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           January 29, 2010
November 25, 2009
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Human Health News ReleaseResults of Independent European Study on Cystistat®
02/06/03 BELLEVILLE ON, June 2, 2003 – At the annual meeting of the American Society of Clinical Oncology in Chicago, Illinois this week, Principal Investigator Dr. José M. Delgado of the Hospital Militar Gomez Ulla, Servicio de Oncologia Radioterapica in Madrid, Spain, presented results of an independent study designed to assess the efficacy of Hyaluronic Acid (Cystistat®) bladder instillation on radiation-induced toxicity in cystitis patients. The study was conducted in the largest specialized radiotherapy department in the Spanish military hospital network, and involved 90 patients with cervical or uterine cancer. A first group of 45 patients received usual care treatment, while a second group of 45 patients received usual care treatment plus Cystistat® bladder instillations. Evaluation was done in both groups at baseline, weekly for four weeks, and monthly for three months. The study results indicated radiotherapy toxicity was greatly reduced by Cystistat® as of the third week and throughout the duration of the treatment. The majority of Cystistat®-treated patients -- 71 percent -- were without symptoms at week 12, compared with 38 percent of the usual care patient group. The difference was statistically significant. No side effects or discomfort to the patients receiving Cystistat® in the treatment protocol were reported. “Further studies are planned to confirm the efficacy of Cystistat® for the prevention of radiation-induced cystitis,” said Marc Rivière, Senior Vice President and Chief Medical Officer for Bioniche Life Sciences. “However, Dr. Delgado concluded the results reported at ASCO indicate that weekly instillations of Cystistat® protected the bladder, decreased radiation-induced toxicity as well as the risk of infection, and helped to enhance the patients’ quality of life.” “It is gratifying for us to see the results of this independent study,” said Graeme McRae, President and CEO of Bioniche Life Sciences. “Cystistat® is an important component of our urology platform, and it is being increasingly recognized as an effective treatment for many patients suffering from this debilitating disease.” Cystistat® is a sterile Hyaluronic Acid solution specifically formulated for bladder instillations. Cystistat® is currently marketed in over 20 countries, including Europe and Canada, as a medical device indicated for the temporary replacement of the glycosaminoglycan (GAG) layer in the bladder. A pivotal trial has recently been completed for registration of Cystistat® in the United States. Analysis of the trial data is underway.
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