YM BioSciences completes enrolment of AeroLEF(TM) Phase IIB pain trial

    - AeroLEF(TM) to be presented at Oppenheimer Pain Management Conference -

    MISSISSAUGA, ON, March 5 /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 that enrolment
has been completed in the randomized, double-blind, and placebo-controlled
portion of its Phase IIB trial (DLXLEF-AP4) of AeroLEF(TM). YM expects that
the results of the primary efficacy and safety analyses will be available in
mid-second quarter of 2007.
    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. AeroLEF(TM) provides both rapid and
extended pain relief. 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 designed to permit patients to match dosage to
their individual pain intensity for each pain episode.
    "We look forward to receiving the results of this study of AeroLEF(TM),
which in previous studies has provided highly-individualized, episode-specific
pain relief in the post-operative setting," said David Allan, Chairman and CEO
of YM BioSciences. "We are continuing to assess the design of additional Phase
II clinical studies and plan to file a US IND shortly. Concurrently, we will
continue to educate potential development and marketing partners about the
unique attributes of AeroLEF(TM)."
    The Phase IIb clinical trial of AeroLEF(TM) for the treatment of moderate
to severe post-surgical pain consisted of two parts. Patients who underwent a
variety of elective orthopedic surgical procedures were enrolled at eight
centers. Part I was an open label trial designed to allow investigators to
gain familiarity with administration of the product and enrolled 21 patients.
Part II was a randomized, double-blind, and placebo-controlled trial of 99
patients and was designed to evaluate the safety and efficacy of AeroLEF(TM)
compared to placebo. The primary endpoint for this study was the Summed Pain
Relief plus Pain Intensity Difference (SPRID) scores during the first four
hours after the start of the initial dose. Secondary endpoints included Time
to Effective Pain Relief, as well as six safety endpoints.
    Dr. Diana Pliura will be presenting AeroLEF(TM) at the Oppenheimer Pain
Management Conference at the Flatotel in New York on March 6th in a session
that begins at 11:00 a.m. EST
    The results of an interim analysis on the first 67 patients in Part II of
this trial were released in September 2006. The data indicated that
AeroLEF(TM) provided benefit compared to placebo but the difference between
the treatment arm and placebo arm had not yet achieved the significance level
predefined in the study protocol and therefore the study was continued as
planned.
    In Part I of the Phase IIb study, patient self-titrated dosing with
AeroLEF(TM) 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(TM), 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(TM) dosing in 35 of
40 (88 percent) treated pain episodes. Study results also suggested that
multiple doses of AeroLEF(TM) 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. Results of Part I of the study were presented at the 2006
American Society of Anesthesiologists (ASA) Annual Meeting in Chicago, IL.

    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.

    %SEDAR: 00004652E

For further information: Thomas Fechtner, The Trout Group LLC, Tel. (212)
477-9007 x31, Fax (212) 460-9028, Email: tfechtner(at)troutgroup.com; James
Smith, the Equicom Group Inc., Tel. (416) 815-0700 x 229, Fax (416) 815-0080,
Email: jsmith(at)equicomgroup.com; Media Enquiries: Mike Beyer, Sam Brown
Inc., (773) 463-4211, beyer(at)sambrown.com
(YM. YMI YMBA)

 



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