Thallion Pharmaceuticals announced its intention to resume patient recruitment in its Phase II SHIGATEC study during October 2011, just before the upcoming high season for Shiga toxin-producing E. coli bacteria ("STEC") infections in South America
MONTREAL, QUEBEC, CANADA | Septber 13, 2011 | Thallion Pharmaceuticals Inc. (TSX: TLN.TO – News) announced today its intention to resume patient recruitment in its Phase II SHIGATEC study during October 2011, just before the upcoming high season for Shiga toxin-producing E. coli bacteria ("STEC") infections in South America.
On July 13, 2011, the Company announced that due to a preliminary product out-of-specification ("OOS") finding observed during routine stability testing of its anti-Stx1 monoclonal antibody, it decided to temporarily suspend screening and enrollment in the SHIGATEC study as a precautionary measure pending a more comprehensive assessment of the situation.
Over the course of the past several weeks, Thallion, in close collaboration with its development partner LFB Biotechnologies ("LFB"), has completed an in-depth analysis of the product OOS finding. The results of this examination provide support for the continued use of the existing clinical product. The Company has nevertheless decided to wait for the results from one additional stability time point in early October before re-activating the study. In parallel, the Company and LFB have committed to the manufacturing of a new lot of anti-Stx1 clinical material to provide further assurance for the timely completion of the trial. This new lot is expected to become available for use in the clinical study, if needed, in December.
"Whether the temporary suspension is lifted in October, as currently anticipated, or we elect to wait until the new lot of clinical material becomes available, we are confident that we will complete the SHIGATEC Phase II trial during this upcoming high season for STEC infections," said Dr. Allan Mandelzys, Thallion’s Chief Executive Officer. "Accordingly, this temporary suspension should not adversely impact our overall clinical development timelines in a material way."
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.
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 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.
SOURCE: Thallion Pharmaceuticals Inc.
Post Views: 53
Thallion Pharmaceuticals announced its intention to resume patient recruitment in its Phase II SHIGATEC study during October 2011, just before the upcoming high season for Shiga toxin-producing E. coli bacteria ("STEC") infections in South America
MONTREAL, QUEBEC, CANADA | Septber 13, 2011 | Thallion Pharmaceuticals Inc. (TSX: TLN.TO – News) announced today its intention to resume patient recruitment in its Phase II SHIGATEC study during October 2011, just before the upcoming high season for Shiga toxin-producing E. coli bacteria ("STEC") infections in South America.
On July 13, 2011, the Company announced that due to a preliminary product out-of-specification ("OOS") finding observed during routine stability testing of its anti-Stx1 monoclonal antibody, it decided to temporarily suspend screening and enrollment in the SHIGATEC study as a precautionary measure pending a more comprehensive assessment of the situation.
Over the course of the past several weeks, Thallion, in close collaboration with its development partner LFB Biotechnologies ("LFB"), has completed an in-depth analysis of the product OOS finding. The results of this examination provide support for the continued use of the existing clinical product. The Company has nevertheless decided to wait for the results from one additional stability time point in early October before re-activating the study. In parallel, the Company and LFB have committed to the manufacturing of a new lot of anti-Stx1 clinical material to provide further assurance for the timely completion of the trial. This new lot is expected to become available for use in the clinical study, if needed, in December.
"Whether the temporary suspension is lifted in October, as currently anticipated, or we elect to wait until the new lot of clinical material becomes available, we are confident that we will complete the SHIGATEC Phase II trial during this upcoming high season for STEC infections," said Dr. Allan Mandelzys, Thallion’s Chief Executive Officer. "Accordingly, this temporary suspension should not adversely impact our overall clinical development timelines in a material way."
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.
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 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.
SOURCE: Thallion Pharmaceuticals Inc.
Post Views: 53
