YM Biosciences' subsidiary DELEX Therapeutics to initiate Phase IIb

    trial for the treatment of acute pain with AeroLEF(TM)

 

    MISSISSAUGA, ON, Aug. 30 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,

AIM:YMBA), the cancer product development company, today announced that its

subsidiary, DELEX Therapeutics Inc., has received permission from Heath Canada

to initiate a randomized Phase IIb study with AeroLEF(TM), its unique

formulation of the opioid, fentanyl, for the treatment of moderate to severe

acute pain.

    "YM has delivered on its first milestone in its clinical development

program for AeroLEF(TM)", said David Allan, Chairman and CEO of YM

BioSciences. "We expect that this trial will continue to demonstrate the

important difference that DELEX's particular approach makes to patients with

its pulmonary delivery of opioids when compared to all the other entrants into

this large market."

    AeroLEF(TM), a proprietary fentanyl formulation for inhalation, is

designed to provide personalized, patient-controlled analgesia to address the

unpredictable variability in analgesic needs that are a hallmark of acute pain

episodes, including breakthrough cancer pain.

    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.

    "Following a unique dose-to-effect self-titration protocol, the widely

variable doses selected by the patients to achieve meaningful pain relief in

the Phase IIa study corroborated a number of published observations of the

highly variable interpatient experience of acute pain and the high variability

between patients in response to analgesics," said Diana Pliura, President and

CEO of DELEX Therapeutics. "To our knowledge, AeroLEF(TM) is the only product

that provides the prospect of personalized, patient-controlled dosing to match

each patient's individual pain event which, by definition, offers 'the right

dose each time'."

    The Phase IIb trial is expected to be initiated in Q4, 2005, in Canada,

at six to eight sites. It will be a randomized, double-blinded, placebo-

controlled study 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 is expected to enroll

approximately 120 patients and complete recruitment in Q1, 2006, with the

prospect of a final report in Q2, 2006.

 

    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, the Company is developing

nimotuzumab, an anti-EGFr humanized monoclonal antibody for which Phase II

clinical data were released in 2005 in pediatric glioma and nasopharyngeal

cancer, and for which Phase III IND applications have been filed.

YM BioSciences is also developing its anti-GnRH, anti-cancer vaccine,

Norelin(TM), for which Phase II data have been released. In May, 2005, the

Company acquired DELEX Therapeutics Inc., a private clinical stage

biotechnology company and in August, 2005 acquired a broad 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: James Smith, The Equicom Group Inc.,       

Tel. (416) 815-0700 x 229, Email: jsmith(at)equicomgroup.com; Carolyn McEwen,

YM BioSciences Inc., Tel. (905) 629-9761, Fax (905) 629-4959,           

Email: ir(at)ymbiosciences.com

    (YM. YMI YMBA)

 



END
YM Bio.'b'ser1 (LSE:YMB)
Historical Stock Chart
From Jun 2024 to Jul 2024 Click Here for more YM Bio.
YM Bio.'b'ser1 (LSE:YMB)
Historical Stock Chart
From Jul 2023 to Jul 2024 Click Here for more YM Bio.