Healthcare Industry News: oral mucositis
News Release - January 16, 2007
Vicus Therapeutics Announces the FDA has Allowed the Phase 2 Trial of VT-122 for the Treatment of Cachexia in Patients With Advanced Lung CancerMORRISTOWN, N.J., Jan. 16 (HSMN NewsFeed) -- Vicus Therapeutics, LLC, an oncology-focused, clinical-stage, biopharmaceutical company, announced today that the Division of Oncology Drug Products of the U.S. Food and Drug Administration (FDA) has determined that it is safe to proceed with the Phase 2 trial of VT-122. The compound will be tested for the treatment of cachexia in weight losing subjects with Stage IV, non-small cell lung cancer (NSCLC). The Phase 2 clinical trial will be conducted in the United States and India, and is expected to be completed in Q3 2007.
This multi-center, randomized, open-label controlled study will assess the safety and efficacy of VT-122 regimen administered to weight losing patients with Stage IV NSCLC. A total of 60 subjects will be enrolled in the study; 40 will be randomized to receive a defined nutritional support and VT-122 regimen (20 patients each receiving either of two doses of the first component and individualized maximum tolerated dose of the second component) and 20 patients receiving only the defined nutritional support. The primary endpoints of the study will be maintenance of muscle (lean body mass) and muscle function (grip strength). The study will also measure total body weight and quality of life. Assessments for safety and efficacy will be continued for 12 weeks. This trial will begin in February 2007 and data from this trial is expected to be available approximately six months after the trial is initiated.
"VT-122 is comprised of two FDA-approved drugs, each with an extensive set of safety data. Therefore, demonstrating efficacy and identifying the optimal dose during this Phase 2 clinical trial will be an especially significant step toward the development of VT-122," said John Maki, President and Chief Executive Officer of Vicus Therapeutics. "Treatment options for patients suffering from cachexia are very limited. There is currently no FDA-approved therapy for over 125,000 cancer patients in the United States who suffer from cachexia each year."
About Cachexia and VT-122
Cancer cachexia results in severe wasting of muscle and connective tissue and is one of the most common debilitating and distressing conditions of advanced cancer. Severe cachexia is associated with extreme weakness, intolerance to chemotherapy and substantially reduced life expectancy. Of patients who develop severe cachexia, approximately 50% have lung cancer. The size of this market has been estimated to exceed $250 million dollars.
VT-122 targets multiple inflammatory and other key pathways involved in the pathophysiology of cancer cachexia. The investigational product will be administered as an oral fixed dose combination, and is designed to block many of the biological targets necessary for cachexia persistence. Three investigator-led pilot trials with a total of seven evaluable subjects were completed in 2006. These trials demonstrated reversal of rapid weight loss in five subjects. No treatment related adverse events were reported.
About Vicus Therapeutics
Vicus Therapeutics is a privately-held, clinical-stage, biopharmaceutical company developing novel strategic approaches to the treatment of cancer supportive care indications. In addition to Vicus' lead program, VT-122, the Company has two preclinical programs for the treatment of oral mucositis and cancer fatigue. Vicus leverages its proprietary science to design and screen two-drug combinations that work together to reverse the body's maladaptive responses to cancer and its treatment. Vicus' development programs are powered by its network of leading clinical investigators in the United States, India and Japan. This global network drives the high quality, rapid and cost effective clinical development of Vicus' product candidates.
Source: Vicus Therapeutics
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