标题: Conatus Pharmaceuticals Initiates Confirmatory Phase 2 Clinical Trial of CTS-102 [打印本页] 作者: StephenW 时间: 2011-2-18 19:47 标题: Conatus Pharmaceuticals Initiates Confirmatory Phase 2 Clinical Trial of CTS-102
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http://www.prnewswire.com/news-releases/conatus-pharmaceuticals-initiates-confirmatory-phase-2-clinical-trial-of-cts-1027-for-the-treatment-of-hepatitis-c-virus-hcv-116411089.html
Conatus Pharmaceuticals Initiates Confirmatory Phase 2 Clinical Trial of CTS-1027 for the Treatment of Hepatitis C Virus (HCV)
SAN DIEGO, Feb. 17, 2011/PRNewswire/ -- Conatus Pharmaceuticals Inc. announced today thetreatment of the first patient in a multi-center Phase 2b clinicaltrial evaluating CTS-1027 in combination with Peginterferon Alfa-2a(Pegasys®) and ribavirin (Copegus®) in a treatment experienced,hepatitis C (HCV) null responder patient population. Safety,tolerability, and antiviral activity of the triple combination will beassessed after up to 48 weeks of therapy.
CTS-1027is an oral, small molecule compound that inhibits the activity of keymembers of a class of protease enzymes, the matrix metalloproteinasesor MMPs. CTS-1027 has been shown to reduce and/or block HCV infectionin in vitro preclinical models and more recently, has displayedthe potential to amplify the effectiveness of existing therapies indifficult to treat HCV-infected patients. This is in addition toCTS-1027's anti-inflammatory and anti-fibrotic effects which have beenwell established in models of acute hepatitis and liver fibrosis.
"Ourprevious clinical trials indicate that CTS-1027 used in combinationwith existing standard-of-care HCV drugs has the potential to impactthe second phase of HCV virus inhibitory kinetics in patients. Thisphase is associated with the gradual reduction and replacement of HCVinfected cells by new uninfected liver cells. While reducing HCV virusproduction in infected cells is extremely important, eliminatingHCV-infected cells is crucial to curing HCV," said Dr. Steven J. Mento,President and CEO of Conatus. "We believe that CTS-1027 represents anovel approach to treating HCV disease and look forward to developingthis drug candidate in combination with the existing standard-of-caredrugs as well as the new antiviral drugs under development."
"Wehave established a collaborative relationship with key opinion leadersand clinical investigators in the hepatitis community," said Ms. MiRa Huyghe,Vice President of Clinical Development of Conatus. "We are encouragedby our investigators' interest in CTS-1027 and together with ourinvestigators look forward to offering a new treatment option for HCVnull responders."
"We are excited to participate in this Phase 2b trial of CTS-1027," said Dr. Paul J. Pockros, Head, Division of Gastroenterology/Hepatology at The Scripps Clinic and Director of the SC Liver Research Consortium in La Jolla, CA. "Current treatment options for HCV null responders are very limited. We believe CTS-1027 may enhance the effectiveness of pegylatedinterferon and ribavirin in this difficult to treat patientpopulation."
Thisclinical trial is a placebo-controlled, multicenter, double-blind,randomized trial of Peginterferon Alfa-2a (Pegasys®) and ribavirin(Copegus®) with or without CTS-1027 in HCV null responders. Dosing willlast for up to 48 weeks. The trial will also examine whether higherdose levels of CTS-1027 will improve on previously observed results. The Company expects approximately 260 patients to be enrolled. Theclinical trial will be conducted at up to fifty medical centers in theU.S. Additional information about the trial can be found at: www.clinicaltrials.gov (Identifier NCT01051921) or http://www.clinicaltrials.gov/ct2/results?term=cts-1027.
ConatusPharmaceuticals Inc. is a privately-held biopharmaceutical companyengaged in the development of innovative human therapeutics to treatliver disease and oncology. Conatus' lead drug candidate, CTS-1027, isin multiple Phase 2 clinical trials for the treatment of hepatitis Cvirus (HCV). Conatus was founded by the executive management team ofIdun Pharmaceuticals in July 2005 following the sale of Idun to Pfizer. For additional information, please visit www.conatuspharma.com.
Pegasys® and Copegus® are registered trademarks of F. Hoffman-La Roche, Inc.
SOURCE Conatus Pharmaceuticals
Conatus制药启动验证二期旅- 1027的C型肝炎病毒(HCV)的治疗临床试验