Category Archives: Stem Cell Human Trials

ALAMEDA, Calif.--(BUSINESS WIRE)-- BioTime, Inc. (NYSE Amex: BTX) announced today that BioTimes CEO Michael West, Ph.D. will provide and update the development of OTX-CP07 by BioTimes subsidiary OrthoCyte Corporation at an investor meeting in New York City. OTX-CP07 is a combination product with human embryonic cartilage progenitors manufactured from human embryonic stem cells formulated with BioTimes proprietary cell delivery device ReneviaTM. Dr. West will describe studies underway at OrthoCyte that have currently identified progenitors to eight diverse cartilage types of the human body, as well as diverse tendon, bone, and muscle progenitors that may be useful in orthopedic research and the development of novel regenerative therapeutics. Dr. West will also show a video presentation from OrthoCytes Chief Scientific Officer, Arnold Caplan, Ph.D., who is also Director of the Skeletal Research Center at Case Western Reserve University. In the video, Dr. Caplan discusses the significance of the potential use of definitive progenitors of human cartilage for the repair of osteoarthritis, a disease afflicting an estimated 27 million Americans. Dr. Wests presentation as well as the video of Dr. Caplans presentation will be available for viewing on BioTimes web site http://www.biotimeinc.com as well as OrthoCyte Corporations web site at http://www.orthocyte.com. About OrthoCyte … Continue reading →

ALAMEDA, Calif.--(BUSINESS WIRE)-- BioTime, Inc. (NYSE Amex: BTX) announced today that Charles S. Irving, Ph.D., the CEO of BioTimes subsidiary Cell Cure Neurosciences, Ltd. will provide an update on the development of OpRegen at an investor meeting in New York City. In his presentation, Dr. Irving will describe the unmet medical needs and markets for the treatment of the dry form of age-related macular degeneration (AMD), and the advantages of Cell Cures OpRegen which has been produced from human embryonic stem cells in culture conditions free of animal products, eliminating the need for designating the product as a xenotransplantation therapeutic. Dr. Irving will also discuss Cell Cures collaboration with Teva Pharmaceutical Industries Ltd., under which Teva has the option to develop and commercialize both OpRegen and OpRegen-Plus. Dr. Irving will describe the nature of the ongoing preclinical studies which are expected to lead to regulatory filings for the initiation of human clinical trials in 2013. Dr. Irvings presentation will be available on BioTimes web site http://www.biotimeinc.com as well as Cell Cure Neurosciences web site at http://www.cellcureneurosciences.com. Background. Age-related macular degeneration is the leading cause of blindness in an aging population. It is widely believed that the loss or dysfunction of … Continue reading →

ALAMEDA, Calif.--(BUSINESS WIRE)-- BioTime, Inc. (NYSE Amex: BTX) and its wholly owned subsidiary OrthoCyte Corporation reported today a means of manufacturing cartilage from human embryonic stem cells that is suited for industrial scale-up of a product for the treatment of osteoarthritis. The paper, published online (ahead of print) in the peer-reviewed journal Regenerative Medicine, characterizes a progenitor cell line produced from human embryonic stem (hES) cells using proprietary ACTCellerate technology. The study reports that the cells are capable of regenerating cartilage with long sought-after identification markers. The study also shows that the cells can be directly expanded on a scale needed for industrial manufacture, which will be necessary in order to make transplantable cells available in commercial quantities. In todays publication, BioTime scientists reported on one ACTCellerate line designated 4D20.8. This proprietary cell line is the cellular component of OrthoCytes product in development, OTX-CP07. The scientific publication demonstrates that 4D20.8 cells possess site-specific markers of craniofacial mesenchyme, in particular, markers of proximal mandibular mesenchyme. This tissue is of significance in that it naturally produces one of the strongest joint cartilages of the body. The study documented conditions in which the cells can be propagated on a large scale, conditions in … Continue reading →

MOBILE, Alabama -- At the end of this past season with the Oakland Raiders, an aching Rolando McClain gave an assignment to his agent: Find out more about stem cell therapies for injuries, like other athletes are trying. Ive been having two seasons of nagging pain in my knee, the former University of Alabama standout said. Not long afterward, McClain was on his way to Gulf Shores. There, radiologist Jason R. Williams performed liposuction on McClain and then injected stem cells from the linebackers own fat cells into his knee and into the area of a high ankle sprain. It feels a lot better, McClain said in an interview last week, adding that hes working out four days a week with the Raiders, running, lifting weights, doing squats and even sprinting with hardly any pain at all. About three months ago, Williams, 38, began the new procedure in which he injects patients -- two of them being McClain and former University of Alabama receiver Marquis Maze -- with their own stem cells in an effort to repair damaged joints and muscles. This is going to be the future of medicine, said Williams, who owns Precision StemCell, which includes a diagnostic … Continue reading →

ALAMEDA, Calif. & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- BioTime, Inc. (NYSE Amex:BTX) and its wholly owned subsidiary LifeMap Sciences today announced that they have signed a definitive agreement to acquire XenneX, Inc. through a merger of XenneX into LifeMap Sciences. The acquisition is expected to close within thirty days. XenneX holds the exclusive, worldwide licenses to market GeneCards and PanDaTox. GeneCards is a searchable, integrated, database of human genes that provides concise genomic, transcriptomic, genetic, proteomic, functional and disease related information, on all known and predicted human genes. GeneCards was developed by a world-leading bioinformatics team at the Weizmann Institute of Science in Israel. PanDaTox is a recently developed, searchable, database that can be used to identify genes and intergenic regions that are unclonable in E. coli, to aid in the discovery of new antibiotics and biotechnologically beneficial functional genes, and to improve the efficiency of metabolic engineering. Since 2003, XenneX has been generating revenue from customers worldwide including biotechnology, pharmaceutical and other life sciences companies, as well as organizations dealing with biotechnology intellectual property. GeneCards and PanDaTox are marketed by XenneX under a license from Yeda Research and Development Company Ltd, the Technology Transfer Company of the Weizmann Institute. Through the … Continue reading →

MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today the dosing of the third patient in its Phase I/II trial for dry age-related macular degeneration (dry AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The outpatient transplantation surgery was performed successfully, and the patient is recovering uneventfully. Gary Rabin, chairman and CEO of ACT, commented, The completion of enrollment of the first cohort of patients in our dry AMD clinical trial is a significant step forward in our RPE clinical program. The first six patients in the U.S. trials have all been treated at UCLA, and as we have recently announced, the trials should soon expand to additional sites. As we have built our clinical team, we have been fortunate to have attracted the attention of some of the highest-caliber ophthalmologists and related institutions in the U.S. and Europe and recognize the huge value that their expertise provides us as we plan for the future of our therapeutic programs. With their guidance, we have also worked with the FDA to successfully expand the criteria of eligibility for patients to participate in our dry … Continue reading →

ALAMEDA, Calif.--(BUSINESS WIRE)-- BioTime, Inc. (NYSE Amex:BTX), a biotechnology company that develops and markets products in the field of regenerative medicine, today announced that Chief Executive Officer Michael D. West, Ph.D. will present at the Future Leaders in the Biotech Industry conference on Friday, April 20, 2012, 9:00 a.m. EDT, at the Millennium Broadway Hotel in New York City. Dr. West will present a corporate overview of BioTime and its subsidiaries with an update on the progress of BioTimes product development programs. The presentation will be webcast and available online at the Investors section of the BioTime website at http://www.biotimeinc.com. The annual Future Leaders in the Biotech Industry conference, now in its 19th year, is the longest-running independent Wall Street conference serving the biotech community. The one-day meeting presented by BioCentury and Thomson Reuters connects leading portfolio managers, bankers and analysts with private and public companies in key therapeutic areas. About BioTime, Inc. BioTime, headquartered in Alameda, California, is a biotechnology company focused on regenerative medicine and blood plasma volume expanders. Its broad platform of stem cell technologies is developed through subsidiaries focused on specific fields of applications. BioTime develops and markets research products in the field of stem cells … Continue reading →

By Suling Liu, Hasan Korkaya, and Max S. Wicha | April 1, 2012 Inthe 30-year battle waged since the initiation of the war on cancer, there have been substantial victories, with cures for childhood malignancies among the most important. Our ever-expanding understanding of cellular and molecular biology has provided substantial insights into the molecular underpinnings of the spectrum of diseases we call cancer. Yet, while researchers view this as tremendous progress, many patients have seen only limited improvement. In fact, the relatively modest gains achieved in treating the most common malignancies have caused some to say that we are actually losing the war on cancer. Based on new intelligence, oncologists are making informed battle plans to attack a particularly pernicious enemythe cancer stem cell. Controversial though they are, cancer stem cells are an incredibly promising target. If treatment-resistant cancer, and the metastases that transplant the cancer throughout the body, could be attributed to the actions of a single cell type, it could explain many of the treatment failures and provide a novel way to attack the disease. The idea that cancers are driven by cells with embryonic features is an old one. Many cancers regress to a less differentiated state, … Continue reading →

The head of a stem cell company has responded to a warning letter issued by the U.S. Food and Drug Administration citing several violations at the company which derives stem cells from adipose tissue or body fat. Dr. Steven Victor of IntelliCell BioSciences said it would be moving to a new facility next month that it believes will address the current good manufacturing practice issues referred to in the warning letter It has also hired consultants with FDA compliance experience that will help bring its new facilities in compliance with the FDA. Victor added that the company will address all of the FDAs observations on April 3. The New York company received a warning letter dated March 13 that was published on the FDAs website yesterday. The letter said that the process that the company uses to produce stem cells from adipose tissue did not meet the FDAs definition of minimal manipulation for structural tissue such as adipose tissue. See original here: CEO of stem cell company responds to FDA warning letter … Continue reading →

ImmunoCellular Therapeutics, Ltd. (ImmunoCellular or the Company) (OTCBB: IMUC), a biotechnology company focused on the development of novel immune-based cancer therapies, announced today that the Company will deliver a presentation on the identification and characterization of immunogenic epitopes from CD133 and their potential for use to immunologically target cancer stem cells (CSCs) at the Annual Meeting of the American Association for Cancer Research, which will be held from March 31 to April 4, 2012 at McCormick Place in Chicago, Illinois. CD133 is a marker that identifies CSCs on many solid tumors and its expression has been correlated with shortened survival. Potential Cytotoxic T Lymphocytes (CTL) epitopes were identified by computer algorithms to predict binding to HLA-A2 tissue type on white blood cells. Studies with human cells in vitro demonstrated immunogenicity of two lead peptides and in vivo studies in mice confirmed the safety and immunogenicity of these peptides as a potential vaccine to target CD133 CSCs. The Company plans to incorporate these peptides into its second product, ICT-121, for recurrent glioblastoma as the initial indication, followed by additional solid tumors. To evaluate the potential for autoimmunity, mouse homolog peptides of the lead epitopes that were shown to have high affinity … Continue reading →