Category Archives: FDA Stem Cell Trials

SUMMIT, N.J.--(BUSINESS WIRE)--Celgene Corporation (NASDAQ: CELG) today announced that after consultation with the U.S. Food and Drug Administration (FDA) Celgene will discontinue treatment with REVLIMID (lenalidomide) in the open-label, phase III ORIGIN trial, which enrolled 450 patients in over 100 sites in 26 countries. An imbalance was observed in the number of deaths in patients treated with lenalidomide versus patients treated with chlorambucil. The FDA placed the ORIGIN study on clinical hold on July 12, 2013, with the discontinuation of lenalidomide treatment. All clinical investigators in ongoing chronic lymphocytic leukemia studies using lenalidomide will be officially advised of this action and instructed to inform their patients accordingly. REVLIMID is not approved as a treatment for patients with chronic lymphocytic leukemia. The ORIGIN study was designed to evaluate the efficacy and safety of lenalidomide versus chlorambucil as single agent in elderly patients 65 years of age with B-cell chronic lymphocytic leukemia and with comorbidities that precluded treatment with more aggressive standard chemo-immunotherapies, including fludarabine and bendamustine containing regimens. The majority of patients presented with multiple comorbidities, such as diabetes, congestive heart failure, renal impairment and elevated bilirubin count. Based on an imbalance in deaths, specifically 34 deaths out of 210 patients … Continue reading →

Merger to Create Fully Integrated Regenerative Medicine Company Combined Company to Offer Clinically Validated, Commercially Scalable, Point-of-Care Cell Therapies for Major Therapeutic Markets RANCHO CORDOVA, Calif. and LOS ANGELES, July 16, 2013 (GLOBE NEWSWIRE) -- ThermoGenesis Corp. (KOOL) ("ThermoGenesis"), a leading supplier of enabling technologies for the processing and storage of stem cells and other biological tissues, and TotipotentRx Corporation ("TotiRx"), a privately held California Corporation, which specializes in developing cell-based therapies in the field of regenerative medicine and is the exclusive provider of cell-based product and services to the Fortis Healthcare System, today announced that they have entered into a definitive merger agreement. The combined company is expected to become one of the first fully integrated regenerative medicine companies, developing clinically validated, commercially scalable, point-of-care cell therapies for major therapeutic markets, including orthopedic, cardiovascular and neurologic indications. Under terms of the agreement, ThermoGenesis will issue approximately 12,491,000 shares of its common stock to TotiRx which equates to a value of approximately $18.6 million, based on ThermoGenesis' closing stock price of $1.49 on July 15, 2013. The merger agreement has been unanimously approved by the board of directors of each company. The transaction is expected to close in the fourth … Continue reading →

Buoyed by another round of multimillion-dollar financing, Sacramento-based startup SynGen Inc. has cleared a significant federal hurdle to get its cord blood-processing products on the market. The midtown Sacramento medical device startup, which develops stem cell harvesting systems, announced Monday that it has received U.S. Food and Drug Administration clearance to market three related products to process cord blood. All three are related to the company's SynGenX-1000 system, which harvests stem and progenitor cells from units of collected umbilical cord blood. The company says harvested cells can be used for treatment of numerous medical conditions, including leukemia, lymphoma and more than 70 genetic diseases. "We thank the FDA for guiding us through the ... clearance process. SynGen is dedicated to developing products that consistently exceed our customers' expectations," said Philip Coelho, company president and CEO. Last year, SynGen received $5 million from San Francisco venture capital firm Bay City Capital LLC to further develop what Coelho has called the next generation in stem cell harvesting systems. SynGen recently received additional financing of up to $3 million from Bay City. Established in 1997, Bay City bills itself as a "life sciences venture capital firm investing in opportunities across the various life … Continue reading →

