DNAtrix, Inc., experts in oncolytic virus development, today announced that the first patient was treated with the company’s lead product, DNX-2401, a replication competent adenovirus plus gamma interferon in a randomized, multicenter, open-label Phase Ib study for patients with recurrent glioblastoma.
“DNAtrix, in collaboration with leading neurosurgeons and neuro-oncologists in the US, is pleased to announce the initiation of our randomized Phase Ib study of DNX-2401 at Moffitt Cancer Center,” stated Frank Tufaro Ph.D., a leader in the field of oncolytic virus therapy and chief executive officer of DNAtrix. “Recurrent glioblastoma is extremely challenging to treat, yet early results with DNX-2401 and gamma interferon indicate that the two drugs, delivered sequentially, could prove to be an important treatment option for the disease.”
Recurrent glioblastoma patients in the Phase 1b “TARGET 1” trial (Therapeutic Adenovirus for Recurrent Glioblastoma EffecT trial) are being randomized to receive sequential therapy of DNX-2401 plus or minus interferon gamma. Interferon gamma is an immunomodulatory cytokine that plays a key role in anti-tumor immunity and will be delivered several weeks after treatment with DNX-2401 to allow for robust oncolytic virus replication and tumor killing. Interferon gamma may trigger a long lasting anti-tumor response, as has already been observed in several patients who were treated with DNX-2401 alone.
“We are excited to be participating in this clinical trial with a promising approach to treating brain tumors. Having worked in the area of virus therapy for many years, it is gratifying to see DNX-2401 used in patients,” stated Dr. Peter Forsyth, chairman of the Neuro-Oncology Program at Moffitt Cancer Center.
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For more information about the study, visit the website ClinicalTrials.gov and search for identifier NCT02197169.
Glioblastoma is a devastating primary brain tumor resistant to conventional therapies and is the second most common cause of death from intracranial disease. The lack of effective therapy for brain tumors has led to intense investigations of novel therapeutic approaches that use vectors and recombinant viruses.
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. Replication amplifies the input dose of the oncolytic virus and helps spread the agent to adjacent tumor cells. DNX-2401, a conditionally replication-competent adenovirus, is being developed for the treatment of several cancer indications including patients with recurrent glioblastoma. DNX-2401 is the culmination of more than a decade of scientific and clinical research and is the most potent and effective oncolytic virus delivered to human brain tumors to date.
DNAtrix is a company developing modified viruses for the treatment of the most aggressive forms of cancer. Since viruses are already efficient at killing cells, scientists have harnessed this ability by modifying a common cold virus so that it targets and selectively kills cancer cells. DNAtrix is a privately held company located in Houston, Texas and San Diego, California. For more information, please visit the Company’s website at www.dnatrix.com.