Vicus Therapeutics' lead product VT-122 has demonstrated a statistically significant improvement in lean body mass in systemic inflammation of lung cancer patients. The company's phase-2 study on advanced lung cancer patients has proved the improved quality-of-life and extended survival. VT-122 will not be marketed now but will be co-prescribed and used, based on evidence, with a partner's proprietary chemotherapy agent.
Patients can have access to the new treatment as soon as the positive clinical results are published. What is needed is clinical evidence of efficacy which is the reason for the phase-2 and phase-3 studies.
The phase-II study included several sites in the US and six sites in India. Five sites in India enrolled subjects and one of which was AIIMS.
Systemic inflammation in advanced cancer manifests as cachexia and is associated with intolerance to therapy, poor quality-of-life and reduced life expectancy. VT-122 is designed to enhance the effectiveness of targeted drug therapies for advanced cancer patients with systemic inflammation.
VT-122 is an orally administered combination of propranolol, a non-selective beta adrenergic receptor blocker, and etodolac, a balanced COX1 and COX2 enzyme inhibitor. Propranolol suppresses autonomic nervous system hyperactivation and excess catecholamine release associated with systemic inflammation. Etodolac targets key cell signalling and inflammatory pathways in the tumour, liver and immune system. By synergistically targeting multiple pathways, VT-122 is designed to attenuate cancer-induced systemic inflammation and thereby reverse cachexia, lengthen duration of treatment, improve quality-of-life and extend survival, Dr Nirupa Bareja, country director, India, Vicus Therapeutics told Pharmabiz.
The global multi-centric study which included India saw 44 per cent of patients treated with VT-122 witness a clinically meaningful gain of more than 5 per cent in lean body mass.
"Our focus is to identify drugs that have already gained FDA approval for non-cancer indications and have completed initial clinical testing for the treatment of cancer-related indications. It is here we partner with pharmaceutical companies to develop these drugs as components of multi-drug treatment regimens that can enhance the effectiveness of the partners' FDA-approved targeted oncology drugs including generic version products," stated Dr Bareja.
Improved treatments for advanced cancer patients with systemic inflammation represent a serious unmet medical need. Multiple studies have shown that these patients with systemic inflammation, as assessed by weight loss, have significantly reduced life expectancy across cancers types. In addition, these patients do not tolerate therapy, become disabled and require costly hospital care, she added.
Vicus Therapeutics is a private biopharmaceutical company which is pioneering a new business model to rapidly bring breakthrough multi-drug treatments to patients with cancer. Currently, there is no FDA approved drug product for the treatment of advanced cancer patients with systemic inflammation. VT-122 is now able to reduce the symptom cluster associated with systemic inflammation, including cachexia, pain, reduced survival, tumour growth promotion, and intolerance to chemotherapy will be covered in the market as a means of providing a much needed solution for patients, caregivers and physicians, informed Dr Bareja.