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Peregrine Completes Patient Enrollment in Cotara(R) Dose Confirmation and Dosimetry Brain Cancer Trial
Date:12/2/2009

The main objectives of the open label dosing and dosimetry study are to confirm the maximum tolerated dose of Cotara, to determine radiation dosimetry and to assess overall patient survival, progression-free survival and the proportion of patients alive at six months following Cotara administration. In both ongoing clinical trials, Cotara is delivered using convection-enhanced delivery (CED), a method developed by the U.S. National Institutes of Health that targets the specific tumor site in the brain.

"We believe the data generated from this dosimetry trial will be an important and necessary part of our Cotara regulatory package as we continue to advance the program," said Joseph Shan, vice president of clinical and regulatory affairs at Peregrine. "The trial design the regulatory authorities asked us to implement was necessarily complex and therefore challenging to enroll, requiring a significant commitment from both patients and the participating health care institutions. We are grateful for their successful efforts and our plan is now to expand the ongoing 40-patient Phase II Cotara GBM trial to these clinical sites, which should help expedite timely completion of the ongoing Phase II clinical trial."

Interim data from the dosimetry trial presented at the Society of Nuclear Medicine 2009 Annual Meeting in June showed that in patients dosed in the first two cohorts of the study, the concentration of Cotara in brain tumors was on average more than 300-fold higher than in other normal organs. In addition, these patients had all either met or exceeded the expected median survival time for recurrent GBM patients. Interim data from a Phase II study of GBM patients who have experienced a first relapse was presented at the XIV World Congress of Neurological Surgery in September. It highlighted a subset of 10 GBM patients and included follow-up durations ranging from seven weeks to over 73 weeks, showing an interim median recurrence-free
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SOURCE Peregrine Pharmaceuticals, Inc.
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