Funding Scientific Research

Long-time members are keenly aware of the scientific research that Life Extension Foundation® funds to develop validated methods to slow and reverse the aging process.

Less known is Life Extension’s multi-prong program to develop safer and more effective cancer therapies.

One reason we focus so heavily on cancer research is that this dreaded disease represents a roadblock in our ability to develop effective means to combat aging.

At a recent scientific conference in San Francisco, one of our staff researchers (Örn Adalsteinsson, Ph.D.) — along with other oncology experts we fund — presented findings from a breast cancer study where an innovative treatment eradicated 35-50% of metastatic lung and liver lesions in patients who had already failed conventional therapy. The scientists we are collaborating with have never seen a therapy demonstrate this much efficacy in these advanced (stage IV) breast cancer cases. What made this presentation so exciting is the potential of this same therapy to be curative if initiated earlier in the disease process.

In Oklahoma City, the Life Extension Foundation pays to maintain a triple-negative (ER-, PR-, Her2Neu-negative) breast cancer cell line overseen by a researcher named Robert Nordquist, Ph.D. This cancer cell colony enables us to test a wide range of compounds to evaluate their efficacy alone, and in combination with other anti-cancer agents. One compound we have identified in this laboratory improved the cytotoxicity of a standard chemotherapy drug (Adriamycin) by 16 to 20 times. A lethal side effect of Adriamycin is cardiotoxicity that can kill the patient. By enabling a reduced effective dose of Adriamycin to be used, this new compound may enable this chemo drug to cure the cancer while sparing the patient’s heart. We plan to carry out clinical studies to determine the efficacy of this novel combination therapy approach.

The most exciting compound we have tested to date is a chemotherapy drug discovered by oncologist Richard Ishmael, M.D. Unlike conventional chemo drugs that work via one or two mechanisms, this compound interferes with cancer progression in several distinct ways. The significance of this discovery is that cancer cells develop their own survival pathways that circumvent the efficacy of chemo drugs. This is why conventional chemotherapy usually provides only a temporary benefit in those with clinically verified metastatic disease. By blocking cancer cell progression via distinct pathways that tumors use to escape eradication, this drug may provide the cancer patient with a greater chance of attaining a complete response or outright cure.

When tested on the breast cancer cell colony we fund in Oklahoma City, Dr. Ishmael’s compound demonstrated greater cytotoxicity than any other compound the scientists have observed in more than 35 years. This compound is now being tested in a group of mice. If the results are what we expect, the next step will be to test the compound on baboons at a St. Kitts Biomedical Primate Research facility. From there, we expect to initiate investigational new drug (IND) human clinical studies.

The breast cancer cell colony in Oklahoma City has historical precedent in identifying better treatment methods. In 2001 and 2002, for example, poster presentations at prestigious cancer conferences revealed that separating the administration of the conventional chemo drugs gemcitabine and docetaxel greatly improved their cytotoxic effect against breast cancer cells. Move forward to year 2005 and a Phase I/II clinical study showed greater efficacy against a wide range of malignancies when alternating doses of these drugs were given (one week apart), i.e., the response rate was significantly improved compared to giving them together. In 2007, we committed to fund a Phase II clinical study to ascertain the efficacy of administering these two conventional chemo drugs (Gemzar® and Taxotere®) on an alternating week dosing schedule, despite no interest being expressed by pharmaceutical companies that owned the patents of these drugs.

Another drug we are studying in the clinical setting is Gc macrophage activating factor (GcMAF), a compound that has demonstrated complete remissions in patients who participated in two separate trials on breast and prostate cancer. The mechanism of action of GcMAF is activation of the immune system (the macrophages) by the use of the Gc protein which is often referred to as vitamin D binding protein.

The reason GcMAF is not more readily available is that it is difficult and expensive to synthesize. A stage IV lung cancer patient with metastatic lesions in the brain came to us for help in October 2008. Therapy was initiated using conventional drugs (cisplatin and Alimta [pemetrexed]) combined with immune enhancing agents that included Anvirzel and Immune26. GcMAF was later added to this patient’s regimen to provide additional immune support. This patient presented to us with a carcinoembryonic antigen (CEA) tumor marker blood level of 498.2, indicating very advanced disease. After 11 months of treatment, the CEA reading is down to 17.9. The patient is not cured, but has responded remarkably well to this integrative treatment, showing reduced size of cancer lesions. We have extensive detailed records that have been maintained during the entire treatment phase — this includes MRI scans, PET scans, pathology reports, blood tests and reports of gamma knife procedures that have been performed at regular intervals. This patient would likely be dead now if not for the aggressive clinical study program we designed for him.

Immunotherapy is one of the hottest fields in cancer treatment research. A potentially revolutionary cancer therapy was developed over a 10-year period by researcher Dr. Zheng Cui of the Wake Forest University School of Medicine. This approach, which has been highly effective in laboratory animals, is called leukocyte infusion therapy. Dr. Cui found that a subpopulation of white blood cells (granulocytes) is primarily responsible for killing cancer cells. He cured animals with different types of cancer by collecting concentrated numbers of granulocytes from healthy animals and infusing them into animals with cancer. Dr. Cui may have found a generalized principle by which the body’s immune system destroys cancer cells, which can be adapted for use in cancer therapeutics.

