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Technology Stocks : SYNSORB (T.SYB)(SYBBF) CURE FOR CANCER? -- Ignore unavailable to you. Want to Upgrade?

To: Tupulak who wrote (80)	11/1/1999 8:42:00 AM
From: Tupulak	Read Replies (1) \| Respond to of 164

November 1/99 SYNSORB Biotech Inc. Announces Company Receives Final Interim Analysis Report for SYNSORB Cd(R) Phase II Clinical Trial CALGARY, ALBERTA-- Company also reports on progress of SYNSORB Cd(R) clinical development plan SYNSORB Biotech Inc. ("SYNSORB") (TSE: SYB, Nasdaq: SYBB) after receiving the final report on the interim analysis of the SYNSORB Cd(R) Phase II clinical trial, reports on the Company's recent progress in the development of SYNSORB Cd(R) for the treatment of recurrent Clostridium difficile Associated Diarrhea (CDAD). The primary objective and expectation of the Phase II trial was to determine whether SYNSORB Cd(R) could reduce the recurrence rate in CDAD patients by 50%. In fact, the final report on the interim analysis of the first 103 patients has confirmed that the group receiving a 16g/day dose of SYNSORB Cd(R) experienced a very significant 80% reduction in the rate of recurrence compared to the group who received the placebo. SYNSORB began to plan and implement its clinical development strategy immediately upon releasing the preliminary interim analysis data on September 13, 1999. Recruitment into the Phase II trial was halted the same day, much sooner than expected owing to the exceptional results, and planning for pivotal Phase III trials to support a New Drug Application (NDA) began immediately. Execution of the development plan for SYNSORB Cd(R) is well underway. The required meetings with regulatory authorities in Canada and the US have been scheduled, sites have been recruited, bids from potential Clinical Research Organizations (CRO's) to assist with monitoring the trials are being reviewed and details of the SYNSORB Cd(R) Phase III clinical trial protocol are in the final stages of review. Before the end of 1999, SYNSORB intends to file this protocol and seek approval to begin the Phase III tests. Once approval is granted, it is expected that patient enrollment will commence in the first half of 2000. In the meantime, approval by Internal Review Boards at the sites will be sought. Manufacturing of clinical trial batches of SYNSORB Cd(R) has already begun at SYNSORB's new cGMP manufacturing facility in Calgary. The compelling nature of the Phase II data has allowed SYNSORB to commence negotiations with candidates for marketing and distribution partnerships (for jurisdictions outside of Canada). The potential size of the market is such that it has captured the attention of large pharmaceutical companies. "SYNSORB is committed to expedited clinical development of SYNSORB Cd(R) and pleased to communicate our progress to shareholders," said Dr. David Cox, President & CEO of SYNSORB. "Careful planning for SYNSORB Cd(R) development is enabling us to proceed as efficiently and quickly as possible through the required steps in order to begin pivotal Phase III trials. We intend to continue this approach through the development program. Concurrently, we also continue to actively recruit patients into our SYNSORB Pk(R) Phase III trial for the prevention of HUS." Primary CDAD is a common disease, which can affect people undergoing antibiotic therapy, hospitalized patients, or otherwise immunocompromised individuals. An estimated 3.5 million North Americans suffer annually from this disease. In a percentage of primary CDAD patients, the disease can recur after the first instance is successfully treated. This recurrent form is thought to affect approximately 700,000 individuals per year in North America. In most cases of recurrent CDAD, available therapies are of limited value and in many cases, the prognosis can be poor. It is widely accepted that there is a clear unmet medical need for a treatment of the recurrent form of CDAD. SYNSORB is a Canadian-based pharmaceutical company dedicated to drug development and manufacturing. The Company has two late-stage products, both of which are based on SYNSORB's proprietary carbohydrate chemistry platform technology. As well as SYNSORB Cd(R), SYNSORB Pk(R) is also in Phase III clinical trials, and is designed to prevent the progression to Hemolytic Uremic Syndrome (HUS) in children who have contracted verotoxigenic E. coli (VTEC) infections, including E. coli O157:H7. SYNSORB has built a cGMP-compliant manufacturing facility that has the capacity to meet or exceed the expected global demand for the Company's products. A pipeline of future products is accessible through affiliated companies and SYNSORB's carbohybrid program. This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company's control which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or expectations implied by these forward-looking statements. These factors include results of current or pending clinical trials, actions by the FDA/HPB and those factors detailed in the Company's registration statement on Form 20 F filed with the Securities and Exchange Commission. -30- FOR FURTHER INFORMATION PLEASE CONTACT: The Equicom Group Jason Hogan Investor Relations (416) 815-0700 ex 222 (416) 815-0080 (FAX) United States: 800-385-5451 jhogan@equicomgroup.com or SYNSORB Biotech Inc. Cindy Gray Investor Relations (403) 270-1315 (403) 283-5907 (FAX) synsorb.com or SYNSORB Biotech Inc. Mr. Doug Froom Vice President Business Development (403) 283-5900 (403) 283-5907 (FAX) dfroom@synsorb.com For product licensing inquiries