Thallion Enrolls First Patient in TLN-4601 Phase II Trial
News Sep 26, 2008
"Initiating enrollment in our TLN-4601 trial is one more step in a series of milestones as we advance our oncology pipeline," said Lloyd M. Segal, Chief Executive Officer of Thallion. "This GBM trial is intended to be the first clinical trial demonstrating the anti-cancer activity of TLN-4601 in a defined cancer patient population and lays the groundwork for future clinical development and potential partnership opportunities."
Thallion also recently received notification from the United States Food and Drug Administration (FDA) that it may proceed with the U.S. 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 anti-cancer agent. Enrollment at the U.S. sites is expected to commence in the coming weeks.
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 7 days off, at 480 mg/m2/day. The primary endpoint of the trial is six-month progression free survival. The secondary endpoints include tumour 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 tumour, 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.
TLN-4601, formerly referred to as ECO-4601, is a novel small molecule derived from a nonpathogenic microorganism. It has demonstrated broad in vitro cytotoxic activity across a diverse panel of tumour cell lines and in vivo efficacy in a number of xenograft tumour models. Preclinical data suggest that TLN-4601 is a targeted anti-cancer agent that inhibits the Ras/MAPK pathway and binds the PBR (peripheral benzodiazepine receptor), a receptor highly overexpressed in a number of different tumours. TLN-4601 was discovered using DECIPHER®, Thallion's proprietary genomics-based drug discovery platform.
Thallion Pharmaceuticals Inc. (TSX:TLN) is a biotechnology company developing pharmaceutical products in the areas of oncology and infectious disease. Thallion has three clinical programs at a Phase II, or later, stage of development. Two late stage Phase II oncology trials which include: TLN-4601, a novel anti-cancer therapy derived from a nonpathogenic microorganism and TLN-232, a targeted therapy with potential efficacy in multiple oncology indications. The Company's third product candidate, Shigamabs®, is a dual antibody product for the treatment of Shigatoxin-producing E. coli bacterial infections. Additional information about the Company can be obtained at www.thallion.com.