Advaxis submits cervical cancer drug for orphan drug designation

Advaxis, a development-stage biotechnology company, has submitted to the FDA its lead drug candidate, ADXS11-001, for orphan drug designation to treat invasive carcinoma of the cervix.

The orphan drug designation is intended to support the clinical development of drugs to treat diseases that affect less than 200,000 people in the US. If approved, such a designation would grant Advaxis fast-track review process as well as market exclusivity for a period of seven years.

In addition, Advaxis would be eligible for direct guidance from the FDA for the design of a clinical plan to further develop the drug. By statute, the FDA must review and respond to an orphan drug application within 60 days.

Thomas Moore, chairman and CEO of Advaxis, said: Over 10,000 women a year are newly diagnosed with cervical cancer. Women with the disease who fail cytotoxic therapy have a very short survival prognosis. Our preliminary clinical data indicates our agent may improve the survival of these patients. The orphan drug designation program affords us the ability to collaborate with the FDA in a manner that provides a clear and more rapid path to market.