Category Archives: Stem Cell Human Trials

SOUTH SAN FRANCISCO, CA--(Marketwire -05/14/12)- VistaGen Therapeutics, Inc. (OTC.BB: VSTA) (VSTA.OB), a biotechnology company applying stem cell technology for drug rescue, today issued the following letter to its stockholders and the investment community from its CEO, Shawn Singh. To our valued Stockholders: Since becoming a public company one year ago, we have progressed to perhaps the most exciting time in our company's 14-year history. To arrive at this point, more than $45 million, obtained through various strategic collaborations, investments and grant awards, has been carefully employed. We believe our pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube, combined with the network of strategic relationships we have announced, will allow us to secure additional capital and the large market drug rescue opportunities that can deliver value to our stockholders. Since the beginning of the year, our team has carefully reviewed our Top 10 drug rescue opportunities and narrowed our focus to our Top 5 candidates. Now we intend to launch our initial drug rescue program and secure strategic capital necessary to support it, as well as launch our second drug rescue program by year-end. We also are working on validation of LiverSafe 3D, our bioassay system for … Continue reading →

NEWARK, Calif., May 10, 2012 (GLOBE NEWSWIRE) -- StemCells, Inc. (Nasdaq:STEM - News), a leading stem cell company developing and commercializing novel cell-based therapeutics and tools for use in stem cell-based research and drug discovery, today reported financial results for the first quarter ended March 31, 2012 and provided a business update. "The first quarter of 2012 turned out to be pivotal in the Company's pursuit of cell-based therapeutics for a broad array of CNS disorders," said Martin McGlynn, President and CEO of StemCells, Inc. "Data from our Phase I trial completed in February, which was designed to evaluate the safety and preliminary efficacy of our proprietary HuCNS-SC(R) neural stem cells in a rare myelination disorder, provided us with the clinical breakthrough that we had been seeking. We have now established proof of principle that our cells are capable of myelinating nerve axons in an appropriate, progressive and durable way in the brains of patients with a severe myelination disorder. Moreover, we observed measurable gains in motor and/or cognitive function in three of the four patients, while the fourth remained clinically stable. We believe this is a departure from the natural history of this fatal disease. This is great news … Continue reading →

BOUDRY, Switzerland--(BUSINESS WIRE)-- Celgene International Srl, a subsidiary of Celgene Corporation (NASDAQ: CELG - News), today announced that results from three phase III studies evaluating the use of continuous REVLIMID (lenalidomide) treatment in newly diagnosed multiple myeloma (MM) patients or maintenance treatment with lenalidomide following autologous stem cell transplant were published online in the May 10, 2012 edition of the New England Journal of Medicine. All three publications highlight the expanding body of clinical evidence supporting lenalidomide treatment in these areas. Continuous Lenalidomide Therapy (non-transplant eligible population): The first article highlights a Celgene-sponsored study of continuous lenalidomide treatment in elderly patients newly diagnosed with multiple myeloma. Continuous Lenalidomide Treatment for Newly Diagnosed Multiple Myeloma (MM-015) This double-blind, phase III, multicenter, randomized study conducted by Celgene compared melphalanprednisonelenalidomide induction followed by lenalidomide maintenance (MPR-R), with melphalanprednisonelenalidomide (MPR), or melphalanprednisone (MP) followed by placebo in 459 patients aged 65 years with newly-diagnosed myeloma who were not eligible for autologous stem-cell transplant. http://www.nejm.org/doi/full/10.1056/NEJMoa1112704 Post-transplant maintenance The two additional articles published in the edition highlighted cooperative group studies that evaluated the use of lenalidomide maintenance following autologous stem cell transplant (ASCT). In each of the studies, one funded by the National Cancer Institute and … Continue reading →

MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Advanced Cell Technology, Inc. (ACT; OTCBB:ACTC), a leader in the field of regenerative medicine, announced today first quarter financial results for the period ended March 31, 2012. The Company reported a loss from operations of $(5.4) million compared to a loss from operations of $(4.8) million in the 2011 first quarter.ACTreported a net loss of $(5.7) million or $(0.00) per share, compared to a loss in the same period in 2011 of $(3.3) million, or $(0.00) per share. Net cash used in operations for the 2011 first quarter was $4.8 million, compared to net cash used in operations of $3.4 million in the same period in 2011. The Company ended the 2012 first quarter with cash and cash equivalents of $10.8 million, compared to $13.1 million as of December 31, 2011. Highlights from the first quarter of 2012 included: We are very pleased with our progress in the clinic so far, said Chairman and CEO Gary Rabin. We are encouraged by the results we have seen from the early patients treated in each of our indications, and look forward to completing the trials on schedule. Conference call and Webcast The Company will hold a conference call tomorrow … Continue reading →

Bio-Matrix Scientific Group, Inc. (OTCQB: BMSN) (PINKSHEETS: BMSN) announced today it has formed a new subsidiary, Regen BioPharma, Inc. Regen BioPharma has developed a vertically-integrated structure for acquiring patents, performing accelerating preclinical and clinical development, and licensing or selling technology developed to large pharma companies in the area of stem cells. To date, Regen BioPharma has reviewed more than 20,000 US issued patents covering stem cell related subject matter, created a shortlist of 30 promising technologies for rapid commercialization, and currently is in negotiations to license several of these. Once the technology is secured, the Company anticipates partnering with industry leading scientists, physicians, and service providers to complete the Investigational New Drug (IND)-enabling work and begin clinical trials. "In biotechnology in general, and specifically in the area of regenerative medicine, the biggest value creation occurs for shareholders when a company files an IND and obtains human data that provides proof of safety and efficacy," said David R. Koos, Chairman and Chief Executive Officer of Bio-Matrix. "We are assembling the team and capabilities to in-license and evaluate technologies rapidly, then to develop the regulatory package and initiate clinical trials. Our business model and partnerships will allow us to take cell therapy … Continue reading →

MIAMI--(BUSINESS WIRE)-- The University of Miami Miller School of Medicines Interdisciplinary Stem Cell Institute (ISCI) today announced that it received a $10 million grant from The Starr Foundation, one of the largest private foundations in the United States. The grant will support ISCI in broadening its preclinical and clinical research on stem cells, and help accelerate its pipeline of translational research and programs for a wide range of debilitating conditions including cardiac disease, cancer, wound healing, stroke, glaucoma and chronic kidney and gastrointestinal diseases. This is a momentous and transformative gift for the Interdisciplinary Stem Cell Institute, said Joshua M. Hare, M.D., F.A.C.C., F.A.H.A., Louis Lemberg Professor of Medicine at the University of Miami Miller School of Medicine and director of ISCI. We are so gratified that the level of science being conducted here was recognized by this very generous grant from The Starr Foundation. With this award, we join the ranks of the other major top-tier universities funded by The Starr Foundation. This support, along with our growing NIH funding, technology transfer, and other philanthropic efforts guarantees the stability of ISCI through the end of the decade, and will allow us to continue to push the boundaries of regenerative … Continue reading →

SAN DIEGO, CA--(Marketwire -05/03/12)- Regen BioPharma (Regen), Inc. a newly-formed subsidiary of Bio-Matrix Scientific Group, Inc. (BMSN.PK - News) (BMSN.PK - News), unveiled today its operational plan for its "Super-Incubator" stem cell company. Month 1-2: Assembly of Team. Regen intends to assemble a team of world-class leaders in the spheres of Technology, Intellectual Property assessment, valuation and Clinical development. Regen will seek to compile a team of Physician-Scientists with experience in the area of clinical trials for regenerative medicine/stem cell products, Regulatory experts who have successfully taken products through the FDA and corresponding agencies internationally, and Biotech Entrepreneurs who have track records of excellence in business formation and value optimization. Month 1-4: In-licensing of Intellectual Property. The Company having already assessed over 20,000 issued patents and having compiled a shortlist of 30 targets; Regen will seek to execute licensing deals on an initial core of 3 technologies. Regen focuses on issued patents that have already passed preclinical studies but are not under clinical development. Month 3-6: Interaction with Regulatory Agencies. Regen intends to develop data packages for each of the technologies and initiate interaction with Regulatory Agencies such as the FDA for initiation of trials. Month 6-18: Clinical Implementation. Regen … Continue reading →

