Category Archives: FDA Stem Cell Trials

SAN DIEGO, CA--(Marketwire -07/13/12)- Medistem Inc. (MEDS) and the Chinese Conglomerate, Shanghai Jia Fu Medical Apparatus Inc, announced today successful administration of Medistem's Endometrial Regenerative Cell (ERC) universal donor stem cell product in 2 patients with critical limb ischemia as part of a 15 patient study. The ERC dosing procedure, which involves a series of intramuscular injections in the ischemic limb, was successfully performed, without any treatment-associated adverse effects observed in either patient. "The ERC is unique amongst clinical grade stem cells in that the cell is derived from the endometrium (lining of the uterus). Every month new blood vessels are formed in the endometrium, which subsequently are sloughed off during menstruation. We believe the ERC plays a critical role in forming new blood vessels, which is supported by numerous experiments we have conducted," said Thomas Ichim, CEO of Medistem. "Since the biological role of the ERC is to produce new blood vessels, it is our desire to use these cells to produce new blood vessels in the legs of patients with critical limb ischemia." Critical limb ischemia is an advanced form of peripheral artery disease that causes approximately 150-200,000 amputations per year in the USA. Dr. Michael Murphy of … Continue reading →

RESEARCH TRIANGLE PARK, N.C., July 9, 2012 /PRNewswire/ -- Chimerix, Inc., a biotechnology company developing orally-available antiviral therapeutics, today announced a late-breaking poster presentation at the 24th International Congress of the Transplantation Society being held July 15-19th, 2012 at the International Congress Centre Berlin in Berlin, Germany. The poster presentation, entitled "CMX001, a Novel Broad Spectrum Antiviral, May Mitigate Signs of BK Virus (BKV) Associated Bladder and Kidney End-Organ Damage," is part of the Late Breaking Abstracts session on Monday, July 16th from 12:15-13:30 pm in the Stockholm room. Herve Mommeja-Marin, MD, Vice President of Clinical Research at Chimerix, will present the data from Study 201, Chimerix's Phase 2 study evaluating CMX001 for the prevention of cytomegalovirus (CMV) disease in hematopoietic stem cells transplant (HSCT) recipients. Phase 2 results presented elsewhere have shown that CMX001, at various doses, was active and well-tolerated in the prevention of CMV infection or disease. This new retrospective analysis focuses on BK virus and shows that CMX001 may prevent end-organ damage in subjects who had BKV infection in the urine upon initiation of therapy. About Chimerix Chimerix is developing novel antiviral therapeutics with the potential to improve quality of life for patients in multiple settings, … Continue reading →

SCHAUMBURG, Ill.--(BUSINESS WIRE)-- The Gateway for Cancer ResearchSM (www.demandcurestoday.org) announces an exciting new Gateway-funded phase II study using ADAPT therapy for treatment of metastatic colorectal cancer based on a 2010 AACR presentation by Dr. Lin and his collaborators. The clinical trial, being led by Dr. Edward Lin, a medical oncologist at the University of Washington, Fred Hutchinson Cancer Research Center and an accomplished researcher and expert in gastrointestinal cancers, is the first to specifically target colon cancer stem cells. The study will use a unique combination drug therapy of Capecitabine (a chemotherapy drug) and Celecoxib (an FDA approved arthritis medication) to wake up and to kill colon cancer stem cells. The treatment works by activating cancer stem cells that hibernate during chemotherapya chief cause of treatment failureso they can be destroyed. The proper sequence is necessary to consistently kill the dormant cells. The ADAPT concept was proposed by Drs. Lin and Linheng Li, a prominent stem cell biologist. It is a very powerful drug combination with good preliminary results. Pilot studies have shown significantly increased survival rates compared with conventional therapy. Of 124 treated patients, 40% of those treated with this protocol achieved complete remission or near remission with a … Continue reading →

