Thallion Announces Publication of ECO-4601 Phase I/II Clinical Data at ASCOMONTRÉAL, June 1, 2007 – Thallion Pharmaceuticals Inc. (TSX: TLN) announced today that preliminary data from its Phase I/II clinical trial investigating ECO-4601 in advanced cancer patients was published in abstract form as part of the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. In the Phase I dose escalation portion of the study, 14 patients (ten colorectal, two ovarian, one duodenal and one glioma), that had completed and not responded to the respective standard of care therapy, were treated with ECO-4601. The product was well tolerated and a maximum tolerated dose (MTD) was not attained. Each of these 14 patients received from one to eight cycles of treatment, with seven patients completing at least three cycles. Of these seven evaluable patients, six demonstrated stable disease (four colorectal, one ovarian, one duodenal).
“The excellent safety profile and the promising signals of clinical efficacy give us confidence in the potential of ECO-4601 as we move forward with our clinical development program,” said Dr. Pierre Falardeau, Chief Operating Officer of Thallion Pharmaceuticals Inc. “We continue to enroll patients as part of the extension portion of the study and anticipate announcing additional efficacy results later this year.” The Phase I/II clinical trial was designed to examine the safety, pharmacologic profile and anti-tumour efficacy of ECO-4601 for the treatment of advanced cancer patients. ECO-4601 was administered in 21 day cycles consisting of a two week continuous intravenous infusion followed by a one week rest period. The first portion of the Phase I/II trial is a dose escalation study with doses ranging from 30 to 480mg/m2/day to assess the safety, pharmacokinetics and MTD of ECO-4601. The second portion of the Phase I/II trial is an extension phase which includes up to 15 additional patients treated at the highest dose, as determined in the first portion of the study, to obtain additional safety and pharmacokinetic data, as well as an early indication of the compound’s clinical efficacy.
The clinical study was conducted at the Segal Cancer Centre, Jewish General Hospital, McGill University in Montreal in conjunction with Thallion Pharmaceuticals Inc. The abstract is titled:
“Phase I study of ECO-4601, a novel Ras pathway inhibitor.” Abstract No. 14128 by P. Kavan, D. Melnychuk, A. Langleben, S. D. Baker, A. Bangash, C. Gauthier, M. Ranger, H. Gourdeau, M. D. Harvey, P. Falardeau and G. Batist. Journal of Clinical Oncology, Volume 24, Issue 18S.
About ECO-4601 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 ECO-4601 is a targeted anti-cancer agent with dual activity: selective binding to the peripheral benzodiazepine receptor (PBR) and inhibition of the Ras- MAPK pathway. ECO-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’s clinical-stage programs include: Shigamabs®, a dual antibody product for the treatment of Shigatoxin-producing E. coli bacterial infections; ECO-4601, a novel anticancer therapy derived from a nonpathogenic microorganism; and CAP-232, a targeted therapy with potential efficacy in multiple oncology indications. Thallion has two proprietary technology platforms: CellCarta®, a proteomics discovery engine, and DECIPHER®, a genomics-based discovery platform. Thallion Pharmaceuticals was formed on March 14, 2007 by the amalgamation of Ecopia and Caprion. Additional information about the Company can be obtained at www.thallion.com.
Forward-Looking Statements This press release contains certain forward-looking statements, including, without limitation, statements containing the words "believe", "may", "plan", "will", "estimate", "continue", "anticipate", "intend", "expect" and other similar expressions which constitute "forward-looking information" within the meaning of applicable Canadian securities laws. Forward-looking statements reflect the Company's current expectation and assumptions, and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated. These forward-looking statements involve risks and uncertainties including, but not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time-to-time in the Company's ongoing filings with the Canadian securities regulatory authorities which filings can be found at www.sedar.com. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. The Company undertakes no obligation to publicly update or revise any forward-looking statements either as a result of new information, future events or otherwise, except as required by applicable Canadian securities laws.
Posted: June 2007