MONTREAL, QUEBEC and LES ULIS, FRANCE--(Marketwire -01/09/12)- Thallion Pharmaceuticals Inc. (TSX: TLN.TO - News) and LFB Biotechnologies announced today that they have completed patient enrollment for the high dose cohort (3 mg/kg) of the Phase II SHIGATEC trial, evaluating Shigamabs® as a treatment for Shiga toxin-producing E. coli (STEC) infection.
"The timely completion of patient recruitment and the two month patient follow up sets the stage for reporting top line SHIGATEC results early in the second quarter," said Dr. Allan Mandelzys, Thallion's Chief Executive Officer. "With the achievement of this significant milestone, we are now focused on moving forward with our anticipated Phase III clinical trial."
"We remain excited about the potential Shigamabs® represents in delivering an important therapy to the thousands of people who suffer from this terrible and potentially life-threatening infection each year" said Guillaume Bologna, Executive Vice-President for Development Programs of LFB Biotechnologies.
About the SHIGATEC Trial
The randomized, double-blind, placebo-controlled trial enrolled 45 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 compares 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 infusion, 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.TO - News) 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.