Research Update
06 June 2006 - 5:00PM
UK Regulatory
YM BioSciences starts patient treatment in Phase II trial combining
tesmilifene with Taxotere(R)
- Study to enroll up to 39 women with rapidly progressing metastatic
breast cancer -
MISSISSAUGA, ON, June 5 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,
AIM:YMBA), the cancer product development company, today announced that
treatment has been started in its Phase II trial combining tesmilifene with
Taxotere(R) (docetaxel). The trial is being conducted in collaboration with
Sanofi-Aventis and will investigate the effect of this drug combination in
women with rapidly progressing metastatic breast cancer.
The purpose of the study is to determine if the addition of tesmilifene
to docetaxel has the potential to improve clinical response without increasing
toxicity in patients. The primary endpoint of the trial is pharmacokinetic;
assessing the effect of addition of tesmilifene on the plasma concentration of
docetaxel. YM anticipates enrolment will be completed in calendar Q4, 2006 and
that pharmacokinetic data will be available in calendar Q1, 2007. The
secondary endpoints are overall survival and progression-free survival.
Survival data from this trial will be compared to historical survival data for
Taxotere(R) alone.
"In the clinic, tesmilifene has been shown to significantly improve the
effectiveness of commonly used cancer chemotherapies, prolonging survival when
compared to chemotherapy alone. Tesmilifene has been shown in both "in vitro"
and "in vivo" preclinical models to allow the specific targeting of multiple
drug resistant cancer cells by anthracyclines, taxanes, vinca alkaloids and
cisplatin. These "smart targeting" effects allow the tesmilifene/cytotoxic
combinations to destroy resistant cancer cells; the growth of non-resistant
cells being retarded or eliminated by the inherent activity of the cytotoxic
agents themselves," said Dr. Paul Keane, Director, Medical Affairs of YM
BioSciences.
"We expect to report survival data from this study in late 2007. While
early analyses of data from our ongoing pivotal Phase III trial will precede
the conclusion of this Phase II trial, a positive result in this trial would
significantly broaden the commercial applicability of our lead drug," said
David Allan, Chairman and CEO of YM BioSciences.
The single-arm study is expected to enroll up to 39 women who are
diagnosed with metastatic breast cancer or had their cancer recur within 24
months of their initial breast cancer diagnosis. Patients will be administered
docetaxel every 21 days and tesmilifene will be administered by a single
infusion at the start of each docetaxel cycle. Following a 5-patient dose
escalation component, patients will be treated for up to 29 weeks unless there
is evidence of unacceptable toxicity or disease progression. The study is
being conducted in Europe and the USA.
Docetaxel is a second-generation taxane that is commonly used to treat
patients with recurrent or metastatic breast cancer.
About tesmilifene
Tesmilifene is a small molecule drug currently undergoing a 700-patient
pivotal Phase III trial in metastatic and recurrent breast cancer that
completed enrolment in 2005. The trial compares tesmilifene combined with
epirubicin/cyclophosphamide against epirubicin/cyclophosphamide alone in women
with rapidly progressing metastatic and recurrent breast cancer. The trial is
the subject of a Special Protocol Assessment by the FDA and is being conducted
under an adaptive clinical design that provides three pre-planned evaluations
of the data each of which could be sufficient for submission for marketing
approval if the survival targets are achieved. The first interim analysis is
expected to occur in mid 2006. YM has received FDA Fast Track designation for
tesmilifene in advanced breast cancer.
Separately, an approval has been received from Health Canada to initiate
a randomized Phase II trial in first-line inoperable gastric cancer, where
tesmilifene will be added to standard chemotherapy consisting of anthracycline
(epirubucin), 5-FU and cisplatin and compared with standard chemotherapy
alone. This trial is anticipated to enroll 120 patients and will be conducted
in North America and Korea where gastric cancer incidence exceeds 65,000. A
randomized first-line trial in hormone-refractory prostate cancer combining
Taxotere(R) with tesmilifene is being designed and is expected to be initiated
before the end of 2006. YM has previously announced that it also intends to
complete the design for a Phase III trial in primary (adjuvant treatment)
breast cancer which it also anticipates could be submitted for regulatory
approval before the end of 2006.
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.
In addition to tesmilifene, YM BioSciences is developing nimotuzumab, an anti-
EGFr humanized monoclonal antibody, in a number of indications and
AeroLEF(TM), a unique inhalation delivered formulation of the established
drug, fentanyl, to treat acute pain including cancer pain. YM BioSciences is
also developing its anti-GnRH, anti-cancer vaccine, Norelin(TM), and owns a
portfolio of preclinical compounds.
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: Thomas Fechtner, The Trout Group LLC, Tel.
(212) 477-9007 x31, Fax (212) 460-9028, Email: tfechtner(at)troutgroup.com;
James Smith, the Equicom Group Inc., Tel. (416) 815-0700 x 229,
Fax (416) 815-0080, Email: jsmith(at)equicomgroup.com
(YMBA)
END
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