SAN MARINO, Calif. and MANILA, Philippines — Epeius Biotechnologies today announced the publication of clinical data from studies conducted at the University of the Philippines, Asian Hospital and Medical Center, Makati Medical Center, Manila, Philippines and Lutheran Medical Center, New York, USA, revealing the safety and single agent efficacy of Rexin-G(TM) for the treatment of a broad spectrum of chemotherapy-resistant cancers.
The milestone article, appearing in this month’s issue of the International Journal of Oncology, reports on 3 clinical studies involving patients with various chemo-resistant tumor types who received Rexin-G in Phase I/II and expanded access protocols. In the first study, progressive tumor reduction and/or necrosis were noted in 83% (n = 6) of patients with advanced or metastatic pancreatic cancer, while in the second study, an objective tumor response was observed in 64% (n = 11) of patients with metastatic breast, colon, uterine, muscle and vocal cord cancer, as well as malignant melanoma.
Median survival after Rexin-G treatment was 10 months in the first study, and greater than six months in the second study. In the third study, wherein an innovative mathematically calculated optimal dose of Rexin-G (designated “Calculus of Parity”) was given to three patients, tumor reduction and/or necrosis were achieved in 100% of patients. Based on these studies, the following conclusions were reached: (i) the functionality of the targeted gene delivery system is profound, (ii) the genetic construct exhibits broad spectrum activity in many resistant tumor types, and (iii) the targeted genetic medicine is exceptionally safe.
The lack of systemic toxicity, taken together with the reduction of tumor burden and the enhanced quality-of-life experienced by patients receiving Rexin-G infusions, constitute meaningful clinical benefits that underscore the need for the expedited development of Rexin-G for pancreatic cancer and, potentially, for all solid tumors.
In a statement to the press, Dr. Frederick L. Hall, President and CEO of Epeius, stated “Whereas logistics had previously stymied the delivery of genetic medicine to target lesions within the human body, intravenous infusions of Rexin-G has stymied intractable cancers without collateral damage to normal organs.”
The results, compiled in these pioneering studies, had convinced the US FDA to grant Rexin-G orphan drug status for pancreatic cancer, and subsequently, to provide federal support to continue clinical trials using Rexin-G in the United States. Further, based on these studies, the Philippine Bureau of Food and Drugs recently granted Rexin-G accelerated marketing approval for the treatment of all chemotherapy-resistant tumor types.
About Epeius Biotechnologies
Epeius Biotechnologies Corporation is a privately held biopharmaceutical company dedicated to the advancement of genetic medicine with the development and commercialization of its proprietary targeted delivery systems. Credited with innovations ranging from oncogene discovery, to designer-gene therapy, to pathotropic (disease-seeking) targeting, to high-performance vector engineering, to advanced GMP and bioprocess development, Epeius Biotechnologies is well positioned to “launch” its enabling platform technologies for the benefit of cancer patients worldwide.
To learn more about Rexin-G and Epeius’ pipeline of proprietary therapeutics currently available for partnership, please visit us at www.epeiusbiotech.com .
[tags]International Journal of Oncology, Epeius Biotechnologies Corporation, orphan drug status for pancreatic cancer, Rexin-G drug vector, biopharmaceutical company, Erlinda Gordon[/tags]
