Our Targeted Peptide Technology(TPT) targets a subpopulation of pro-inflammatory immune cells and presents a possible treatment for immune-mediated conditions.
Our Targeted Peptide Technology(TPT) targets a subpopulation of immune cells behind some autoimmune diseases, presenting a possible treatment. Our current, second generation TPT compound is called VG1177.
Autoimmune diseases occur when the immune system attacks the body’s own cells, mistaking them for pathogens. In some cases, this confusion can arise from an initial infection, where the pathogen possesses antigens similar to self-tissues. Additionally, the immune system can be activated non-specifically, that is, it mounts an inflammatory response without a target. When non-infected, healthy self-cells are inappropriately targeted by the immune system, the resulting conditions, effects, and symptoms are termed chronic inflammatory and autoimmune diseases.
“We expect our TPT drug compounds to enable the body to destroy the cells that may underlie autoimmune diseases.”
Certain molecular patterns, antigens, are displayed on all cell surfaces and allow the immune system to distinguish self from non-self cells as well as healthy cells from infected cells. When a cell displays a non-self molecular pattern, that pattern both alerts the immune system to the presence of pathogen(s) and provides an identity of the pathogen(s). This recognition initiates an immune response: acute inflammation followed by targeted destruction of invaders and of compromised self-cells.
Certain cells in the body ingest foreign, damaged or infected cells and then display a receptor on the cells surface, the MHC-II receptor (Major Histocompatibility Complex II). The MHC-II receptor allows other immune cells, such as T-cells, to identify the foreign, damaged or infected cell and cause the cell’s death, eliminating the threat and stopping the immune response.
Our research indicates that the self-peptide CLIP (Class II-associated invariant chain peptide),, can be displayed on external MHC-II receptors, preventing T-cells from recognizing an antigenless MHC-II receptor and thus preventing T-cell mediated apoptosis of antigen-presenting cells. This disruption may prolong a non-specific immune activation, leading to chronic inflammation. Our research also indicates that these CLIP+ immune cells have increased pro-inflammatory characteristics; thus, CLIP prolongs the activity of pro-inflammatory cells.
Current therapies that combat these immune disorders generally focus on eliminating pro-inflammatory cells and/or their pro-inflammatory signals. Such therapies may be non-specific and immunosuppressive, weakening a patient’s ability to fight secondary infections.
We believe we have produced a peptide therapy by computational binding affinity models that may selectively eliminate certain pro-inflammatory B-cell and T-cell subsets that may play a key role in inflammatory and autoimmune conditions. As the peptide is narrow in its target, it may avoid drawbacks characteristic of current therapies.
TPT, in a general sense, is related to discovering pro-inflammatory receptor-mediated pathwaysand designing peptides that augment receptor function. These peptides were designed to function in all MHC-II phenotypes We expect our TPT compounds to enable the body to destroy the cells that help trigger autoimmune diseases.
We also believe that various other conditions, such as traumatic brain injury, hypertension, preeclampsia, glioblastoma, Type I and Type II diabetes, Lyme disease, Crohn’s disease, ulcerative colitis, lymphedema, staphylococcus, streptococcus, and sepsis infection, multiple sclerosis, transplant rejection, and Pediatric Autoimmune Neuropsychiatric Disorders (PANDAS) may be treatable using TPT.
Our MDT compounds disrupt tumor cells’ ability to meet their increased energy requirements, therefore sensitizing cancer cells to other treatments.
Our Metabolic Disruption Technology, or MDT, covers a group of compounds that can be combined with existing treatments to fight drug resistant cancers. MDT compounds sensitize cancer cells to treatment by disrupting the metabolic strategies those cells use to survive.
Every cell in the body uses carbohydrates, proteins, or fats in different proportions to gain sufficient energy. The cell’s distinct fuel proportion, its metabolic strategy, depends upon its activation state, differentiation state, as well as the extracellular environment.
Since cancer cells rapidly divide, they have very high energy demands. As such, tumor cells employ unique mechanisms to meet demand, mechanisms not found in healthy cells; these pathways could be targets for novel therapies. Specifically, we have targeted glucose and lipid consumption, as well as inhibiting autophagy. Our research indicates that metabolic disrupting agents prevent sufficient energy generation, weakening the tumor cells’ repair functions, slowing growth, and overall resulting in statistically significant susceptibility to common standards of care.
Our in vitro and in vivo research indicates that MDT compounds can interfere with both drug sensitive and multi-drug resistant cancer cells. The MDT treatments demonstrate a lack of toxicity and impressive therapeutic activity, activity that is synergistic when used with standards of care, even with drug-resistant tumor cells.
