Meaningless press release. We already know it passed DSMB review with no issues other wise they would not have proceeded to the next dose. I would like to see more regular updates on the number of patients enrolled to date. Get some momentum building on when to expect trial results.
Press release:
Thallion Pharmaceuticals Inc.: Blinded Results From Low Dose Cohort of Phase II SHIGATEC Trial Presented at IDSA Annual Meeting
MONTREAL, QUEBEC--(Marketwire - Oct. 24, 2011) - Thallion Pharmaceuticals Inc. (TSX:TLN) 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.