YMB YM Bio.'b'ser1

    YM BioSciences initiates Non-Small-Cell Lung Cancer trial with

    nimotuzumab

 

    - First patient treated in Canada with trial to expand to Korea -

 

    MISSISSAUGA, ON, March 23 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,

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

first patient has been enrolled in its multi-center Phase I/II Non-Small-Cell

Lung Cancer (NSCLC) trial utilizing YM's anti-EGFr monoclonal antibody,

nimotuzumab (TheraCIM). The randomized Phase II part of the 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.

    "Together with our European development partner, Oncoscience AG, our

Southeast Asian partner, Innogene Kalbiotech Pte. Ltd., and our partner in

Korea, Kuhnil Pharmaceutical Co., we have expanded the clinical development

program for nimotuzumab to include trials in children and adults with brain

cancer, advanced metastatic pancreatic cancer and now NSCLC. In addition, the

licensor has trials ongoing for nimotuzumab in glioma, breast, esophageal and

prostate cancer," said David Allan, Chairman and CEO of YM. "We expect to

complete recruitment for the NSCLC trial in approximately 20 months."

    The Phase I portion of the NSCLC trial will be an open-label dose

escalation study in which increasing doses of nimotuzumab will be studied in

combination with palliative radiation in patients with Stage IIB and III

disease who are unable to receive standard chemoradiation treatment with

curative intent. Separate dose escalation studies will be conducted in Canada

by YM and in Korea by YM's partner Kuhnil Pharmaceutical Co. The primary

objectives of the Phase I studies are to determine the optimal dose, any dose

limiting toxicity (DLT), safety profile and observe any evidence of antitumour

activity of nimotuzumab when used in combination with radiation. The enrolment

in this study is expected to be up to 30 evaluable patients and will depend

upon the number of dose levels tested.

    The Phase II portion of the trial is expected to enroll approximately 120

patients in total who will be randomized to receive either palliative

radiation therapy or nimotuzumab in combination with palliative radiation

therapy. The primary clinical endpoints for the Phase II study will be local

tumor control and survival.

    Nimotuzumab is being developed in a number of indications and is in the

class of EGF-targeting drugs which have repeatedly demonstrated their ability

to enhance the effect of radiation. A randomized trial with nimotuzumab that

included 130 patients suffering from nasopharyngeal cancer was 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

that country. Nimotuzumab has shown clinical benefit as a monotherapy as well;

a Phase II monotherapy trial of nimotuzumab produced evidence of efficacy and

a strong indication of survival benefit in children with recurrent brain

cancer. Nimotuzumab is unique because it has not produced the emotionally and

physically debilitating side effects of rash or severe diahhrea suffered by

patients treated with the other drugs in this class. Phase III IND

applications have been filed in Europe for the drug.

    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 Peoples' 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. (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 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. 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

    (YMBA)

 

 

 

 

 

 

 



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