MONTREAL, CANADA and LES ULIS, FRANCE--(Marketwire -05/09/12)- Thallion Pharmaceuticals Inc. (TLN.TO) and LFB Biotechnologies announced that, earlier today, positive top-line results from the Phase II SHIGATEC trial evaluating the Company's Shigamabs® drug candidate as a treatment for Shiga toxin-producing E. coli (STEC) infection were presented at the 8th International Symposium on Shiga Toxin (Verocytotoxin)-Producing Escherichia coli Infections (VTEC 2012) in Amsterdam, The Netherlands.
Based on core Phase II data, the study has met its primary endpoint of safety and tolerability in a STEC-infected pediatric population.
STEC infection remains a significant public health concern, as highlighted by last year's German outbreak in which over 4,000 infections and 50 deaths were reported. There are presently no drugs approved for treating STEC infections or their associated medical complications. Shigamabs® uses a proven anti-toxin approach to neutralize the two types of toxins secreted by pathogenic E. coli with the intent of preventing the incidence and/or reducing the severity of a life-threatening disease called hemolytic uremic syndrome (HUS). An additional benefit of this anti-toxin approach is that it is bacterial strain independent.
The randomized, double-blind, placebo-controlled Phase II SHIGATEC Trial enrolled 45 patients, aged six months to 18 years and testing positive for STEC infection, in two cohorts. The first cohort compared standard of care combined with a low dose of Shigamabs® (1 mg/kg/dose) versus standard of care with placebo. The second cohort compared standard of care combined with a high dose of Shigamabs® (3 mg/kg/dose) versus standard of care with placebo. As expected from published epidemiology data, most patients (60%) enrolled in the study were under the age of 2.
In the SHIGATEC trial, Shigamabs® appears to be well tolerated and no drug-related adverse events were observed. This is consistent with the safety profile determined in the four previous Phase I studies in healthy adult volunteers. An independent data monitoring committee will conduct a thorough review of the core safety data and will continue to monitor safety throughout the one year extension phase of the study. As expected, given the small size of the trial, there were no statistically significant trends in efficacy; however, data analysis is ongoing.
"As the SHIGATEC trial was our first study conducted in the at risk pediatric population, confirming safety was our primary objective", said Dr. Allan Mandelzys, Thallion's Chief Executive Officer. "Having achieved that, once the SHIGATEC trial data are fully analyzed, we plan on meeting with key regulators to present the results and obtain guidance on the next phase of clinical development."
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. (TLN.TO) 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.
- Shiga Toxin