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YM BIOSCIENCES RECEIVES CLEARANCE TO INITIATE RANDOMIZED DOUBLE-BLIND CLINICAL TRIALS OF NIMOTUZUMAB IN LUNG CANCER AND BRAIN METASTASES FROM LUNG CANCER
Date:1/5/2009

or after failing other treatments," said Dr. Leonardo Viana Nicacio, Director of Clinical Affairs for YM BioSciences. "Nimotuzumab combined with palliative radiotherapy is a rational step towards a better treatment regimen that is safe and has the prospect of improving survival in this population that has typically exhausted all other options."

A retrospective study identified that of 11,084 Medicare beneficiaries aged 65 years or older presenting with stage IV NSCLC between 1991 and 1996, 58% received palliative radiotherapy treatment. (Hayman JA, Abrahamse PH, Lakhani I, Earle CC, Katz SJ. Use of palliative radiotherapy among patients with metastatic non-small-cell lung cancer. Int J Radiat Oncol Biol Phys 2007;69:1001-7). Another recent meta-analysis of 13 trials that included 3,473 patients showed that better local treatment was associated with longer survival. (Fairchild A, Harris K, Barnes E, Wong R, Lutz S, Bezjak A, Cheung P, Chow E. Palliative thoracic radiotherapy for lung cancer: a systematic review. J Clin Oncol 2008;26:4001-11).

Brain metastases trial

This randomized, double-blind, Phase II study will compare nimotuzumab plus whole-brain radiation therapy (WBRT) to WBRT alone in patients with brain metastases from NSCLC. The trial is designed enroll approximately 88 patients over twelve months followed by a twelve-month follow-up period and will likely include 12 investigational centers in Canada plus additional centers in other countries.

Nimotuzumab (200 mg IV infusions) will be administered weekly during radiotherapy and following radiotherapy until disease progression, unacceptable toxicity or at the discretion of the physician. Radiotherapy will consist of 30 Gy, in 10 fractions of 3 Gy/day. Patients will be assessed by laboratory tests, imaging studies, standardized neurologic examination, and neurologic symptoms. The primary efficacy endpoint is intracranial disease progression over six months. Th
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