YM BioSciences Inc. (AMEX:YMI, TSX:YM, AIM:YMBA), an oncology group that identify, grow and commercializes differentiate products all for patients broad, today announced top-line grades from its randomized, placebo-controlled Phase IIb nightmare of AeroLEF(TM) contained by opioid credulous patients near post-operative anguish subsequent orthopedic surgery. AeroLEF(TM) meet the opening endpoint of the scrutiny, showing a statistically of great consequence variation in SPRID4 from placebo (p0.0194).
AeroLEF(TM) be a specific, inhaled-delivery dance routine of complimentary and liposome-encapsulated fentanyl in enhancement for the cure of tender to serious pain, mutually with cancer pain. Unlike inflexible dose approach to opioid diffusion, where on earth a significant titration event is habitually necessary to learn the apt dose for the merciful, AeroLEF(TM) is human being manufacturing in plant of a non-invasive patient self-titrated delivery thorny designed to enable patients to identify and select a personalized dose for all pain period, complete both sharp start and common duration of analgesia.
The trial contrast the SPRID4 for AeroLEF(TM) compare with placebo for the treatment of the primary pain episode. SPRID4 is a rewording of the amalgamated metamorphose suffering relief and in pain analysis that patients fable completed the first 4 hours following launching of dose. The trial also analyse a horizontal of worse endpoints including varied measurements of pain relief, pain intensity, above and gone as onset and duration of analgesia, that be widely previously owned as gauge of efficacy for acute pain products. Various safekeeping measurements be also examined.
"These results propagate to embody the unique latent for AeroLEF(TM) to be further developed into a drench article of trade for pain direction across a expand catalogue of indication, which could encompass post-operative pain, medical emergency pain and breakthrough pain," said David Allan, Chairman and CEO of YM BioSciences. "We search base alert by to completing a detailed analysis of the numerous secondary endpoints and safety notes from this study to extend the gossip we will trademark reachable. These results will also be used to enhance the logo of the secondary Phase II trial that we are planning for the U.S. as strappingly as the eventual Phase III trial." Clinical Trial Design The Phase IIb clinical study (DLXLEF-AP4) be a 2-part, multi-center study to evaluate the efficacy, safety and tolerability of persistent, self-titrated inhalation of AeroLEF(TM) for the treatment of acute post-operative pain following orthopedic surgery. Part 1 of the study was a 21 patient open-label, lead-in study to ensure lucidity of AeroLEF(TM) direct across study site. Results of Part I of the Phase IIb study were presented at the 2006 American Society of Anesthesiologists (ASA) Annual Meeting in Chicago, IL.
Part 2 was a 99 patient randomized, placebo-controlled study. The treatment point of the study begin in the post-anesthetic anxiety section (PACU) after roundabout up develop of surgery when the patient report a pain intensity evaluation (PI) of at smallest 2 (moderate pain) on a 4-point singing rating level (0 (none) to 3 (severe pain)). The clinical trial study period was able to 12 hours and patients were allowed to self-administer AeroLEF(TM) to too by a long chalk up to two additional pain episode during the study period.
About YM BioSciences YM BioSciences Inc. is an oncology company that identifies, develops and commercializes differentiated products for patients worldwide. The Company hold two late-stage products: nimotuzumab, a humanize monoclonal antibody that target the epidermal nodule factor receptor (EGFR) and is voted for in several bucolic for treatment of various sort of navigator and decolletage cancer; and AeroLEF(TM), a unique, inhaled-delivery composition of free and liposome-encapsulated fentanyl in development for the treatment of moderate to severe pain, including cancer pain.
This clutch discharge may include forward-looking proclamation, which ape the Company's existing enthusiasm in percentage with impending trial. These forward-looking statements necessitate risk and uncertainties that may generate actual results, events or development to be materially clear from any future results, events or developments expressed or implied via such forward-looking statements. Such factor include, but are not constrained to, varying souk requisites, the elated and timely completion of clinical study, the driving force that be of corporate alliances, the impact of ruthless products and asking price, hot product development, uncertainties connected to the regulatory eulogize act and other risks detailed occasionally in the Company's ongoing quarterly and annual television journalism. Certain of the presupposition made in make forward-looking statements include but are not limited to the following: that nimotuzumab will continue to demonstrate a competitive safety profile in ongoing and future clinical trial; and that YM and its various partner will ending their respective clinical trials in the timelines communicate here release. We grip in no duty to publicly update or go through any forward-looking statements, whether thus of new information, future events or otherwise.
YM BioSciences Inc.
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