VG Life Sciences, Inc., (OTCQB: VGLS), a biotechnology company developing therapies for cancer, autoimmune and infectious diseases, announced that the U.S. Patent and Trademark Office (USPTO) will issue Patent No. 9073985 covering VGLS' combination therapy for treating drug-resistant cancer by combining an autophagy inhibitor with a chemotherapy drug.
In addition, the USPTO will extend the term of the patent an extra 684 days to account for the time taken to process the application.
"This patent strengthens and broadens VGLS' intellectual property that has already been translated into promising results during Phase I clinical trials in which the combination therapies were shown to be safe and tolerable, while also showing tumor size reduction and stabilization in patients with metastatic cancers," said John Tynan, VGLS Chief Executive.
Since cancer cells rapidly divide, they have very high energy demands. They employ unique mechanisms to meet these demands, mechanisms not found in healthy cells. VGLS' technology targets those pathways that the cells may use to fuel themselves, inhibiting autophagy.
Hydroxychloroquine, the inhibiting compound used in the combination therapy, disrupts the cancer cells' metabolic strategies, weakens their repair functions, slows their growth and makes them more sensitive to the chemotherapy drugs.
VGLS has completed a Phase I clinical trial of the combination therapy at the Cancer Therapy & Research Center at the University of Texas Health Sciences Center at San Antonio. The trial involved patients with solid tumors and examined the safety and efficacy of Hydroxychloroquine in combination with sorafenib (marketed as Nexavar®) co-developed by Bayer AG and Onyx Pharmaceuticals.
Primary investigator and medical oncologist Dr. Tyler Curiel, M.D., M.P.H., reported: "There are sufficient evaluable patients to conclude that this combination, maximum dose, and schedule are sufficiently safe for additional clinical testing. In addition, the study found tumor reduction and stabilization in a number of patients in the third and fourth cohorts who had higher dosing."