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About Cachexia and VT-122 Phase II trial done !!


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Vicus Therapeutics Records Last Patient Visit of Phase 2, VT-122 Trial for the Treatment of Cachexia in Patients With Advanced Lung Cancer

- Final study report expected in June 2008 -

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.

Website: http://www.vicustherapeutics.com

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