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.


Vicus Therapeutics, LLC

http://www.vicustherapeutics.com