YMB YM Bio.'b'ser1

    YM BioSciences and Oncoscience Report Response Rate of 35.3% in

    Pediatric Glioma

 

    - TheraCIM h-R3 (nimotuzumab) Phase II Results Presented at European High

      Grade Glioma Conference -

 

    MISSISSAUGA, ON, Feb. 28 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,

AIM:YMBA) today announced that it has been advised by its European partner,

Oncoscience AG, that a Phase II trial in children with brain cancer (glioma)

utilizing the EGF receptor monoclonal antibody TheraCIM h-R3 (nimotuzumab,

"Theraloc" in Europe) as a monotherapy achieved a response rate of 35.3%.

    Six of the 17 children who were fully evaluable at the time of the

conference were reported to have demonstrated either stable disease or a

partial response.

    Of the six, four were identified by investigators to have been suffering

from pontine glioma (diffuse intrinsic brain stem glioma) - a form of the

disease that is particularly aggressive and generally untreatable.

    No skin toxicity or allergic reactions were reported, consistent with all

the previous trials conducted with TheraCIM h-R3.

    These results were formally presented on February 25th, 2005 at the

"European High-Grade Glioma Meeting" in Regensburg, Germany and a conference

call to discuss these data will be held today at 1:00pm EST.

 

    Phase II Trial Results

 

    The trial included 20 children who had been treated surgically for their

glioma and had also received radiation and mono chemotherapy or combination

chemotherapy treatment. They were entered into the trial when all prior

treatments had failed and progression had been documented by MRI assessment.

One child was determined to be ineligible and was withdrawn. The trial's

protocol required the trial to stop for futility if no patients responded to

the treatment with h-R3; to continue as monotherapy if two patients responded,

and to stop for success if at least three patients responded to treatment with

the antibody.

    At the time of the conference, 17 of the 19 patients were available for

evaluation at eight weeks after induction therapy. Response was documented by

MRI in week eight and 21 after the start of therapy and evaluated centrally

using the RECIST criteria. Of the six children (35.3%) in the trial who were

reported to have responded to treatment, five had stable disease and one was

evaluated as a partial response. Of the six patients diagnosed with intrinsic

pons glioma at primary tumour diagnosis, four children (66%) responded to

treatment with the antibody.

    One of the inclusion criteria was that patients had a minimum expected

lifespan of four weeks. The survival noted in the responding patients at the

time of the report were respectively: greater than 8.0; 5.0; greater than 4.0;

greater than 3.5; greater than 3.0; and 1.3 months, in contrast to the      

non-responders who had a median and average lifespan of 1.15 months with a

range of 0.3-2.0 months.

    No skin toxicity or allergic reactions were reported. No severe

hematological or non-hematological side effects associated to the h-R3

antibody were noted and no side effects were noted in 95% of patients. The

trial was conducted at seven of the 52 hospitals that compose the BFM (Berlin,

Frankfurt and Munster) Group of hospitals in Germany. The principal

investigator was Prof. Dr. U. Bode, Department of Pediatric

Hematology/Oncology, University of Bonn.

    The positive results of the trial permit Oncoscience to apply for an IND

to conduct a pivotal trial testing the combination of the h-R3 antibody with

radiation against radiation alone for the first line treatment of pediatric

glioma. If approved, the pivotal trial could start in Q2/2005, possibly

include up to 100 patients and possibly recruit all patients within 12 months

following initiation.

    TheraCIM h-R3/Theraloc/nimotuzumab is a humanized monoclonal antibody

licensed from CIMAB S.A., the corporation representing the Center of Molecular

Immunology in Havana.

    YM and Oncoscience AG will host a teleconference on the data presented at

the European High-Grade Glioma Meeting on Monday, February 28, 2005 at

1:00pm EST which may be accessed by calling +1-416-695-7860 (from Europe) or 

1-800-565-5185 (in North America) and utilizing the participant code 261890.

 

    About Oncoscience AG

 

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

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

Banking including research in the Genome/Proteome field.

 

    About YM BioSciences

 

    YM BioSciences Inc. is a cancer drug 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 demonstrated a

substantial increase in survival in the same indication for women treated with

the combination of tesmilifene and chemotherapy compared to chemotherapy

alone, which demonstrated that tesmilifene significantly enhanced the

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

developing the EGFr humanized monoclonal antibody described above and a GnRH

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

 

    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, 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 YMBA)

 

 

 

 



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