Research Update
January 26 2006 - 7:00AM
UK Regulatory
YM Biosciences' subsidiary DELEX Therapeutics announces enrollment of
first patient in Phase IIb trial for the treatment of acute pain with
AeroLEF(TM)
MISSISSAUGA, ON, Jan. 26 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,
AIM:YMBA), the cancer product development company, today announced that its
subsidiary, DELEX Therapeutics Inc., has enrolled the first patient for its
randomized 120-patient Phase IIb trial for the treatment of moderate to severe
acute pain with AeroLEF(TM). AeroLEF(TM) is a proprietary formulation of free
and liposome-encapsulated nebulized fentanyl, which permits delivery through
the lung. AeroLEF(TM) provides personalized, patient- controlled analgesia to
address the unpredictable variability in analgesic needs that are a hallmark
of acute pain episodes, including breakthrough cancer pain.
The current Phase IIb study is randomized, double-blinded, and
placebo-controlled, and is designed to evaluate the safety and efficacy of
multiple doses of AeroLEF(TM) for management of pain in post-surgical patients
following elective orthopedic surgeries. The trial, for which seven of the
eight clinical sites have been initiated, is expected to enroll approximately
120 patients, complete recruitment and report in the first half of 2006. The
primary endpoint for this study is the Summed Pain Relief plus Pain Intensity
Difference (SPRID) scores during the first four hours after the start of the
initial dose. Secondary endpoints include Time to Effective Pain Relief, as
well as six safety endpoints.
In a previous single dose Phase IIa study, 95% of post-surgical patients
achieved clinically meaningful analgesia following self-administration of
AeroLEF(TM) to treat their moderate to severe pain. Patients reported rapid
onset of analgesia followed by an extended duration of pain relief.
About DELEX
DELEX Therapeutics Inc. is a wholly-owned subsidiary of YM BioSciences
Inc. DELEX develops products that deliver therapeutics to the systemic
circulation via inhalation through the lungs. Using DELEX's proprietary Rapid
Onset and Sustained Effect Delivery System (ROSE-DS) platform technology,
AeroLEF(TM) offers the opportunity for patient controlled analgesia for the
treatment of acute and breakthrough pain, conditions that are common in cancer
patients and underserved by existing fixed dose delivery technologies.
About YM BioSciences
YM BioSciences Inc. is a cancer product development company. Its lead
drug, tesmilifene, is a small molecule chemopotentiator currently undergoing a
700- patient pivotal Phase III trial in metastatic and recurrent breast
cancer. Published results from tesmilifene's first Phase III trial in the same
indication demonstrated a substantial increase in survival for women treated
with the combination of tesmilifene and chemotherapy compared to chemotherapy
alone, demonstrating that tesmilifene significantly enhanced the therapeutic
effect of chemotherapy. In addition to tesmilifene, YM BioSciences is
developing nimotuzumab, an anti-EGFr humanized monoclonal antibody, in a
number of indications. A Phase II monotherapy trial of nimotuzumab produced
cytotoxic efficacy and evidence of survival benefit in children with recurrent
brain cancer. YM BioSciences is also developing its anti-GnRH, anti-cancer
vaccine, Norelin(TM), for which Phase II data have been released. The Company
also has a portfolio of preclinical compounds shown to act as
chemopotentiators while protecting normal cells.
Except for historical information, this press release may contain
forward-looking statements, which reflect the Company's current expectation
regarding future events. These forward-looking statements involve risk and
uncertainties, which may cause 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.
For further information: Thomas Fechtner, The Trout Group LLC, Tel.
(212) 477-9007 x31, Fax (212) 460-9028, Email: tfechtner(at)troutgroup.com;
Carolyn McEwen, YM BioSciences Inc., Tel. (905) 629-9761, Fax (905) 629-4959,
Email: ir(at)ymbiosciences.com
(YM. YMI)
END
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