The Sage Group Represents VAL401 - A Unique Formulation of Respiridone for Cancer Supportive Care
The Sage Group is working with UK-based ValiRx, which is developing a unique, patented, cancer supportive care product, VAL401, for which it seeks a global or regional partner. VAL401 is the first, and as far as we know, only cancer supportive care product to use risperidone in a unique lipid-based formulation with rumenic acid, an essential and functional component of the combination, specifically to improve the quality of life of late-stage cancer patients thus contributing to their Progression Free Survival (PFS) and Overall Survival (OS).
Risperidone is approved for the treatment of schizophrenia, bipolar disease, and certain aspects of autism. It is reported to be used off label for adjunctive treatment of major depression disorder delusional parasitosis, post-traumatic stress disorder (PTSD), Tourette syndrome, and other mental health conditions. Several publications support the use of risperidone in cancer patients to treat chemotherapy induced delirium, opioid-induced nausea, and cachexia, but no drug has been approved for improved survival related to Quality-of-Life improvements.
In a small open label Phase 2 study of the VAL401 to treat late-stage non-small cell lung cancer (NSCLC), VAL401 achieved a statistically significant difference (P=.0109) in OS. Importantly, 19 out of 28 measures of quality of life showed improvement between treatment initiation and removal from trial with respect to reduced pain and fatigue. Notably, responders and non-responders equally reported improvements in Quality-of- Life measures suggesting these effects are in addition to survival benefit.
A scientific meeting held with key opinion leaders (KOLS) resulted in their recommending that the next clinical trial study of VAL401 have “Time to Quality-of-Life deterioration” as the primary end point with secondary end points measuring survival and anti-cancer markers in first-line pancreatic ductal adenocarcinoma in combination with standard of care in a randomized controlled trial against standard of care with placebo. Pancreatic ductal adenocarcinoma was recommended because of the high mortality rate, and associated treatment side effects, thus addressing the pressing need for treatments which improve the quality of life for these patients
ValiRx envisions the regulatory path in the US to be the 505(b)(2) and to follow a similar path in Europe. Moreover, pancreatic ductal adenocarcinoma is an orphan indication and as such is expected to further facilitate regulatory approval.
ValiRx seeks a global or regional partner to advance VAL401 in clinical development and ultimately to assist in its commercialisation globally, or regionally.
Dr. Bill Mason
+44 7785 950134