Research Update
January 31 2005 - 2:00AM
PR Newswire (US)
Research Update 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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