It appears to me that Dr. Patel felt that Cotara was superior to the S.O.C. at the time the phase 2 trial was completed.
Am I wrong ?
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Peregrine Announces Preliminary Results From Phase II Brain Cancer Trial; Data Presented at the American Society of Clinical Oncology
Business Wire, May 14, 2001
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TUSTIN, Calif.--(BUSINESS WIRE)--May 14, 2001
Peregrine Pharmaceuticals Inc. (Nasdaq:PPHM) today announced Dr. Sunil Patel, associate professor of neurosurgery at the Medical University of South Carolina, presented preliminary efficacy and safety results from a Phase II brain cancer trial using Cotara(TM), Peregrine's Tumor Necrosis Therapy drug.
Patel presented his findings at the American Society of Clinical Oncology's (ASCO) 37th annual meeting, being held in San Francisco, where he was representing the Cotara brain tumor study consortium.
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The primary objective of the Phase II Cotara study is to determine the median time to progression of treated patients compared with a historical control population. Patel presented data on the first 29 patients in the study.
This group possessed a uniformly poor prognosis, the majority of them having been diagnosed with recurrent glioblastoma multiforme (GBM), which is a form of malignant brain tumor. Primary side effects of the Cotara infusion were well tolerated in this patient population. The overall median time to progression was 13.9 weeks, despite inclusion of many heavily pretreated patients.
By contrast, the median time to progression for the historical control population was eight weeks.
"I am enthusiastic about Cotara, and its potential in the treatment of both newly diagnosed and recurrent malignant gliomas. Compared to current standard therapy, Cotara may offer a promising alternative," said Patel. "I am looking forward to doing further studies with Cotara."
"Glioblastoma multiforme is a deadly disease, and we are pleased to be able to show an impact on this most difficult clinical situation," said Dr. Terrence Chew, Peregrine's vice president of clinical and regulatory affairs.
"Peregrine plans to continue to enroll and treat patients under the Phase II protocol while the final preparations are being made for the Phase III study which will commence later this year. We look forward to moving the Cotara brain cancer program forward."
"We are encouraged by the data from the Phase II study, and we are pleased that Cotara is slowing the progression of these aggressive tumors while having few side effects on the patients," said Edward Legere, Peregrine's president and CEO. "If approved by the FDA, Cotara would be a humane treatment alternative for patients with this aggressive form of cancer."
Cotara is currently being studied in a multi-center Phase II study for brain cancer. Peregrine expects to begin a Phase III study for brain cancer later this year. Cotara is also in Phase I studies for colorectal, pancreatic, biliary and sarcoma cancers at Stanford University and a Phase I liver cancer study at the Mayo Clinic. Peregrine plans to open additional Cotara Phase I studies in the future.
About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals is a biopharmaceutical company focused on the development, commercialization and licensing of unique technologies for the treatment of cancer, primarily based on its "collateral targeting technologies."
These technologies therapeutically target cell structures and cell types, rather than surface cancer cells, as a means to attack solid tumors, without causing damage to surrounding healthy tissue. The company has three collateral targeting technologies: Tumor Necrosis Therapy (TNT), Vasopermeation Enhancement Agents (VEA), and Vascular Targeting Agents, (VTA).
The company also has a direct tumor-targeting agent called Oncolym(R) for the treatment of advanced non-Hodgkin's B-cell Lymphoma. Oncolym has been licensed to Schering AG, Germany, which is now responsible for all existing and future Oncolym clinical trial programs as well as marketing.
Safe Harbor Statement: This release may contain certain forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ from the company's expectations as a result of risk factors discussed in Peregrine's reports on file with the U.S. Securities and Exchange Commission, including, but not limited to, the company's report on Form 10K for the year ended April 30, 2000 and Form 10Q for the quarter ended Jan. 31, 2001.
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