Romark Initiates Clinical Trial of Alinia for Treatment of Influenza

TAMPA, Fla., Feb. 1 /PRNewswire/ -- Romark Laboratories announced that it has initiated enrollment of patients in a clinical trial of Alinia® (nitazoxanide) for treating acute uncomplicated influenza including illness caused by the currently circulating H1N1 strain.  

(Logo:  http://www.newscom.com/cgi-bin/prnh/20100201/FL47022 )

The clinical trial is being conducted in approximately 25 sites across the United States and is expected to enroll 440 adult patients with acute uncomplicated influenza.  The trial is designed to test the hypothesis that treatment with oral nitazoxanide administered 500 mg twice daily for 5 days will reduce the duration of symptoms of influenza.  The trial will also evaluate the effect of treatment on other parameters including the severity of symptoms, complications of influenza and time to return to normal activities.

This clinical trial follows a published report in the October 23, 2009 issue of the Journal of Biological Chemistry titled, "Thiazolides, A New Class of Anti-influenza Molecules Targeting Viral Hemagglutinin at the Post-Translational Level."  In the article, scientists reported that nitazoxanide (the active ingredient of Alinia) and other drugs from the class called thiazolides inhibit the replication of influenza A viruses including H1N1 and H5N9 (a low pathogenicity avian strain) and influenza B virus in laboratory studies by a novel mechanism.(1)

"This drug works differently than the drugs we currently use for treating influenza," said Professor M. Gabriella Santoro, Ph.D., Head of Virology Laboratory, Department of Biology at the University of Rome Tor Vergata in Rome, Italy and senior author of the article in the Journal of Biological Chemistry.  "It targets the maturation and intracellular transport of the viral hemagglutinin protein (HA), while Tamiflu® (oseltamivir) and Relenza® (zanamivir) target the neuraminidase protein (NA), and older drugs target the M2 protein. This unique mechanism is potentially very important in the setting of resistance or the threat of resistance to existing drugs."

Initiation of the clinical trial comes at a time of heightened public awareness of influenza due to the global pandemic of H1N1 influenza.  The emergence of highly contagious and perhaps more pathogenic strains of influenza A virus represents a serious threat to global human health.  Efforts to control emerging influenza strains focus on surveillance and early diagnosis, as well as the development of vaccines and new antiviral drugs.  There is an important need for a new class of drugs that could be used as an alternative to existing drugs or in combination with existing drugs to improve effectiveness and delay or prevent resistance.

"Following completion of the research published last October, we filed an Investigational New Drug application with FDA in November and have been working quickly to initiate this clinical trial so that it can be conducted in the United States during the current flu season," said Jean-François Rossignol, M.D., Ph.D., Chief Science Officer of Romark.  Dr. Rossignol was lead author on the article published in the Journal of Biological Chemistry.  He discovered the new class of antiviral drugs called the thiazolides and has led the clinical development of nitazoxanide.

"We need to complete this clinical trial," Rossignol said, "but if our results are favorable, we will move aggressively to complete a full development program.  Alinia is already marketed in the United States for treating other infectious diseases.  Our experience with the product coupled with heightened awareness of the threat of pandemic influenza and the need for a new class of drugs could provide an accelerated path to obtaining regulatory approvals and making the product available for the prevention and treatment of influenza.  A product with a new mechanism of action could become an important part of the armamentarium for combating this important public health threat."

Romark is also developing nitazoxanide for treating a broad range of patients with chronic hepatitis C.  Phase 2 clinical trials of nitazoxanide in combination with peginterferon or peginterferon plus ribavirin have either been completed or are ongoing in treatment-naive and treatment-experienced patients infected with HCV genotypes 1 and 4 and in patients co-infected with HCV and HIV.  Data from ongoing studies will be reported at medical conferences during the first half of this year.  Studies in genotypes 2 and 3 chronic hepatitis C patients and other novel combination trials are in planning stages.  The company expects to begin phase 3 clinical trials of nitazoxanide in combination with peginterferon with or without ribavirin during 2010.

"These are exciting developments," said Marc Ayers, President and Chief Executive Officer of Romark.  "As we continue to grow our existing business in the United States, we are preparing to move new products into late-stage clinical development during the coming year for two major indications – chronic hepatitis C and influenza.  We believe we have the opportunity to play an important role in improving the treatment of both of these diseases."

About Clinical Trial RM01-2027

Additional information on the clinical trial is available at http://clinicaltrials.gov/ct2/show/NCT01056380.

About Influenza

Influenza is a highly contagious acute respiratory illness caused by influenza viruses including the new H1N1 influenza.  Common symptoms include fever, runny nose, nasal congestion, sneezing, cough, sore throat, headache, muscle aches, sweats, chills and fatigue. Influenza illness affects all age groups and can lead to complications including sinusitis, otitis, bronchitis, pneumonia and central nervous system disease. In the United States, influenza is responsible for approximately 36,000 deaths and 216,000 hospitalizations per year.

About Romark Laboratories

Romark Laboratories, L.C. (www.romark.com) is a biopharmaceutical company committed to the discovery and development of innovative new small molecules for treating infectious diseases and cancers.

About Alinia

Alinia for Oral Suspension (patients 1 year and older) and Alinia Tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum.  Alinia for Oral Suspension and Alinia Tablets have not been shown to be superior to placebo for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients.

Important Safety Information Regarding Alinia

• In clinical studies involving HIV-uninfected patients age 12 years and older receiving Alinia Tablets, the most common adverse events reported regardless of causality assessment were abdominal pain (6.6%), diarrhea (4.2%), headache (3.1%) and nausea (3.0%). In clinical studies involving HIV-uninfected pediatric patients receiving Alinia for Oral Suspension, the most common adverse events reported regardless of causality assessment were abdominal pain (7.8%), diarrhea (2.1%), vomiting (1.1%) and headache (1.1%). These were typically mild and transient in nature. In placebo-controlled clinical trials using the recommended dose, the rates of occurrence of these events did not differ significantly from those of the placebo.
• Alinia Tablets and Alinia for Oral Suspension are contraindicated in patients with a prior hypersensitivity to nitazoxanide or any other ingredient in the formulations.
• The pharmacokinetics of nitazoxanide in patients with compromised renal or hepatic function have not been studied. Therefore, nitazoxanide must be administered with caution to patients with hepatic and biliary disease, to patients with renal disease and to patients with combined renal and hepatic disease.
• Tizoxanide is highly bound to plasma protein (>99.9%). Therefore, caution should be used when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices, as competition for binding sites may occur (e.g. warfarin).
• It is not known whether nitazoxanide is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nitazoxanide is administered to a nursing woman.
• Long-term carcinogenicity studies have not been conducted.

Alinia is an investigational new drug for chronic hepatitis C and influenza.

(1) Rossignol JF, La Frazia S, Chiappa L, Ciucci A, Santoro MG. Thiazolides, a new class of anti-influenza molecules targeting viral hemagglutinin at the post-translational level. J Biol Chem 2009; 284:29798-29808.

SOURCE Romark Laboratories, L.C.

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