VG Life Sciences, (OTC Pink: VGLS) a biotechnology company, announces today an update to its Physician-IND Phase I Study to test tolerability and toxicity of its patented technology in patients with advanced stage solid tumors.
This study is being conducted at the Cancer Therapy and Research Center at the University of Texas Health Sciences Center at San Antonio . The primary investigator is medical oncologist Tyler Curiel, M.D., MPH and is based on the research of Dr. M. Karen Newell-Rogers, PhD VG Life Sciences, Inc.'s Chief Scientific Advisor.
The study, which is ongoing in patients with refractory or relapsed solid tumors, examines the safety and efficacy of hydroxychloroquine (HCQ), in combination with sorafenib (marketed as Nexavar®), which was co-developed by Bayer AG and Onyx Pharmaceuticals. VG Life Sciences, Inc. holds the use patent for this combination treatment.
The study is reporting two clinical responses in cohort 3: disease stabilization in a patient with metastatic ovarian cancer for 4 months, and disease stabilization going into its fifth month in a patient with triple negative breast cancer. Further test information and data will be forthcoming.
"This is significant news", said John Tynan, President and CEO of VG Life Sciences, Inc. "The special characteristics of triple negative breast cancer make this unique application noteworthy."
The fourth and final cohort will begin in January which will increase the HCQ dosage from cohort 3. For procedural reasons the start of the final cohort was delayed as previously reported.
VG Life Sciences, Inc.'s research postulates that when the tumor cells' specific energy strategies are interrupted with "metabolic disrupting" agents such as HCQ, the consequences are two-fold: the cancer cells can no longer generate energy needed to survive and the disruption of the intracellular energy levels reduces their ability to repair damage from other cytotoxic agents, resulting in a much greater sensitivity to chemotherapy and radiation.
The goal with this treatment is to weaken the drug resistant cancer cells so that they may be sensitized to other treatments as well as become vulnerable to the body's immune system. Thus, this Physician-IND Phase I Study is an important clinical step to prove this research.