YM BioSciences announces update on trial
June 07 2006 - 8:11AM
UK Regulatory
YM BioSciences announces update on tesmilifene pivotal trial
MISSISSAUGA, ON, June 7 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,
AIM:YMBA), a company engaged in the acquisition, development and
commercialization of oncology and acute care products, advises that the
milestone of 192 events required for the first interim analysis in its pivotal
Phase III trial of tesmilifene in metastatic and recurrent breast cancer has
occurred.
The Data Safety Monitoring Board (DSMB), at its meeting conducted during
ASCO on June 5th, 2006 required further clarification of the data in respect
of a small number of patients. When this is received it will permit the DSMB
to complete a formal statistical analysis. YM anticipates that this should
occur within the next four weeks.
The DSMB advised YM that there were no safety concerns and that the trial
should continue as planned.
"We look forward to learning the outcome of this first interim analysis
in several weeks," said David Allan, Chairman and CEO of YM BioSciences. "The
reporting of no major safety concerns provides additional confirmation of the
safety of tesmilifene as observed in earlier clinical trials."
The primary endpoint of the study is overall survival and the study is
designed to detect a 33% improvement in overall survival based on 384 events.
The sequential adaptive design of the study provides for interim analyses
during the course of the study. At each interim analysis, the tesmilifene-
containing treatment arm is compared with the control arm, and the trial can
be stopped if it is clear that the experimental treatment is superior to the
control or that such evidence is not going to be found. If the evidence is
insufficient for either conclusion to be drawn, then the trial continues until
the next interim analysis. This allows the study to be stopped early if the
survival benefit is achieved at pre-determined times, however, the fewer
number of events requires a higher percentage improvement in survival. Based
on 192 events, the survival improvement would have to exceed 50%.
Tesmilifene is a small molecule drug currently in a 700-patient pivotal
Phase III trial in metastatic and recurrent breast cancer. The trial compares
tesmilifene combined with epirubicin/cyclophosphamide against
epirubicin/cyclophosphamide alone in women with rapidly progressing metastatic
and recurrent breast cancer. Enrollment has been completed and the trial is
the subject of a Special Protocol Assessment by the FDA and is being conducted
under an adaptive clinical design, each of which could be sufficient for
submission for marketing approval if the survival targets are achieved. YM has
received FDA Fast Track designation for tesmilifene in advanced breast cancer.
About YM BioSciences
YM BioSciences Inc. is a company engaged in the acquisition, development
and commercialization of oncology and acute care products. 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
inhaled delivery of free and lipsome encapsulated 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
(YM. YMI YMBA)
END
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