Thallion Receives Health Canada Approval To Initiate Phase II Study For TLN-232 In Metastatic Melanoma Patients

Main Category: Melanoma / Skin Cancer
Also Included In: Clinical Trials / Drug Trials;  Regulatory Affairs / Drug Approvals
Article Date: 28 Jun 2008 - 12:00 PDT

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Thallion Pharmaceuticals Inc. (TSX:TLN) announced it has received authorization from the Therapeutic Products Directorate of Health Canada to initiate a Phase II clinical trial evaluating TLN-232 as a treatment for metastatic melanoma in patients that have failed at least one prior therapy. The TLN-232 trial is the second Phase II study to be initiated this year from Thallion's oncology pipeline.

"We have now moved both of our oncology product candidates into Phase II efficacy trials this year. Our recent progress provides us with a deeper, more balanced pipeline of late-stage opportunities in multiple indications," said Lloyd M. Segal, Chief Executive Officer of Thallion Pharmaceuticals Inc. "Together with the initiation of the TLN-4601 clinical trial last month, we have demonstrated an ability to execute clinical plans on time and advance our pipeline candidates. Our objective in this trial is to replicate the response rate we achieved in an earlier small Phase II trial in metastatic melanoma patients."

The multi-centre open label Phase II trial will enroll up to 49 patients and will consist of a dose escalation segment and a dose expansion segment. The first segment will consist of consecutive cohorts of at least three patients each, up to a total of 15 patients, that 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 34 additional patients at that dose until disease progression. The primary endpoint of the trial is tumor response at four months.

In an earlier 13-patient Phase II trial in metastatic melanoma patients, TLN-232 achieved a 31% response rate following four-hour daily infusions of the compound over four cycles, each cycle consisting of seven days on treatment and seven days of rest. The results included three patients showing stable disease and one partial response. Subsequent to that trial, Thallion recently completed a Phase II trial in renal cell carcinoma patients. Full results will be presented in the near future.

About CAP-232

CAP-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 derived from a nonpathogenic microorganism and TLN-232, a targeted 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 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.

Thallion Pharmaceuticals Inc.