YMB YM Bio.'b'ser1

    YM BioSciences completes enrolment of pivotal trial for tesmilifene

 

    - First interim analysis planned for mid-2006 could lead to approval -

 

    MISSISSAUGA, CANADA, Sept. 28 /CNW/ - YM BioSciences Inc. (AMEX:YMI,

TSX:YM, AIM:YMBA), the cancer product development company, today announced

that it has completed enrolment in its 700 patient pivotal trial of

tesmilifene for the treatment of metastatic and recurrent breast cancer.

    "We anticipate that the first planned interim analysis of data from this

pivotal trial will occur in mid calendar 2006," said Dr. Vincent A. Salvatori,

Executive Vice President of YM BioSciences. "If survival results are similar

to those in the first tesmilifene Phase III trial then, through a Special

Protocol Assessment agreed to with the FDA, the data could be sufficient to

seek regulatory approval."

    "Enrolment for our 700 patient pivotal trial was achieved on schedule in

just 18 months, demonstrating the quality of the clinical group we have

assembled at YM," said David Allan, Chairman and CEO. "We are committed to

maintaining this momentum as we progress the trial towards completion and look

forward to the results of several planned interim analyses, any of which could

produce data suitable to submit the drug for approval. The first analysis will

occur following 192 events and subsequent analyses, if required, will occur

every 64 events which we expect on approximately a quarterly basis. The

threshold for success at each interim analysis decreases."

    The "DEC" pivotal Phase III trial includes more than 100 clinical sites

around the world. The trial compares tesmilifene combined with

epirubicin/cyclophosphamide against epirubicin/cyclophosphamide alone in women

with rapidly progressing metastatic and recurrent breast cancer. An analysis

of overall survival in a subgroup of patients enrolled in a previous Phase III

trial ("MA.19") were published in the Proceedings of ASCO 2005 and

demonstrated that tesmilifene extended median survival in a similar patient

population from 12.2 months to 29.7 months (143%; p(equal sign)0.0016) when

added to doxorubicin versus doxorubicin alone.

    Tesmilifene is a small molecule chemopotentiator effective in enhancing

all known classes of chemotherapies currently used to treat cancer. YM has

been cleared to commence a Phase II trial combining tesmilifene with Taxotere

for the treatment of metastatic and recurrent breast cancer. Separately, YM is

partnered with the Shin Poong Pharmaceutical Company of Seoul, South Korea to

expand the development program for tesmilifene into gastric cancer. The South

West Oncology Group, a U.S. National Cancer Institute cooperative group, has

proposed to sponsor a Phase III trial for tesmilifene in hormone refractory

prostate cancer.

 

    About YM BioSciences

    YM BioSciences Inc. is a cancer product development company. In addition

to tesmilifene YM BioSciences is developing nimotuzumab, an anti-EGFr

humanized monoclonal antibody, in a number of indications. A Phase II

monotherapy trial of nimotuzumab produced cytotoxic efficacy and evidence of

survival benefit in children with brain cancer. YM BioSciences is also

developing its anti-GnRH, anti-cancer vaccine, Norelin(TM), for which Phase II

data have been released. In May 2005, the Company acquired DELEX Therapeutics

Inc., a private clinical stage biotechnology company developing AeroLEF(TM), a

unique inhalation delivered formulation of the established drug, fentanyl, to

treat acute pain including cancer pain. This product has completed a Phase IIa

trial with positive results and randomized a Phase IIb pain trial has been

cleared to start. The Company also has a broad portfolio of preclinical

compounds shown to act as chemopotentiators while protecting normal cells.

 

    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: Enquiries: James Smith, the Equicom Group Inc.,

Tel. (416) 815-0700 x 229, Fax (416) 815-0080, Email:

jsmith(at)equicomgroup.com; YM BioSciences Inc.: Tel. (905) 629-9761,

Fax (905) 629-4959, Email: ir(at)ymbiosciences.com

    (YM. YMI YMBA)



END

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