YMB YM Bio.'b'ser1

    YM BioSciences to Initiate Non-Small-Cell Lung Cancer Trial with

    Nimotuzumab

 

    - Company expands target indications for its anti-EGF receptor monoclonal

    antibody -

 

    MISSISSAUGA, ON, Aug. 17 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,

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

Canada has cleared a Clinical Trial Application (CTA) for a multi-center

Phase I/II trial utilizing YM's anti-EGFr monoclonal antibody, nimotuzumab

(TheraCIM). The randomized Non-Small-Cell Lung Cancer (NSCLC) trial will

compare the effects of the combination of nimotuzumab with radiation against

radiation alone in patients with stage IIB and III disease who are found to be

insufficiently fit to tolerate the standard-of-care or who are not amenable to

treatment with curative intent.

    "YM has achieved another milestone by further broadening the clinical

development program for nimotuzumab. We expect that the population of

essentially untreatable patients with NSCLC, whose only option is to be

treated palliatively with radiation, will benefit from the addition of our

antibody to this treatment modality," said David Allan, Chairman and CEO of

YM. "Together with our European development partner, Oncoscience AG, we have

identified numerous important tumour targets where we expect nimotuzumab could

benefit patients. In particular, nimotuzumab has demonstrated very encouraging

results in both children and adults with brain cancer, and we anticipate being

able to further demonstrate this benefit in planned pivotal Phase III trials.

The drug is also currently undergoing a Phase II monotherapy trial in Europe

in patients with advanced metastatic pancreatic cancer."

    The NSCLC trial will be initiated in Canada and extended to Korea, where

YM partner Kuhnil Pharmaceutical Co. will fund the development of nimotuzumab

for this territory. The trial is expected to enroll approximately 100 patients

in total and complete recruitment in approximately 20 months with the prospect

of a final report before the end of 2007. The endpoint of the Phase II trial

is an increase in local tumor control.

    "The entire class of EGFr-targeting agents has clearly and clinically

demonstrated its ability to enhance the effect of radiation," said Dr. Paul

Keane, Director of Medical Affairs at YM. "A randomized trial with nimotuzumab

that included 130 patients suffering from nasopharyngeal cancer was recently

completed in China and demonstrated the substantial benefit of nimotuzumab

when added to standard radiation therapy, resulting in the drug being approved

for sale in China. Nimotuzumab has shown clinical benefit as a monotherapy as

well and is unique in its class because it has not produced the emotionally

and physically debilitating side effects of rash or severe diarrhea suffered

by patients treated with the other drugs in this class."

    Nimotuzumab is licensed to YM's subsidiary CIMYM Inc. by CIMAB S.A., a

corporation representing the Center of Molecular Immunology in Havana. CIMYM's

licenses are for the major market countries including Europe, North America

and the Pacific Rim countries excluding China. CIMAB has separate licenses in

India with Biocon Biopharmaceuticals Limited and the People's Republic of

China with Biotech Pharmaceuticals Limited.

    Lung cancer is the leading cause of cancer-related mortality in both men

and women. The prevalence of lung cancer is second only to that of prostate

cancer in men and breast cancer in women. Non-small cell lung cancer (NSCLC)

accounts for approximately 75% of all lung cancers. The standard of care for

the treatment of NSCLC is radical therapy utilizing the chemotherapy cisplatin

in combination with high dose radiation. Dr. Mark Vincent, staff oncologist at

the London Regional Cancer Centre, estimates that the combined population of

patients unfit for chemotherapy or unwilling to undergo the treatment because

of the often intolerable side effects of chemotherapies may approximate 20% of

patients diagnosed with an advanced form of this cancer. In addition,

virtually all patients with NSCLC will eventually become refractory to

chemotherapy and be treated with radiation as palliative care.

 

    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, YM BioSciences is developing nimotuzumab, an

anti-EGFr humanized monoclonal antibody for which Phase II clinical data were

released in 2005 in pediatric glioma and nasopharyngeal cancer, and for which

Phase III IND applications have been filed. The Company is also developing an

anti-GnRH anti-cancer vaccine, Norelin(TM), for which Phase II data have been

released. In May 2005, YM BioSciences 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 YM proposes to advance AeroLEF(TM) through a Phase

IIb pain trial in 2005. 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;

YM BioSciences Inc., Tel. (905) 629-9761, Fax (905) 629-4959, Email:

ir(at)ymbiosciences.com

    (YMBA)



END

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