Vicus Therapeutics, has announced positive results from its phase II randomised, open-label, controlled clinical trial of its lead compound, VT-122, in combination with sorafenib, in patients with advanced hepatocellular carcinoma (HCC). The study was conducted in India on 24 patients.

In an intent-to-treat (ITT) population, investigators reported an 11-month increase in median overall survival (OS) in patients treated with VT-122 plus sorafenib, compared to those receiving sorafenib alone. The data was presented at the 8th Annual International Liver Cancer Association (ILCA) conference in Kyoto, Japan.

VT-122 is a novel, oral, chronodosed combination of etodolac, a non-steroidal anti-inflammatory drug (NSAID), and propranolol, a beta-blocker. It is designed to damp tumour-promoting inflammation and restore a tumour-suppressing immune state by inhibiting two major stress systems that are activated in cancer: prostaglandin and beta-adrenergic signaling.

“Results of the proof-of-concept trial provide the first evidence that VT-122 is active in hepatocellular carcinoma and suggest a demonstrable survival benefit in patients with advanced disease who are receiving the standard-of-care therapy, sorafenib,” said Dr G S Bhattacharyya, principal investigator and head, Department of Medical Oncology, Fortis Hospitals, Kolkata.

“Coupled with the evidence suggesting that the use of NSAIDs and beta-blockers are associated with significant improvement in overall survival in patients with cancer, these results provide a strong basis for advancing VT-122 into further studies for this difficult-to-treat population,” he added.

Dr. Bhattacharyya and colleagues presented data from a phase II, randomised, open-label, controlled study of 24 patients with advanced HCC who were randomized to receive VT-122 plus sorafenib or sorafenib alone.

Of the 12 patients receiving VT-122 plus sorafenib, 10 (83.3 per cent) were alive at 12 months, compared to 3 of 12 patients (25 per cent) in the sorafenib-only group). VT-122 was well-tolerated in the study, with no unexpected serious adverse events reported, Dr Nirupa Bareja , director India operations, Vicus.

The addition of VT-122 to sorafenib was also associated with stabilisation of weight loss and reduced incidence of hand-foot skin reaction (HFSR), a major dose-limiting side effect of sorafenib therapy. At six months, 42 per cent of patients in the combination therapy arm had gained more than 5 per cent of total body weight and none had lost more than 5 per cent of body weight. In contrast, 50 per cent of patients receiving sorafenib alone had lost more than 5 per cent of their body weight at six months, and none had gained more than 5 per cent of their body weight. In addition, only 17 per cent of patients treated with VT-122 plus sorafenib experienced grade 2 HFSR, compared to 67 per cent receiving sorafenib alone.

“VT-122, a product of our precision medicine modeling technology, appears to be a safe, potent, and synergistic inhibitor of signalling pathways in the tumour micro environment and the neuro-immune system. The latest results strengthen the rationale for combination immunotherapy as a promising approach in oncology,” said Dr Newell F Bascomb, executive vice president research and COO at Vicus Therapeutics.

“Hepatocellular carcinoma is a devastating disease. This study has provided us with a unique opportunity to advance VT-122 into further development in a population with few attractive treatment options,” added John Maki, president and chief executive officer, at Vicus Therapeutics.