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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

e 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.

"Approximately 25% of all patients with lung cancer are expected to develop brain metastases. In recent studies, the median survival of patients with brain metastases, most of whom were treated with WBRT, has ranged from three to five months highlighting the desperate need for new therapies to address this indication," said Dr. Leonardo Viana Nicacio. "In an ongoing exploratory study, nimotuzumab administered concurrently with WBRT has yielded meaningful clinical responses in similar late-stage patients. A randomized trial in this indication is a promising opportunity to demonstrate the efficacy of our EGFR-targeting drug and its best-in-class safety profile."

Preliminary results from the ongoing exploratory trial evaluating nimotuzumab in combination with radiation therapy for the treatment of brain metastases, conducted by YM's licensor, were presented at the 2008 EORTC-NCI-AACR annual meeting held in Geneva, Switzerland. Data were reported from the first 21 patients in a randomized, open label trial of 30 patients with advanced NSCLC and unresectable brain metastases. Patients received nimotuzumab (200 mg administered as weekly IV infusions over weeks 1-6) plus palliative radiation (40 Gy in four weeks) or palliative radiation alone. The disease control rate (DCR = Complete Response + Partial Response + Stable Disease) was 91.6% for the nimotuzumab plus radiation arm compared to 44.4% for the radiation alone arm. At the time of the presentation, patients treated with the combination had a mean and median survival of 7.32 and 7.00 months respectively (with five patients alive), compared to the control group for whom the mean and median survival was 3.03 and 2.47 months respectively (with one patient alive). This differ
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