YM BioSciences Cleared by FDA to Initiate Phase III Registrational Trial for Breast Cancer Drug
04 Novembro 2003 - 3:07AM
PR Newswire (US)
YM BioSciences Cleared by FDA to Initiate Phase III Registrational
Trial for Breast Cancer Drug - Pivotal trial to confirm previous
positive phase III results for tesmilifene - MISSISSAUGA, ON, Nov.
4 /PRNewswire-FirstCall/ -- YM BioSciences Inc. (AIM:YMBA, TSX:YM),
a cancer drug development company with an advanced-stage portfolio,
today announced that it has received written confirmation from the
U.S. Food and Drug Administration (FDA) that it may initiate a
pivotal Phase III, or registrational trial, for its lead
small-molecule anti-cancer therapeutic, tesmilifene. "We are
extremely pleased the FDA has cleared us to begin this trial and
look forward to establishing tesmilifene's ability to enhance
traditional chemotherapies and extend the survival time of women
with metastatic breast cancer, as the drug has demonstrated in a
previous Phase III trial," said David Allan, Chairman and CEO of YM
BioSciences. "The incorporation of a sequential design into the
protocol creates the possibility of significantly reduced trial
time and costs compared with the usual, classic Phase III trial
design in this indication." The planned multi-center international
trial will compare the overall survival times of advanced
metastatic/recurrent breast cancer patients receiving tesmilifene
in combination with epirubicin (an anthracycline) and
cyclophosphamide versus epirubicin/cyclophosphamide alone. The
primary endpoint of this pivotal trial is survival. The FDA has
approved the incorporation of a sequential design into the trial
protocol, enabling an interim analysis to be made by an independent
Data Monitoring Board after 50% of the planned number of events
(deaths) have occurred, and if necessary every six months
thereafter, without incurring any statistical penalty. If the
required survival differential is achieved at the first interim
analysis, recruitment for the trial could be completed in
approximately two years. This notification also follows the
positive Special Protocol Assessment (SPA) by the FDA, approving
the trial protocol design and endpoints. About Tesmilifene
Tesmilifene is a small molecule anti-cancer drug that enhances
traditional chemotherapy agents. It has been administered to over
500 patients in nine clinical trials and has been demonstrated to
be safe. Tesmilifene has completed a successful Phase III
international trial with 305 patients that compared the combination
of tesmilifene and an anthracycline versus anthracycline alone in
metastatic breast cancer patients. Results of the trial
demonstrated that patients receiving the tesmilifene/anthracycline
combination therapy had greater than 50% (23.6 months vs. 15.6
months; p(equal sign)0.03) median survival improvement compared
with those receiving anthracycline alone. Further analysis
indicated that patients in that trial suffering from aggressive
breast cancer, defined as a disease free interval of less than 36
months, showed an even greater median overall survival increase.
About YM BioSciences YM BioSciences Inc. is a cancer drug
development company that was established in Canada in 1994. Its
drug development portfolio includes three different anti-cancer
compounds in a number of formulations targeting five different
tumours or stages of cancer in clinical development. The products
have been licensed principally from academic centres of excellence
internationally. Drugs in development include tesmilifene, a small
molecule chemopotentiator (for taxanes and anthracyclines) that has
completed a Phase III trial with positive results in metastatic
breast cancer; an EGFr humanized monoclonal antibody having
completed Phase II trials; and a GnRH cancer vaccine also in
clinical trials. In addition, the company is supporting the
preclinical development of two additional cancer products. 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.
DATASOURCE: YM BioSciences Inc. CONTACT: Enquiries: James Smith,
The Equicom Group Inc., Tel. +1-416-815-0700 x 229, Email: ; YM
BioSciences Inc., Tel. +1-905-629-9761, Fax +1-905-629-4959, Email:
Copyright