Blinded results from the low dose cohort of its Phase II SHIGATEC study were presented at the 49th Infectious Disease Society of America ("IDSA") Annual Meeting in Boston, MA.
MONTREAL, Canda I October 24, 2011 I Thallion Pharmaceuticals Inc. (TSX: TLN.TO – News) announced that blinded results from the low dose cohort of its Phase II SHIGATEC study were presented at the 49th Infectious Disease Society of America ("IDSA") Annual Meeting in Boston, MA.
The presentation entitled "SHIGATEC Trial: A Phase II Study Assessing Monoclonal Antibodies Against Shiga Toxin 1 and 2 in Shiga Toxin-producing E. coli-infected Children" reported on a total of 22 patients (out of 305 patients screened) that were enrolled in the low dose cohort. Approximately two-thirds of the enrolled patients were less than four years old.
This was the first time Shigamabs® was assessed in a Shiga toxin-producing E. coli (STEC)-infected pediatric population and the presentation concluded that the treatment was safe and well tolerated. The majority of the infections were attributed to non-O157 E. coli strains, with a predominance of Shiga toxin 2 producers.
"We continue to be encouraged by the consistency of the Shigamabs® safety results across studies," said Dr. Allan Mandelzys, Thallion’s Chief Executive Officer. "Earlier this year, based on a planned safety analysis, the Independent Data Monitoring Committee for the SHIGATEC trial recommended that the study continue as per the protocol."
Enrollment in the high dose cohort is ongoing and Thallion expects to present the unblinded data at a future scientific conference.
For further detail, please visit the Company’s website at www.thallion.com
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 single low dose of Shigamabs® (1 mg/kg) versus standard of care with placebo. The second cohort will compare standard of care combined with a single 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 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
Post Views: 37
Blinded results from the low dose cohort of its Phase II SHIGATEC study were presented at the 49th Infectious Disease Society of America ("IDSA") Annual Meeting in Boston, MA.
MONTREAL, Canda I October 24, 2011 I Thallion Pharmaceuticals Inc. (TSX: TLN.TO – News) announced that blinded results from the low dose cohort of its Phase II SHIGATEC study were presented at the 49th Infectious Disease Society of America ("IDSA") Annual Meeting in Boston, MA.
The presentation entitled "SHIGATEC Trial: A Phase II Study Assessing Monoclonal Antibodies Against Shiga Toxin 1 and 2 in Shiga Toxin-producing E. coli-infected Children" reported on a total of 22 patients (out of 305 patients screened) that were enrolled in the low dose cohort. Approximately two-thirds of the enrolled patients were less than four years old.
This was the first time Shigamabs® was assessed in a Shiga toxin-producing E. coli (STEC)-infected pediatric population and the presentation concluded that the treatment was safe and well tolerated. The majority of the infections were attributed to non-O157 E. coli strains, with a predominance of Shiga toxin 2 producers.
"We continue to be encouraged by the consistency of the Shigamabs® safety results across studies," said Dr. Allan Mandelzys, Thallion’s Chief Executive Officer. "Earlier this year, based on a planned safety analysis, the Independent Data Monitoring Committee for the SHIGATEC trial recommended that the study continue as per the protocol."
Enrollment in the high dose cohort is ongoing and Thallion expects to present the unblinded data at a future scientific conference.
For further detail, please visit the Company’s website at www.thallion.com
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 single low dose of Shigamabs® (1 mg/kg) versus standard of care with placebo. The second cohort will compare standard of care combined with a single 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 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
Post Views: 37
