SANTA BARBARA, Calif., March 14, 2014 (GLOBE NEWSWIRE) -- 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.
The study reported two clinical responses in cohort 3 with 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. The final patient in cohort #3 has stage IV (metastatic) adenocarcinoma of the lung. The four (4) separate lung lesions have all regressed about 20%.
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 university's Data Safety Monitoring Committee (DSMC) has approved expansion to cohort #4. In the final cohort, the trial is at maximum sorafenib plus maximum HCQ. Cohort #4 has enrolled the first 3 patients and thus the conclusion of the study could be in about 60 – 90 days.
The total daily dosing for this escalation trial is as follows:
| Cohort # | Sorafenib | HCQ |
| 1 | 400 mg | 200 mg |
| 2 | 600 mg | 200 mg |
| 3 | 800 mg | 200 mg |
| 4 | 800 mg | 400 mg |
"The clinical outcomes in cohort #3 are very encouraging," said John Tynan, President and CEO of VG Life Sciences, Inc. "We are looking forward to seeing the results in cohort #4 with maximum dosing."
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.
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.