Research Update
June 27 2006 - 3:01AM
UK Regulatory
Attention Business/Health Editors:
YM Biosciences announces independent Data Safety Monitoring Board
recommends tesmilifene pivotal trial continue as planned
MISSISSAUGA, ON, June 26 /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, today announced that
the independent Data Safety Monitoring Board (DSMB) for the pivotal Phase III
trial of tesmilifene in metastatic and recurrent breast cancer has completed
its first planned interim safety and efficacy analysis and concluded that the
trial continue as planned. The interim analysis was based on 215 events
(deaths) which occurred as of June 8th. The second of three planned interim
analyses is designed to occur after 256 events and is expected to occur in the
calendar third quarter of 2006. YM remains blinded to the study data.
"The next interim analysis for our trial is expected to occur shortly
and, as per the statistical plan and design of the trial, at each subsequent
analysis the level of survival improvement tesmilifene must demonstrate is
lowered. Thus the probability of success improves with each interim analysis,"
said David Allan, Chairman and CEO of YM BioSciences. "We are pleased that
tesmilifene continues to display a good safety profile and remain optimistic
based on the efficacy results tesmilifene produced in its first Phase III
trial."
The pivotal Phase III trial compares the overall survival of patients
treated with tesmilifene combined with epirubicin/cyclophosphamide to
epirubicin/cyclophosphamide alone in women with rapidly progressing metastatic
and recurrent breast cancer. The trial completed enrollment of 723 patients in
September 2005, is the subject of a Special Protocol Assessment by the FDA,
and is being conducted according to a sequential adaptive clinical design. The
sequential adaptive design allows for three interim analyses prior to a final
fourth analysis. Therefore, a total of four analyses are possible without
statistical penalty. In addition, YM has received FDA Fast Track designation
for tesmilifene in advanced breast cancer.
The study is statistically powered to detect a 33% improvement in overall
survival based on 384 events at the final analysis. The trial will be
considered positive if the tesmilifene arm is superior to the control arm with
an improvement in overall survival ranging from 50% initially (first interim
analysis) to 33% at the final analysis.
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 liposome 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
(YMBA)
END
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