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YM BIOSCIENCES REPORTS NIMOTUZUMAB APPROVED FOR MARKETING IN MEXICO
Date:9/17/2009

ment of squamous cell carcinoma of the head and neck (SCCHN), adult glioma and pediatric glioma. The approval was granted to Laboratorios PiSA in Guadalajara, Mexico and nimotuzumab will be commercialized under the name VECTHIX(R).

    First patients enrolled in multinational randomized, double-blind brain
    metastases trial

YM BioSciences recently enrolled and treated the first two patients in its multinational randomized, double-blind trial evaluating 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. The patients were enrolled at the L'Hopital Maisonneuve-Rosemont in Montreal, Canada.

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. The secondary endpoints are overall survival (OS); time to neurologic progression (TNP) or death with evidence of neurologic progression; OS rate at six months; time to intracranial disease progression; and time to overall progression.

"This randomized, double-blinded, multicentric trial was based on a randomized pilot open-label trial from which encouraging, preliminary results were presented at the EORTC-NCI-AACR "Molecular Targets and Cancer Therapeutics" meeting held on October 21-24, 2008 in Geneva. YM is preparing to imminently open the first international centers on both th
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SOURCE YM BioSciences Inc.
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