Adherex, a biopharmaceutical firm based in RTP, took a major step in its product development Tuesday, announcing the FDA had approved an investigational new drug application for an anti-tumor product.
In winning the IND status, Adherex can now proceed with a Phase I clinical trial.
A similar trial is already underway in Canada.
The proposed drug is called Exherin.
The study, which is expected to being this month, will be led by David Stewart, a doctor and a professor in the Department of Thoracic/Head and Neck Medical Oncology at The University of Texas M.D. Anderson Cancer Center in Houston.
“Vascular targeting is a novel approach to cancer treatment,” Stewart said in a statement. “This type of rationally developed, molecularly targeted therapy is a novel strategy and may offer cancer patients new hope. The study is designed to evaluate the safety and drug metabolism of the agent as well as to look at the drug’s activity on the tumor and its vasculature.”
Exherin is a small peptide molecule that disrupts the blood vessels of cancers.
Early data in Canada “indicated safety through a range of six dose levels used to date and encouraging hints of biological activity in two patients,” the company said.
“It was a critical event for Adherex to begin its dialogue with the FDA about Exherin, and the fact that we can proceed with this next clinical trial following clearance of our IND application by the FDA is another very important milestone for Adherex,” said William Peters, chairman and CEO of Adherex, in a statement.