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Biotech / Medical : YMI: YM Biosciences, Inc. (YMI on AMEX) -- Ignore unavailable to you. Want to Upgrade?

To: DewDiligence_on_SI who wrote (30)	2/17/2007 10:40:00 AM
From: LaFayette555	Respond to of 66

All subjective considerations aside... would you not rate these results for AeroLEF positive & promising ? Keeping marketing considerations aside, I would rate the chances of a successful outcome for this trial as excellent based on the open label results. Would you agree ? Objectively. YM BioSciences announces results of AeroLEF(TM) Phase IIb open-label study 23:00 EDT Tuesday, October 17, 2006 - Data presented at ASA Annual Meeting show inhaled AeroLEF(TM) produced clinically meaningful, highly-individualized analgesia for acute pain - MISSISSAUGA, ON, Oct. 17 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM, AIM:YMBA), a company engaged in the acquisition, development and commercialization of oncology and acute care products, today announced results from the open-label portion of its Phase IIb trial (DLXLEF-AP4) of AeroLEF(TM). The results demonstrated that the majority of the patients were able to achieve effective analgesia for episodes of moderate to severe acute post-surgical pain by self-titrating the amount of medication they inhaled using AeroLEF(TM). Results of the study were presented at the American Society of Anesthesiologists (ASA) Annual Meeting in Chicago, IL. 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. AeroLEF is designed to permit patients to match dosage to their individual pain intensity and experience rapid and extended pain relief. "The time course of analgesia demonstrated in this study suggest that AeroLEF is suitable for the stabilization of acute post-operative pain," said Sugantha Ganapathy, MD, director, regional anesthesia, Department of Anesthesia and Perioperative Medicine, University of Western Ontario, London, Ontario, Canada, who presented the results. "Furthermore, differences in median times to effective analgesia for patients taking second and third doses of AeroLEF suggests that patients were capable of safely self-limiting dosing to match the intensity of each pain episode." In the study, patient self-titrated dosing with AeroLEF provided clinically meaningful analgesia in 81 percent, 100 percent and 87.5 percent of treated pain episodes during doses 1, 2 and 3 respectively. Within 10 minutes of initiating dosing with AeroLEF, 38 percent, 73 percent and 63 percent of patients reported a reduction in pain intensity to mild pain during doses 1, 2 and 3 respectively. Achieving effective pain relief was the reason for stopping AeroLEF dosing in 35 of 40 (88 percent) treated pain episodes. Study results also suggested that multiple doses of AeroLEF were well tolerated. No treatment-emergent adverse events were reported in 9 of 21 (43 percent) of patients. The majority ((greater than)70 percent) of treatment-emergent adverse events were mild and considered typical of those associated with opioid analgesia in the post-operative setting. Adverse events of a respiratory nature were reported in 4 patients. These events were mild and transient and resolved with minimal intervention. "We are pleased that AeroLEF performed well in this open-label portion of our Phase IIb study, providing highly-individualized, episode-specific pain relief in the post-operative setting," said David Allan, Chairman and CEO of YM BioSciences. "We continue to enroll patients in the randomized portion of the trial based on an interim analysis that showed benefit versus placebo." The Phase IIb of AeroLEF in moderate to severe post-surgical pain consists of two parts. Part I, reported today, was an open label trial designed to allow investigators to gain familiarity with administration of the product. Part I enrolled 21 patients who underwent a variety of elective orthopedic surgical procedures at eight centers. Part II, currently underway, is a randomized, double-blind, and placebo-controlled trial of 99 patients and is designed to evaluate the safety and efficacy of AeroLEF compared to placebo for management of pain following elective orthopedic surgery.