YMB YM Bio.'b'ser1

    YM BioSciences' partner, Oncoscience AG, cleared for Phase III trial in

    Germanywith nimotuzumab

 

    - Phase II results presented at the 27th Annual German Cancer

    Conference -

 

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

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

partner, Oncoscience AG, has been cleared by the German regulatory authority

for biological products, the Paul Ehrlich Institute, to initiate a Phase III

trial of nimotuzumab in combination with radiation in children with inoperable

pontine (brain stem) glioma. The clinical trial was also reviewed with the

EMEA and is designed as a prospectively registrable study on the basis of a

single arm trial because of the absence of treatment options for children

suffering from pontine glioma. It is anticipated that marketing authorization

subsequent to a successful trial would be sought under the EMEA centralized

procedure.

    The trial is a single arm study in which 40 children with inoperable

pontine glioma will be treated with radiation concomitant with nimotuzumab.

The primary clinical endpoints in the trial will be Progression-Free Survival

at 3, 6, 12 and 24 months with Median Survival as secondary endpoint. Clinical

sites will be located in Germany, Italy, Belarus and Russia and it is

anticipated that recruitment could be completed within approximately 12 months

after the start of patient enrolment. Based on a historical median survival

for this form of cancer of approximately 8.5 months, the trial could be

completed in the second quarter of 2007.

    Additional data from the 40 patient Phase II trial conducted by

Oncoscience AG were presented at the 27th Annual German Cancer Conference in

Berlin on March 25th, 2006. The study reported 8 out of 40 patients were

evaluable for response after consolidation therapy and showed three partial

responses (PR), one Stable Disease (SD) and four progressive disease (PD) in

week 21. Eight patients with consolidation therapy were free of progression

for a median of 4.6 months (1.9-14.5 months). Eight children out of the

40 recruited into the trial were still surviving as of March 25th (2.9-20.6)

months. Non-responders to treatment had a median survival of 1.1 months. No

severe side effects and no rash, diarrhea or conjunctivitis related to the

study medication were observed.

    YM BioSciences has previously announced that it and its majority owned

subsidiary, CIMYM Inc., propose to file for authorization to conduct a

Phase III trial in North America following a clearance for such a trial in

Germany. In addition YM proposes to pursue the clinical development of

nimotuzumab in adult glioma as well as the current target of Non-Small Cell

Lung Cancer. YM's licensor, CIMAB SA and its parent, the Center for Molecular

Immunology, are conducting trials with nimotuzumab in glioma, breast,

esophageal, cervical, prostate and head and neck cancer.

    Data from trials with nimotuzumab will be presented by Oncoscience AG in

two separate posters: at the AACR meeting in Washington, DC on April 04, 2006

in the late breaking news poster session and at the ASCO meeting in Atlanta,

Georgia on June 05, 2006. YM will also have results disclosed from a

pharmacodynamic/pharmacokinetic study of nimotuzumab conducted by the

University of Torontoat the ASCO meeting.

 

    Analyst Day Announcement

    YM BioSciences invites analysts and investment managers to attend a

Research and Development Day on Wednesday, April 5, 2006 from 11:30am to

3:00pm ET, at the Harvard Club of NYC, The Harvard Hall, 27 West 44th Street,

New York, NY. Please RSVP to Thomas Fechtner at (212) 477-9007 x31;

tfechtner(at)troutgroup.com. Unconfirmed attendees may not be accommodated.

 

    About Oncoscience AG

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

focused in Oncology (nimotuzumab), 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 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 and nimotuzumab, the Company is also

developing an anti-GnRH anti-cancer vaccine, Norelin(TM), for which Phase II

data have been released. YM's subsidiary DELEX Therapeutics Inc. is 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 a randomized Phase IIb

pain trial has been initiated. 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: Enquiries: Thomas Fechtner, The Trout Group

LLC, Tel. (212) 477-9007 x31, Fax (212) 460-9028,                         

Email: tfechtner(at)troutgroup.com; Carolyn McEwen, YM BioSciences Inc.,      

Tel. (905) 629-9761, Fax (905) 629-4959, Email: ir(at)ymbiosciences.com; 

James Smith, the Equicom Group Inc., Tel. (416) 815-0700 x 229,            

Fax (416) 815-0080, Email: jsmith(at)equicomgroup.com

    (YM. YMI YMBA)



END

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