RestorGenex Corporation and Diffusion Pharmaceuticals have formed a merger agreement under which a newly formed subsidiary of RestorGenex will merge with and into Diffusion, which will become a wholly owned subsidiary of RestorGenex.

The current directors and executive officers of RestorGenex will resign from their positions and the combined company will be under the leadership of Diffusion’s current executive management team with David Kalergis serving as chief executive officer. The corporate headquarters of the combined company will be located in Charlottesville, VA, and the combined company will be renamed Diffusion Pharmaceuticals Inc.

The merger will create a clinical-stage company with a diversified development portfolio of product candidates addressing novel targets in oncology, including several orphan indications. Initially, the combined company will be focused on the development of Diffusion’s lead molecule trans sodium crocetinate (TSC). TSC has received orphan drug designation for the treatment of glioblastoma multiforme (GBM) and expects to enter a Phase III study in newly diagnosed GBM patients in 2016. Future development of TSC includes other orphan indications such as pancreatic cancer and brain metastases. TSC’s novel mechanism of action enhances the diffusion of oxygen to cancerous tumors, improving the effects of cancer treatments such as radiation therapy and chemotherapy.

“We have chosen to combine with Diffusion in order to add a clinical-ready product to our oncology portfolio,” said Stephen Simes, RestorGenex’s chief executive officer. “Specifically the key Diffusion product is scheduled to enter a Phase III clinical trial in 2016 thereby accelerating our product development dramatically.”

David Kalergis, chief executive officer, Diffusion Pharmaceuticals, said, “We expect to be positioned to move forward with a pivotal Phase III trial of TSC in newly diagnosed GBM patients, with plans to begin enrollment in 2016.  We also are planning to commence a Phase II/III trial in pancreatic cancer in 2016 with a Phase II/III study in brain metastases to follow.”