ROCKVILLE, Md., April 25, 2012 /PRNewswire/ --Neuralstem, Inc. (CUR) announced that Karl Johe, PhD, Chairman and Chief Scientific Officer, will present at the Fourth International Spinal Cord Injury Treatments and Trials Symposium, in Xi'an, China on Friday, May 4, at 1:00 PM (http://iscitt.org/iscitt4/). Dr. Johe's talk, entitled "Human spinal cord-derived neural stem cells (HSSC) for treatment of neurological diseases," willreview the readiness of Neuralstem's cells to enter clinical trials in China, as well as provide an overview of the US clinical programs in amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) and in spinal cord injury. Neuralstem has an ongoing FDA-approved Phase I trial testing the safety of its cells in the treatment of ALS and has submitted an IND (Investigational New Drug) to the FDA to initiate trials with its cells in chronic spinal cord injury. Neuralstem's wholly-owned subsidiary in China, Neuralstem China(Suzhou Neuralstem Biopharmaceutical Company Ltd.), is developing cell therapy treatments for chronic motor disorder from stroke in collaboration with BaYi Brain Hospital in Beijing. (Logo: http://photos.prnewswire.com/prnh/20061221/DCTH007LOGO ) About Neuralstem Neuralstem's patented technology enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation … Continue reading →

ALAMEDA, Calif.--(BUSINESS WIRE)-- BioTime, Inc. (NYSE Amex: BTX) announced today that David Warshawsky, Ph.D., CEO of BioTimes subsidiary LifeMap Sciences, Inc. will provide and update on product development at an investor meeting in New York City today. Dr. Warshawsky will describe the origins of XenneX, a company that LifeMap has agreed to acquire, and the business strategy that led to its rapid rise to profitability. He will describe the GeneCards database (www.genecards.com) which is used as a research tool world-wide in academia, research hospitals, patent offices, and leading biotech and pharma companies. He will report that GeneCards enjoys more than 12 million page visits/year by hundreds of thousands of unique users, consistently in top positions for gene search results in Google. Dr. Warshawsky will discuss LifeMaps work to build an integrated map of the thousands of cell types in human development, beginning with the fertilized egg and ending in the developed human. Combined with genomics information, the database is expected to become a road atlas of human biology benefiting medicine and research. In addition, LifeMap is developing its own proprietary technology to effectively analyze data gathered from the data bases for use in the development of cell-based therapies. LifeMap also … Continue reading →

ALAMEDA, Calif.--(BUSINESS WIRE)-- BioTime, Inc. (NYSE Amex: BTX) announced today that Steven Kessler, Ph.D., Vice President of Research at BioTimes subsidiary ReCyte Therapeutics, Inc. will provide and update on the development of reprogramming technologies and the generation of patient-specific vascular endothelial cells with essentially 100% purity using proprietary ACTCellerateTM technology. Dr. Kessler will also describe the use of ACTCellerateTM cell lines to manufacture specific secreted biologically active proteins, and will show animal preclinical data on the use of particular ACTCellerateTM lines as a potential means of improving recovery after stroke. Also presenting will be ReCytes collaborator Shahin Rafii, M.D., the Arthur B. Belfer Professor of Genetic Medicine and Director of the Ansary Stem Cell Institute at Cornell Weill Medical College. Drs. Kessler and Rafii will describe the wide array of age-related degenerative diseases potentially addressed by novel vascular cell therapies, including coronary heart disease afflicting an estimated 82 million Americans, and stroke that caused one out of every 18 deaths in the United States in 2007. Drs. Kesslers and Rafiis presentation will be available for viewing on BioTimes web site http://www.biotimeinc.com as well as ReCyte Therapeutics web site at http://www.recytecorp.com. About ReCyte Therapeutics ReCyte Therapeutics, Inc. is a majority-owned privately-held … Continue reading →