SAN DIEGO, CA--(Marketwired - Jul 15, 2013) - Medistem, Inc. (PINKSHEETS: MEDS), announced today that it has filed a Form 10 registration statement with the Securities and Exchange Commission. The filing is part of the Company's strategy to become fully reporting and access the public capital markets. It is expected that the Form 10 will become effective 60 days from the filing date, allowing liquidity for existing shareholders. In 2009, the Company voluntarily elected to stop reporting under the 1934 Securities and Exchange Act to focus its resources on advancing its lead product, ERC-124, a universal donor stem cell. The Company successfully obtained FDA clearance to initiate clinical trials for its product in patients with critical limb ischemia (CLI). In addition, the Company has treated 18 congestive heart failure (CHF) patients in an ongoing double-blind placebo controlled trial. On October 2012, the Company strengthened its management team with the addition of biopharmaceutical veteran Alan J. Lewis, Ph.D. as Chief Executive Officer. Dr. Lewis has previously served as CEO and Chairman of Ambit BioSciences, CEO of the Juvenile Diabetes Research Foundation, President, CEO and Director of Novocell, Inc., and CEO and Director of Signal Pharmaceuticals. Dr. Lewis also serves as a … Continue reading →

Buoyed by another round of multimillion-dollar financing, Sacramento-based startup SynGen Inc. has cleared a significant federal hurdle to get its cord blood-processing products on the market. The midtown Sacramento medical device startup, which develops stem cell harvesting systems, announced Monday that it has received U.S. Food and Drug Administration clearance to market three related products to process cord blood. All three are related to the company's SynGenX-1000 system, which harvests stem and progenitor cells from units of collected umbilical cord blood. The company says harvested cells can be used for treatment of numerous medical conditions, including leukemia, lymphoma and more than 70 genetic diseases. "We thank the FDA for guiding us through the clearance process. SynGen is dedicated to developing products that consistently exceed our customers' expectations," said Philip Coelho, company president and CEO. Last year, SynGen received $5 million from San Francisco venture capital firm Bay City Capital LLC to further develop what Coelho has called the next generation in stem cell harvesting systems. SynGen recently received additional financing of up to $3 million from Bay City. Established in 1997, Bay City bills itself as a "life sciences venture capital firm investing in opportunities across the various life sciences … Continue reading →

NEWARK, Calif., July 1, 2013 (GLOBE NEWSWIRE) -- StemCells, Inc. (STEM) today announced its addition to the Russell Microcap Index following Russell Investments' reconstitution of its comprehensive set of U.S. and global equity indexes. The Russell Microcap Index measures the performance of the microcap segment of the U.S. equity market. Microcap stocks make up less than 3 percent of the U.S. equity market (by market cap) and consist of the smallest 1,000 securities in the small-cap Russell 2000(R) Index, plus the next smallest eligible securities by market cap. The Russell Microcap Index is constructed to provide a comprehensive and unbiased barometer for the microcap segment trading on national exchanges, while excluding lesser-regulated OTC bulletin board securities and pink-sheet stocks due to their failure to meet national exchange listing requirements. The Russell Microcap is completely reconstituted annually to ensure larger stocks do not distort performance and characteristics of the true microcap opportunity set. About StemCells, Inc. StemCells, Inc. is engaged in the research, development, and commercialization of cell-based therapeutics and tools for use in stem cell-based research and drug discovery. The Company's lead therapeutic product candidate, HuCNS-SC(R) cells (purified human neural stem cells), is currently in development as a potential treatment … Continue reading →

