Trial Receives Positive Review from Independent Data Monitoring Committee
MONTREAL, QUEBEC, CANADA | May 16, 2011 | Thallion Pharmaceuticals Inc. (TSX:TLN – News) today announced that the Independent Data Monitoring Committee (IDMC) for the Company’s Phase II SHIGATEC trial has completed a planned safety analysis and recommends that the trial continue as per the protocol. This scheduled review by the IDMC occurred after the treatment and 56-day follow-up of the 22 patients that received the low dose treatment (1 mg/kg/dose) in the first cohort of the trial. The purpose of the IDMC is to provide objective, independent safety monitoring of the SHIGATEC trial, a study evaluating Shigamabs® as a treatment for Shiga toxin-producing E. coli (STEC) infection.
Thallion has advised its clinical sites to initiate enrollment of the second, high dose, cohort of the trial in which patients will receive 3 mg/kg/dose. The Company anticipates the completion of patient enrollment and the top line results to be available prior to the end of the year.
"The IDMC’s recommendation based on the Phase II data obtained to date is consistent with the strong safety profile observed during the four previous Phase I studies," said Dr. Allan Mandelzys, Chief Executive Officer of Thallion Pharmaceuticals Inc. "We can now proceed as planned to enroll the final 21 patients in this Phase II trial at our clinical sites in South America."
Thallion expects to present the blinded safety results from the first cohort at a scientific conference in the second half of 2011.
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) versus standard of care with placebo, followed by an interim analysis of data for safety conducted by an Independent Data Monitoring Committee. 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.
About Shigamabs®
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 – 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.
SOURCE: Thallion Pharmaceuticals Inc.
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Trial Receives Positive Review from Independent Data Monitoring Committee
MONTREAL, QUEBEC, CANADA | May 16, 2011 | Thallion Pharmaceuticals Inc. (TSX:TLN – News) today announced that the Independent Data Monitoring Committee (IDMC) for the Company’s Phase II SHIGATEC trial has completed a planned safety analysis and recommends that the trial continue as per the protocol. This scheduled review by the IDMC occurred after the treatment and 56-day follow-up of the 22 patients that received the low dose treatment (1 mg/kg/dose) in the first cohort of the trial. The purpose of the IDMC is to provide objective, independent safety monitoring of the SHIGATEC trial, a study evaluating Shigamabs® as a treatment for Shiga toxin-producing E. coli (STEC) infection.
Thallion has advised its clinical sites to initiate enrollment of the second, high dose, cohort of the trial in which patients will receive 3 mg/kg/dose. The Company anticipates the completion of patient enrollment and the top line results to be available prior to the end of the year.
"The IDMC’s recommendation based on the Phase II data obtained to date is consistent with the strong safety profile observed during the four previous Phase I studies," said Dr. Allan Mandelzys, Chief Executive Officer of Thallion Pharmaceuticals Inc. "We can now proceed as planned to enroll the final 21 patients in this Phase II trial at our clinical sites in South America."
Thallion expects to present the blinded safety results from the first cohort at a scientific conference in the second half of 2011.
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) versus standard of care with placebo, followed by an interim analysis of data for safety conducted by an Independent Data Monitoring Committee. 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.
About Shigamabs®
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 – 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.
SOURCE: Thallion Pharmaceuticals Inc.
Post Views: 34
