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Thallion Pharmaceuticals Inc. (TSX:TLN) today announced it has received authorization from the Therapeutic Products Directorate of Health Canada to initiate a Phase II clinical trial evaluating TLN-4601 as a monotherapy treatment for patients with glioblastoma multiforme (GBM), an advanced form of brain cancer, as a second line therapy
MONTREAL, QUEBEC, CANADA | May 12, 2008 | Thallion Pharmaceuticals Inc. (TSX:TLN) today announced it has received authorization from the Therapeutic Products Directorate of Health Canada to initiate a Phase II clinical trial evaluating TLN-4601 as a monotherapy treatment for patients with glioblastoma multiforme (GBM), an advanced form of brain cancer, as a second line therapy.
"This Phase II clinical trial in GBM 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 U.S. Food and Drug Administration in the coming weeks, with the intent of opening additional centers in the United States this summer," said Lloyd M. Segal, Chief Executive Officer of Thallion Pharmaceuticals Inc. "Glioblastoma multiforme is a deadly disease that has proven difficult to treat with existing therapies. As a novel Ras pathway inhibitor, TLN-4601 represents a potential new therapy for GBM patients. The animal data we released last fall, which demonstrated that TLN-4601 crosses the blood brain barrier and preferentially accumulates in glioblastoma tumours, made GBM a natural choice as the initial indication for TLN-4601."
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 7 days off, at 480 mg/m2/day. The primary endpoint of the open label 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 expects to be in a position 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.
About TLN-4601
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.
About Thallion Pharmaceuticals Inc.
Thallion Pharmaceuticals Inc. (TSX:TLN) is a biotechnology company developing pharmaceutical products in the areas of infectious disease and oncology. Thallion has three active clinical programs at a Phase II, or later, stage of development which include: Shigamabs®, a dual antibody product for the treatment of Shigatoxin-producing E. coli bacterial infections; 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. Additional information about the Company can be obtained at www.thallion.com.
SOURCE: Thallion Pharmaceuticals Inc. |
