FDA News

FDA puts AeroLEF pain drug study on hold

(Jan 17,2008)-- YM BioSciences said it has been informed by the US Food and Drug Administration that the regulator has put on hold the Phase II Acute Pain Study of AeroLEF and is requesting additional safety information on specific patients in previous clinical studies.

The additional requested data is limited to a small group of patients that experienced oxygen desaturation, a class effect of opioids including fentanyl, the company said, adding it will conduct a subgroup analysis on these patients.

To date, no patients have been dosed in the US AP5 study and there are no other clinical trials involving AeroLEF currently ongoing. AeroLEF is an inhaled-delivery composition of free and liposome-encapsulated fentanyl in development for the treatment of moderate to severe pain, including cancer pain.

The FDA has requested additional safety information on specific patients in previous clinical studies. The additional requested data is limited to a small group of patients that experienced oxygen desaturation, a class effect of opioids including fentanyl. The Company will conduct a subgroup analysis on these patients. To date, no patients have been dosed in the US AP5 study and there are no other clinical trials involving AeroLEF(TM) currently ongoing.

'We are confident that we can provide the information the FDA has requested in a timely manner,' said David Allan, Chairman and CEO of YM BioSciences. 'We appreciate that the FDA has to ensure that any risk to patients during clinical trials is minimized and we understand their caution with opioid-based therapeutics.'
Dr. Diana Pliura, Executive Vice President, AeroLEF(TM) added, 'Data reported in May 2007from our successful randomized Phase 2b trial demonstrated that patients had a statistical and clinical benefit from AeroLEF(TM). We remain strongly committed to the clinical development of this unique product.'
YM BioSciences also reported that it held its scheduled End-of-Phase 2 (EoP2) meeting with the FDA on January 16, 2007as planned.

YM recently reported that its lead drug, nimotuzumab, is in numerous trials internationally including a Phase III randomized trial in adult glioma and a Phase II/III randomized trial in patients with advanced pancreatic cancer. Data from the fully recruited Phase III trial in Europein children with inoperable brain cancer, if positive, are expected to be submitted to the EMEA for marketing approval.

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