Thallion suspends patient enrollment in Phase II melanoma trial

Wed. July 08, 2009; Posted: 01:10 PM

Jul 08, 2009 (Datamonitor via COMTEX) -- TLNFF | Quote | Chart | News | PowerRating -- Thallion Pharmaceuticals, a biotechnology company, 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.

Thallion's multi-center, 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 US. 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, 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.

Lloyd Segal, CEO of Thallion, said: "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.

"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."

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