VG Life Sciences announced an update to its physician-initiated IND phase I study to test safety and tolerability of its patented technology in patients with advanced stage solid tumors. Primary investigator and medical oncologist Dr. Tyler Curiel, MD, MPH reported, "the trial has completed enrollment of the final cohort (cohort #4) using the maximum doses of sorafenib (800 mg) combined with hydroxychloroquine (400 mg). There are sufficient evaluable patients to conclude that this combination, maximum dose and schedule are sufficiently safe for additional clinical testing." 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.

Noteworthy in terms of tolerance, two patients in this final cohort are still receiving treatment at maximum drug doses and are in cycle 6, which is encouraging. They will continue with additional cycles until the patients fail according to protocol. A third patient was withdrawn from the study for unrelated infection.

Based on current results, the safety and tolerability of this drug combination at these maximum doses have been established to allow for planned expansion studies in the most promising cancers studied to date with this combination. Based on clinical leads seen thus far, additional testing in patients with sarcomas, non-small cell lung cancer, epithelial ovarian cancer and triple negative breast cancer are being considered.