YM BioSciences Inc.
(AMEX:YMI, TSX:YM, AIM:YMBA), an oncology company that identifies, develops
and commercializes differentiated products for patients worldwide, today
announced top-line results from its randomized, placebo-controlled Phase
IIb trial of AeroLEF(TM) in opioid naive patients with post-operative pain
following orthopedic surgery. AeroLEF(TM) met the primary endpoint of the
study, showing a statistically significant difference in SPRID4 from
placebo (p=0.0194).
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. Unlike fixed dose approaches to
opioid delivery, where a significant titration period is often required to
determine the suitable dose for the patient, AeroLEF(TM) is being developed
as a non-invasive patient self-titrated delivery system designed to enable
patients to identify and select a personalized dose for each pain episode,
achieving both rapid onset and extended duration of analgesia.
The trial evaluated the SPRID4 for AeroLEF(TM) compared with placebo
for the treatment of the first pain episode. SPRID4 is a summary of the
combined changes in pain relief and in pain intensity that patients report
over the first 4 hours following initiation of dosing. The trial also
examined a number of secondary endpoints including various measurements of
pain relief, pain intensity, as well as onset and duration of analgesia,
that are commonly used as indicators of efficacy for acute pain products.
Various safety measurements were also examined.
"These results continue to demonstrate the unique potential for
AeroLEF(TM) to be further developed into a valuable product for pain
management across a broad range of indications, which could include
post-operative pain, medical emergency pain and breakthrough pain," said
David Allan, Chairman and CEO of YM BioSciences. "We look forward to
completing a detailed analysis of the numerous secondary endpoints and
safety data from this study to extend the information we will make
available. These results will also be used to enhance the design of the
additional Phase II trial that we are planning for the U.S. as well as the
eventual Phase III trial."
Clinical Trial Design
The Phase IIb clinical study (DLXLEF-AP4) was a 2-part, multi-center
study to evaluate the efficacy, safety and tolerability of repeated,
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 consistency of AeroLEF(TM)
administration across study sites. 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 phase of the study began in the post-anesthetic care unit (PACU)
after completion of surgery when the patient 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.
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 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 press release may contain forward-looking statements, which
reflect the Company's current expectation regarding future events. These
forward-looking statements involve risks and uncertainties that may cause
actual results, events or developments to be materially different from any
future results, events or developments expressed or implied by such
forward-looking statements. Such factors include, but are not limited to,
changing market conditions, the successful and timely completion of
clinical studies, the establishment of corporate alliances, the impact of
competitive products and pricing, new product development, uncertainties
related to the regulatory approval process and other risks detailed from
time to time in the Company's ongoing quarterly and annual reporting.
Certain of the assumptions made in preparing 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 trials; and that YM and its various partners will complete their
respective clinical trials within the timelines communicated in this
release. We undertake no obligation to publicly update or revise any
forward-looking statements, whether as a result of new information, future
events or otherwise.
YM BioSciences Inc.
ymbiosciences