PharmaMar has initiated phase-I / II trials of Irvalec in combination Tarceva (erlotinib) in solid tumours. The combination demonstrates great synergism even in erlotinib resistant non-small cell lung cancer (NSCLC) cell lines.
The simultaneous administration of the two compounds is the most effective schedule for inhibiting in vitro cell growth. The available preliminary safety data for Irvalec indicates an acceptable risk-benefit relationship and the probability of non-overlapping toxicities of both compounds supporting the proposal phase-I/II clinical trial. The study will determine the safety and tolerability and will identify dose-limiting toxicity (DLT) and the recommended dose (RD) of the combination in patients with advanced malignant solid tumours.
A preliminary pharmacogenomic (FgX) study will also be carried out to find molecular predictor factors of response to antagonists of ErbB receptors and to Irvalec. The trial is being conducted in centres in Spain and the United States. The recruitment for the trial will last for the next 18 months.
Irvalec is a new synthetic depsipeptide resulting from PharmaMar's internal investigation for obtaining derivatives of marine natural compounds.