Thallion initiates enrollment for Phase II brain cancer trial

The open label Phase II trial will enroll up to 40 patients. TLN-4601 will be continuously administered intravenously over 21-day cycles, consisting of 14 days on treatment and seven days off, at 480mg/m2/day. The primary endpoint of the 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 anticipates releasing certain data throughout the trial, including imaging studies supporting that TLN-4601 reaches and penetrates the brain tumor, biomarker analyses demonstrating that TLN-4601 inhibits the Ras/MAPK signaling pathway in vivo, and any early signs of clinical efficacy. Full results from the study are expected in the second half of 2009.

Thallion also 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 (IND) submission for TLN-4601.

The IND submission included safety and pharmacokinetic data from the earlier Phase I/II study, as well as data from in vitro and in vivo studies demonstrating the potential broad applicability of TLN-4601 as an anticancer agent. Enrollment at the US sites is expected to commence shortly.

Lloyd Segal, CEO of Thallion, said: “Initiating enrollment in our TLN-4601 trial is one more step in a series of milestones as we advance our oncology pipeline. This glioblastoma multiforme trial is intended to be the first clinical trial demonstrating the anticancer activity of TLN-4601 in a defined cancer patient population and lays the groundwork for future clinical development and potential partnership opportunities.”