The Life Extension Foundation provided initial funding for a phase I/II clinical trial designed to test this new approach (leukocyte infusion therapy) to treating cancer in human cancer patients. Work is progressing on the clinical trial at the South Florida Bone Marrow/Stem Cell Transplant Institute in Boynton Beach, Florida under the direction of Dr. Dipnarine Maharaj.

We are also funding a study at the University of Arkansas Medical Center to study the effects of a generic compound called dicloroacetate (DCA) against lymphoma and triple negative breast cancer cells when used in conjunction with conventional chemotherapy drug combinations.

Cancer is a complex disease that requires a multi-pronged effort to provide the best chances of attaining a cure, remission, or a mere extension of life. Discoveries are occurring in the research setting, but the process by which they are incorporated into clinical oncology practice is excruciatingly slow. Through various clinical research programs we fund, access to novel treatments and state-of-the-art labs that analyze a patient’s cancer profile are expedited. Our costs involved in funding these cancer research programs are significant, but we view the results as well worth the expenditure of our time and financial resources.

Alzheimer’s Disease Clinical Research

More than 5 million Americans are stricken with Alzheimer’s disease today. As the aging population increases, the prevalence will approach 13 to 16 million cases in the United States by 2050. One out of three Americans over age 85 is diagnosed with Alzheimer’s.

A startling scientific breakthrough revealed that a FDA-approved arthritis drug (Enbrel®) may reverse the clinical course of Alzheimer’s disease by blocking an inflammatory chemical (TNF-a) that damages the brain. Alzheimer’s patients who had this drug injected in a way that it was delivered directly to their brains experienced remarkable cognitive improvements within minutes that were sustained for up to three years.

The company that owns Enbrel®, however, has shown no interest in funding research to fully evaluate the effects of this drug as an Alzheimer’s treatment.

Based on the extraordinary preliminary findings, the Life Extension Foundation is funding an expanded study with the objective of measuring the long-term effects of weekly Enbrel® injections plus other compounds that suppress the production of excess TNF-alpha.

Enbrel® is an extremely expensive drug and administering it in a way that delivers it directly to the brain is an intricate medical process. The Life Extension Foundation is funding all the costs of this clinical study on early-stage Alzheimer’s disease patients who reside in the South Florida area. The objective of the research initiative is to validate a method to reverse Alzheimer’s dementia.

Regenerative Medicine Stem Cell Research

One of the most promising new research fields is Regenerative Medicine, in which a variety of biological breakthroughs are being used to regenerate tissues, organs, and vital body systems such as the cardiovascular and immune systems. Regenerative Medicine is at the cutting edge of biomedical research. It is likely to lead to revolutionary therapies to treat the degenerative diseases of aging, severe injuries, and aging itself.

We have come to the conclusion that the most promising field in Regenerative Medicine is the use of human embryonic stem cells (hES) and induced pluripotent stem cells (IPS), which can be derived from differentiated adult cells (such as skin cells). IPS cells are similar or identical to the embryonic cells that develop into mature specialized cells such as neurons, immune system cells (T-cells and B-cells), muscle cells, heart cells, kidney cells, liver cells, and skin cells in every human being. Each specialized type of tissue in the body retains adult stem cells, which help to regenerate and replace dysfunctional and dying cells in our bodies as we grow older. While adult stem cells are essential for maintenance of the body, and are being used increasingly by researchers to develop new therapies, they eventually die out themselves and don’t have nearly the regenerative potential of their younger stem cell counterparts.

We are funding the stem cell research of Michael West, Ph.D., a pioneer in cloning and gerontology research through BioTime, the company that he runs. BioTime is a public company whose technologies include ACTCellerateTM that allows the generation of over 140 purified cell types from human embryonic stem cells, and ReCyteTM, a technology for generation of patient-specific stem cells to address the problem of transplant rejection. BioTime is developing some therapeutic applications of stem cell technology through its subsidiaries BioTime Asia, Ltd, and OncoCyte Corporation and markets products for research use through its subsidiary Embryome Sciences.

The Life Extension Foundation’s funding of research at BioTime provided much-needed support of the early development of the ACTCellerateTM and ReCyteTM technologies. Approximately one year following the receipt of Life Extension Foundation funding, BioTime reported the results of the ACTCellerateTM research to the California Institute for Regenerative Medicine (CIRM), which has been allocated $3 billion over the next 10 years to fund basic research in California. In a competitive grant review process where the ACTCellerateTM research competed with other projects proposed by USC, Stanford, Cal Tech, and other leading medical research institutions, BioTime was awarded $4.7M from CIRM to advance these core technologies to the clinic.

The Life Extension Foundation is working with scientists, entrepreneurs, and government officials in a major country outside the U.S. in an attempt to transform the huge promise of the technologies developed at BioTime into revolutionary clinical therapies to help cure the diseases of aging and attempt to rejuvenate aging systems in the body, including the cardiovascular and immune systems.

A comprehensive overview of all the scientific research supported by the Life Extension Foundation can be found in the Appendix on page 312 in the back of this Directory. The purpose of this initial description is to enlighten members about research programs we are funding that they might not have been aware of.

These research projects are made possible with proceeds from the dietary supplements you buy from us. Each time you purchase a Life Extension product, you directly support targeted scientific research aimed at eradicating age-related disease. We know of no other supplement or pharmaceutical company that is funding so many diverse research projects to obliterate the lethal diseases that preclude humans from attaining a long and healthy life span.