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news.Thallion 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.
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The TLN-232 trial is the second Phase II study to be initiated this year from Thallion’s oncology pipeline. 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, one, two or three milligram/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.
Lloyd Segal, CEO of Thallion said: “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.”