Thallion Announces Positive Safety and Efficacy Data From ECO-4601 Phase I/II Trial
MONTREAL, QUEBEC--(Nov. 15, 2007) - Thallion Pharmaceuticals Inc. (TSX:TLN) today presented positive safety and efficacy data from the completed Phase I/II trial of ECO-4601 for the treatment of advanced cancer patients. These results support and confirm preliminary results from the dose escalation portion of the study disclosed earlier this year at the annual ASCO meeting. ECO-4601 was safe and well-tolerated up to the maximum dose tested of 480mg/m2/day. Adverse events potentially related to ECO-4601 were nonspecific and common in this type of patient population. Furthermore, in seven refractory cancer patients who had completed six cycles of treatment, six patients achieved stable disease.
"These results confirm the excellent safety profile of ECO-4601, which is a critical step necessary to advance this product candidate to the next stage of development. With six of seven patients demonstrating stable disease after six cycles of therapy, we believe this represents a positive signal of efficacy that warrants continued product development," said Lloyd M. Segal, Chief Executive Officer of Thallion. "At this stage, we believe ECO-4601 could potentially be used as either a monotherapy or as part of a combination therapy approach for the treatment of several cancer indications. The data from this trial, together with the non-clinical data we have collected to date, now allow us to select an appropriate indication for our next phase of clinical development."
The Company intends to advance ECO-4601 into a Phase II trial in an indication to be selected over the coming weeks. The Company plans to initiate regulatory filings prior to the end of the fourth quarter in order to commence a Phase II trial.
The six patients that had demonstrated stable disease included four colorectal, one duodenal and one ovarian cancer patient. The pharmacokinetic data demonstrated that estimated therapeutic plasma concentrations of ECO-4601 were reached at the higher doses and that ECO-4601 was rapidly eliminated from the bloodstream following infusion.
The most common adverse events related to the treatment of the study were all mild to moderate, including: fatigue, nausea, vomiting and anemia. Only two serious adverse events related to the treatment were observed in the study: one anaphylaxis (grade 4) that occurred in the first patient and was procedure-related (flushing of central line) and one rash (grade 2) that was handled by premedication with pednisone.
The Phase I/II clinical trial was designed to examine the safety, pharmacologic profile and anti-tumour efficacy of ECO-4601 as a treatment in 26 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 trial was conducted in two portions. The first portion was a dose escalation study in 14 patients with doses ranging from 30 to 480mg/m2/day to assess the safety, pharmacokinetics and maximum tolerated dose of ECO-4601. The second portion of the Phase I/II trial included 12 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 and Hopital Charles LeMoyne, Centre affilie universitaire et regional de la Monteregie in Montreal in conjunction with Thallion Pharmaceuticals Inc.
Thallion presented the ECO-4601 Phase I/II results today in Toronto at the 4th International Society of Chemotherapy, Infection and Cancer International Conference on Cancer Therapeutics and the 7th Princess Margaret Hospital Conference: New Developments in Cancer Management.
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 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; ECO-4601, a novel anti-cancer therapy derived from a nonpathogenic microorganism; and CAP-232, a targeted therapy with potential efficacy in multiple oncology indications. Additional information about the Company can be obtained at www.thallion.com.
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.
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Posted: November 2007