Getting FDA approval to begin trial of a new drug had never been easy task for the pharma or contract research companies. FDA’s thorough investigation on background data of a new drug allows only 5 to 10 new molecules to get IND (Investigational New Drug) approval out of 5000-10,000 newly developed anticancer molecules.

Houston based Christus Stehlin Foundation for Cancer Research has developed this new anticancer drug which is being tested on patients after quickly receiving approval from the U.S. Food and Drug Administration for Phase I clinical trials. They got FDA nod within 30 days
of submitting the application.

In Phase I, the drug has been planned to be tested on about 50 patients with advanced solid tumor to determine ideal dose and side effects.

Jaye Thompson, senior vice president of inVentiv Clinical Solutions, a Houston-based CRO considers it as a Good News. He gives credit to the adequate preclinical data and dosage which Stehlin can go further with.