“…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.”
Doctors at Scott & White Healthcare in Temple, Texas, and the Cancer Therapy and Research Center at the University of Texas at San Antonio, are conducting a Phase I Physician’s IND trial, for patients with solid tumors utilizing an MDT compound, called hydroxychloroquine, in combination with an existing cancer drug, called sorafenib, which is marketed as Nexavar®.
MDT Compound for Drug Resistant Cancer called Hydroxychloroquine
Hydroxychloroquine is a MDT compound that can be used in combination with other cancer drugs, such as sorafenib, which is marketed as Nexavar ®, to treat drug resistant cancer. We hold a license to a pending patent application for the combination treatment. Our Physician-IND Phase I Study is testing the tolerability and toxicity of our patented technology in patients with advanced stage solid tumors. The study, which is ongoing in patients with solid tumors that do not respond to treatment or have returned after a period of improvement, examines the safety and efficacy of hydroxychloroquine, or HCQ, in combination with sorafenib, marketed as Nexavar®, which was co-developed by Bayer AG and Onyx Pharmaceuticals. Our MDT trial was initially only approved for ovarian cancer, but has expanded to include other solid tumors, including those located in the breast, colon, liver, lung, and pancreas.
The study is designed with four cohorts, three cycles of administration in each cohort and four different patients in each cohort. Thus there are 16 total patients targeted to complete the trial. Sorafenib and HCQ are FDA approved and thus the study is testing the drugs in combination for safety and toxicity.
As a Physician’s IND Phase I study, the investigators are primarily testing for safety, but are also monitoring for efficacy in reducing tumor mass or stunting tumor growth.
- No patients have been dropped from the study for toxicity.
- The primary investigator reported two clinical responses in cohort number 3 with four months of disease stabilization in a patient with metastatic ovarian cancer, which has spread throughout portions of the body, and five months of disease stabilization in a patient with triple-negative breast cancer, which is a type of cancer that does not express three genes that are key to traditional cancer treatment, making treatment more difficult.
- The final patient in cohort number 3 has stage IV, or metastatic, adenocarcinoma of the lung, which is a common form of lung cancer, and has four separate lung lesions. During the course of the study, the four lesions have all regressed about 20% in size.
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 Dr. Tyler Curiel, M.D., MPH and is based on the research of Dr. M. Karen Newell-Rogers, PhD, our Chief Scientific Advisor. In March 2014, the University of Texas Data Safety Monitoring Committee approved an expansion to cohort number 4. In the final cohort, the trial is at maximum sorafenib plus maximum HCQ. Cohort number 4 has enrolled the first 3 patients.
VG Life Sciences is in discussion with the University of Texas regarding the feasibility of expanding the study into a Phase II or an extended Phase I P-IND. This would involve using combination therapy dosing over a 1 year period to test for efficacy.
Make an Investment
Opportunities for purchasing stock in VG Life Sciences exist currently through traditional and discount brokerages, such as Charles Schwab, Scottrade, E*TRADE, TD Ameritrade, Fidelity, Merrill Edge, ShareBuilder, and more. Additional opportunities exist for institutional and accredited investors to support key phases of VG Life Sciences’ TPT and MDT pre-clinical and clinical trials.
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SEC Filings & Disclosures
On June 20, 2014, the company filed a Form 10-12G with the Securities and Exchange Commission and, as of August 19, 2014, is required to make ongoing disclosures and reports under the SEC’s online EDGAR system including annual and quarterly reports on Form 10-QSB or Form 10-KSB, as well as Current Reports on Form 8-K. The company responded to SEC comments on September 10, 2014 and October 1, 2014. The company cleared SEC comments on October 14, 2014.
Previously, on March 25, 2009, the company filed a Form 15 with the Securities and Exchange Commission terminating its reporting obligations under Section 12(g) of the Securities Exchange Act of 1934. As a result, the company was no longer eligible or required to make ongoing disclosures and reports under the SEC’s online EDGAR system including annual and quarterly reports on Form 10-QSB or Form 10-KSB, as well as Current Reports on Form 8-K. The company addressed this gap in disclosure by making disclosures under the OTCIQ service.
SEC filings on EDGAR are available; however, investors should also consult the company’s disclosures made on the OTCIQ system (see below) and the company’s standard press releases.
Stock Information (As of September 26, 2014)
|Issued and Outstanding Common Shares||30,320,628|
|Authorized Common Shares||150,000,000|
|Issued and Outstanding Preferred Shares||9,715,443|
|Authorized Preferred Shares||20,000,000|