Ecopia BioSciences Inc. has announced the successful completion of the first portion, dose-escalation, of its phase I clinical trial for ECO-4601, the company's lead anticancer drug candidate. The completion of this milestone allows Ecopia to initiate the second portion of its clinical trial, the extension phase.
During the dose-escalation portion of this phase I trial, ECO-4601 was administered to 14 patients in doses up to 480 mg/m2/day, the maximum dose set as per the protocol since no dose limiting toxicity was observed. Ecopia's extension portion, which could involve up to 15 patients, is being initiated and should be completed by the end of Q2-07. The company recently opened an additional clinical site at the Charles Lemoyne Hospital, on Montréal's South Shore, where Dr Benoît Samson will be the Principal Investigator. Clinical results for both portions of this trial will be released when compiled data is audited.
"We are very excited with the fact that no dose-limiting toxicity was observed in the first portion of the trial," said Dr. Pierre Falardeau, president and chief executive officer of Ecopia. "This is clearly a key advantage in developing a novel oncology drug such as ECO-4601," he added.
In April of last year, Ecopia's phase I clinical trial involving ECO-4601 was initiated at the Clinical Research Unit of the Sir Mortimer B. Davis - Jewish General Hospital. Dr. Gerald Batist is the Study Chair with Dr. Petr Kavan as the site's Principal Investigator. This trial involves 21-day cycles wherein different patients receive a specified dose of compound via continuous infusion using ambulatory pumps for 14 days, followed by a 7-day rest period. Ecopia's phase I trial includes brain, breast, prostate, ovarian, lung, colon or pancreatic cancer patients refractory to the current standard of care. The purpose of this trial is dose-selection and evaluation of safety and tolerability of ECO-4601, as well as determination of clinical pharmacokinetics.