Thallion announces first patient enrolled in high dose cohort of phase II Shigatec trial - Published on 05/30/2011
Montréal, Les Ulis, May 30, 2011 – Thallion Pharmaceuticals Inc. (TSX: TLN) and LFB Biotechnologies today announced the enrollment of the first patient in the high dose cohort of the Company’s Phase II SHIGATEC trial. The high dose cohort (3 mg/kg/dose) is expected to enroll 21 patients which will complete the Phase II trial evaluating Shigamabs® as a treatment for Shiga toxin-producing E. coli (STEC) infection. The Company anticipates top line results to be available prior to the end of the year.
“Following the positive recommendation from the IDMC after the low dose cohort and the resumption of patient enrollment in our SHIGATEC trial, we continue to push forward with the clinical development of our novel Shigamabs® treatment. Shigamabs® represents the most advanced clinical treatment in development for the prevention of a condition in which the current standard of care is simply to hydrate, wait and then monitor disease progression,” said Dr. Allan Mandelzys, Chief Executive Officer of Thallion Pharmaceuticals Inc.
“We believe a clear medical need exists for the treatment of STEC infections, and the recent German outbreak, where approximately 300 cases of haemolytic uraemic syndrome (HUS) and 10 deaths have been reported, is an unfortunate reminder of that,” said Guillaume Bologna executive Vice-President for Development Programs of LFB Biotechnologies.
About the SHIGATEC Trial
The randomized, double-blind, placebo-controlled trial will enroll 42 patients, aged six months to 18 years testing positive for STEC infection, distributed in two cohorts. The first cohort compares standard of care combined with a low dose of Shigamabs®
(1 mg/kg/dose) versus standard of care with placebo. The second cohort will compare standard of care combined with a high dose of Shigamabs® (3 mg/kg/dose) versus standard of care with placebo. The primary endpoints for the Phase II trial are safety and tolerability. Secondary endpoints include pharmacokinetics and objective measures of efficacy using single and composite endpoints.
Shigamabs® consists of two monoclonal antibodies designed to bind specifically and exclusively to the Shiga toxin 1 and Shiga toxin 2 toxins secreted by Shiga toxin-producing E. coli bacteria. STEC infections are primarily foodborne bacterial infections that cause serious health complications, particularly in young children and the elderly, and affect approximately 314,000 people annually in the industrialized world. There are no approved products available for the treatment of STEC infections. The Shigamabs® antibodies, administered as a single intravenous injection, bind to their respective toxin and neutralize them by forming a complex that is absorbed and destroyed by the liver and spleen. The dual antibody approach enables Shigamabs® to address STEC infections caused by E. coli secreting either Shiga toxin 1, Shiga toxin 2 or both Shiga toxins. Shigamabs® has obtained orphan drug designation both in the U.S. and in Europe.
About Thallion Pharmaceuticals Inc.
Thallion Pharmaceuticals Inc. (TSX: TLN) is a biotechnology company developing pharmaceutical products in the areas of infectious disease and oncology. The Company’s clinical programs include Shigamabs® and TLN-4601, a novel anti-cancer therapy. Shigamabs® is a dual antibody product being evaluated in a Phase II clinical trial for the treatment of Shiga toxin-producing E. coli bacterial infections. Additional information about Thallion can be obtained at www.thallion.com.
LFB is a biopharmaceutical group that develops, manufactures and markets medicinal products for the treatment of serious and often rare diseases in several major therapeutic fields, namely Hemostasis, Immunology and Intensive Care. The LFB Group is the leading manufacturer of plasma-derived medicinal products in France and 6th worldwide and is also among the leading European companies for the development of monoclonal antibodies and new-generation proteins based on biotechnologies. With its strong focus on research, the LFB Group is pursuing a growth strategy that seeks to extend its activities at the international level and develop innovative therapies. In 2010, the LFB Group reported total turnover of 411.6 million euros, up 9.6%, and invested 86.5 million euros in product development. The LFB Group markets its products in 20 countries around the world.
This press release contains certain forward-looking statements, including, without limitation, statements containing the words "believe", "may", "plan", "will", "estimate", "continue", "anticipate", "intend", "expect" and other similar expressions which constitute "forward-looking information" within the meaning of applicable Canadian securities laws. Forward-looking statements reflect Thallion's current expectation and assumptions, and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated. These forward-looking statements involve risks and uncertainties including, but not limited to, the determination of the level of the TLN-232 licensor’s damages by the Arbitral Tribunal as part of the final award, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time-to-time in Thallion's ongoing filings with the Canadian securities regulatory authorities which filings can be found at www.sedar.com. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. Thallion undertakes no obligation to publicly update or revise any forward-looking statements either as a result of new information, future events or otherwise, except as required by applicable Canadian securities laws.
For further information contact:
Thallion Pharmaceuticals Inc.
Chief Financial Officer
Phone: (514) 940-3600
Fax: (514) 228-3622
The Equicom Group Inc.
Phone: (416) 815-0700 (Ext. 238)
Fax: (416) 815-0080
+33 1 69 82 72 80