Thallion initiates enrollment for Phase II melanoma trial

Thallion’s multi-center, open-label Phase II trial will enroll up to 49 patients at multiple sites in both Canada and the US. 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, 2 or 3mg/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 tumor response at four months.

Thallion has recently received notification from the FDA that it may proceed with the US portion of the trial following a positive review of its investigational new drug submission for TLN-232. Enrollment at multiple Canadian sites is ongoing and US sites are expected to commence recruiting in early 2009.

Thallion has published positive data from a previously completed Phase II trial of 13 refractory metastatic melanoma patients, in which a four-hour daily infusion of TLN-232 achieved a 31% response rate, including three-patients showing stable disease and one 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.