SANTA BARBARA, Calif., Sept. 4, 2014 (GLOBE NEWSWIRE) -- VG Life Sciences, (OTC Pink: VGLS) a biotechnology company, announces today 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."
This study is being conducted at the Cancer Therapy & Research Center at the University of Texas Health Sciences Center at San Antonio. The study 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.
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 A third patient was withdrawn from the study for unrelated infection.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.
Dr. Curiel is also encouraged by the reduction of certain inflammatory mediators that can promote tumor progression and make them refractory to standard treatments.
"The overall study is taking longer than we anticipated but for a good reason, the patients are tolerating maximum dosage which is the primary goal of a phase I study. We attained the safety endpoints for the study and we have encouraging disease stabilization reports," said John Tynan, President and CEO of VG Life Sciences Inc.
"In addition we are particularly interested in the observation that the combination can potentially reduce inflammation and look forward to exploring this in future studies. This has implications to our targeted peptide technology and our drug VG1177 currently in pre-clinical animal safety trials at ITR Laboratories in Montreal," said Tynan.
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.
The trial is supported in part by a donation from the Scott and White Healthcare Foundation.
About VG Life Sciences Inc.
Santa Barbara, California-based VG Life Sciences Inc., formerly known as Viral Genetics, is a biotechnology company focused on discovering and developing drug therapies for cancer, infectious disease, and inflammatory, autoimmune disorders. VGLS controls over 50 US and international patents and pending patents protecting its exclusive biotech platform technologies.
For more information and upcoming events, visit www.vglifesciences.com or find VG Life Sciences Inc. on Facebook, Twitter, and LinkedIn.
Safe Harbor Statement and Forward-Looking Statements
This news release may contain forward-looking statements that involve risks and uncertainties associated with financial projections, milestone timelines, clinical development, regulatory approvals and other risks described by VG Life Sciences from time to time in its periodic reports. None of VG Life Sciences' drug compounds are approved by the US FDA or by any comparable regulatory agencies elsewhere in the world. Therefore, there can be no assurance that the forward-looking statements included in this release will prove to be accurate. In light of the significant uncertainties inherent in the forward-looking statements included herein, the forward-looking statements should not be regarded as a representation by VG Life Sciences or any other person that the objectives and plans of VG Life Sciences will be achieved.