Thallion Pharmaceuticals and LFB Biotechnologies Today Announced the Initiation of a Phase II Trial (SHIGATEC Trial) in South America Evaluating Shigamabs® as a Treatment for Shigatoxin-Producing E. Coli (Stec) Infections
MONTREAL, QUEBEC, CANADA | November 29, 2010 | Thallion Pharmaceuticals Inc. (TSX:TLN – News) and LFB Biotechnologies (LFB) Today Announced the Initiation of a Phase Ii Trial (SHIGATEC Trial) in South America Evaluating Shigamabs® as a Treatment for Shigatoxin-Producing E. Coli (Stec) Infections. the Timing of the Phase Ii Clinical Trial Coincides With the Seasonal High Period for Stec Infections in the Southern Hemisphere. the Study Will Comprise Up to 18 Clinical Sites in Argentina, Chile and Peru.
"Since signing the licensing agreement with LFB last February, our primary development goal was to get Shigamabs® back into the clinic before year end and maximize recruitment during the high incidence season in South America," said Dr. Allan Mandelzys, Chief Executive Officer of Thallion Pharmaceuticals Inc. "STEC infection is a completely unmet medical need that affects more than 300,000 people in the industrialized world annually. No approved therapies exist today, with the current standard of care being to hydrate and then wait for disease progression. Our novel, dual-antibody approach has the potential to be the first treatment to address this patient population."
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 will compare standard of care combined with a low dose of Shigamabs® (1 mg/kg) versus standard of care with placebo, followed by an interim analysis of data for safety conducted by an Independent Data Monitoring Committee (IDMC). Following a positive recommendation to proceed by the IDMC, the second cohort will compare standard of care combined with a high dose of Shigamabs® (3 mg/kg) 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. Data from the core study is expected within 9-12 months, with long term safety data available after a one year follow-up period (extension phase).
About Thallion Pharmaceuticals Inc.
Thallion Pharmaceuticals Inc. (TSX:TLN – 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.
About LFB
LFB is a French biopharmaceutical group that develops, manufactures and commercializes medicinal products for the treatment of serious and often rare diseases in the following main therapeutic fields: Immunology, Hemostasis and Intensive Care. The LFB group is the number one manufacturer of plasma-derived medicinal products in France and 6th worldwide and via its subsidiary: LFB Biotechnologies; LFB is also among the leading European companies in the development of monoclonal antibodies and new-generation proteins based on biotechnologies.
In 2009, LFB devoted 76 million Euros to research and development, 20% of its total turnover of 376 million Euros. The LFB Group is directed by Christian Bechon and has 1700 employees.
SOURCE: Thallion Pharmaceuticals Inc.
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Thallion Pharmaceuticals and LFB Biotechnologies Today Announced the Initiation of a Phase II Trial (SHIGATEC Trial) in South America Evaluating Shigamabs® as a Treatment for Shigatoxin-Producing E. Coli (Stec) Infections
MONTREAL, QUEBEC, CANADA | November 29, 2010 | Thallion Pharmaceuticals Inc. (TSX:TLN – News) and LFB Biotechnologies (LFB) Today Announced the Initiation of a Phase Ii Trial (SHIGATEC Trial) in South America Evaluating Shigamabs® as a Treatment for Shigatoxin-Producing E. Coli (Stec) Infections. the Timing of the Phase Ii Clinical Trial Coincides With the Seasonal High Period for Stec Infections in the Southern Hemisphere. the Study Will Comprise Up to 18 Clinical Sites in Argentina, Chile and Peru.
"Since signing the licensing agreement with LFB last February, our primary development goal was to get Shigamabs® back into the clinic before year end and maximize recruitment during the high incidence season in South America," said Dr. Allan Mandelzys, Chief Executive Officer of Thallion Pharmaceuticals Inc. "STEC infection is a completely unmet medical need that affects more than 300,000 people in the industrialized world annually. No approved therapies exist today, with the current standard of care being to hydrate and then wait for disease progression. Our novel, dual-antibody approach has the potential to be the first treatment to address this patient population."
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 will compare standard of care combined with a low dose of Shigamabs® (1 mg/kg) versus standard of care with placebo, followed by an interim analysis of data for safety conducted by an Independent Data Monitoring Committee (IDMC). Following a positive recommendation to proceed by the IDMC, the second cohort will compare standard of care combined with a high dose of Shigamabs® (3 mg/kg) 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. Data from the core study is expected within 9-12 months, with long term safety data available after a one year follow-up period (extension phase).
About Thallion Pharmaceuticals Inc.
Thallion Pharmaceuticals Inc. (TSX:TLN – 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.
About LFB
LFB is a French biopharmaceutical group that develops, manufactures and commercializes medicinal products for the treatment of serious and often rare diseases in the following main therapeutic fields: Immunology, Hemostasis and Intensive Care. The LFB group is the number one manufacturer of plasma-derived medicinal products in France and 6th worldwide and via its subsidiary: LFB Biotechnologies; LFB is also among the leading European companies in the development of monoclonal antibodies and new-generation proteins based on biotechnologies.
In 2009, LFB devoted 76 million Euros to research and development, 20% of its total turnover of 376 million Euros. The LFB Group is directed by Christian Bechon and has 1700 employees.
SOURCE: Thallion Pharmaceuticals Inc.
Post Views: 111
