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METABLOX: A NEXT GENERATION CANCER THERAPY ABOUT METABLOXTM Metablox is a formulation for treating metastatic tumor. Metablox exploits metabolic differences between cancer cells and healthy cells. By doing so, Metablox preferentially kills cancer cells while leaving normal cells largely untouched. Because of the selective killing of cancer cells, Metablox does not have typical side effects related to damaging healthy cells. Metablox is an experimental medicine with a great promise. Most patients who used Metablox have been enjoying recurrence-free life. In most cases, the tumor burden was reduced by 90-95% (hence the pain, too), and what’s left stopped growing. In a few cases, tumors were reduced below the level of detection. Life returned to normal during Metablox treatment as the side effects have been close to none. These are remarkable improvements for patients with terminal cancer. Here is the story of Metablox. the rate of glycolysis is much faster in cancer cells. Digging further, he discovered enzymes that are normally “off” in glycolysis are “on” in cancer cells. Warburg named his observation as “Warburg effect.” THE HISTORY OF CANCER METABOLISM MEDICAL APPLICATION OF WARBURG EFFECT OTTO WARBURG’S NOBEL PRIZE IN 1931 Dr. Warburg was a physician and a scientist in Germany. Warburg earned his doctor of chemistry in Berlin in 1906, and doctor of Medicine in Heidelberg in 1911. He started his work as a professor at the Kaiser Wilhelm institute of Biology. Warburg investigated the metabolism of cancer cells. Warburg learned that cancer cells grew much faster than normal cells. He did not know, however, how the cancer cells generate the large amount of cellular energy needed to sustain the abnormally high rate of growth. Eventually, Warburg discovered that cancer cells turn on certain enzymes in the cell to generate more energy. In normal cells, energy is generated by breaking down glucose. This process is known as glycolysis. Glycolysis is usually a slow process. Warburg noticed that MEDICAL IMAGING One of the medical applications of Warburg effect is cancer imaging. To detect cancer cells, a patient is injected with radioactive glucose. The cells in the body take up the injected radioactive glucose molecules. Because of the Warburg effect, cancer cells take up a lot more radioactive glucose molecules than normal cells. Observing the different rate of radioactive emissions, CT or NMR scan distinguishes cancer cells from normal cells. CURRENT STATE OF ANTI-‐CANCER DRUG For the most part of 20th century, Warburg effect has been overlooked and ignored as a potential strategy to cure cancer. Instead, drug companies extensively focused on developing anti-cancer drugs that disrupt DNA replication, which is a hallmark of rapidly multiplying 2 cells. Because cancer cells multiply rapidly, these drugs were effective in killing cancer cells. Unfortunately, these drugs also killed normal, rapidly dividing cells because the drugs indiscriminatingly attacked any DNA replication whether it was for normal cells or for cancer cells. These drugs cause huge side effects for killing rapidly dividing normal cells, e.g., hair cells, gut cells, liver cells, immune cells, and blood cells. The outcome was, and has been, that the battle against cancer is won, but the battlefield is ravaged beyond repair. Patient would die because of the ravaged battlefield, i.e., complications and organ failures arising from the death of normal cells. Unfortunately, the majority of mainstream chemotherapy drugs are still DNA replication inhibitors. This is especially true in generics. There have been other drugs targeting specific enzymes that have gone rogue by genetic mutations. For example, Gleevac targets a very specific mutation of a cellular enzyme. These drugs work well for cancers caused by very specific mutations. The downside of these drugs is that cancer cells continue to mutate, and render these drugs ineffective. Just like a new flu vaccine is needed every year because of rapid mutations of flu virus, drugs that target specific mutations stop working because the occurrence of mutations in cancer cells is not a static affair. Rather, mutations continue on as the cancer cells divide and change, and new mutations emerge inevitably. In late 20th century, drug companies switched to a new strategy, targeting cancer cells using antibodies. Antibodies specifically trained to kill only cancer cells reduced the kill the cancer cells by implosion.1 A Pubmed search of medical literature resulted in more than 800 research papers, reporting on various effects of shutting down the cancer metabolic pathways. These observations include laboratory studies, animal studies, and certain human clinical trials. There are biotech startups developing the next generation drugs targeting cancer metabolism. tumor cells originated from central nervous system, hematopoietic, kidney, liver, pancreas, prostate, skin, testis, lung, breast, colon, thyroid, stomach, and