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Romark Announces Publication Of Data From A Thorough Qt Study Of Nitazoxanide

Clinical Trial Results Published in the Journal of Clinical Pharmacology

Study Provides Safety Data to Support New Drug Application for NT-300 in Treatment of Influenza

TAMPA, Fla. – September 30, 2014 – Romark Laboratories announced today that results of a Thorough QT Study of nitazoxanide have been published in the September 2014 issue of the Journal of Clinical Pharmacology.

This study involved treating each of 56 subjects with two doses of nitazoxanide, moxifloxacin (a positive control), and a placebo administered in double-blind fashion during four treatment periods. Moxifloxacin showed a significant effect on cardiac repolarisation (prolongation of QTc), while neither nitazoxanide nor the placebo showed any significant effect.

"The data published in the Journal of Clinical Pharmacology is important to our development program," said Jean-François Rossignol, M.D., Ph.D., Chairman and Chief Science Officer of Romark. "The TQT study has become a requirement of regulatory authorities evaluating new drugs. We have been pleased with the results of this study and its contribution to our development program for NT-300."

IThe findings of this study were previously communicated at Pharmacology 2013 (formerly the British Pharmacological Society Winter Meeting) on December 17 – 19, 2013 in London.

IThe complete reference for the publication is: Taubel J, Lorch U, Rossignol JF, Ferber G, Camm AJ. Analyzing the relationship of QT interval and exposure to nitazoxanide, a prospective candidate for antiviral therapy – a formal TQT study. Journal of Clinical Pharmacology, 2014;54:987-994.

IEarlier this year, The Lancet Infectious Diseases published results of a Phase 2b/3 clinical trial of NT-300 (nitazoxanide) tablets in the treatment of acute uncomplicated influenza. Romark is presently conducting a Phase 3 clinical trial to evaluate the efficacy and safety of NT-300 or NT-300 plus oseltamivir compared to a placebo or to oseltamivir alone in treating outpatients 13 to 65 years of age with acute uncomplicated influenza. Upon successful completion of the Phase 3 clinical trial, the company plans to submit a New Drug Application for NT-300 administered alone and in combination with oseltamivir for treatment of influenza.

IThe Phase 3 clinical trial along with other licensure-enabling nonclinical and clinical development work (but not the TQT study) for NT-300 and the NDA submission are being conducted under contract HHSO100201300004C with the U.S. Department of Health and Human Services.

About the Thorough QT Trial

In this randomized, double-blind, placebo controlled study, the safety of therapeutic (675 mg) and supra-therapeutic (2700 mg) doses of nitazoxanide was evaluated in accordance with the ICH E14 guidelines. Fifty six (56) subjects participated in four treatment periods and received single doses of nitazoxanide 675 mg, nitazoxanide 2,700 mg, moxifloxacin 400 mg, or placebo. For 675 mg nitazoxanide, the largest change in QTcF from baseline was observed at 12 hours post-dose with a peak value of 1.6 ms (two-sided 90% CI: -0.3, 3.6 ms). The largest negative change in QTcF was observed at 1 hour post-dose (-2.7 ms with two-sided 90% CI: -4.5, -0.8 ms). The largest change in QTcF from baseline for 2,700 mg nitazoxanide was observed at 24 hours post-dose with a peak value of 3.4 ms (two-sided CI: 1.4, 5.4 ms). These findings demonstrate that neither a single dose of 675 mg nor 2,700 mg nitazoxanide prolonged the QT interval in healthy male and female volunteers. The safety results also demonstrate that all four treatments were well-tolerated, and the most frequently reported adverse events in the nitazoxanide and moxifloxacin treatment groups were gastrointestinal disorders which were as expected according to the reference safety information.

About NT-300

NT-300, a controlled release tablet for oral administration containing 300 mg of nitazoxanide (NTZ) as active ingredient, is being developed by Romark Laboratories for treatment of influenza. NTZ inhibits replication of a broad range of influenza viruses in cell culture assays, including oseltamivir- and amantadine-resistant strains, as well as other respiratory viruses that may cause flu-like symptoms in humans including the paramyxoviridae and the coronaviridae. In cell culture assays, NTZ and oseltamivir act synergistically in inhibiting replication of influenza viruses. In a Phase 2b/3 clinical trial conducted in the United States during the 2010-2011 influenza season, NT-300 administered 600 mg orally twice daily for 5 days reduced the duration of symptoms of acute uncomplicated influenza compared to a placebo and reduced viral titers in nasal swabs collected during treatment.

About Romark Laboratories

Romark Laboratories, L.C. is a vertically integrated biopharmaceutical company committed to the discovery and development of innovative small molecule drugs for treating infectious diseases and cancers. The Company markets Alinia® (nitazoxanide) tablets, 500 mg in the United States through a specialty sales force focused on gastroenterologists and primary care physicians.

Romark is developing a class of small molecule drugs called thiazolides. The Company’s product, NT-300 (nitazoxanide), is presently undergoing Phase 3 clinical development on a global basis for treatment of acute uncomplicated influenza. The NT-300 development program is being conducted under contract HHSO100201300004C with the U.S. Department of Health and Human Services. Other new drugs from the Company’s platform technology are proposed for treatment of viral diseases and cancers.