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The clinical trial is designed to evaluate the effectiveness and safety ofAlinia tablets administered in combination with Pegasys(R) (peginterferonalfa-2a) and Copegus(R) (ribavirin) in 60 patients with chronic hepatitis Cgenotype 1 who have failed to respond to standard therapy (peginterferon andribavirin). Pegasys and Copegus are being provided under a collaborativeagreement between Romark and F. Hoffmann-La Roche Ltd.
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"We are excited to be participating in this clinical trial," said DavidNelson, M.D., Associate Professor of Medicine, Medical Director of LiverTransplantation, and Chief of the Hepatobiliary Disease Section at theUniversity of Florida. "There is a critical need for new therapies forpatients with hepatitis C, particularly those who have already failed existingtherapies."
The company also announced that interim data from an internationalclinical trial in patients with chronic hepatitis C will be communicated atthe 58th Annual Meeting of the American Association for the Study of LiverDiseases (AASLD) in early November 2007.
"Initiation of the US study and communication of our international datarepresent important milestones for our development program," saidJean-Francois Rossignol, M.D., Ph.D., Chairman and Chief Science Officer ofRomark who invented nitazoxanide and is leading its clinical development. "Weare enthusiastic about the results to be presented at the upcoming AASLDmeeting and the opportunity to develop an important new treatment for patientssuffering from chronic hepatitis C."
The company's STEALTH C (Studies to Evaluate Alinia for Treatment ofHepatitis C) development program is being directed in collaboration with theDivision of Gastroenterology and Hepatology at Stanford University School ofMedicine by Emmet B. Keeffe, M.D., Jeffrey S. Glenn, M.D., Ph.D. and Dr.Rossignol who is also a Stanford affiliate.
Nitazoxanide is the first of a new class of small molecule drugs calledthe thiazolides that target cell signaling pathways used in viral replication.Data related to the in vitro activity of nitazoxanide against virusreplication in hepatitis C virus (HCV) replicons was presented earlier thisyear at the 20th International Conference on Antiviral Research.
Stephen A. Harrison, M.D., Chief of Hepatology at Brooke Army MedicalCenter in Fort Sam Houston, Texas, said, "The potential for use ofnitazoxanide in the treatment of chronic hepatitis C is exciting. To betteroptimize treatment outcomes for patients, we need new antiviral drugs that canbe used safely and effectively in combination with existing drugs or withother new drugs in development."
STEALTH C Clinical Development Program
The US and international clinical trials described above comprise part ofthe company's STEALTH C (Studies to Evaluate Alinia for Treatment of HepatitisC) clinical development program, a series of clinical trials designed toevaluate the safety and efficacy of Alinia tablets in combination withpeginterferon or peginterferon and ribavirin in patients with chronichepatitis C.
The STEALTH C-1 trial, conducted in Egypt in interferon-experienced andnaive patients with chronic hepatitis C genotype 4, is a phase II randomizedcontrolled trial evaluating the effectiveness and safety of three treatmentregimens: (i) Alinia administered 500 mg twice daily for 12 weeks followed byAlinia-Pegasys combination therapy for 36 weeks, (ii) Alinia 12 weeks followedby Alinia-Pegasys-Copegus combination therapy for 36 weeks and (iii) Pegasys-Copegus combination therapy for 48 weeks (standard of care). The studyrandomized 120 patients. Patients enrolled in this trial have reached the endof treatment and are undergoing follo
