Research Update

    YM BioSciences Reports AeroLEF(TM) Randomized Phase IIb Trial Meets Primary
Endpoint in Patients with Post-Surgical Pain

    MISSISSAUGA, ON, May 2 /CNW/ - 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 naïve 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(equal
sign)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.

   
For further information: Enquiries: Thomas Fechtner, the Trout Group LLC,
Tel. [phone] x31, Fax [phone], Email:
tfechtner(at)troutgroup.com; James Smith, the Equicom Group Inc., Tel. (416)
815-0700 x 229, Fax [phone], Email: jsmith(at)equicomgroup.com
(YM. YMI)

 



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