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Romark Announces Clinical Trial Results for New Influenza Drug Presented at IDSA Meeting 2011
Date:10/21/2011

iate another Phase 3 clinical trial of NT-300 during the coming flu season and to seek FDA approval to market NT-300 for treatment of acute uncomplicated influenza.  The company also plans to develop NT-300 for prevention of influenza and for treatment of influenza in special populations (e.g., pediatric patients under 12 years of age, geriatric patients and patients with severe illness or underlying medical conditions).

NT-300, an investigational new drug in the United States, is an oral controlled release tablet that contains 300 mg of nitazoxanide (NTZ) as active ingredient. NTZ is the first of a new class of small molecule immunomodulatory drugs called thiazolides. Romark is using this new class of drugs as a technology platform for developing new drugs for treating a broad range of viral diseases and cancers.  NT-300 is undergoing clinical development for treatment of influenza.

There are presently only two classes of drugs approved by the FDA for treating flu: the neuraminidase inhibitors, oral Tamiflu® (oseltamivir) and inhaled Relenza® (zanamivir), and the older M2 inhibitors, amantadine and rimantadine. The M2 inhibitors are no longer effective against circulating influenza strains. Resistance to the neuraminidase inhibitors has been observed, and during the 2008-2009 flu season, approximately 99% of circulating influenza A H1N1 strains were resistant to oseltamivir (Tamiflu®), the only oral drug for treating influenza. There has not been a new class of drugs approved for treating influenza since Tamiflu® and Relenza® were approved by FDA in 1999.  

Data from laboratory studies of NTZ to be presented at the IDSA meeting have shown that NTZ is active against a broad range of influenza viruses including oseltamivir- and amantadine-resistant strains.  Laboratory studies designed to create or select for influenza strains resistant to NTZ could not identify viruses resistance to NTZ in cell cult
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SOURCE Romark Laboratories, L.C.
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