salivary gland. In human, Metablox have been found effective in treating cancers of the lungs (SCLC and NSCLC), breast, colon, ovary, pancreas, prostate, and kidney (renal carcinoma). Other types include sarcomas in various regions, glioblastoma, and astrocytoma. METABLOX IS A FORMULATION THAT SPECIFICALLY KILLS CANCER CELLS BY SHUTTING DOWN THE CANCER-‐SPECIFIC METABOLISM. side effects significantly. These drugs are, however, extremely expensive to manufacture, and takes very long time to develop. Because of the huge upfront development costs, drug companies have been reluctant to develop antibody drugs unless there is a broad market enough to justify billions of dollars or more in sales. Antibody drugs also have caused unforeseen side effects by triggering host immune defense. The discovery of unforeseeable side effects will continue to rise, as modern understanding of human immune system is still incomplete. METABLOX ANTI-‐CANCER DRUG TARGETING CANCER METABOLISM The next generation anti-cancer drugs take advantage of the Warburg effect. More than a handful of enzymes specifically associated with the Warburg effect, that is, enzymes only turned on in cancer cells, but not in normal cells, have been identified. Theoretically, shutting down these enzymes will either slow the growth of cancer cells, or WHAT TYPE OF CANCER CAN METABLOX TREAT? As Metablox targets cancer metabolism, which is common to any and all forms of cancer, Metablox can be used for any type of cancer. In a laboratory test, Metablox killed Metablox is a formulation that specifically kills cancer cells by shutting down the cancer-specific metabolism. Metablox is administered by intravenous injection. Upon injection, key ingredients of Metablox are taken up by cancer cells. These ingredients then home to enzymes necessary to maintain high level of energy production, and impair them. In response, apoptosis is triggered in the cancer cells due to the loss of their energy production mechanism, leading to cell death. FAQ 1 Cells have a mechanism, known as apoptosis, that commit suicide when something is wrong with them. Disrupting energy supply of a cell is one of the ways known to trigger apoptosis. 3 WHO WERE THE PATIENTS OPT FOR METABLOX? As an experimental drug, Metablox has only been offered to cancer patients who failed to see improvements with FDA-approved drugs. These patients had advanced metastasis. Thus, treatment followups through imaging were focused on controlling metastasis in the liver and large tumors pressing against vital organs. WHAT ARE THE SIDE EFFECTS OF METABLOX? The side effects of taking Metablox are minimal as compared to traditional anti-cancer drugs. Of the 16 patients, no serious adverse reaction was observed. There was one case of grade 1 anemia, one case of erythema, and 5 cases of mild nausea that required no further treatment. In certain patients with very large tumor burden, tumor lysis syndrome (TLS) was observed. TLS is now treated prophylactically by giving the patient a dose of antiTLS medicine. Also, 10-12 years is a time some patients cannot afford. I AM INTERESTED. WHERE CAN I GET METABLOX? Metablox IS available in jurisdictions where treatment with experimental drugs is allowed either on a compassionate use doctrine, or freedom to treat oneself with his/her own choice without interference from the government is guaranteed as basic human rights. Clinics offering Metablox are within 2 hours of flying from major cities of the U.S. HOW MANY HAVE TRIED METABLOX SO FAR? About 24 patients so far. WHAT ARE THE CLINICAL OUTCOMES OF THE PATIENTS WHO HAVE TRIED? We have not documented their outcomes in a systematic way other than their survival. More than 90% of the people have lived and still living beyond their doctors’ predictions. More importantly, because of almost nonexistence of side effects, the patient’s quality of life has been dramatically improved. quires clinical trials. Clinical trials for a cancer drug costs on average $300-$500 million over 7-9 year period. We have approached drug companies and venture capital companies to finance the U.S. clinical trial. We were turned down because Metablox is a combination of known compounds. As such, a patent cannot be secured over its composition. Without a patent, drug companies and other financing institutions are not willing to invest. HOW LONG IS THE TREATMENT? A patient goes through 5 infusions per week for three weeks. After having one or two weeks of break, the physician will examine the patient, and repeat the 3-week cycle up to two more times to a total of 9 weeks. Once the tumor is resolved, a patient would have a weeklong treatment every 3 to 6 months. WHY IS IT NOT AVAILABLE IN THE U.S.? We could offer Metablox in the U.S. To do so, it would take 10-12 years until we secure the FDA approval. Securing an approval re- 4 HOW IS METABLOX ADMINISTERED? Metablox is administered via intravenously. CAN I SEE THE CLINICAL RESULTS? Yes. A summary of clinical results is available upon signing of confidentiality agreement.