NEW YORK, NEW YORK and PETACH TIKVAH, ISRAEL--(Marketwired - Jun 26, 2013) - BrainStorm Cell Therapeutics (OTCQB: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, today announced that it has signed a Memorandum of Understanding (MOU) with PRC Clinical, a Contract Research Organization (CRO) based in the San Francisco Bay Area, in anticipation of its planned Phase II multi-center ALS clinical trial in the United States. "We chose PRC Clinical to manage our upcoming US-based trial based on their comprehensive range of support services, their experience with both orphan drug trials and neurological disease, specifically ALS, and their use of state-of-the-art monitoring and management technologies," said Alon Natanson, BrainStorm's CEO. "PRC Clinical is delighted to have been selected as the CRO for this trial and we are committed to providing BrainStorm's clinical development program with the highest quality management and data," commented Curtis Head, President and CEO of PRC Clinical. BrainStorm is currently conducting a Phase IIa dose-escalating trial with 12 ALS patients at the Hadassah Medical Center in Jerusalem, Israel. The company anticipates launching a Phase II multi-center trial at three leading institutions in the United States towards the end of 2013, pending FDA approval. … Continue reading →

Article updated: 6/24/2013 1:23 PM The U.S. Food and Drug Administration as approved a supplemental new drug application for the use of Northbrook-based Astellas Pharma U.S. drug Mycamine for injection by intravenous infusion for the treatment of pediatric patients four months and older with candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses, esophageal candidiasis, and prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplants. "We are pleased with FDA's approval of Mycamine for use in pediatric patients four months and older," said Sef Kurstjens, M.D., chief medical officer, Astellas Pharma, Inc. "This expanded indication supports the safety and efficacy of Mycamine and delivers on our mission to provide treatments that can help to improve patient care." Candida, a yeast that causes common fungal infections, is the third most common cause of pediatric health care associated bloodstream infection. Mycamine inhibits an enzyme essential for fungal cell-wall synthesis and is fungicidal (lethal) for Candida, the company said in a release. The overall safety of Mycamine was assessed in 479 patients, ages three days through 16 years, who received at least one dose of Mycamine in 11 separate clinical trials. Continue reading here: FDA approves Astellas’ Mycamine for injection … Continue reading →

NORTHBROOK, Ill., June 24, 2013 /PRNewswire/ --Astellas Pharma US, Inc. ("Astellas"), a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo:4503), announced that the U.S. Food and Drug Administration (FDA) has approved its Supplemental New Drug Application (sNDA) for the use of MYCAMINE (micafungin sodium) for injection by intravenous infusion for the treatment of pediatric patients four months and older with candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses, esophageal candidiasis, and prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplants (HSCT). "We are pleased with FDA's approval of MYCAMINE for use in pediatric patients four months and older," said Sef Kurstjens, M.D., chief medical officer, Astellas Pharma, Inc. "This expanded indication supports the safety and efficacy of MYCAMINE and delivers on our mission to provide treatments that can help to improve patient care." "Candida infections are a significant concern to pediatric healthcare professionals, and there are limited treatment options," said Antonio C. Arrieta, M.D., Director Pediatric Infectious Diseases, Children's Hospital of Orange County and Clinical Professor, Pediatrics, University of California, Irvine. "Because MYCAMINE has been shown to be safe and effective in treating candidemia in many adult patients, it is an important new option for treating Candida infections … Continue reading →

Pluristem Therapeutics Inc. ( PSTI ) recently announced that it has provided the US Food and Drug Administration (FDA) with additional information regarding the clinical trials for intermittent claudication (IC) pursuant to a clinical hold on the phase II IC study earlier this month. We remind investors that on Jun 4, 2013, the company was informed that the FDA has placed a clinical hold on a phase II IC study following a serious allergic reaction in one of the patients who required subsequent hospitalization. The patient was discharged the next day after the symptoms were managed. Pluristem pointed out that the patient was suffering from multiple diseases which might have affected the severity of the allergic reaction. Although the 30-day period within which the FDA is expected to provide a letter to the company containing a list of questions and information required is yet to expire, Pluristem has already provided the agency with additional information so as to speed up the review and resolution of the issues. The company provided information from a database compiled from previous clinical studies. Meanwhile, as the study is being conducted both in the US and Germany, Pluristem informed the Paul-Ehrlich-Institute (PEI) in Germany about … Continue reading →