Research Update
January 31 2005 - 2:03AM
UK Regulatory
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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