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Biotech / Medical : CYTR: CytRx Corporation -- Ignore unavailable to you. Want to Upgrade?


To: GARY P GROBBEL who wrote (1)6/14/2001 10:36:53 AM
From: wgh613  Read Replies (1) | Respond to of 51
 
CYTR in news today:
FLOCOR Granted 'Fast Track' Status By FDA For Treatment of Acute Chest Syndrome in Sickle Cell Disease
ATLANTA, Jun 14, 2001 /PRNewswire via COMTEX/ -- CytRx Corporation (Nasdaq: CYTR chart, msgs) today announced that its experimental product, FLOCOR (purified poloxamer 188), has been designated as a "fast track" product by the United States Food and Drug Administration (FDA) for treatment of acute chest syndrome associated with sickle cell disease. The FDA has previously granted fast track status to FLOCOR for treatment of the vaso-occlusive crisis of sickle cell disease.

Fast track designation was granted because acute chest syndrome in sickle cell disease patients is a serious medical condition causing significant morbidity and mortality, and because there is currently no effective treatment for this life-threatening condition.

The fast track development programs of the FDA are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast track designation provides for a pre-NDA (New Drug Application) meeting with the FDA to discuss and achieve agreement on critical issues, will ordinarily provide for priority review of the NDA (6 months) for the specified indication, and allows for early submission of portions of the NDA on an agreed upon schedule to the FDA in order to expedite review of the NDA.

About CytRx Corporation

CytRx Corporation is a biopharmaceutical company focused on the development and commercialization of high-value human therapeutics. The Company's current research and development activities include CRL-5861, an intravenous agent for treatment of sickle cell disease and other acute vaso- occlusive disorders, and TranzFect, a delivery technology for DNA-based vaccines and therapeutics. CytRx has a research pipeline with opportunities in the areas of muscular dystrophy, cancer, spinal cord injury, vaccine delivery, gene therapy and food animal feed additives.

This press release may contain forward-looking statements that involve risks and uncertainties. Actual results may differ materially from those discussed in this release, due to, among other things, the research, development, and market risks which could adversely affect the Company's timeline for clinical trials, regulatory approval, and if such approval is received, time to market thereafter. Additional uncertainties