YMB YM Bio.'b'ser1

    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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