YMB YM Bio.'b'ser1

    YM BioSciences and Oncoscience Achieve Clinical Milestone

 

      - Results Permit Pediatric Brain Cancer Trial to be Converted into

                  Pivotal Randomized First-Line Therapy Trial -

 

    MISSISSAUGA, ON, Jan. 25 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,

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

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

utilizing the EGF receptor monoclonal antibody (h-R3) as a monotherapy

achieved the clinical milestone that permits conversion of the trial into a

pivotal trial in this population.

    The new study will be a randomized Phase III trial comparing radiation

(the standard-of-care) to radiation plus h-R3 as a first-line therapy

following surgery. YM has been advised that the trial is expected to enroll

100 patients and is targeted for completion in the second quarter of 2006.

Results from the original trial will be formally presented at the "European

High-Grade Glioma Meeting" on February 25-26, 2005 in Regensburg, Germany.

    "Although the results are preliminary in nature, we have been advised

that at least three patients responded to the treatment, allowing the early

conversion of the trial into a more significant pivotal trial. This is a

welcome and unanticipated result in a patient population for whom no other

therapy is available and prognosis is very poor," said David Allan, Chairman

of YM BioSciences.

    The study is being conducted in Germany by YM's partner in Europe,

Oncoscience AG, and is the first trial of this antibody as a monotherapy and

its first trial in children.

    "Early termination of the trial for success in this heavily pretreated

patient group and the consequent ability to proceed to a first-line therapy

study is more than expected. We are looking forward to seeing the entire data

set in a few weeks," stated Ferdinand Bach, CEO of Oncoscience AG.

    Eighteen children were recruited into the original trial and are

available for response evaluation. Patients were treated with the humanized

EGFr monoclonal antibody, nimotuzumab (TheraCIM h-R3 in North America and

Theraloc in Europe). The patients, for whom the prognosis is extremely poor

and the expected survival period short, had brain cancer which had progressed

following all other available therapies (surgery, radiation and combination or

mono-chemotherapy). Under the protocol, the trial would have been terminated

if no patients had responded to the monotherapy. Alternatively, it would have

continued as a monotherapy with an additional 29 patients if two of the 18

patients responded and moreover, would have been defined as having achieved a

sufficient response if at least three patients responded to the treatment,

permitting a follow-on trial with h-R3 as a first-line (post-surgery) therapy,

combining the antibody with radiation.

    Commenting on these results, Dr. Paul Keane, Director of Medical Affairs

at YM said, "Although the results are preliminary in nature, the early

termination for success, i.e. exceeding the predefined threshold, thus

allowing the initiation of a first-line therapy study in which the combination

of antibody with radiation will be compared with radiation alone, is

encouraging for the continued development of the drug. The combination of h-R3

with radiation has been shown effective in other trials, and these results are

consistent with those obtained with other EGF receptor monoclonal antibodies."

    In previous clinical trials in adult glioma, head and neck cancer and

nasopharyngeal cancer, TheraCIM h-R3/Theraloc has been shown to significantly

improve the therapeutic effects of radiation. A report on one of these trials

was published in the Journal of Clinical Oncology (Volume 22, No. 9, May 1,

2004) and other trials have been described in press releases by YM BioSciences

Inc.

    A parallel monotherapy trial, also being conducted in Germany in

metastatic pancreatic cancer, was initiated at the end of November 2004, has

enrolled 14 patients to date and is targeted to complete its first clinical

assessment in mid-2005 following the review of the first 30 patients in that

trial. Application has been made for a randomized trial in adults with glioma

and the trial in children could be supportive of that application.

    Theraloc/TheraCIM has been awarded Orphan Drug designation by both the

European health regulatory authority - EMEA - and by the FDA in the USA for

treatment of glioma.

    H-R3 is licensed to YM's subsidiary, CIMYM, for Europe, North America and

the Pacific Rim excluding China, by CIMAB S.A, the commercial arm of the

Center for Molecular Immunology in Havana.

 

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

the European High-Grade Glioma Meeting immediately following that conference

on Monday, February 28, 2005 at 1:00pm ESTand 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 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: Enquiries: James Smith, The Equicom Group Inc.,

Tel. (416) 815-0700 x229, 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)



END

YM Bio.'b'ser1 (LSE:YMB)
Historical Stock Chart
From Jun 2024 to Jul 2024

YM Bio.'b'ser1 (LSE:YMB)
Historical Stock Chart
From Jul 2023 to Jul 2024