Vicus initiates VT-122 Phase 2 trial in advanced liver cancer, systemic inflammation and cachexia

Vicus Therapeutics, LLC, today announced the initiation of a Phase 2 trial evaluating VT-122, a novel investigational combination of etodolac and propranolol, and Nexavar® (sorafenib) tablets, as a potential new treatment option for patients with advanced liver cancer (hepatocellular carcinoma), systemic inflammation and cachexia.  

The randomized, open label, multi-center Phase 2 study will evaluate whether VT-122 in combination with Nexavar increases "Clinical Benefit Response," which is a composite measurement of pain, performance status, and lean body mass, as compared to Nexavar alone.  The secondary efficacy endpoints of this study are cancer and cachexia specific symptoms, duration of Nexavar therapy and overall survival.

The study will be conducted under Vicus' US IND and is expected to enroll 80 patients with advanced liver cancer, systemic inflammation and cachexia at multiple sites in the United States.  Enrollment into this study is expected to be completed by the end of 2011. For more information about enrolling in the study, please visit www.clinicaltrial.gov.

Vicus Therapeutics, LLC, Bayer HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals, Inc. have entered into an agreement pursuant to which Bayer and Onyx have agreed to support the study. The terms of the agreement are confidential.