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TheraCIM h-R3 to Start Phase I/II in New Indication (PR Newswire)YM BioSciences Inc. announced today that the Health Products & Food Protection Branch of Canada has approved YMB`s IND to conduct a phase I/II study of its EGF receptor antibody, TheraCIM h-R3, in conjunction with radiotherapy in patients with brain cancer resulting from metastases from non-small cell lung cancer.- Jul 10 4:10 PM ET


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Posted on: 07/10/2001

"Yahoo - TheraCIM h-R3 to Start Phase I/II in New Indication"
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Tuesday July 10, 4:10 pm Eastern Time

Press Release

SOURCE: YM BioSciences Inc.

TheraCIM h-R3 to Start Phase I/II in New Indication

- Brain Metastases -

MISSISSAUGA, Ontario, July 10 /PRNewswire/ -- YM BioSciences Inc. ("YMB") announced today that the Health Products & Food Protection Branch of Canada has approved YMB's IND to conduct a phase I/II study of its EGF receptor antibody, TheraCIM h-R3, in conjunction with radiotherapy in patients with brain cancer resulting from metastases from non-small cell lung cancer (NSCLC).

Brain metastases are a common complication in cancer patients and an important cause of morbidity and mortality. There is currently no effective therapy and median survival of treated patients with brain metastases is reported to be approximately four months. In an effort to address the need for more effective, novel treatments of this disease, YMB will be conducting this 30 patient trial in Canada and may expand it to other countries. In adults, some 50% of NSCLC metastasize to the brain. Other tumors associated with brain metastases are: breast cancer (15% to 20%), unknown primary tumor (10% to 15%), melanoma (10%), and colon cancer (5%).

Trials with EGF receptor antibodies together with radiation in head-and-neck cancers strongly suggest that the effect of radiation is significantly improved through combination with antibody. YMB's new trial is intended to test the premise in cancers metastasizing to the brain from NSCLC.

Radiation therapy for brain metastases from lung is reportedly administered to approximately 80,000 patients per year in the USA alone. This combined approach of radiation and anti-EGFr antibody therapy has the potential to be used in a much wider population of cancer patents. In total, some 50% of the approximately 1.2 million newly diagnosed cancer patients in the USA are irradiated and the total number of patients irradiated for all cancers in that country approximates 750,000.

YMB expects to shortly announce completion of recruitment for its ongoing Canadian Phase II trial of TheraCIM h-R3 in conjunction with radiation for head-and-neck cancers. This new brain metastases trial is one of a number which may be undertaken to test the effectiveness of this antibody in the range of solid tumors to which the antibody applies.

About TheraCIM h-R3

TheraCIM h-R3, a humanized monoclonal antibody tyrosine kinase inhibitor, targets Epidermal Growth Factor receptor (EGFr), which has been shown to be overexpressed in cancers of epithelial origin such as head-and-neck, lung, colorectal, stomach, kidney, esophogeal, renal carcinoma, breast cancer, ovarian, prostate, glioma and others.

Products such as TheraCIM h-R3, which are expected to increase the results of radiation treatment, will, if proven effective, become important entrants on the cancer therapeutic stage. TheraCIM h-R3 is being developed through CIMYM, a joint venture between YM BioSciences and the Center of Molecular Immunology (Havana), the originator of the technology (www.cim.sld.cu).

About the Company

YM BioSciences Inc., a Canadian life sciences company, develops innovative cancer therapeutics. It partners with biotechnology and pharmaceutical companies, as well as with drug discovery organizations and academic institutes, to develop cancer applications of their novel agents and technologies. Products are in-licensed and taken through the regulatory and clinical research process by the company's team of clinical, regulatory, licensing and business development executives. The development plans generally anticipate partnering the products prior to initiation of Phase III trials.

YMB has built a portfolio of cancer therapeutics across a variety of technologies and indications. With one product having completed a Phase III trial and with three Phase II trials ongoing, for a total of six distinct cancer products targeted to be in clinical development in 2001, YMB has one of the broadest biotech oncology development programmes in North America.

SOURCE: YM BioSciences Inc.

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