Investigational glioblastoma drug receives fast track designation from FDA

The FDA has granted fast track designation to DNAtrix Inc.’s replication competent adenovirus for patients with recurrent glioblastoma, according to a press release from the company.

DNX-2401, a conditionally replication-competent adenovirus, was developed for the treatment of several cancer indications, including patients with recurrent glioblastoma.

The FDA based its decision on results of a phase 1 dose-escalating monotherapy study conducted with DNX-2401 at The University of Texas MD Anderson Cancer Center for patients with recurrent malignant glioma. Study results demonstrated evidence of total tumor destruction and long-term survival in several patients.

A second phase 2 trial evaluating DNX-2401 combined with the temozolomide is currently underway at the Clínica Universidad de Navarra in Pamplona, Spain, for patients with recurrent glioblastoma.

“We’re very pleased to receive Fast Track status for DNX-2401 and are pleased that the FDA supports our position that there is an urgent need for additional therapies to treat glioblastoma,” Frank Tufaro, PhD, president and CEO of DNAtrix, said in a press release. “Fast Track status reinforces our goal to quickly move forward with the development of DNX-2401. Recurrent glioblastoma is extremely challenging to treat, and clinical results from DNX-2401 to date indicate that the drug may be an important treatment option for the disease.”

The FDA provides fast track status to facilitate the development of new products for serious or life-threatening conditions that demonstrate the potential to address unmet medical needs, with the goal of getting important new products to patients earlier. Fast track status will also allow the company to work closely with the FDA to expedite the review of aspects of the DNX-2401 program to improve the efficiency of product development.