YM BioSciences Inc, the cancer drug development company with an advanced-stage portfolio, announced the publication of a research paper in the May 1st, 2004 issue of the Journal of Clinical Oncology entitled "Use of the Humanized Anti-Epidermal Growth Factor Receptor Monoclonal Antibody h-R3 in Combination With Radiotherapy in the Treatment of Locally Advanced Head and Neck Cancer Patients".
The paper concluded that TheraCIM hR3 is a well-tolerated drug that may enhance radiation-induced tumour responses in patients with unresectable head and neck cancers.
"This trial demonstrated that TheraCIM hR3 combined with radiation therapy achieved similar survival rates to traditional chemoradiation while sparing the patient from chemoradiation's considerable higher toxicity," said David Allan, Chairman and Chief Executive Officer of YM BioSciences. "With these exciting results in hand, we look forward to the initiation of trials for this drug in the near term by our European partner, Oncoscience AG, designed to lead to registration of the drug in Europe."
The purpose of the single-center Phase I/II clinical trial was to evaluate the safety and preliminary efficacy of TheraCIM hR3, a humanized anti-epidermal growth factor receptor (EGFr) monoclonal antibody (MAb) in combination with radiotherapy (RT) in unresectable head and neck cancer patients. Twenty-four patients with advanced carcinomas of the head and neck received six weekly infusions of TheraCIM hR3 at 50, 100, 200, and 400 mg dose levels in combination with RT. The trial was conducted by the Center of Molecular Immunology; National Institute of Oncology; Institute of Pharmacy and Food, University of Havana; the Center for Chemistry and Pharmacy, Havana, Cuba; and the London Regional Cancer Center, London, Ontario, Canada.
YM BioSciences and its majority-owned subsidiary, CIMYM Inc., recently licensed TheraCIM hR3 to Oncoscience AG, which will be responsible for the development, clinical trials and regulatory processes required to bring this product to market in Europe and certain other jurisdictions. Oncoscience has identified three clinical indications for which Orphan Drug designation has been applied. The antibody will be used to enhance the effectiveness of conventional radiation therapy, and trials are anticipated to begin in the second quarter 2004. Given the typically short trial times required in the lead indications, it may be possible to achieve regulatory approval for TheraCIM hR3 as early as 2006.