Thallion Initiates Enrollment In Phase II Metastatic Melanoma Trial

Main Category: Melanoma / Skin Cancer
Also Included In: Clinical Trials / Drug Trials;  Cancer / Oncology
Article Date: 18 Nov 2008 - 9:00 PDT

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Thallion Pharmaceuticals Inc. (TSX:TLN) today announced that the first patient has been enrolled in its Phase II trial evaluating TLN-232 as a treatment for metastatic melanoma in patients who have failed one prior therapy.

"With the successful initiation of this Phase II trial, TLN-232 now joins our other pipeline candidate, TLN-4601, to give us two Phase II oncology trials actively recruiting patients," said Lloyd M. Segal, Chief Executive Officer of Thallion Pharmaceuticals Inc. "Our immediate development goal is to replicate the significant response rate we achieved in the smaller, prior metastatic melanoma trial and to bring forward an important potential new treatment option for these cancer patients."

Thallion recently received notification from the United States Food and Drug Administration (FDA) that it may proceed with the U.S. portion of the trial following a positive review of its Investigational New Drug (IND) submission for TLN-232. Enrollment at multiple Canadian sites is ongoing and U.S. sites are expected to commence recruiting in early 2009. Each year there are approximately 8,000 metastatic melanoma related deaths in the U.S. and the standard of care for metastatic melanoma patients is limited to experimental therapies according to the American Society for Clinical Oncology (ASCO).

Thallion's multi-centre, open label Phase II trial will enroll up to 49 patients at multiple sites in both Canada and the U.S. The trial will be split into a dose escalation segment and a dose expansion segment. The first segment will consist 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.

Thallion has published positive data from a previously completed Phase II trial of 13 refractory metastatic melanoma patients, in which a 4-hour daily infusion of TLN-232 achieved a 31% response rate, including 3 patients showing stable disease and 1 partial response. These results were achieved at the lowest dosage level currently being tested in the ongoing trial.

The Company anticipates receiving interim data from the trial as early as the second quarter of calendar 2009. Full results from the study are expected in the fourth quarter of 2009.

About TLN-232

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.

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 a Phase II, or later, stage of development. Two late stage Phase II oncology trials which include: TLN-4601, a novel anti-cancer therapy targeting the RAS-MAPK pathway in cancer and TLN-232, a targeted peptide therapy with potential efficacy in multiple oncology indications. The Company's third product candidate, Shigamabs®, is a dual antibody product for the treatment of Shigatoxin-producing E. coli bacterial infections. Additional information about the Company can be obtained at http://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 http://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.

Thallion Pharmaceuticals Inc.