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VG Life Sciences Reports Positive Results from First Stage of Ovarian Cancer Clinical Trial Using Sorafenib (Nexavar) Combined with Hydroxychloroquine
SAN MARINO, Calif. --(Business Wire)--
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 healthcareorganization. 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 (News - Alert): BayerAG annual report, 02/28/12

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