YMB YM Bio.'b'ser1

    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)

 

 

 



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