Thallion Pharmaceuticals Inc.
TSX : TLN
|
LFB Biotechnologies
|
|
May 30, 2011 07:54 ET
Thallion Announces First Patient Enrolled In High Dose Cohort of Phase II SHIGATEC Trial
MONTRÉAL, LES ULIS, QUEBEC--(Marketwire - May 30, 2011) -Thallion Pharmaceuticals Inc. (TSX:TLN) and LFB Biotechnologies todayannounced the enrollment of the first patient in the high dose cohort ofthe Company's Phase II SHIGATEC trial. The high dose cohort (3mg/kg/dose) is expected to enroll 21 patients which will complete thePhase II trial evaluating Shigamabs® as a treatment for Shiga toxin-producing E. coli (STEC) infection. The Company anticipates top line results to be available prior to the end of the year.
"Followingthe positive recommendation from the IDMC after the low dose cohort andthe resumption of patient enrollment in our SHIGATEC trial, we continueto push forward with the clinical development of our novel Shigamabs® treatment. Shigamabs®represents the most advanced clinical treatment in development for theprevention of a condition in which the current standard of care issimply to hydrate, wait and then monitor disease progression," said Dr.Allan Mandelzys, Chief Executive Officer of Thallion PharmaceuticalsInc.
"We believe a clear medical need exists for the treatment ofSTEC infections, and the recent German outbreak, where approximately300 cases of haemolytic uraemic syndrome (HUS) and 10 deaths have beenreported, is an unfortunate reminder of that," said Guillaume Bolognaexecutive Vice-President for Development Programs of LFBBiotechnologies.
About the SHIGATEC Trial
The randomized, double-blind, placebo-controlledtrial will enroll 42 patients, aged six months to 18 years testingpositive for STEC infection, distributed in two cohorts. The firstcohort compares standard of care combined with a low dose of Shigamabs® (1mg/kg/dose) versus standard of care with placebo. The second cohortwill compare standard of care combined with a high dose of Shigamabs®(3 mg/kg/dose) versus standard of care with placebo. The primaryendpoints for the Phase II trial are safety and tolerability. Secondaryendpoints include pharmacokinetics and objective measures of efficacyusing single and composite endpoints.
About Shigamabs®
Shigamabs® consists of twomonoclonal antibodies designed to bind specifically and exclusively tothe Shiga toxin 1 and Shiga toxin 2 toxins secreted by Shigatoxin-producing E. coli bacteria. STEC infections are primarilyfoodborne bacterial infections that cause serious health complications,particularly in young children and the elderly, and affectapproximately 314,000 people annually in the industrialized world. Thereare no approved products available for the treatment of STECinfections. The Shigamabs® antibodies, administered as asingle intravenous injection, bind to their respective toxin andneutralize them by forming a complex that is absorbed and destroyed bythe 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) is abiotechnology company developing pharmaceutical products in the areas ofinfectious disease and oncology. The Company's clinical programsinclude Shigamabs® and TLN-4601, a novel anti-cancer therapy. Shigamabs®is a dual antibody product being evaluated in a Phase II clinical trialfor the treatment of Shiga toxin-producing E. coli bacterialinfections. Additional information about Thallion can be obtained at www.thallion.com.
About LFB
LFB is a biopharmaceutical group that develops,manufactures and markets medicinal products for the treatment of seriousand often rare diseases in several major therapeutic fields, namelyHemostasis, Immunology and Intensive Care. The LFB Group is the leadingmanufacturer of plasma-derived medicinal products in France and 6thworldwide and is also among the leading European companies for thedevelopment of monoclonal antibodies and new-generation proteins basedon biotechnologies. With its strong focus on research, the LFB Group ispursuing a growth strategy that seeks to extend its activities at theinternational level and develop innovative therapies. In 2010, the LFBGroup reported total turnover of 411.6 million euros, up 9.6%, andinvested 86.5 million euros in product development. The LFB Groupmarkets its products in 20 countries around the world.