YMB YM Bio.'b'ser1

    YM BioSciences reports positive EGF-R antibody pivotal Phase II results

 

       90.6% complete responses seen with no evidence of skin toxicity

 

    MISSISSAUGA, ON, Dec. 21 /CNW/ - YM BioSciences Inc. (TSX:YM, AIM:YMBA,

NASDAQ:YMI), today announced preliminary results from a randomized Phase II

pivotal trial assessing the efficacy and safety of its EGF receptor monoclonal

antibody, TheraCIM h-R3 (nimotuzumab), combined with radiation compared to

radiation alone in locally advanced, Stage 3-4, nasopharyngeal carcinoma, a

subset of head-and-neck cancer. The study was conducted by YM's licensor,

CIMAB S.A. and Biotech Pharmaceuticals Limited, CIMAB's joint-venture partner

in China.

    Of the 130 patients in the intent-to-treat analysis, those in the

combination arm were reported to have a 90.6% Complete Response compared to

51.5% in the radiation-alone group. "Complete Response" is defined as the

elimination of tumour at the primary site, locoregional lymph nodes and

distant metastases. TheraCIM h-R3 was administered intravenously at a dose of

100 mg/person once a week for eight weeks beginning on the first day of

radiotherapy. There was no evidence of the acneiform rash commonly associated

with administration of therapeutic agents designed to block the EGF receptor

system, corroborating the results of a previous study for TheraCIM h-R3 in

head-and-neck cancer (Journal of Clinical Oncology, Volume 22, No. 9, May 1,

2004).

    "No other product targeting the EGF receptor has demonstrated a

difference in response rates of this magnitude," said David Allan, Chairman of

YM BioSciences. "This result adds further justification to YM's approach of

combining TheraCIM h-R3 with radiation or as a monotherapy in a variety of

cancers including head-and-neck, metastatic pancreatic and pediatric and adult

glioma, all of which conditions are currently being tested in a variety of

clinical trials."

    "The magnitude of the response from the combined therapy at the 17 week

evaluation point is very impressive. The duration of this response will

ultimately be important in assessing these data in comparison to the data from

trials conducted with other EGF receptor monoclonal antibodies," said Dr. Paul

Keane, Director of Medical affairs at YM BioSciences.

    TheraCIM h-R3 is licensed to YM's subsidiary, CIMYM for Europe, North

America and the Pacific Rim excluding China. In YM's territories TheraCIM h-R3

has been awarded Orphan Drug Designation for glioma by both the European

Medicines Agency for the Evaluation of Medical Products (EMEA) and by the FDA

in the US. The drug is currently in a Phase I/II trial in pediatric glioma

from which preliminary data are expected in January 2005 and in a trial in

metastatic pancreatic cancer, for which a clinical milestone is expected in

Q3, 2005. YM's European partner, Oncoscience AG, anticipates initiating a

Phase III pivotal trial in adult glioma in Q1, 2005, designed as a trial

leading to approval for registration.

    Nasopharyngeal cancer is particularly prevalent in South-East Asian

populations where incidence is about 20/100,000 and as high as 150/100,000 in

Hong Kong. In the general North American population the incidence is about

1/100,000. People of Chinese descent living in North America are five to ten

times more susceptible than the North American population as a whole.

 

    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 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, the Company is developing

TheraCIM h-R3, an EGFr humanized monoclonal antibody, 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 x 229, Email: jsmith(at)equicomgroup.com; 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