Thallion Pharmaceuticals Inc. announced that it has agreed on a path forward with the FDA in respect of the Company’s Shigamabs® program for the treatment of Shigatoxin-mediated E. coli infections
MONTREAL, Canada | February 12, 2008 | Thallion Pharmaceuticals Inc. (TSX: TLN) today announced that it has agreed on a path forward with the U.S. Food and Drug Administration (FDA) in respect of the Company’s Shigamabs® program for the treatment of Shigatoxin-mediated E. coli infections. Based on its most recent interaction with the FDA, Thallion and the FDA have agreed on a regulatory framework, which can now include U.S. sites in the Phase II/III study currently planned to begin in the first half of 2008.
“We are pleased that we were able to arrive at a mutually satisfactory solution with the FDA. This follows the recent positive review by the European Medicines Agency (EMEA) of our protocol for the Phase II/III study in that region,” said Lloyd M. Segal, Chief Executive Officer of Thallion. “With the positive feedback of the key regulators in the jurisdictions where we intend to run the Phase II/III trial, specifically South America, Europe and the United States, we now believe that we have a clear regulatory pathway by which to execute our global Shigamabs® clinical development strategy.”
The Company announced in October that it intended to proceed with the trial outside the U.S. in the absence of a clear U.S. regulatory path. Thallion will now prepare – as it had originally planned – to include U.S. sites in the clinical trial. Prior to the initiation of the trial in the U.S., the Company must submit its final protocol and other standard documentation to the FDA for review and approval. Based on the most recent discussions with the FDA, together with the collective exchanges between the Company and the regulator over the past year, Thallion believes that it can now conduct a Phase II/III trial consistent with the protocol for which the Company has agreements in principle from regulators in other major jurisdictions. Thallion has agreed to conduct certain additional animal studies concurrent with the U.S. clinical study, the results of which will be submitted to the FDA in advance of filing for marketing approval.
The Company will present further details of its clinical development programs, including Shigamabs®, during an analyst day presentation and meeting with clinical experts, which will be scheduled shortly.
About Shigamabs®
Shigamabs® consists of two monoclonal antibodies designed to bind specifically and exclusively to the Shigatoxin 1 and Shigatoxin 2 toxins secreted by Shiga-toxin E. coli (STEC) bacteria. STEC infection is primarily a foodborne bacterial infection that causes serious health complications, particularly in young children and the elderly, and affects approximately 314,000 people annually in the industrialized world. There are no approved products available for the treatment of STEC infections. The Shigamab® antibodies, administered as a single intravenous injection, 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 cases in which both Shigatoxins are present and also overcomes the inability of existing diagnostic technology to distinguish between cases caused by only one of the two toxins.
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 anti-cancer 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.
Forward-Looking Statements
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.
SOURCE: Thallion Pharmaceuticals Inc.
Post Views: 66
Thallion Pharmaceuticals Inc. announced that it has agreed on a path forward with the FDA in respect of the Company’s Shigamabs® program for the treatment of Shigatoxin-mediated E. coli infections
MONTREAL, Canada | February 12, 2008 | Thallion Pharmaceuticals Inc. (TSX: TLN) today announced that it has agreed on a path forward with the U.S. Food and Drug Administration (FDA) in respect of the Company’s Shigamabs® program for the treatment of Shigatoxin-mediated E. coli infections. Based on its most recent interaction with the FDA, Thallion and the FDA have agreed on a regulatory framework, which can now include U.S. sites in the Phase II/III study currently planned to begin in the first half of 2008.
“We are pleased that we were able to arrive at a mutually satisfactory solution with the FDA. This follows the recent positive review by the European Medicines Agency (EMEA) of our protocol for the Phase II/III study in that region,” said Lloyd M. Segal, Chief Executive Officer of Thallion. “With the positive feedback of the key regulators in the jurisdictions where we intend to run the Phase II/III trial, specifically South America, Europe and the United States, we now believe that we have a clear regulatory pathway by which to execute our global Shigamabs® clinical development strategy.”
The Company announced in October that it intended to proceed with the trial outside the U.S. in the absence of a clear U.S. regulatory path. Thallion will now prepare – as it had originally planned – to include U.S. sites in the clinical trial. Prior to the initiation of the trial in the U.S., the Company must submit its final protocol and other standard documentation to the FDA for review and approval. Based on the most recent discussions with the FDA, together with the collective exchanges between the Company and the regulator over the past year, Thallion believes that it can now conduct a Phase II/III trial consistent with the protocol for which the Company has agreements in principle from regulators in other major jurisdictions. Thallion has agreed to conduct certain additional animal studies concurrent with the U.S. clinical study, the results of which will be submitted to the FDA in advance of filing for marketing approval.
The Company will present further details of its clinical development programs, including Shigamabs®, during an analyst day presentation and meeting with clinical experts, which will be scheduled shortly.
About Shigamabs®
Shigamabs® consists of two monoclonal antibodies designed to bind specifically and exclusively to the Shigatoxin 1 and Shigatoxin 2 toxins secreted by Shiga-toxin E. coli (STEC) bacteria. STEC infection is primarily a foodborne bacterial infection that causes serious health complications, particularly in young children and the elderly, and affects approximately 314,000 people annually in the industrialized world. There are no approved products available for the treatment of STEC infections. The Shigamab® antibodies, administered as a single intravenous injection, 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 cases in which both Shigatoxins are present and also overcomes the inability of existing diagnostic technology to distinguish between cases caused by only one of the two toxins.
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 anti-cancer 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.
Forward-Looking Statements
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.
SOURCE: Thallion Pharmaceuticals Inc.
Post Views: 66
