Thallion Suspends Patient Enrollment of TLN-232 Metastatic Melanoma Trial Over Licensing Dispute
MONTREAL, QUEBEC--(July 7, 2009) - Thallion Pharmaceuticals Inc. (TSX:TLN) today announced that it has suspended patient enrollment in its Phase II trial evaluating TLN-232 as a treatment for metastatic melanoma, due to an ongoing dispute with the licensor. A binding arbitration proceeding has been initiated and Thallion will re-evaluate the status of the program based on the outcome of the adjudication.
"Based on our experience with this licensor, it is in the best long-term interests of our shareholders to suspend development of TLN-232 as opposed to investing additional resources to develop the product under recurring allegations of breach from the licensor and ensuing disputes over a termination of the license," said Lloyd M. Segal, Chief Executive Officer of Thallion Pharmaceuticals Inc. "We believe that the assertions made against us under the license agreement are without merit. We will vigorously defend our rights in this matter, and we intend to pursue claims of our own against the licensor during the proceedings. We believe this decision represents the most responsible course of action and is especially prudent in light of today's constrained capital environment."
TLN-232 is a novel seven amino-acid peptide with potential efficacy in multiple oncology indications and targets pyruvate kinase M2 (M2PK), a protein shown to be over-expressed in a number of different tumour types. The expression of M2PK during tumourigenesis has been shown recently to mediate the Warburg effect, a phenotype in which cancer cells utilize the glycolytic pathway to a far greater extent than do their non-malignant counterparts.
TLN-232 Phase II Trial
Thallion's multi-centre, open label Phase II trial is targeting to enroll up to 49 metastatic melanoma patients, who have failed one prior therapy, at multiple sites in both Canada and the U.S. The trial design is comprised of a dose escalation segment followed by a dose expansion segment. The first segment consists of consecutive cohorts of at least three patients each, who will receive 0.5, 1.0, 2.0 or 3.0 mg/kg/day of TLN-232 in multiple cycles. Each cycle will consist of 21 days of treatment and seven days of rest. Once the optimal dose has been determined, the second segment of the trial will enroll and treat up to 34 additional patients at that dose until disease progression. The primary endpoint of the trial is tumour response at four months.
About Thallion Pharmaceuticals Inc.
Thallion Pharmaceuticals Inc. (TSX:TLN) is a biotechnology company developing pharmaceutical products in the areas of oncology and infectious disease. Thallion has three clinical programs at the Phase II stage of development. The two oncology product candidates include TLN-4601, a novel anti-cancer therapy targeting the RAS-MAPK pathway, and TLN-232. TLN-4601 is currently recruiting patients in a multi-centre, Phase II trials in Canada and the United States. Thallion's third product candidate, Shigamabs®, is a dual antibody product for the treatment of Shigatoxin producing E. coli bacterial infections. Additional information about Thallion can be obtained at www.thallion.com<http://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 Thallion'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, the obtaining of court and other regulatory approvals and consents, the satisfaction of closing conditions, 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 Thallion's ongoing filings with the Canadian securities regulatory authorities which filings can be found at www.sedar.com<http://www.sedar.com/>. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. Thallion 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: July 2009