FDA Approves Clinical Trials Of Rexin-G For Breast Cancer And Sarcoma
Epeius Biotechnologies Corporation announced the expansion of ongoing clinical trials using Rexin-G to include breast cancer and all types of sarcomas that have failed standard chemotherapy.
Following on the heels of their landmark clinical trials in the United States and abroad, the US FDA granted Orphan Drug Status for Rexin-G for the treatment of pancreatic cancer while the Philippine BFAD granted Expanded Access Use of Rexin-G for the treatment of all chemo-resistant solid tumors.
Rexin-G is the world's first tumor-targeted nanomedicine -- a targeted gene delivery system that seeks out and destroys both primary tumors and metastatic cancers that have spread throughout the body. Delivered by simple intravenous infusion, Rexin-G has demonstrated unprecedented single-agent efficacy against a broad spectrum of solid tumors where chemotherapy, radiotherapy and other targeted therapies have failed.
According to Dr. Erlinda M. Gordon, M.D., Medical Director of Epeius, "In advancing these new trials in the United States, we are keeping our promise to the Food and Drug Administration, who originally granted us permission to make Rexin-G available to foreign countries with the proviso that we would "open clinical trials in the United States as soon as practicable." With more than three years of clinical experience with Rexin-G in an increasing number of otherwise intractable cancers in the Philippines, Japan and the US, we have gained valuable insights into the general safety, optimal dosing parameters, and best treatment regimens that provide the greatest benefits for the cancer patient without compromising safety. In addition, we have brought the formulation of Rexin-G to its highest clinical potency, enabling treatments of only two or three simple infusions per week."
The clinical trials of Rexin-G for breast cancer and sarcoma will initially be centered in San Marino, CA, where Epeius Biotechnologies Corp. has its headquarters, and in Santa Monica, CA at the Sarcoma Oncology Center. Dr. Sant P. Chawla, M.D., who trained at the University of Texas M.D. Anderson Cancer Center, is a renowned expert on malignant sarcomas, and has agreed to serve as Principal Investigator (PI) for both clinical trials. With the global demand for Rexin-G increasing, Epeius is actively engaged in the development of additional trials and the establishment of treatment centers in the United States and around the world.