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YM BioSciences Inc. (YMB)

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Wednesday 28 September, 2005

YM BioSciences Inc.

Research Update


YM BioSciences partner, Oncoscience AG, reports update of pediatric

    brain cancer data

 

    - Nimotuzumab (Theraloc; TheraCIM h-R3) Phase II results awarded best

    poster prize at the 37th congress of the International Society of

    Paediatric Oncology -

 

    MISSISSAUGA, ON, Sept. 27 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,

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

updated data from a Phase II monotherapy trial of nimotuzumab in children with

resistant or relapsed high-grade gliomas (brain cancers) were reported in a

poster presented on September 23rd, 2005 at the 37th Congress of The

International Society of Paediatric Oncology in Vancouver, Canada. Nimotuzumab

produced cytotoxic efficacy and evidence of survival benefit in children with

heavily pretreated relapsed high grade gliomas, especially those with diffuse,

intrinsic pontine glioma.

    The presentation updated data originally contained in a press release by

YM BioSciences issued on February 28th, 2005 that described results in 17

evaluable children. The updated data now includes results from 34 children of

which 27 were evaluable at an eight week assessment. The trial design

evaluates the children after eight weeks (induction) of therapy and after week

21 (consolidation) of therapy.

    Nine of the 27 patients evaluable following induction had brain-stem

(diffuse intrinsic pontine) glioma, a treatment-resistant tumor. In the nine

evaluable patients with pontine glioma, five demonstrated clinical benefit at

week eight; four with Stable Disease (SD) and one with Partial Response (PR).

At the same time-point, three of the 18 remaining patients diagnosed with high

grade gliomas (grades III/IV) were assessed with clinical benefit (SD) at week

eight.

    Of the five patients (all pontine gliomas) who went on to complete the

consolidation period of five months of treatment, two who were evaluated at

induction with SD are now assessed as PR.

    Survival in the eight patients who derived clinical benefit post-

induction is as follows:

 

    -------------------------------------------------------------------------

                                 Pontine Glioma      Other High-Grade Gliomas

    -------------------------------------------------------------------------

    Months of Survival       15.5+; 14+; 11; 10; 3+         11+; 2.5; 8+

    -------------------------------------------------------------------------

    (+ remains alive)

    Median survival of the children who did not respond to nimotuzumab was

    1.3 months.

 

    The conclusions of the presentation were:

 

    -   Nimotuzumab has cytotoxic efficacy in heavily pretreated relapsed

        high grade gliomas, especially in diffuse, intrinsic pontine glioma.

 

    -   Repeated application of nimotuzumab is well tolerated and safe; no

        severe hematological or non-hematological side effects were reported.

 

    -   High quality of life with long intervals of home care, attending the

        school or kindergarten.

 

    -   A phase III study on the effectiveness of nimotuzumab in newly

        diagnosed intrinsic pontine glioma concomitant with radiotherapy in

        children and adolescents is planned.

 

    'This study demonstrated the strong anti-tumour activity of nimotuzumab

in the absence of the toxicities, namely rash and diarrhea, normally

associated with other drugs in this class,' said Dr. Paul Keane, Director of

Medical Affairs at YM BioSciences.

    The poster presentation was awarded best poster prize at the conference

in the section 'Experimental Therapeutics'. Posters were judged based on

scientific merit, visual presentation and the potential significance of the

clinical research.

 

    About Oncoscience AG

    Oncoscience AG is a private biotech company based in Germany and is

focused in Oncology (Theraloc), Organ Transplantation (Lifor) and Tumor tissue

banking including research in Genomics/Proteomics.

 

    About YM BioSciences

    YM BioSciences Inc. is a cancer product development company. Its lead

drug, tesmilifene, is a small molecule chemopotentiator currently completing

enrollment in 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 nimotuzumab, an anti-EGFr humanized monoclonal

antibody in a number of indications. 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: James Smith, the Equicom Group Inc., Tel.

(416) 815-0700 x 229, Fax (416) 815-0080, Email: jsmith(at)equicomgroup.com;

Carolyn McEwen, YM BioSciences Inc., Tel. (905) 629-9761, Fax (905) 629-4959,

Email: ir(at)ymbiosciences.com

    (YM. YMI)