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YM BioSciences Reports AeroLEF Randomized Phase IIb Trial Meets,Primary Endpoint in Patients with Post-Surgical Pain

MISSISSAUGA, ON, May 02, 2007 /PRNewswire-FirstCall/ - YM BioSciences Inc. , an oncology company that identifies, develops and commercializes differentiated products for patients worldwide, today announced top-line results from its randomized, placebo-controlled Phase IIb trial of AeroLEF(TM) in opioid naive patients with post-operative pain following orthopedic surgery. AeroLEF(TM) met the primary endpoint of the study, showing a statistically significant difference in SPRID4 from placebo (p=0.0194).

AeroLEF(TM) is a unique, inhaled-delivery composition of free and liposome-encapsulated fentanyl in development for the treatment of moderate to severe pain, including cancer pain. Unlike fixed dose approaches to opioid delivery, where a significant titration period is often required to determine the suitable dose for the patient, AeroLEF(TM) is being developed as a non-invasive patient self-titrated delivery system designed to enable patients to identify and select a personalized dose for each pain episode, achieving both rapid onset and extended duration of analgesia.

The trial evaluated the SPRID4 for AeroLEF(TM) compared with placebo for the treatment of the first pain episode. SPRID4 is a summary of the combined changes in pain relief and in pain intensity that patients report over the first 4 hours following initiation of dosing. The trial also examined a number of secondary endpoints including various measurements of pain relief, pain intensity, as well as onset and duration of analgesia, that are commonly used as indicators of efficacy for acute pain products. Various safety measurements were also examined.

"These results continue to demonstrate the unique potential for AeroLEF(TM) to be further developed into a valuable product for pain management across a broad range of indications, which could include post-operative pain, medical emergency pain and breakthrough pain," said David All
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