SAN MARINO, Calif., April 4, 2013 /PRNewswire/ -- VG Life Sciences, Inc. (OTC Pink: VGLS), a biotechnology company focused on leveraging its innovative platform technologies for the discovery and development of drug therapies for cancer, infectious disease, and inflammation, announced today positive results from stage two of its Pre-IND Phase I Study to test tolerability and toxicity in patients with advanced stage solid tumors. The study, which is ongoing in patients with refractory or relapsed solid tumors, examines the safety and efficacy of hydroxychloroquine (HCQ), developed with VGLS' proprietary metabolic disruption technology (MDT), in combination with sorafenib (marketed as Nexavar®), which was co-developed by Bayer AG and Onyx Pharmaceuticals.
Haig Keledjian, CEO of VG Life Sciences, said, "We are happy to report we attained the safety endpoints we anticipated for our second cohort of patients. Similar to the positive results we announced previously for our first patient cohort, no significant toxicities were observed at a higher dose of HCQ in combination with sorafenib. We have begun enrolling patients into the next dosing cohort in this dose-escalation study and look forward to reporting those results in a timely fashion. We anticipate patient recruitment to accelerate since opening up the enrollment criteria to include patients with breast, colon, lung, liver, pancreatic, and ovarian cancer, and look forward to an ultimate study completion date, from a safety standpoint, of third quarter 2013."
Dr. Tyler Curiel, gynecological oncologist at the Cancer Therapy & Research Center in San Antonio, TX, and principal investigator for the trial said, "Having successfully finished enrollment in cohort two, we have begun treating patients in the third cohort. The safety of our patients is paramount and these results give us the needed information so that we can continue advancing in this next cohort. The purpose of this study is to establish the safety profile and determine appropriate doses of this combination of anti-cancer drugs."
The trial is supported by a donation from the Scott and White Foundation.
Details on the Phase 1 study protocol can be downloaded from VG Life Sciences' website and viewed here. Additional information on the trial can be found at www.clinicaltrials.gov
About VG Life Sciences, Inc.
Founded in 1994, San Marino, California-based VG Life Sciences, Inc. is a biotech company researching treatments for drug-resistant cancer, Lyme disease, Strep, Staph and Sepsis, and HIV/AIDS. The company's current drug candidates are based on two exclusively licensed platform technologies: Metabolic Disruption (MDT) and Targeted Peptides (TPT); and are covered by the company's portfolio of more than 60 patents. A physician-initiated Phase I clinical trial of VG Life Sciences' MDT compound in combination with Nexavar is ongoing at the Cancer Therapy and Research Center of The University of Texas Health Science Center at San Antonio in patients with refractory or relapsed solid tumors. For more information, visit www.VGLifeSciences.com.
A majority-owned subsidiary, VG Energy (www.vgenergy.net), is dedicated to exploring biofuel and agricultural applications for the MDT platform.
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.
VG Life Sciences Contact:
Haig Keledjian, Founder, CEO & President
For Investors & Media:
Tiberend Strategic Advisors, Inc.
Joshua Drumm, Ph.D. / Andrew Mielach
SOURCE VG Life Sciences, Inc.