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Fellow ListMembers - I thought this would be of interest to the group. As most of you probably know, I am 1 of the 12 patients in the first phase of this study. It offers great hope to all of us! My 15-month evaluation is in the next few weeks and, as always, I will report the results to you. For those who have not read my previous postings, I will gladly E-Mail them to you if requested. Jim Finn 49 / 18 START***** Genzyme Corporation - Investor Information - Press Releases - Tissue Repair Division Genzyme Tissue Repair, Diacrin Announce NeuroCell-PD Phase I Results September 29, 1997 Genzyme Tissue Repair (Nasdaq:GENZL) and Diacrin Inc. (Nasdaq:DCRN) announced today that their NeuroCell-PD porcine neural cell product for transplantation into people with advanced Parkinson's disease was well tolerated in patients treated with the therapy in a phase I study. The study results, presented Sunday at a medical symposium in San Diego, also showed evidence of clinical improvement in patients who were treated with NeuroCell-PD. In the study's 10 evaluable patients who were measured at a time when their L-dopa medication was wearing off, preliminary data indicated an average improvement of 13.2 points at six months after surgery on a standardized scale that measures a patient's ability to perform a variety of movements. This result was statistically significant, compared to an evaluation that was taken prior to surgery. "It's a good start for us," said study presenter Samuel Ellias, M.D, Ph.D., assistant professor of neurology at Boston University Medical Center. "One patient has been followed for more than two years now, and has not had any significant adverse effects from the surgery. We're looking forward to finding out how much potential this promising treatment holds for Parkinson's disease patients." Based on these results, the companies plan to start a pivotal phase II trial later this year. Although there have not been any absolute epidemiologic studies on Parkinson's disease, medical experts believe that approximately 500,000 Americans have Parkinson's disease, and another 50,000 cases are diagnosed each year. Patients experience a variety of motor symptoms, including tremors, falls, rigidity, slowed movements, and difficulties with speech and swallowing. Therapy with the drug L-dopa is initially effective but begins to lose its efficacy in 6 to 12 years. Medical experts believe that approximately 150,000 people in the United States are in the late stages of the disease, during which L-dopa provides a diminishing benefit. The resulting medical expenses, early retirement, and nursing home care cost $5.6 billion a year. Study Results In the phase I study, 12 patients with moderate to severe Parkinson's disease received a transplant of porcine cells into three sites in the brain located just below the cortex, which is involved with smoothing and coordinating movement. Half of the patients received the drug cyclosporine to suppress the immune system to avoid rejection of the transplant. The other 6 patients received a new technology in which the donor cells are treated prior to transplantation so that the patient's immune system does not recognize them as foreign and thus, does not attack them. The patients were evaluated both before and after surgery using a standardized scale for measuring a patient's ability to perform several different types of movement, timed movement tests, and neuropsychological tests. Patients were measured when their L-dopa medication was working and when its therapeutic effects had worn off. Two of the patients were too sick to be evaluated properly before surgery and therefore were not included in the group data. There were no serious adverse events or decrements in neuropsychological tests attributable to the porcine cells. In addition to the preliminary efficacy shown at 6 months, the two evaluable patients at 15 months after surgery showed an average improvement of 29 points when their L-dopa medication was wearing off. The first patient to be treated was followed for 24 months and showed improvement of greater than 45 points, both when the L-dopa medication was working as well as when it was wearing off. One of the patients died suddenly of a pulmonary embolism (which was not related to the transplant) 7 months after surgery. Histological studies of the patient showed that the porcine cells survived and showed signs of reconnecting nerve tissue damaged by the disease. The histological results were published in the March 1997 issue of Nature Medicine. The study sites for the trial were Boston University Medical Center and the Lahey-Hitchcock Clinic, both located in the Boston area. Diacrin develops and produces transplantable porcine cells for the treatment of intractable human diseases characterized by cell dysfunction or cell death. Product candidates in preclinical development include NeuroCell-FE for focal epilepsy, NeuroCell-CD for cognitive disorders, HepatoCell for liver failure and hypercholesterolemia, and CardioCell for repair of damaged heart muscle. Genzyme Tissue Repair is a leading developer of biological products for the treatment of cartilage damage, severe burns, chronic skin ulcers, and neurodegenerative diseases. It is a division of Genzyme Corp. and has its own common stock intended to reflect its value and track its performance. Last year, Genzyme Tissue Repair and Diacrin formed a 50-50 joint venture, Diacrin/Genzyme LLC, to speed the development and commercialization of NeuroCell-PD and NeuroCell-HD for the treatment of Huntington's disease, which is currently in a phase I clinical trial. This news release contains a forward-looking statements about the potential market size for NeuroCell-PD and the planned start of a pivotal trial of NeuroCell-PD. The actual market size may differ, depending on the accuracy of the company's information about the prevalence of advanced Parkinson's disease. The planned timing of the pivotal trial may vary, depending on the schedule of implementation at the various clinical trial sites. END*****