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news.The U.S. Food and Drug Administration (FDA) has granted Fast Track status to DNAtrix's drug DNX-2401, a replication competent adenovirus, for patients with recurrent gliobastoma.
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Being developed for the treatment of several cancer indications including patients with recurrent glioblastoma, DNX-2401 is claimed to be the most potent and effective oncolytic virus delivered to human brain tumors to date.
DNAtrix president and chief executive officer Dr. Frank Tufaro said that the FDA supports the company’s position that there is an urgent need for additional therapies to treat glioblastoma.
"Fast Track status reinforces our goal to quickly move forward with the development of DNX-2401," Tufaro added.
"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."
In a Phase I dose-escalating monotherapy study conducted with DNX-2401 at the UT MD Anderson Cancer Center for patients with recurrent malignant glioma, efficacy results have been extremely promising, with evidence of total tumor destruction and long-term survival in several patients, according to the company.
The currently underway second Phase 1 trial is evaluating DNX-2401 in combination with the drug Temozolomide for patients with recurrent glioblastoma.