YM BioSciences starts trial of nimotuzumab for non-small-cell lung cancer

New York, March 23 - YM BioSciences Inc. said the first patient has enrolled in its phase 1/2 trial of nimotuzumab (TheraCIM) for non-small-cell lung cancer.

Recruitment is expected to be completed in about 20 months.

The randomized phase 2 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 current standard of care or who are not amenable to treatment with curative intent. In total, 120 patients are expected to be enrolled in this study.

The phase 1 portion 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 1 studies are to determine the optimal dose, any dose limiting toxicity, safety profile and observe any evidence of antitumour activity of nimotuzumab when used in combination with radiation. Up to 30 patients are expected to be enrolled.

YM noted that it has already expanded its work on nimotuzumab, an anti-EGFr monoclonal antibody, to include trials in children and adults with brain cancer and advanced metastatic pancreatic cancer. In addition, trials are under way in glioma, breast, esophageal and prostate cancer.

It is a member of a class of EGF-targeting drugs that have "repeatedly demonstrated their ability to enhance the effect of radiation," YM said in a news release. Nimotuzumab has also shown benefit as a treatment on its own.

YM is a Mississauga, Ont., cancer product development company.

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