Thallion Pharmaceuticals Inc. 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.