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FDA grants orphan drug status to DNX-2401 for glioma treatment

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DNAtrix Inc. recently announced that the FDA has granted orphan drug designation to DNX-2401 for the treatment of malignant glioma.

DNX-2401 — a conditionally replicative oncolytic adenovirus — targets tumors with minimal damage to the normal tissue by selectively infecting and replicating in cancer cells. The therapy also has demonstrated a long-lasting anti-glioma immune effect that may lead to prolonged survival in patients with glioma.

“We are pleased to have been granted orphan drug designation for our lead glioma oncolytic virus therapy,” Frank Tufaro, PhD, president and CEO of DNAtrix, said in a press release. “Results from our clinical trials with DNX-2401 continue to indicate that the drug may be an important treatment option for the disease.”

DNX-2401 received the orphan drug designation because glioma is a condition for which there is a significant unmet medical need, according to a press release from the company. The agent received FDA fast track status in June.

Trials evaluating DNX-2401 are underway in the United States and Europe.