YM Biosciences subsidiary begins phase 2b trial of inhaled analgesic

By Angela McDaniels

Seattle, Jan. 26 - YM BioSciences Inc. said its subsidiary Delex Therapeutics Inc. has enrolled the first patient in its phase 2b trial of AeroLEF for the treatment of moderate to severe acute pain.

The randomized, double-blinded, placebo-controlled phase 2b study is designed to evaluate the safety and efficacy of multiple doses of AeroLEF for management of pain in post-surgical patients following elective orthopedic surgeries.

The trial is expected to enroll 120 patients at eight clinical sites and report results during the first half of 2006, the company said.

The primary endpoint is the Summed Pain Relief plus Pain Intensity Difference scores during the first four hours after the start of the initial dose. Secondary endpoints include time to effective pain relief and six safety endpoints.

AeroLEF is a proprietary formulation of free and liposome-encapsulated nebulized fentanyl, which permits delivery through the lung, according to a company news release.

YM said it provides personalized, patient-controlled analgesia to address the unpredictable variability in analgesic needs that are a hallmark of acute pain episodes, including breakthrough cancer pain.

In a previous, single-dose phase 2a study, 95% of post-surgical patients achieved clinically meaningful analgesia following self-administration of AeroLEF to treat their moderate to severe pain, and patients reported rapid onset of analgesia followed by an extended duration of pain relief, the company said.

YM is a cancer product development company based in Mississauga, Ont. Subsidiary Delex develops products that deliver therapeutics to the systemic circulation via inhalation through the lungs.

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