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Microcap & Penny Stocks : TGL WHAAAAAAAT! Alerts, thoughts, discussion. -- Ignore unavailable to you. Want to Upgrade?

To: SSP who wrote (93342)	10/10/2001 11:21:19 AM
From: Rocket Red	Respond to of 150070

Cryq going into the cockpit tempering?

To: SSP who wrote (93342)	10/10/2001 11:34:42 AM
From: Rocket Red	Respond to of 150070

FDA Grants Peregrine Pharmaceuticals Fast Track Review Status For Cotara in Brain Cancer FDA Grants Peregrine Pharmaceuticals Fast Track Review Status For Cotara in Brain Cancer TUSTIN, Calif., Oct 10, 2001 (BUSINESS WIRE) -- Peregrine Pharmaceuticals, Inc. (Nasdaq:PPHM) today announced that the U.S. Food and Drug Administration (FDA) has granted fast track status to Cotara(TM) for the treatment of recurrent glioblastoma multiforme. Peregrine plans to open a Phase III clinical study of Cotara by the end of this year. The FDA's fast track review process is intended to facilitate the development and expedite the review of treatments that have the potential to address unmet medical needs for serious or life-threatening diseases. Fast track drug applications are typically reviewed in six months, and there is close interaction between the company and the FDA for products with fast track designation. Cotara is Peregrine's Tumor Necrosis Therapy (TNT) drug. It is a radiolabeled monoclonal antibody that binds to the necrotic core of tumors and uses beta-radiation to kill the tumors from the inside out. Unlike traditional treatments such as chemotherapy, pre-clinical studies have shown TNT grows more effective with successive use as the region of necrosis grows in size. Since necrotic tissue is common to all tumors, TNT may have broad application across all tumor types. Cotara is currently being studied in a multi-center Phase II study for brain cancer. Cotara is also in a Phase I study for colorectal, pancreatic, biliary and sarcoma cancers at Stanford University and a Phase I for liver cancer at the Mayo Clinic. "We appreciate the FDA's interest in Cotara for this deadly cancer and anticipate working closely with the agency," stated Dr. Terrence Chew, Peregrine's Senior Vice President of Clinical and Regulatory Affairs. "Fast track status is granted to facilitate the development of promising therapies. The clinical data we have generated to date for Cotara demonstrated such promise. The drug is well tolerated by patients receiving the treatment. The designation of fast track status should potentially afford Cotara the quickest route to approval." "We are pleased to have Fast Track and Orphan Drug status for Cotara in brain cancer," said Edward Legere, Peregrine's President and CEO. "We look forward to moving Cotara into a Phase III study by the end of this year." Brain cancer is one of the fastest growing and deadliest forms of cancer. According to the Central Brain Tumor Registry of the United States, each year in the U.S. alone, an estimated 35,500 new cases of primary brain tumors are diagnosed. Approximately 23% of all brain tumors are glioblastomas, which are very rarely curable with available therapies. 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 target cell structures and cell types that are common among solid tumor cancers, giving them broad applicability across various tumor types. In clinical and pre-clinical studies, collateral targeting technologies have been shown to deliver various anti-cancer compounds selectively to the tumor site 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's lead anti-cancer drug, Cotara(TM), is currently in a multi-center Phase II clinical study for the treatment of brain cancer and in four Phase I clinical studies for the treatment of colorectal, pancreas, liver, and soft tissue sarcoma and biliary cancers. The company also has a direct tumor targeting agent called Oncolym(R) for the treatment of advanced non-Hodgkin's B-cell Lymphoma which is currently in a multi-center Phase I/II. Copies of Peregrine press releases, SEC filings, current price quotes and other valuable information for investors may be found on the websites peregrineinc.com and hawkassociates.com. 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 10-K for the year ended April 30, 2001 and 10-Q for the quarter ended July 30, 2001. CONTACT: Susan E. Atkins & Associates Media: Alex Boese, 858/860-0266 irpr.com or Investor: Hawk Associates, Inc. Frank Hawkins, 305/852-2383 hawkassociates.com URL: businesswire.com Today's News On The Net - Business Wire's full file on the Internet with Hyperlinks to your home page. Copyright (C) 2001 Business Wire. All rights reserved. -0- KEYWORD: CALIFORNIA INDUSTRY KEYWORD: BIOTECHNOLOGY MEDICAL MEDICAL DEVICES PHARMACEUTICAL SOURCE: Peregrine Pharmaceuticals, Inc. STOCK SYMBOLS: [(pphm)]