Thallion Provides Update on Shigamabs Clinical Development and U.S. Regulatory Plan
Thallion to Initiate Phase II/III Trial in Europe, South America and Canada
MONTREAL, QUEBEC--(Oct. 29, 2007) - Thallion Pharmaceuticals Inc. (TSX:TLN) today announced that the Company has not yet been able to reach a mutual agreement with the United States Food and Drug Administration (FDA) on the appropriate clinical trial design and strategy for Shigamabs®, a dual antibody product for the treatment of Shigatoxin-producing E. coli (STEC) bacterial infections. The Company intends to submit the appropriate regulatory documents in Europe, South America and Canada and expects to initiate a Phase II/III trial in these jurisdictions in the first half of 2008.
"After numerous constructive discussions with the FDA, we have not yet been able to reach an agreement on our Shigamabs clinical development strategy in the U.S. Since the pressing need for a treatment for STEC infections is undisputed, we are determined to initiate a pivotal trial and to commercialize Shigamabs as quickly as possible. To this end, we have decided to continue to move forward with our clinical strategy in Europe, Canada and South America as originally planned. Our intent is to set in motion the regulatory submission process in these jurisdictions by the end of the fourth quarter of 2007, which would potentially enable us to initiate a pivotal Phase II/III Shigamabs trial in the first half of 2008," said Lloyd M. Segal, Chief Executive Officer of Thallion Pharmaceuticals Inc. "We believe that our existing clinical development plan is appropriate to demonstrate the safety and efficacy of Shigamabs, and we will continue to engage the FDA to resolve the outstanding issues. Our upcoming clinical trial will be designed to accommodate the potential addition of U.S. sites should the Company and the FDA reach a consensus in the future."
About Thallion Pharmaceuticals Inc.
Thallion Pharmaceuticals Inc. (TSX:TLN) is a biotechnology company developing pharmaceutical products in the areas of infectious disease and oncology. Thallion has three active clinical programs at a Phase II, or later, stage of development which include: Shigamabs®, a dual antibody product for the treatment of Shigatoxin-producing E. coli bacterial infections; ECO-4601, a novel anticancer therapy derived from a nonpathogenic microorganism; and CAP-232, a targeted therapy with potential efficacy in multiple oncology indications. Additional information about the Company can be obtained at www.thallion.com.
This press release contains certain forward-looking statements, including, without limitation, statements containing the words "believe", "may", "plan", "will", "estimate", "continue", "anticipate", "intend", "expect" and other similar expressions which constitute "forward-looking information" within the meaning of applicable Canadian securities laws. Forward-looking statements reflect the Company's current expectation and assumptions, and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated. These forward-looking statements involve risks and uncertainties including, but not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time-to-time in the Company's ongoing filings with the Canadian securities regulatory authorities which filings can be found at www.sedar.com. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. The Company undertakes no obligation to publicly update or revise any forward-looking statements either as a result of new information, future events or otherwise, except as required by applicable Canadian securities laws.
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Posted: October 2007