YM BioSciences Expands Development Program for Lead Cancer Drug

 

    - YM Partners with Shin Poong Pharmaceutical Co. to Develop Tesmilifene

    for Gastric Cancer -

 

    MISSISSAUGA, ON, Jan. 31 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,

AIM:YMBA), the cancer drug development company, today announced that it has

partnered with the Shin Poong Pharmaceutical Company of Seoul, Korea to expand

the development program for its lead drug, tesmilifene, into gastric cancer.

    "This agreement is the first key milestone in our strategy to expand

tesmilifene's market potential both geographically and by demonstrating its

efficacy in additional cancer patient populations beyond metastatic breast and

hormone-refractory prostate cancer, the indications for which clinical trials

have concentrated to date," said David Allan, Chairman and CEO of

YM BioSciences. "Shin Poong management have advised us that they expect

tesmilifene could be launched as early as 2008 for the treatment of gastric

cancer, a fast follower to tesmilifene's late-stage program in breast cancer."

    The two companies will form a Joint Development Team to oversee the

development of tesmilifene in gastric cancer. Shin Poong will fully fund

development costs and provide an undisclosed amount of up-front, milestone and

royalty payments. In addition, Shin Poong will launch a bridging study in the

local population in calendar 2005 in order to allow the breast cancer

indication currently under study by YM to be launched in Korea and other Asian

countries. Shin Poong recently completed recruitment for a gastric cancer

study with its proprietary taxane drug, Padexol(R).

    "Shin Poong has significant experience developing therapeutics for

gastric cancer, making it the ideal partner for YM to work with in this area,"

said Sean Thompson, Director of Corporate Development for YM BioSciences.

"Because Korean drug development practices conform to International Committee

for Harmonization (ICH) standards, the data from this program will form an

important part of the global regulatory dossier for tesmilifene in this

indication."

    Gastric cancer is a significant disease in East Asian populations. While

more than 25,000 cases of gastric cancer are diagnosed annually in the United

States and more than 50,000 in Western Europe, approximately 110,000 cases are

diagnosed annually in Japan and approximately 58,000 cases are diagnosed

annually in Korea. The principal treatment for gastric cancer, a disease with

poor prognosis and a five-year survival rate of only 20%, is surgery which may

be used in combination with chemotherapy in Stage III/IV disease. Doxorubicin

is used in combination with other cytotoxic agents in these chemotherapeutic

approaches.

    Tesmilifene has been demonstrated to improve the effect of the known

chemotherapies in cancer. In the previous Phase III clinical trial, the

combination of tesmilifene with doxorubicin demonstrated a very significant

increase in the overall survival of women with metastatic or recurrent breast

cancer compared to those treated with doxorubicin alone. The success of that

trial is the basis for combining tesmilifene with a doxorubicin containing

regimen in the upcoming gastric cancer trials.

 

    About Shin Poong

    Shin Poong Pharmaceutical Company is a publicly traded company

established in 1962 in Seoul, South Korea. It is a top ranked marketer of

pharmaceuticals in Korea and has a leading position in oncology through its

Oncology Business Unit. It has manufacturing operations in five countries and

1,350 employees in manufacturing, R&D, sales and marketing. The company is

collaborating with the World Health Organization on the development of a novel

anti-malarial drug.

 

    About YM BioSciences

    YM BioSciences Inc. is a cancer drug 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

TheraCIM h-R3, an EGFr humanized monoclonal antibody on which Phase II

clinical data have recently been released in pediatric glioma and

nasopharyngeal cancer, and for which Phase III IND applications have been

filed. The Company also has a GnRH anti-cancer vaccine in that is in earlier

stage clinical trials.

 

    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: Enquiries: 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)



END



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