MORRISTOWN, N.J., April 30 /PRNewswire/ -- Vicus Therapeutics, LLC, a biopharmaceutical company focused on oncology supportive care, announced today the completion of the last patient visit in its study VT1-CAX-001, a Phase 2 trial of VT-122. The compound was tested for the treatment of cachexia in weight losing subjects with Stage IV, non-small cell lung cancer (NSCLC). The Phase 2 clinical trial was conducted in India and the final study report is expected in June 2008.
A total of 59 subjects were deemed eligible for this multi-center, randomized, open-label controlled Phase 2 study in weight losing Stage IV NSCLC patients not on chemotherapy. The 12 subjects randomized to the control arm received best supportive care and the 25 subjects randomized to the treatment arms received best supportive care and one of two doses of VT-122. Twenty-two of the screened subjects were not randomized. The primary efficacy endpoints assessed were maintenance of muscle mass (lean body mass) and function (grip strength). Efficacy endpoints of total body weight and quality of life were also assessed. Assessments for safety and efficacy were continued for 12 weeks after randomization. No treatment related serious adverse events were reported.
"The successful completion of the Phase 2 study marks an important milestone in the development of VT-122," said John Maki, President and Chief Executive Officer of Vicus Therapeutics. "Based on favorable analysis of the preliminary data, we expect to initiate discussions with prospective partners to secure resources to maximize the potential of VT-122."
About Cachexia and VT-122
Cachexia is a debilitating, progressive muscle wasting condition manifested by unintentional weight loss, muscle weakness, anemia, fatigue, and death. In advanced cancer patients, the prevalence of cachexia increases from 50% at diagnosis to more than 80% prior to death. There is currently no FDA-approved therapy for treating cancer cachexia.
VT-122 is an oral, multi-targeted, chrono-modulated, fixed dose combination of propranolol and etodolac. Vicus chose the constituent drugs based on the results of its cancer cachexia disease model that predicted blocking systemic inflammation would reverse the wasting process. The use of this combination was initially assessed in investigator-led pilot trials. Data obtained from a total of nine evaluable subjects demonstrated reversal of rapid weight loss in seven subjects. No treatment related serious adverse events were reported.
About Vicus Therapeutics
Vicus Therapeutics is a privately-held biopharmaceutical company focused on developing oncology supportive care drug products for serious unmet medical needs. These products include: VT-122, in Phase 2 clinical trials, for cancer cachexia; VT-211 and VT-212, in investigator-led pilot trials, for chemotherapy-induced oral mucositis and neutropenia; and VT-310, in pre-clinical evaluation, for cancer-related fatigue. Each product candidate is a novel combination and dosing regimen of two generic drugs with known safety profiles. The constituent drugs and dosing regimens are chosen based on the results of Vicus' predictive disease models and the company's understanding of the body's maladaptive response to cancer and its treatment.
SOURCE Vicus Therapeutics, LLC