Treatment for glioma, which is the most common form of primary brain cancer, remains a significant unmet medical need.
The FDA Orphan Drug Designation provides companies with development and commercial incentives for designated compounds.
The company’s DNX-2401 program has already been granted fast track status by the FDA.
DNAtrix president and chief executive officer Dr Frank Tufaro said: "Results from our clinical trials with DNX-2401 continue to indicate that the drug may be an important treatment option for the disease.
Oncolytic virus therapy is based on the concept of using live viruses to selectively infect and replicate in cancer cells, with minimal destruction of normal tissue.
Currently, DNX-2401 is being evaluated in clinical studies in the US and Europe.