization projects that this number is set to rise to 366 million by the year 2030. According to the American Diabetes Association, 1.9 million new cases of diabetes are diagnosed in people aged 20 years and older in 2010, an estimated 7.0 million Americans have undiagnosed diabetes, and another 79 million have pre-diabetes. In addition, approximately 25.8 million children and adults in the United States-8.3% of the population-have diabetes. Several kinds of treatment for diabetes are currently available, but all of them present specific drawbacks to the patient. For example, insulin therapy can trigger everything from weight gain to hypoglycemia, and its administration must be constantly controlled and monitored by the patient. A novel approach to this problem is currently being pursued by a small biotech company named Orgenesis, which initiated its approach by asking the following question: What if a diabetes patient`s own cells-extracted from his or her own mature tissue-could be made to produce insulin, secreting the compound automatically when needed? This particular variety of cell therapy is a form of what has been dubbed "autologous cell replacement." For years, … Continue reading →

13-06-2012 04:51 Date: 05-19-12 Host: John B. Wells Guests: Jonathan Emord, Douglas Dietrich Attorney Jonathan Emord discussed the corrupt relationship between the FDA and 'Big Pharma'. "Without question the FDA's system for drug approval is broken and results in horrific consequences both when it approves drugs and when it denies terminally-ill patients access to drugs," he stated. The FDA plays favorites with large pharmaceutical companies, Emord continued, citing the example of a Sanofi-Aventis drug called Ketek that was approved even after it had been revealed the primary clinical trials were entirely made up. Perhaps even worse than approving potentially unsafe drugs, the FDA often denies patients access to promising experimental treatments. A drug called Gleevec was found effective in treating Chronic Myelogenous Leukemia yet the FDA denied, and essentially condemned to death, thousands of patients, Emord said. Eighty percent of the few subjects allowed to receive the treatment are still alive, he added. Emord encouraged listeners who have been denied access to treatment by the FDA to email him their stories at jemord@emord.com. Emord commented on recent developments around the National Defense Authorization Act (NDAA) and similar draconian legislation. Section 1021 of the NDAA allows the armed forces to arrest … Continue reading →