MONTRÉAL, QUÉBEC--(Marketwire - Oct. 11, 2011) - Thallion Pharmaceuticals Inc. (TSX:TLN) announced today that it is resuming patient enrollment in the Company's Phase II SHIGATEC trial.
In July, 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 study enrollment as a precautionary measure pending a comprehensive assessment of the finding. The latest stability data and analyses, as well as positive regulatory feedback, support the continued use of the original lot of anti-Stx1 antibody for clinical testing. Consequently, the participating clinical centers are being advised to resume the screening and enrollment of patients.
"Having reconfirmed the quality of our product and prioritizing, as always, the safety of our patients, we are pleased to resume the SHIGATEC study", said Dr. Allan Mandelzys, Thallion's Chief Executive Officer. "We are well positioned to capture the beginning of the high season for Shiga toxin-producing E. coli ("STEC") infection which we expect to result in a similarly high patient recruitment rate as we experienced during enrollment of the low dose cohort."
Guillaume Bologna, Executive Vice President Business Development and Development Programs at LFB Biotechnologies commented, "The human and economic toll of the recent German STEC outbreak demonstrated the urgent need for an effective treatment for STEC. Fortunately, the recent suspension and resumption of the SHIGATEC trial did 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.