PALO ALTO, Calif. - (Business Wire) StemCells, Inc. (NASDAQ:STEM) today announced that Stewart Craig, Ph.D., an acknowledged expert in the development of cell-based therapeutics, will be joining the Company as Senior Vice President, Development and Operations, effective September 15, 2008. Dr. Craig will report to Martin McGlynn, the Company
’s President and Chief Executive Officer, and will be responsible for process design and engineering, GMP manufacturing operations, regulatory affairs, quality assurance, facilities and supply chain management.
Dr. Craig has over twenty-five years of experience in the biotechnology sector, the last 15 of which have been in the cell therapy field. Dr. Craig was most recently Vice President and Chief Technology Officer of Progenitor Cell Therapy, LLC (PCT), a contract provider of GMP cell processing and development services. As a member of the executive team at PCT, Dr. Craig was responsible for the design, construction and validation of PCT’s GMP cell processing facilities, business development, and for the provision of consulting services to PCT’s clients in such areas as manufacturing process development, product characterization, stability testing, quality systems, and regulatory affairs. Prior to joining PCT, Dr. Craig was chief operating officer of Xcyte Therapies, Inc., a publicly traded cell-based immunotherapy company. At Xcyte, Dr. Craig was responsible for research and development, GMP manufacturing operations, quality systems, regulatory affairs, business development, and facilities, including the design construction and validation of a commercial-scale manufacturing facility. Dr. Craig has previously held senior management positions with the pioneering stem cell companies Osiris Therapeutics, Inc., where he built the original development and manufacturing infrastructure for Osiris that was integral to the initiation of clinical trials, including the design, construction, validation, and operation of the pilot-scale GMP manufacturing facility, and SyStemix, Inc., where he was responsible for the development of cell isolation reagents and processes, assay methods development, quality systems, and technology transfer.
Dr. Craig earned his B.Sc. (Hons) in Biochemistry and his Ph.D. in Physical Biochemistry from the University of Newcastle upon Tyne, United Kingdom. Dr. Craig is a member of the International Society for Cell Therapy, and was previously a member of the U.S. Pharmacopeia Cell and Gene Therapy Advisory Panel and the International Society for Pharmaceutical Engineering.
“Stewart is an outstanding addition to our team and we are thrilled that he has chosen to join StemCells Inc.,” said Mr. McGlynn. “His unique experience and expertise will be a tremendous asset as we pursue our goal of bringing cell-based therapies into clinical practice for the treatment of a whole range of serious conditions affecting the central nervous system, the liver and the pancreas.”
“This is a wonderful opportunity,” said Dr. Craig. “StemCells has long been recognized for conducting rigorous research and development, and the Company is among the leaders in translating this pioneering stem cell science into real clinical applications. I look forward to contributing to that effort and to being part of a team that is committed to bringing cell-based therapeutics to clinical use.”
About StemCells, Inc.
StemCells, Inc. is a clinical-stage biotechnology company focused on the discovery, development and commercialization of cell-based therapeutics to treat diseases of the central nervous system and liver. The Company’s product development programs seek to repair or repopulate CNS and liver tissue that has been damaged or lost as a result of disease or injury. StemCells has pioneered the discovery and development of HuCNS-SC® cells, its highly purified, expandable population of human neural stem cells. StemCells has completed enrollment and dosing of a six patient Phase I clinical trial of its proprietary HuCNS-SC product candidate as a treatment for neuronal ceroid lipofuscinosis (NCL) and expects the trial to be completed in early 2009. NCL, which is often referred to as Batten disease, is a rare and fatal neurodegenerative disease that affects infants and young children. StemCells owns or has exclusive rights to more than 50 issued or allowed U.S. patents and more than 150 granted or allowed non-U.S. patents. Further information about the Company is available on its web site at: www.stemcellsinc.com.
Apart from statements of historical fact, the text of this press release constitutes forward-looking statements regarding, among other things, the future business operations of StemCells, Inc. (the “Company”) and its ability to conduct clinical trials as well as its research and product development efforts. These forward-looking statements speak only as of the date of this news release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Such statements reflect management’s current views and are based on certain assumptions that may or may not ultimately prove valid. The Company’s actual results may vary materially from those contemplated in such forward-looking statements due to risks and uncertainties to which the Company is subject, including uncertainty as to whether the FDA or other applicable regulatory agencies will permit the Company to continue clinical testing in NCL or in future clinical trials of proposed therapies for other diseases or conditions despite the novel and unproven nature of the Company’s technologies; uncertainties regarding the Company’s ability to obtain the increased capital resources needed to continue its current research and development operations and to conduct the research, preclinical development and clinical trials necessary for regulatory approvals; uncertainty regarding the validity and enforceability of the Company’s patents; uncertainty as to whether HuCNS-SC and any products that may be generated in the future in the Company’s cell-based programs will prove safe and clinically effective and not cause tumors or other adverse side effects; uncertainties regarding the Company’s manufacturing capabilities given its increasing preclinical and clinical commitments; uncertainties as to whether the Company will achieve revenues from product sales or become profitable; and other factors that are described under the heading “Risk Factors” in Item 1A of Part II of the Company’s Annual Report on Form 10-K.
StemCells, Inc.
Rodney Young, 650-475-3100, ext. 105
Chief Financial Officer
irpr@stemcellsinc.com
