Specialty pharmaceutical company Cumberland Pharmaceuticals Inc (Nasdaq:CPIX) and healthcare provider Vanderbilt Health on Tuesday announced data from a Phase 2a clinical trial of ifetroban to prevent metastasis in high-risk solid tumours.

The randomised, double-blind, placebo-controlled Phase 2a trial was designed to evaluate the safety of ifetroban, an investigational thromboxane A2 receptor antagonist, in patients with solid tumours at high risk of early metastatic recurrence. Cancer types included breast, lung, pancreatic, soft tissue, bladder, and renal cancers.

The study's primary safety endpoint was achieved, along with favourable trends in decreased metastasis recurrence and metastasis-free survival.

This was the first trial evaluating the effects of ifetroban in people with solid tumours with high risk for early recurrence. The intervention was given after all cancer-related therapies and surgical procedures had been completed; participants received the intervention for 12 months and were then followed for an additional 12 months. Among 29 participants, 10 received placebo and 19 received ifetroban.

Preclinical studies subsequently published in Molecular Cancer Therapeutics demonstrated that ifetroban reduced metastasis in several animal models without affecting tumour growth, and that the drug's effects appeared to involve strengthening of the vascular endothelial barrier and inhibiting the ability of tumour cells to migrate across blood vessel walls.

Results of this Phase 2a clinical trial will be used to guide further clinical development verifying efficacy and further demonstrating safety.