NEW YORK, July 4, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue: Neuroprotective Products: World Market Prospects 2012-2022 http://www.reportlinker.com/p0923285/Neuroprotective-Products-World-Market-Prospects-2012-2022.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Pathology Report Details Your guide to trends and revenue prospects in neuroprotection What are the commercial prospects for neuroprotective treatments? Visiongain's new report shows you potential revenues and trends to 2022, discussing data, opportunities and outlooks. Many neuroprotective products are in development. Our study lets you assess projected sales at overall world market, therapeutic submarket and product level to 2022. The protection of nerve tissues is becoming more important. You can assess the potential for drug revenues there, as well as finding discussions of stem cells and gene therapy. In particular, how will 11 products - including Rasagiline, Minocycline, Memantine and NeuroSTAT - perform to 2022? Our investigation gives you business research and analysis with sales forecasts. You also see forecasting of five world-level submarkets to 2022, finding potential revenues: Read the original here: Neuroprotective Products: World Market Prospects 2012-2022 … Continue reading →

NEW YORK, July 4, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue: India Biotechnology in India Industry http://www.reportlinker.com/p0553099/India-Biotechnology-in-India-Industry.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Drug_Disc This report analyzes the market for Biotechnology in India in US$ million by the following Key Sectors: Bio-Pharmaceuticals, Bio-Agriculture, Bio-Industrial, Bioinformatics, and Bio-Services. Annual estimates and forecasts are provided for the period 2009 through 2017. Also, a six-year historic analysis is provided for this market. The report profiles 102 companies including many key and niche players such as Advanced Enzymes Technologies Ltd., Ajeet Seeds Ltd., Anthem BioSciences Pvt. Ltd., Bharat Biotech International Limited, Bharat Serums and Vaccines Ltd., Biocon Limited, Syngene International Limited, Dr. Reddy's Laboratories Ltd., Ecron Acunova, Eli Lilly and Company (India) Pvt. Ltd., GlaxoSmithKline Pharmaceuticals Ltd., Indian Immunologicals Ltd., Jubilant Life Sciences Limited, Krishidhan Seeds Private Limited, Lambda Therapeutic Research Ltd., Mahyco, Max Neeman, Monsanto, Novo Nordisk India Pvt. Ltd., Novozymes South Asia Pvt. Ltd., Nuziveedu Seeds Pvt. Ltd., Ocimum Biosolutions Ltd., Panacea Biotec Ltd., Piramal Healthcare Limited, Quintiles India, Rasi Seeds (P) Ltd., Reliance Life Sciences, Serum Institute of India Ltd., Shantha Biotechnics Limited, SIRO Clinpharm, Strand Life Sciences, Veeda Clinical Research Limited, and Vimta Labs Limited. Market data and … Continue reading →

CARMIEL, Israel, July 2, 2012 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (PLX) (PLX) announced today that new clinical data on taliglucerase alfa was presented at the 10th Annual European Working Group on Gaucher Disease Meeting that took place June 28-30 in Paris, France. Taliglucerase alfa is approved in the United States as an enzyme replacement therapy for the treatment of adults with type 1 Gaucher disease. Laura van Dussen, M.D., of the Academic Medical Center, University of Amsterdam, presented long-term bone marrow responses in Gaucher patients from the Company's pivotal and extension trials. Bone marrow imaging can be used as an important indicator for determining bone risk potential for Gaucher patients. Bone marrow fat fractions of eight naive patients from the pivotal and extension trials who were treated with taliglucerase alfa for at least 36 months, and 15 untreated Gaucher patients, were evaluated using Quantitative Chemical Shift Imaging (QCSI) MRI. At 36 months, the patients treated with taliglucerase alfa demonstrated a significant improvement in fat fraction from baseline (p-value = 0.012 after 36 months of follow-up). The range of absolute fat fraction values was between 0.19% and 0.42%, which corresponds to a mean change of 92% from baseline of fat … Continue reading →

