NEWARK, Calif., Feb. 12, 2014 (GLOBE NEWSWIRE) -- StemCells, Inc. (Nasdaq:STEM) announced today that it has completed enrollment of the first of two planned patient cohorts in the Company's clinical trial of its proprietary HuCNS-SC ® product candidate (purified human neural stem cells) for dry age-related macular degeneration (AMD). This cohort consisted of eight subjects, four of whom each received 200,000 cells and four of whom each received 1,000,000 cells. The last patient in this cohort was transplanted by Dr. Ted Leng, M.D. Director of Ophthalmic Diagnostics at the Byers Eye Institute at Stanford. "Our immediate goal for the study in the next quarter is to complete enrollment of the second cohort. The eight patients in this stage of the trial will have better visual acuity than those in the first cohort," said Stephen Huhn, M.D., FACS, FAAP, Vice President, CNS Clinical Research at StemCells, Inc. "We are expanding the trial from two sites at the beginning to ultimately a total of five sites, and with additional sites actively evaluating patients, the second cohort should be completed by mid-year. We also expect to announce interim follow-up data on the first cohort later this year. Following enrollment of the second cohort, we expect to initiate a controlled phase II efficacy proof-of-concept study by year end." About Age-Related Macular Degeneration Age-related macular degeneration refers to a loss of photoreceptors (rods and cones) from the macula, the central part of the retina. AMD is a degenerative retinal disease that typically strikes adults in their 50s or early 60s and gradually progresses to destroy central vision. According to the Foundation Fighting Blindness website, an estimated 10 million people in the U.S. either have AMD or are at substantial risk for receiving the diagnosis. Overall, about 85% of patients with AMD suffer from the dry form of the disease, and the advanced dry form of AMD is referred to as Geographic Atrophy.
About the TrialThe Phase I/II trial will evaluate the safety and preliminary efficacy of HuCNS-SC cells as a treatment for dry AMD. The investigation will be divided into two sequential cohorts. Subjects will be enrolled into each cohort based on best-corrected visual acuity (BCVA) visual acuity as determined by the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) acuity test. BCVA of less than or equal to 20/400 in the Study Eye will be enrolled in Cohort I. Subjects with BCVA of 20/320 to 20/100 in the Study Eye will be enrolled in Cohort II. Cohort I will consist of four subjects who will undergo transplant with 200,000 cells followed by four subjects who will undergo transplant with 1 million cells. Cohort II will consist of 8 subjects who will undergo transplant with 1 million cells. The HuCNS-SC cells will be administered by a single injection into the space behind the retina in the most affected eye. Patients' vision will be evaluated using both conventional and advanced state-of-the-art methods of ophthalmological assessment. Evaluations will be performed at predetermined intervals over a one-year period to assess safety and signs of visual benefit. Patients will then be followed for an additional four years in a separate observational study. The trial is currently enrolling patients at four centers: Retina Foundation of the Southwest, Dallas, TX; Byers Eye Institute at Stanford, Stanford Hospital and Clinics; Palo Alto, CA; New York Eye and Ear Infirmary, New York City, NY; and Retina Research Institute of Texas, Abilene, TX. Patients who are interested in participating in the study should contact the Retina Foundation of the Southwest at 214-363-3911, Byers Eye Institute at 650-498-4486, the New York Eye and Ear Infirmary at 212-979-4251, or the Retina Research Institute of Texas at 325-690-4414. Information about the Company's Dry Age Related Macular Degeneration program can be found on the StemCells, Inc. website at:
CONTACT: Greg Schiffman StemCells, Inc. Chief Financial Officer (510) 456-4128 Andrea Flynn Russo Partners (646) 942-5631