Business Wire - May 18, 2000
SYNSORB also received a Notice of Allowance from the USPTO on March 30, 2000 on an additional US patent application containing claims to pharmaceutical composition of matter for treatment of C. difficile toxin B associated conditions.
"The issued patent and Notice of Allowance offers additional coverage to SYNSORB's intellectual property base with respect to the treatment of recurrent Clostridium difficile associated diarrhea," said Dr. David Cox, President and CEO of SYNSORB. "We remain committed to developing the first satisfactory treatment for recurrent CDAD and will continue to improve our technologies to offer the best possible treatments for sufferers of this debilitating disease."
Recurrent CDAD is a common hospital-acquired infection usually associated with antibiotic use, AIDS and chemotherapy. The most severe form of the disease affects upwards of 800,000 patients each year worldwide. There is currently no satisfactory treatment for those patients suffering from Recurrent CDAD, and SYNSORB Cd(R) is the most advanced of any product under development. SYNSORB Cd(R) has been designated "Fast Track" by the US FDA, a special designation granted only to those products that are intended to treat serious or life-threatening conditions, and for which there is an unmet medical need.
Phase III clinical trials for SYNSORB Cd(R) began with the enrollment of the first patient announced in early April. There has been a very enthusiastic response from potential sites that want to participate in these trials, and SYNSORB has secured close to the 120 sites targeted for the trials.
The interim analysis on the SYNSORB Pk(R) Phase III data continues, and information regarding this analysis is expected by the end of the second quarter of 2000.
SYNSORB is a Canadian-based pharmaceutical company dedicated to drug development and manufacturing. The Company's two late-stage products have been granted "Fast Track" designation by the FDA and are both based on SYNSORB's proprietary carbohydrate chemistry platform technology. SYNSORB Pk(R) 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 Cd(R) is a potential treatment for recurrent C. difficile antibiotic associated diarrhea (CDAD), a common hospital acquired infection. 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 SYNSORB's carbohybrid program.
Shares of SYNSORB Biotech Inc. trade on the Toronto Stock Exchange in Canada (symbol "SYB") and on NASDAQ in the United States (ticker "SYBB").
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 other 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.
CONTACT: SYNSORB Biotech Inc. Cindy Gray, 403/270-1315 Fax: 403/283-5907 E-mail: Cgray@synsorb.com URL: www.synsorb.com or The Equicom Group Jason Hogan, 416/815-0700, ext. 222 Fax: 416/ 815-0080 E-mail: Jhogan@equicomgroup.com
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