NEW YORK, June 27, 2012 /PRNewswire/ -- Thursday, June 28, 2012 The event will feature 30-minute corporate presentations with accompanying slides by executives from seven industry leaders. Presentations begin at 9:00 a.m. Eastern Time and can be accessed at http://www.informedinvestors.com. Individual presentations also will be available at each presenting company's website. We hope you can join us. If you cannot attend the live event, presentations will be archived at http://www.informedinvestors.com and at each presenting company's website for approximately 90 days. If you have any questions, please call Carolyn Curran at (212) 838-3777 or ccurran@lhai.com. LHA is a leading independent investor relations firm. As IR specialists with more than 25 years of experience, we partner with public and soon-to-be public companies to create and support best practices investor and media relations programs. By focusing on the development of public company identity and the communication of strategic vision, we build awareness, enthusiasm and sponsorship among target audiences in the investment community to maximize valuation. Our programs deliver measurable results so clients can assess the impact of their investor relations initiatives. LHA Life Sciences & Medical Technologies Virtual ConferenceJune 28, 2012 beginning at 9:00 a.m. Eastern Time 9:00 a.m. Eastern TimeCAS Medical Systems … Continue reading →

MADISON, Wis., June 27, 2012 /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 LHA Life Sciences & Medical Technologies Virtual Conference on Thursday, June 28, 2012. Mr. Palmin is scheduled to present at 12:30 p.m. Eastern time. A webcast of the Novelos presentation may be accessed at http://www.novelos.com The webcast will be archived for 90 days following the presentation. This day-long virtual conference event includes 30-minute presentations with accompanying slides from seven industry leaders, and begins at 9:00 a.m. Eastern time. The event may be accessed at the PrecisionIR event site http://www.vcall.com/CustomEvent/lipper/index.asp About Novelos Therapeutics, Inc. We are a pharmaceutical company developing novel drugs for the treatment and diagnosis of cancer. Our three 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 therapy by providing efficacy versus all three major drivers of mortality in cancer: primary tumors, … Continue reading →

IRVINE, CA--(Marketwire -06/25/12)- Dr. Sumit "Sam" Garg, cornea surgeon at UC Irvine Health's Gavin Herbert Eye Institute successfully implanted a tiny telescope in a patient's eye with end-stage macular degeneration (AMD). The first Orange County patient received a telescope implant late last year by fellow cornea surgeon Dr. Marjan Farid. The Gavin Herbert Eye Institute at UC Irvine is the only academic institution in Southern California currently implanting the mini telescope for end-stage AMD. "Through our participation in the clinical trials, we know the impact the telescope technology can have on a patient's life. We are excited to finally be able to offer this technology on a broader basis and to be one of the first provider teams in the area to help these patients improve their vision and achieve a greater quality of life," says Dr. Garg, cornea surgeon at UC Irvine Medical Center and Vice Chair of Clinical Ophthalmology at The Gavin Herbert Eye Institute, who performed the most recent surgery on a 94-year old patient. The first-of-kind telescope implant is integral to CentraSight, a new patient care program for treating patients with end-stage age-related macular degeneration, the most advanced form of AMD and the leading cause of … Continue reading →

TAIPEI, June 25, 2012 /PRNewswire-Asia/ -- TaiGen Biotechnology Company, Limited ("TaiGen") and Zhejiang Medicine Company, Limited ("ZMC") today announced that they have signed an exclusive agreement to manufacture and commercialize nemonoxacin, a novel broad-spectrum antibiotic, in China (excluding Hong Kong, and Macau). Nemonoxacin is a novel broad-spectrum non-fluorinated quinolone antibiotic under development for respiratory infections. TaiGen will be responsible for completing the Phase 3 clinical trial for community acquired pneumonia ("CAP") in China. ZMC will be responsible for manufacturing, sales and marketing of nemonoxacin in China through its wholly-owned subsidiary, XinChang Pharmaceuticals. TaiGen will retain full development and commercialization rights outside the licensed territory including Taiwan, the United States, European Union, and Japan. Under the terms of the agreement, TaiGen will receive an upfront payment of US$ 8 million from ZMC and will receive additional milestones as well as royalties on product sales. The term of the agreement is 20 years. Nemonoxacin has demonstrated efficacy and safety in CAP and diabetic foot infection in multinational and multi-center clinical trials conducted by TaiGen. In particular, nemonoxacin has excellent activity against drug-resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and quinolone-resistant MRSA. Nemonoxacin is taken once-a-day and available in both oral and … Continue reading →