YMB YM Bio.'b'ser1

    YM BioSciences' TheraCIM receives investigator sponsored IND from FDA

 

    - TheraCIM h-R3 (nimotuzumab) to treat child with brain cancer

      under physician-led IND in USA

 

    MISSISSAUGA, ON, March 16 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,

AIM:YMBA) today announced that the FDA has approved the use of TheraCIM h-R3

as a monotherapy in the treatment of a child with advanced glioma under an

IND.

    "Clearance to conduct a US-based investigation using TheraCIM h-R3 is

significant in the development path for this drug," said David Allan, Chairman

and CEO of YM BioSciences. "The clinical success that was achieved with

TheraCIM in Europe, Canada and Asia may now begin to be repeated in the US.

The IND will initially result in the treatment of a single patient, but we are

in the process of designing a protocol that, if approved, would open a new

trial to many pediatric patients in the United States. Our US strategy is

further supported by the FDA and European Regulatory Authority awarding Orphan

Drug status to TheraCIM for the treatment of glioma, received in 2004."

    For reasons of patient confidentiality neither the name of the

investigator nor the hospital will be disclosed. Further, the currently

limited supply of antibody renders it impossible for YM to support additional

investigator-led INDs at this time although quantities of the product are

being manufactured to enable YM to conduct a pivotal trial in pediatric

glioma.

    The application to the FDA which resulted in the issuance of the IND to

the investigator was prompted by the release of data from a monotherapy trial

in pediatric glioma conducted at seven of the 52 hospitals that compose the

BFM (Berlin, Frankfurt and Munster) Group of hospitals in Germany. Data from

that trial, which was sponsored by Oncoscience AG, YM's partner in Europe,

were presented at the European High-Grade Glioma Meeting in February 2005.

 

    TheraCIM h-R3 in Pediatric Glioma

 

    In a Phase II trial conducted in Germany in children with brain cancer

(glioma), TheraCIM h-R3 (Theraloc in Europe) produced an Overall Response rate

of 35.3%, with six of 17 evaluable patients demonstrating either stable

disease (in five patients) or a partial response (in one patient). Of the six

patients who derived clinical benefit, four were diagnosed by investigators

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

disease that is particularly aggressive and generally untreatable. Of the five

patients with stable disease all but one experienced tumour shrinkage.

    The progression-free interval recorded in the six patients responding 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 greater than 2.0 months, in

contrast to the eleven patients who had no response to the treatment whose

average progression-free interval was 1.15 months with a range of 0.3-2.0

months.

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

the previous trials conducted with TheraCIM h-R3.

    The positive results of the trial permit Oncoscience AG 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 is a monoclonal antibody licensed from CIMAB S.A., the

corporation representing the Center of Molecular Immunology in Havana.

 

    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

    (YMBA)

 

 

 

 

 

 

 

 



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