VG Life Sciences (OTC Pink: VGLS) reports details of the successful completion of the first stage of its Phase I Trial to treat ovarian cancer. The study examines the safety and efficacy of one of VG Life Sciences’ MDT compounds, hydroxychloroquine (HCQ), in combination with an existing cancer drug, sorafenib (marketed as Nexavar™), which was co-developed by Bayer AG and Onyx Pharmaceuticals.
Haig Keledjian, the Company’s CEO, said, “Effective treatment options are urgently needed for patients suffering from ovarian cancer and we are excited to have achieved the safety results we expected from our first set of patients. As detailed in our press release of July 19th, 2012, there are three phases of this safety and efficacy study. The first stage, just completed, focused on the safety dosages, and all indications came in exactly as expected when designing the protocol. Patient safety is paramount throughout this level of study, and Phase II trials cannot commence, unless acceptable levels of safety are revealed in Phase I. These just completed results enable the Trial’s primary investigator, Dr. Tyler Curiel, to proceed to the second set of patients, the screening for which has already commenced.”
Mr. Keledjian also noted, “Success at this phase of this ovarian cancer trial has enabled us to expand our studies to all hard tumors, and we are also initiating additional preIND Phase 1 trials for breast, colon, lung, liver, and pancreas tumors.”
Upon successful completion of the second stage of testing, a third group of patients will be enrolled. A total of four sets of patients (stages) will be studied, each of which will have up to 6 patients. Presuming low levels of toxicity following dosing, additional patients will be added and higher doses of the combination will be given up to a pre-specified maximum dosage level.
Ovarian cancer is a particularly deadly form of the disease afflicting approximately 20,000 women each year in the United States. Amongst women, it is the most lethal of the gynecological cancers and the fifth leading cause of cancer death.
Nexavar is already approved to treat liver and kidney cancer in more than 100 countries, with peak sales of approximately $993 million a year.1
The trial is supported by a donation from the Scott and White Foundation. Scott and White Healthcare recently announced an agreement to combine its operation with Baylor Healthcare to create a single $7.7 billion healthcare organization. The new system, to be known as Baylor Scott & White Health, will include the organizations’ combined 42 hospitals, more than 350 patient care sites, more than 4,000 active physicians, and 34,000 employees.
As with all clinical trials, the study can be stopped in the event of significant adverse events, including toxicity. Treatment will generally continue for as long as toxicity results remain within acceptable limits and patients experience clinical benefit.
Details on the protocol can be downloaded from the company site and viewed here.
About VG Life Sciences Inc.
San Marino, California-based VG Life Sciences Inc., formerly known as Viral Genetics, discovers and develops drug therapies from two exclusively licensed platform technologies based on over 60 patents: Metabolic Disruption (MDT) and Targeted Peptides (TPT). A physician-initiated Phase I clinical trial of an MDT compound in combination with Nexavar™ on Stage III and IV ovarian cancer patients is ongoing at the Cancer Therapy and Research Center of The University of Texas Health Science Center at San Antonio. A majority-owned subsidiary, VG Energy (www.vgenergy.net), is dedicated to exploring biofuel and agricultural applications for the MDT platform. Founded in 1994, the biotech company is researching treatments for drug-resistant cancer, Lyme disease, Strep, Staph and Sepsis, and HIV/AIDS. For more information, visit www.viralgenetics.com.
About Baylor Health Care System
Baylor Health Care System is a not-for-profit, faith-based supporting organization providing services to a network of acute care hospitals and related health care entities that provide patient care, medical education, research and community service. Baylor recorded more than 2.8 million patient encounters, $4 billion in total operating revenue, $5.2 billion in total assets and $502 million in community benefit in fiscal year 2011 (as reported to the Texas Department of State Health Services). Baylor’s network of more than 300 access points includes 30 owned/operated/ ventured/affiliated hospitals; joint ventured ambulatory surgical centers satellite outpatient locations; senior centers and more than 180 HealthTexas Provider Network physician clinics. For more information, visit www.baylorhealth.com.
About Scott & White Healthcare
Scott & White Healthcare is a non-profit collaborative health care system established in 1897 in Temple, Texas. Among the leading health systems encompassing one of the nation's largest multi-specialty group practices, Scott & White provides personalized, comprehensive health care enhanced by medical education and research. Scott & White Healthcare includes 12 hospital sites with two additional announced facilities, and 178 clinics at more than 65 clinic locations throughout Central Texas providing adult and pediatric care in 46 medical specialties. Integrated, high-quality care is delivered by a dedicated staff of more than 14,000 (including 1,000 employed physicians and scientists and more than 300 advanced practice providers). For more information, visit www.sw.org.
SAFE HARBOR FOR FORWARD-LOOKING STATEMENTS:
This news release contains forward-looking statements that involve risks and uncertainties associated with financial projections, budgets, milestone timelines, clinical development, regulatory approvals, and other risks described by VG Life Sciences from time to time in its periodic reports, including statements about its VG Energy, Inc. subsidiary. None of VG Life Sciences’ drug compounds are approved by the US Food and Drug Administration or by any comparable regulatory agencies elsewhere in the world, nor are any non-pharmaceutical products of VG Energy, Inc. commercialized. While VG Life Sciences believes that the forward-looking statements and underlying assumptions are reasonable, any of the assumptions could be inaccurate, including, but not limited to, the ability of VG Life Sciences to establish the efficacy of any of its drug therapies in the treatment of any disease or health condition, the development of studies and strategies leading to commercialization of those drug compounds in the United States, the obtaining of funding required to carry out the development plan, the completion of studies and tests on time or at all, the successful outcome of such studies or tests, or the successful commercialization of VG Energy, Inc.’s non-pharmaceutical products. 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.
1 Source: BayerAG annual report, 02/28/12