VG Life Sciences, Inc.'s Reports on Clinical Outcomes in Phase I Cancer Study
March 14 2014 - 6:06AM
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.
CONTACT: Allison Trabucco
Corporate Communications
(805) 679-6786
atrabucco@vglifesciences.com
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