YM BioSciences survival analysis data published at ASCO

 

    MISSISSAUGA, ON, May 19 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,

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

updated results for a completed phase III metastatic breast cancer trial using

the Company's lead drug, tesmilifene, were released in conjunction with an

abstract published in the Proceedings of the 2005 American Society of Clinical

Oncology's (ASCO) annual meeting. The abstract (No. 756) describes an analysis

of overall survival in a subgroup of patients enrolled in the "MA.19" trial.

    A total of 305 patients were enrolled in the MA.19 trial. Of the

191 patients in whom cancer metastasized or recurred within 36 months from

original diagnosis to trial entry, patients in the arm combining doxorubicin

with tesmilifene had a median survival of 29.7 months compared to 12.2 months

for patients on doxorubicin alone, a 143% improvement in overall survival

(p(equal sign)0.0016). The patient population of 305 was divided into tertiles

of patients who had a disease-free interval (DFI) of greater than 36 months,

6 to 36 months and less than 6 months. The DFI group greater than 36 months

demonstrated no benefit from the additional tesmilifene while the combined

groups of less than 36 months DFI demonstrated the significant 143% difference

in this unplanned, post-hoc analysis.

    A review of possible prognostic or post treatment factors demonstrated

that none could have contributed to the significant increase in overall

survival compared to the trial as a whole. The data from the full complement

in MA.19 (J. Clinical Oncology, 22:269-276, January 15, 2004) reported that

the median survival in the arm of doxorubicin plus tesmilifene was 23.6 months

compared to 15.6 months for patients on doxorubicin alone, a 51% improvement

in overall survival (p less than 0.03).

    The published analysis that tesmilifene appeared most effective in

patients with early metastatic disease or ER and PR negative tumours

complements pre-clinical observations which demonstrated that tesmilifene's

potentiation of chemotherapies is primarily evident in mdr+ cells. The

important differential in overall survival observed in women treated with

tesmilifene plus doxorubicin compared to doxorubicin alone in the

subpopulation of patients with rapidly progressing disease is thought to be

attributable to the effect of tesmilifene on mdr+ cells.

    In MA.19, response rates and median progression-free survival were not

different. The subset analysis appears to suggest that the differential effect

of tesmilifene on the minority population on mdr+ cells causes the (late)

survival benefit in the absence of an (early) response difference or a

difference in progression-free survival. This hypothesis is being further

explored in a currently ongoing trial of epirubicin plus cyclophosphamide with

or without tesmilifene in patients with early-recurring advance breast cancer.

    This latter trial, known as "DEC", is being undertaken by YM and is a

pivotal Phase III trial enrolling 700 women in more than 100 hospitals and

20 countries worldwide. As at today's date 420 women have been enrolled and

recruitment is anticipated to be complete in Q3 2005. Under an agreement with

the FDA, the trial is subject to a sequential analysis under which the trial

could be completed if an agreed differential in survival is demonstrated after

192 events. If the survival in the control arm mirrors the results from the

similar population in MA.19, YM anticipates the trial could be completed in

mid-2006 and, if the outcomes are positive, tesmilifene could be available to

patients in mid-2007.

 

    ASCO Publication Abstract No. 756

    Title: Subgroup analysis of a phase III trial of doxorubicin vs.

doxorubicin plus tesmilifene in advanced breast cancer (ABC): Tesmilifene

survival benefit focused on patients with more aggressive disease.

    Short Title: Subset analysis randomized breast

    Category: Breast Cancer

    SubCategory: Metastatic Breast Cancer

 

    Author(s): M.D. Vincent, P. Keane, H. Chen, K. Pritchard; London Regional

Cancer Program, London, ON, Canada; YM BioSciences Inc., Toronto, ON, Canada;

McDougall Scientific Ltd., Toronto, ON, Canada; Sunnybrook Regional Cancer

Centre, Toronto, ON, Canada

 

    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.

Published results from tesmilifene's first Phase III trial in the same

indication demonstrated a substantial increase in survival for women treated

with the combination of tesmilifene and chemotherapy compared to chemotherapy

alone, demonstrating that tesmilifene significantly enhanced the therapeutic

effect of chemotherapy. In addition to tesmilifene, the Company is developing

TheraCIM hR3, an EGFr humanized monoclonal antibody on which Phase II clinical

data have recently been released in pediatric glioma and nasopharyngeal

cancer, and for which Phase III IND applications have been filed, and a GnRH

anti-cancer vaccine that is in earlier stage clinical trials. YM BioSciences

recently 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 YM proposes to advance AeroLEF(TM) through a Phase IIb pain trial

in 2005.

 

    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)

 



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