StemCells, Inc.'s Spinal Cord Injury Trial Approved by Health Canada
Trial Open to Patients With Complete or Incomplete Injury
NEWARK, Calif., June 3, 2013 (GLOBE NEWSWIRE) -- StemCells, Inc. (Nasdaq:STEM) today announced that Health Canada has authorized the Company to expand its Phase I/II clinical trial for chronic spinal cord injury into Canada. The Phase I/II trial, currently underway in Zurich, Switzerland, is designed to evaluate the safety and preliminary efficacy of the Company's proprietary HuCNS-SC® product candidate (purified human neural stem cells) as a treatment for chronic spinal cord injury. With this authorization from Health Canada, the Company is actively working to open one or more trial sites in Canada and begin screening patients.
"This should be very welcome news for spinal cord injury patients in North America," said Stephen Huhn, MD, FACS, FAAP, Vice President and Head of the CNS Program at StemCells, Inc. "One of the patients in our trial is a Canadian and he endured some challenging logistics to get to and from Switzerland. The addition of sites located in North America will significantly ease the burden on Canada- and US-based patients and their families who may wish to participate in our trial.
"In addition, given the excellent safety profile and encouraging results seen to date in the three patients with complete injury, we have amended the clinical protocol to allow continued enrolment of patients with complete injury in addition to patients with the less severe, or incomplete injury. We are confident that the amended protocol combined with the addition of North American trial sites will accelerate enrollment of patients with varying degrees of spinal cord injury."
To date, four patients have been enrolled in the Company's Phase I/II trial and transplanted with HuCNS-SC cells. The first three patients had all suffered a complete injury to the thoracic (chest-level) spinal cord, classified as AIS A according to the American Spinal Injury Association Impairment Scale (AIS). In a complete injury, there is no neurological function below the level of injury, and sensory function of all three patients was stable before transplantation of the HuCNS-SC cells. The first three patients completed the trial in December 2012 and data from these patients showed multi-segment gains in sensory function in two patients twelve months post-transplantation of the HuCNS-SC cells. One of these two patients converted from a complete injury classification to an incomplete injury, while the third patient remained stable. Unlike the first three patients, the fourth patient in the study had suffered an incomplete injury, classified as AIS B, because of preserved sensory function below the level of injury.
About the Spinal Cord Injury Clinical Trial
The Phase I/II clinical trial of the Company's HuCNS-SC cells is designed to assess both safety and preliminary efficacy. The Company anticipates twelve patients with thoracic (chest-level) neurological injuries at the T2-T11 level will be enrolled. The trial is open to patients in Europe and North America with a complete or incomplete injury classified according to the American Spinal Injury Association Impairment Scale. In a complete injury, there is no neurological function below the level of injury, while in an incomplete injury, there is some preservation of function below the level of injury.
All patients who enroll will receive HuCNS-SC cells through direct transplantation into the spinal cord and will be temporarily immunosuppressed. Patients will be evaluated regularly in the post-transplant period in order to monitor and assess the safety of the HuCNS-SC cells, the surgery and the immunosuppression, as well as to measure any change in neurological function below the injury site. Preliminary efficacy will be evaluated based on defined clinical endpoints, such as changes in sensation, motor function and bowel/bladder function. The Company intends to follow the effects of this therapy long-term, and each of the patients will be invited to enroll into a separate four-year observational study after completing the Phase I/II study.
The trial is currently being conducted at Balgrist University Hospital, University of Zurich, a world-leading medical center for spinal cord injury and rehabilitation. If you believe you may qualify and are interested in participating in the study, please contact the study nurse either by phone at +41 44 386 39 01 or by email at firstname.lastname@example.org. The Company is working to open trial sites in Canada.
Information about the clinical trial is available at the ClinicalTrials.gov website of the National Institutes of Health at http://www.clinicaltrials.gov/ct2/show/NCT01321333?lead=StemCells+Inc.&rank=4. Additional information about the Company's spinal cord injury program can be found on the StemCells, Inc. website at http://www.stemcellsinc.com/Therapeutic-Programs/Clinical-Trials.htm and at http://www.stemcellsinc.com/Therapeutic-Programs/Spinal-Cord-Injury.htm.
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® cells (purified human neural stem cells), is currently in development as a potential treatment for a broad range of central nervous system disorders. In a Phase I clinical trial in Pelizaeus-Merzbacher disease (PMD), a fatal myelination disorder in children, the Company has shown preliminary evidence of progressive and durable donor-derived myelination in all four patients transplanted with HuCNS-SC cells. The Company is also conducting a Phase I/II clinical trial in chronic spinal cord injury in Switzerland and has reported positive interim data for the first three patients. The Company has also initiated a Phase I/II clinical trial in dry age-related macular degeneration (AMD), and is pursuing preclinical studies in Alzheimer's disease. StemCells also markets stem cell research products, including media and reagents, under the SC Proven® brand. Further information about StemCells is available at http://www.stemcellsinc.com.
Apart from statements of historical fact, the text of this press release constitutes forward-looking statements within the meaning of the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended, and is subject to the safe harbors created therein. These statements include, but are not limited to, statements regarding whether the improvements in sensory function seen in the Company's Phase I/II clinical study of spinal cord injury will persist and whether they will prove to be clinically meaningful; continued authorization to conduct a clinical trial in Switzerland and Canada in chronic spinal cord injury; the timing and prospect of securing clinical trial sites in Canada to conduct the Company's Phase I/II trial in spinal cord injury; the prospect for screening and then enrolling additional patients with incomplete spinal cord injury; the prospect for evaluating trial patients for changes in their sensation, motor function and bowel/bladder function; the potential of the Company's HuCNS-SC cells to treat spinal cord injury and other central nervous system disorders; and the future business operations of the Company. 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 the fact that additional trials will be required to demonstrate the safety and efficacy of the Company's HuCNS-SC cells for the treatment of any disease or disorder; uncertainty as to whether the FDA, Health Canada or other applicable regulatory agencies will permit the Company to continue clinical testing in spinal cord injury or in future clinical trials of proposed therapies for other diseases or conditions; uncertainties regarding the ability of preclinical research, including research in animal models, to accurately predict success or failure in clinical trials; uncertainties regarding the Company's ability to recruit the patients required to conduct its clinical trials or to obtain meaningful results; uncertainties regarding the Company's ability to obtain the increased capital resources needed to continue its current and planned research and development operations; uncertainty as to whether HuCNS-SC cells 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 ability to commercialize a therapeutic product and its ability to successfully compete with other products on the market; and other factors that are described under the heading "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2012, and in its subsequent reports on Form 10-Q and Form 8-K.
CONTACT: Rodney Young StemCells, Inc. Chief Financial Officer (510) 456-4128 Ian Stone Russo Partners (619) 308-6541