Promising therapies that GlobalCures will pursue fall into four broad categories. A few examples are listed below:
(1) Off-label use of FDA approved drugs: celecoxib, statins (on-patent); cimetidine, valproic acid, chloroquine, digitoxin, naltrexone (off patent or never patented)
(2) Foods, herbs & supplements: fish oil, flaxseed oil, green tea, curcumin, whey protein, vitamins C, D, K, selenium, zinc, coenzyme Q10, alpha lipoic acid
(3) Other agents: artemisinin, cesium chloride, methylglyoxal, dichloroacetate, tetrathiomolybdate, melatonin
(4) Unconventional protocols: insulin potentiation therapy, Coley’s toxins, Budwig protocol, Gerson therapy, low dose chemotherapy, ketogenic diet
This list is by no means comprehensive. The therapies listed above treat cancer by different mechanisms: some are directly cytotoxic, others block blood vessels from forming that are needed for tumors to grow and spread, still others enhance the immune system to recognize and eliminate the cancer, and still others cause the cancer cells to behave like normal cells (differentiate). There is scientific basis and in some cases human data on many of these therapies. It is fair to say that some of them have evoked major controversies. If scientifically justifiable, GlobalCures will test combinations of the above and also test the best regimens of conventional medicine with these. Since many of the promising compounds above are “off-patent” or were never patented, GlobalCures will bring to patients innovative and affordable therapies for unmet medical needs.
At present, it is confusing and overwhelming for patients to choose among such therapies based on available data. Step I of GlobalCures’ plans includes a compilation and an in-depth scientific evaluation of such a list. Step II will be the conduct of clinical trials. Even a negative result from a well designed trial will be useful – allowing patients and physician to eliminate treatment options.
|Examples of clinical trials:
Consider combination of drugs that already have FDA approval for other indications, extensive phase I, II data or are generally considered safe.
For example, if GlobalCures were to design a breast cancer study of fish oil, celecoxib and a standard of care chemotherapy regimen, a small phase I trial would first evaluate the safety of such a combination. Blood levels of the drugs used, as well as inflammatory biomarkers before and during therapy would be collected and may be able to give clues as to the patient population that might benefit most from this combination. A phase II trial would then be designed with such a group to test this hypothesis.
GlobalCures may be able to partner with the National Center for Complementary and Alternative Medicine arm of the NIH, the National Cancer Institute, the Breast Cancer Research Foundation, the American Cancer Society, the Susan B. Komen Foundation and others as well as the manufacturers of celecoxib and the chemotherapy agents to fund such a study.
Typically, there is a time gap of two to three weeks between a biopsy proven diagnosis of cancer and surgical intervention, at which time the physician will have access to tumor tissue again. If a cocktail of drugs that causes differentiation of cancer cells (vitamin D, retinoids, etc) is started immediately upon diagnosis, one may be able to obtain substantial information on its cellular effects by comparing the pathology in the biopsy sample with the sample obtained at surgery.
These types of trials are of short duration and inexpensive, yet can yield much insight to aid in the design of future trials.
Trials abroad, where current “standard of care” is not available.
Metastatic renal cancer has very few treatment options since no chemotherapy is effective. In the US, high dose IL2 and most recently several targeted anti-angiogenesis drugs are the standard of care options. Most individuals in developing countries cannot obtain these treatments because of the considerable costs involved or the lack of proper facilities.
GlobalCures will consider conducting trials of a number of therapies such as insulin potentiation therapy, Coley’s toxins, etc. in such a population. This would create a win-win situation – individuals with no treatment options would now have some hope and the world at large will obtain invaluable information on these historic but forgotten therapies. In some situations, from a scientific standpoint, cancer patients that had not been heavily pre-treated, would receive treatments earlier in the progression of disease and hence have a better chance of success. An additional benefit would be cost savings and faster enrollment.
Governments of developing countries may have an interest in funding these trials. Stringent precautions will be taken to ensure that the highest standards of clinical care are used in such protocols.