5/13/2014 10:33:11 AM
SANTA BARBARA, Calif., May 13, 2014 (GLOBE NEWSWIRE) -- VG Life Sciences Inc. releases a Q1 2014 Shareholder Update Letter:
May 13, 2014
Here at VG Life Sciences, our goal is to move our revolutionary drug from the research laboratory, to pre-clinical studies, to clinical trials and to market expeditiously. The path is clear and we are working ever harder to increase your shareholder value. This is a company update since the beginning of the year.
For the past four months we have been working with our independent auditors, our accounting firm and our law firm to complete our audit. The company has not had the funds with competing budget demands and available capital to have an audit completed since 2006. The audit through December 31, 2013 is now complete and will be filed with the SEC with our Form 10 filing.
The audit gives the company transparency to the financial community and to you our shareholders and it allows us to initiate the necessary steps file Form 10 with the SEC to relist the company from the Pink Sheets to an OTC market composed of audited public companies. This should help facilitate trading of our stock.
You will notice on our financials an Accumulated Deficit of $99,779,313. This is not unusual for a biotech company coming out of its research phase. As the company moves to market and revenues, this carry forward will be used against those revenues to lessen our tax obligations as permitted by the IRS.
In the last year since our management involvement in the company we have increased its market capitalization by almost ten times. Our goal is to aggressively continue that growth.
The centerpiece of our drug platform is our patented peptide VG1177 (Patent No: US 8,557,764). The VG1177 peptide prevents the survival of pro-inflammatory cells under conditions where inflammation is unwanted, thereby allowing the body's natural containment systems to provide protection from harm.
We have completed a pre-investigational new drug (IND # 110820) meeting with the FDA and started preclinical work in November 2013 with our animal safety and toxicity study, a requirement before human clinical testing can commence. This work is being completed by ITR Laboratories in Montreal, Canada. At the advice of our biotech expert Chrysalis Pharma Partners, LLC, we have expanded the scope of the study to include a pharmacodynamics (PD) model and thus completion is now anticipated for October (versus July) of this year.
At the same time we are continuing research at our laboratory at Texas A & M under the direction of VG Life Sciences' Lead Scientist, Dr. M. Karen Newell Rogers, PhD. Collaborating with research scientists from institutions around the country Dr. Newell is actively researching applications of VG1177 in the following diseases:
Equally exciting is Dr. Newell's metabolic disruption technology (MDT) which offers an innovative approach for oncology. This is covered under our US patent application number 12/918741 and other US and international patent applications.
Cancer tumors have a "greed" for glucose, and the selective use of amino acids, and/or fatty acids as sources of energy. MDT disrupts the pathways involved in the cancer cell's ability to meet those survival requirements. Therefore, the cancer cells become more vulnerable to other cancer treatments.
MDT is currently in a Phase I Clinical Trial at the University of Texas. As previously reported, the trial is in the fourth and final cohort which is testing the maximum dosing. This study centers around the effect of MDT compound hydroxychloroquine (HCQ), combined with an existing cancer drug, sorafenib (marketed by Bayer as Nexavar™). While a Phase I's purpose is to test for human toxicity, there have been encouraging signs of efficacy as previously reported.
VG Life Sciences is in discussion with the University of Texas regarding the feasibility of expanding the study into a Phase II. This could start later this year. This would involve using combination therapy dosing over a 1 year period to test for efficacy.
Intellectual Property (IP)
Finally, our primary asset is our intellectual property and we must sacredly guard this impressive portfolio. To do that the company has a long relationship with one of the country's best IP attorneys in Wolf, Greenfield & Sacks, P.C. in Boston They advise us on over 40 US and international patents and patent applications. Over the past 9 months we have careful scrubbed all our intellectual property with our attorneys to make sure our applications, fees and filings are current and prioritized. Thus I can report that our IP is in order.
I would like to thank all our colleagues here at VG Life Sciences, our researchers and institutions across the country, our experts in law, securities, IP and accounting and you - our investors. As we continue to move through 2014, we will keep you informed of our progress.
John P. Tynan
President & CEO
VG Life Sciences, Inc.
Allison Trabucco, Corporate Communications
VG Life Sciences, Inc.
Phone: (805) 879-9000
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