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The FDA has requested additional safety information on specific patients in previous clinical studies
MISSISSAUGA, Canada | January 17, 2008 | YM BioSciences Inc. (AMEX: YMI, TSX: YM, AIM: YMBA), an oncology company that identifies, develops and commercializes differentiated products for patients worldwide, today announced that it has received a letter from the U.S. Food and Drug Administration (FDA) informing the Company that the Phase II Acute Pain Study (AP5) of AeroLEF™ for which FDA clearance was announced on June 27, 2007, upon re-review of data from the IND submission, has been placed on clinical hold. 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™ 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™ added, “Data reported in May 2007 from our successful randomized Phase 2b trial demonstrated that patients had a statistical and clinical benefit from AeroLEF™. 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, 2007 as 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 Europe in children with inoperable brain cancer, if positive, are expected to be submitted to the EMEA for marketing approval.
About AeroLEF™
AeroLEF™ 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. In contrast to fixed-dose approaches to opioid delivery, where a significant titration period is often required to determine the suitable dose for the patient, AeroLEF™ is being developed as a non-invasive delivery system designed to enable patients to self-titrate. Using AeroLEF™, patients can identify and select a personalized dose for each pain episode, achieving both rapid onset and extended duration of analgesia.
About YM BioSciences
YM BioSciences Inc. is an oncology company that identifies, develops and commercializes differentiated products for patients worldwide. The Company has two late-stage products: nimotuzumab, a humanized monoclonal antibody that targets the epidermal growth factor receptor (EGFR) and is approved in several countries for treatment of various types of head and neck cancer; and AeroLEFÔ, a proprietary, inhaled-delivery composition of free and liposome-encapsulated fentanyl in development for the treatment of moderate to severe pain, including cancer pain.
SOURCE: YM BIOSCIENCES
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