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YM BioSciences Announces Secondary Efficacy and Safety Findings in,Randomized Phase IIB Aerolef Trial

- Company Announces Lead Investigator for U.S. Trial -

MISSISSAUGA, ON, July 11, 2007 /PRNewswire-FirstCall/ - YM BioSciences Inc. , an oncology company that identifies, develops and commercializes differentiated products for patients worldwide, today announced results of secondary endpoint data from its 99 patient, randomized, placebo-controlled, multi-center Phase IIb trial (DLXLEF-AP4) with AeroLEF(TM). 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. YM previously announced that this trial had successfully achieved its primary endpoint, the summed pain intensity difference/pain relief scores (SPRID4) during the 4 hours from the start of the initial dose of study medication (p=0.0194).

Additional Secondary Efficacy and Safety Findings

The treatment phase of the study began in the post-anesthetic care unit (PACU) after completion of surgery when patients reported a pain intensity score (PI) of at least 2 (moderate pain) on a 4-point verbal rating scale (0 (none) to 3 (severe pain)). The clinical trial study period was up to 12 hours and patients were allowed to self-administer AeroLEF(TM) to treat up to two additional pain episodes during the study period. For each pain episode, patients were instructed to continue the self-administration of drug until achievement of one of the following endpoints: achievement of effective analgesia, completion of full dose, or onset of dose-limiting side effects. Patients were allowed rescue medication at any time following initiation of study treatment.

For the first dose administered in the PACU, the percentage of patients reporting a pain intensity (PI) score of less than or equal to 1 (mild pain or no pain) at the end of the dosing period with AeroLEF(TM) was 59%, a statistically significant difference from placebo (27%)
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