Our lead product, VT-122, is currently being evaluated in Phase 2 trials for
cancer cachexia, a debilitating, progressive muscle wasting condition
associated with advanced cancers. VT-122 is the oral, multi-targeted,
chrono-modulated, fixed dose combination of propranolol, a non-selective
beta adrenergic receptor blocker, and etodolac, a balanced COX1 and COX2
enzyme inhibitor.
We chose the constituent drugs based on the results of our cancer cachexia disease model
that predicted blocking systemic inflammation would reverse the wasting
process. While etodolac targets key inflammatory pathways in the tumor, liver and
immune system, propranolol suppresses autonomic nervous system activation and excess
catecholamine release.
Each day of therapy consists of four doses (capsules) each containing propranolol
and etodolac. The pattern of administration during the day is designed to match the
diurnal pattern in the change in blood pressure and heart rate as controlled by the
autonomic nervous system. In addition, the impact on the pulmonary system, sleep and
pain are all optimized with the prescribed dose. The blister card and variable dosing
regimen provides enhanced compliance and ease of use for the patient and caregiver.
Multiple Causes of Involuntary Weight Loss in Cancer Patients
In the early stages of cancer, weight loss is primarily due to inadequate
nutrition (anorexia-cachexia) which could be from chemotherapy induced nausea and
vomiting, psychosocial factors or even obstruction. As the cancer progresses,
weight loss is largely driven by systemic inflammation and this weight loss is not
responsive to nutrition (hypercatabolic-cachexia). In some types of cancers, there
may be specific factors that lead to weight loss including treatment or cancer induced
hormonal imbalances. In other cases, severe cancer-related fatigue may induce inactivity
and muscle atrophy.
VT-122 Targets Weight Loss Caused by Systemic Inflammation
VT-122 is the first cachexia drug that targets multiple mechanisms associated with the
cancer-induced systemic inflammation that causes muscle wasting and related symptoms
of advanced cancer. This therapeutic approach differentiates our drug candidate from
products used off-label, or in development, that target only single mechanism, or only
symptoms of cachexia. While these mono-targeted and symptomatic-based approaches have
been shown to drive weight gain in early stages of disease progression, none have been
shown to be safe and effective in reversing muscle wasting and associated morbidity in
patients with advanced cancer.
Intellectual Property
The first of several patents filed by Vicus on combinations for treatment of
cachexia was published on February 8, 2008 entitled “Drug combination
pharmaceutical compositions and methods for using
them”. http://www.wipo.int/pctdb/en/wo.jsp?wo=2008014471&IA=WO2008014471
Clinical Trials
Vicus Therapeutics has recently completed the last patient visit of a multi-center,
randomized, open-label, controlled, Phase 2 trial of VT-122 in 37 weight losing
subjects with advanced lung cancer. The Final Study Report will be available
in June 2008. Based on positive results of the Phase 2 trial, Vicus is currently planning additional studies for lung cancer as well as other cancer types.
