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August 02, 2015 4:07 AM ET


Company Overview of DNAtriX, Inc.

Company Overview

DNAtriX, Inc., a biotechnology company, engages in the development of an oncoloytic virus platform for the treatment of malignant glioma. The company’s product includes delta24RGD, an oncolytic adenovirus. DNAtriX is based in Houston, Texas.

One Greenway Plaza

Suite 930

Houston, TX 77046

United States

Key Executives for DNAtriX, Inc.

Chief Executive Officer and Director
Compensation as of Fiscal Year 2015.

DNAtriX, Inc. Key Developments

FDA Grants Orphan Drug Designation to DNAtrix, Inc.'s DNX-2401 for the Treatment Of Malignant Glioma

DNAtrix, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for DNX-2401, a conditionally-replicative oncolytic adenovirus for malignant glioma. Glioma is the most common form of primary brain cancer, the treatment of which remains a significant unmet medical need. Under the designation, companies are provided with development and commercial incentives for designated compounds. The company's DNX-2401 program has already been granted fast track status. The FDA's orphan drug program designates a special status to drugs and biologics intended to treat, diagnose, or prevent diseases and disorders that affect fewer than 200,000 people in the U.S. It can be easier to gain marketing approval for drugs with orphan status, and orphan drugs typically also enjoy extended marketing exclusivity periods. 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. Virus replication amplifies the input dose of the oncolytic virus and helps spread the agent to adjacent tumor cells. Moreover, there is evidence for a long-lasting anti-glioma immune effect that can lead to durable tumor destruction and long-term survival in some patients. DNX-2401, which has been engineered to be highly potent and selective for killing tumors, is currently being evaluated in clinical studies in the United States and Europe.

DNAtrix, Inc. Announces Treatment Of First Patient with DNX-2401 in Recurrent Glioblastoma Trial

DNAtrix, Inc. announced that the first patient was treated with the company's product, DNX-2401, a replication competent adenovirus plus gamma interferon in a randomized, multicenter, open-label Phase Ib study for patients with recurrent glioblastoma. 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.

FDA Grants Fast Track Status to DNAtrix Drug DNX-2401 For Recurrent Glioblastoma

DNAtriX, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track status for its lead product, DNX-2401, a replication competent adenovirus, for patients with recurrent gliobastoma. The FDA gives Fast Track status to facilitate the development of new products for serious or life-threatening conditions which 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.

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