"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."
SOURCE Romark Laboratories, L.C.