Cancer-related fatigue is a nearly universal symptom in patients receiving cytotoxic chemotherapy, radiation therapy, bone marrow transplantation, or treatment with biological response modifiers. The problem, which affects 70% to 100% of cancer patients, has been exacerbated by the increased use of fatigue-inducing multimodal treatments and of dose dense, dose-intense protocols.

In patients with metastatic disease, the prevalence of cancer-related fatigue exceeds 75%, and cancer survivors report that fatigue is a disruptive symptom months or even years after treatment ends. Patients perceive fatigue to be the most distressing symptom associated with cancer and its treatment, more distressing even than pain or nausea and vomiting, which, for most patients, can generally be managed by medication.

Fatigue in cancer patients has been under-reported, underdiagnosed, and undertreated. The most important effect of persistent cancer-related fatigue is on quality of life (QOL), as cancer patients become too tired to participate fully in the roles and activities that make life meaningful, Health care professionals have been challenged in their efforts to help patients manage this distressful symptom and to remain as fully engaged in life as possible. Because of the successes in cancer treatment, health care professionals are now likely to see patients with prolonged states of fatigue related to the late effects of treatment.

Cancer-related fatigue is a complex disease with multiple underlying causes. VT-310 has been designed to inhibit many of the pathways involved. VT-310 is an oral combination of two approved drugs impacting multiple targets. Each component drug of VT-310 has demonstrated excellent clinical safety and tolerability. Vicus anticipates that Investigator-led trials will be initiated by end of 2009.National Comprehensive Cancer Network, Clinical Practice Guidelines in Oncology, Cancer-Related Fatigue*, V.I.2006 MS-1