SANTA BARBARA, Calif.,
June 16, 2015 /PRNewswire/ --
Dear Shareholders,
Here at VG Life Sciences (OTC-QB: VGLS), our mission is to save
and improve lives through the development of transformative
treatments for cancer, infectious diseases, and the chronic
inflammation intrinsic to autoimmune diseases. We have made
significant progress in a number of areas in the first half of
2015. We'd like to update you on our accomplishments.
Intellectual Property
Our intellectual property, a portfolio of over 40 U.S. and
foreign patents and/or pending patent applications, is our primary
asset. Earlier this year, that portfolio was strengthened with
important new additions.
The U.S. Patent and Trademark Office (USPTO) issued a
composition-of-matter patent covering methods for modulating immune
system function through the targeting of CLIP (Class II-associated
invariant chain peptide), which plays a key role in chronic
inflammation and autoimmune diseases, including HIV/AIDS,
hypertension, preeclampsia, and traumatic brain injury. U.S.
Patent No. 8957031 covers the targeted peptide technology
underlying VGLS's VG1177, a synthetic peptide that has the ability
to displace CLIP and block its harmful effects.
The USPTO also issued U.S. Patent No. 8906846, covering a method
of treating inflammatory bowel disease (IBD). Over a million
Americans have IBD and as of now are not medically curable.
The USPTO advised VGLS that it is issuing a use patent on the
company's hydroxychloroquine (HCQ)/sorafenib combination
cancer treatment. VGLS is currently sponsoring clinical
trials at the University of Texas using
this combination treatment.
We also renegotiated an institutional licensing agreement with
Scott & White Healthcare for the rights to certain tangential
intellectual property. During those negotiations, our
auditors required us to report that we withheld payment to Scott
& White; shortly thereafter, a new agreement was executed, and
we are current on all payments.
Research
As reported previously, we have completed our Phase 1 clinical
trial conducted at the Cancer Therapy & Research Center at the
University of Texas Health Science
Center at San Antonio. This trial
involved patients with solid tumors and examined the safety and
efficacy of HCQ in combination with sorafenib (marketed as
Nexavar®), co-developed by Bayer AG and Onyx Pharmaceuticals.
In Phase 1, tumor reduction and stabilization was shown in a
number of patients in the third and fourth cohorts, all of whom had
higher doses of the combination therapy. The design of this
clinical trial allowed us to conclude that these positive effects
can be attributed to the combination therapy and not sorafenib
alone.
We are currently working with the University of Texas on the design and funding of
the next phase of this important clinical trial.
Meanwhile, research has continued at our laboratory at
Texas A & M University under the
direction of VGLS Chief Scientist M. Karen
Newell-Rogers, PhD. Collaborating with research
scientists from leading institutions around the country, Dr.
Newell-Rogers is actively pursuing applications of VG1177 in
autoimmune diseases and chronically inflammatory conditions.
For the past 18 months, the Company has been conducting animal
safety studies with our patented peptide VG1177, which is a
significantly longer investigation than anticipated. In those
studies, we have been unable to develop a proper dose response
curve using direct and indirect methods for measuring peptide
exposure in vivo.
Examples of the indirect methods we have used included a mouse
epileptic seizure model (Theiler's virus model) at the University of Utah and a rheumatoid arthritis rat
model at Bolder BioPATH Laboratory in Colorado. Neither study
generated the information necessary to develop a dose response
curve.
Thus, we have implemented our chemist's recommendations and
modified VG1177 to increase its stability, while also improving its
tolerability and solubility. These peptide modifications are not
expected to alter VG1177's biological activity.
After completing the modifications, we began conducting
validation studies at our laboratory at Texas
A & M University. We expect these studies to conclude in
2016. When they are completed, we intend to resume animal safety
studies at ITV Laboratories in Canada. The animal safety studies are the next
important step toward clinical trials.
Concurrently, we will continue using the original sequence of
VG1177 in vivo and in vitro as a valuable tool to
research the role of CLIP and invariant chain peptide in autoimmune
and chronic inflammatory conditions.
Financial
In 2Q 2015, VGLS received a commitment of an additional
$600,000 secured with convertible
debentures and a further revolving line of credit from MedBridge
Development LLC to meet our financial requirements.
For the remainder of 2015, we will complete the validating
studies for our VG1177 modifications, restart the animal safety
studies and expand our cancer clinical trial at the University of
Texas. Meanwhile, we will keep you updated with the latest
news and exciting developments through company press releases.
Be well,
John P. Tynan
President & CEO
VG Life Sciences, Inc.
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, inflammatory disease, and
autoimmune disorders. VGLS controls over 40 U.S. 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 Inc. or any other person that
the objectives and plans of VG Life Sciences will be achieved.
Contact:
Terri Somers
Somers Media
Phone: (619) 991-2369
Email: tsomers@somersmedia.com
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SOURCE VG Life Sciences, Inc.
