Back in April, BioNews Texas reported on positive safety results for California-based VG Life Sciences‘ Phase I study of its promising anti-cancer drug, which were conducted at The University of Texas Health Science Center in San Antonio (UTHSCSA). Since that time, continued Phase I testing of Physician-IND for tolerability and toxicity of its patented technology in patients with advanced stage solid tumors has revealed more positive results.
The study’s primary investigator, medical oncologist Tyler Curiel, M.D., MPH is leading the Phase I testing of the drug, which is based on the research of Dr. M. Karen Newell-Rogers, PhD VG Life Sciences, Inc.’s Chief Scientific Advisor. The study seeks to determine “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,” according to a company press release.
Thus far, the study has revealed two noteworthy results in its 3rd cohort: one patient with metastatic ovarian cancer experienced disease stabilization for 4 months, while another with triple negative breast cancer saw disease stabilization into the 5th month of treatment. 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.
The concept behind VG Life Sciences, Inc.’s research centers on the theory that 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.