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news.Thallion Pharmaceuticals has received authorization from the Therapeutic Products Directorate of Health Canada to begin a Phase II clinical trial evaluating TLN-4601 as a monotherapy treatment for patients with glioblastoma multiforme, an advanced form of brain cancer, as a second line therapy.
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The Phase II trial will enroll up to 40 patients. TLN-4601 will be continuously administered intravenously over a 21 day cycle, consisting of 14 days on treatment and seven days off, at 480mg/m2/day. The primary endpoint of the open label trial is six-month progression free survival. The secondary endpoints include tumor response, progression-free survival at 12 months, as well as overall survival.
The company expects to release preliminary data from an interim analysis of the trial in late 2008, with results from the entire study anticipated by the third quarter of 2009.
Lloyd Segal, CEO of Thallion, said: “This Phase II clinical trial in glioblastoma multiforme is a major step forward for our TLN-4601 development program. In addition to recruiting patients from five Canadian centers, we intend to submit this protocol to the FDA in the coming weeks, with the intent of opening additional centers in the US in summer 2008.”