FAN-C®

The research team of America's leading scientist Dr. K. N. Matsumura (Time Magazine Inventor of the Year, 2001) in Berkeley (California, USA), has discovered a means for greatly reducing the toxic side-effects of chemotherapy agents. With the substantial reduction of toxic side-effects, scientists believe chemotherapy can be made more effective. The newly discovered side effect reducing medicament is used during chemotherapy. However, for the side effect medicament to be used safely, chemotherapy must be monitored much more carefully than usually. Baja Institute with its rigorous quality controls is the first clinic in the world to be ready to monitor patients using the new FAN-C™ side effect medicament.

FAN-C® therapy is designed not only to minimize side effects, but also to make chemotherapy more powerful. Usually, only a fraction of cells in a tumor are immediately killed by chemotherapy. Many more cells are damaged without being killed. These damaged cancer cells can repair themselves, unless they are located and dissolved by "helper" blood cells in the patient's body (the "immune system"). Ordinary chemotherapy destroys "helper" cells; FAN-C® therapy solves that problem by protecting "helper" cells. Thus, FAN-C® therapy not only kills cancer cells directly, but also assures that "helper" cells can dissolve damaged cancer cells that would otherwise survive and kill the patient.

Latest clinical trial results are promising. A 62 years old male lung cancer patient was bedridden and on narcotics around the clock for severe pain. After a round of radiotherapy and FAN-C® chemotherapy with carboplatin and gemcitabine, he became free of cancer seven months later and remains without a trace of cancer almost two years later. A second lung cancer patient is also now 18 months without a trace of cancer. Lung cancer patients like these usually have a year's lifespan. A 59 years old woman with a uterus sarcoma was first treated with gemcitabine and capecitabine. Subsequently, when her tumor showed no shrinkage with four cycles of carboplatin and gemcitabine given every three weeks (side effect to bone marrow was so severe she required Filgristim to stimulate her bone marrow), she was placed on weekly doses of carboplatin with FAN-C®. After only three cycles, her tumor showed twenty per cent shrinkage. A 53 years old woman with lobular carcinoma of the breast was found to have a solitary metastasis to the liver. Despite four cycles of taxane and capecitabine, her liver metastasis persisted. She was placed on weekly doses of carboplatin with FAN-C®. After five cycles, the liver metastasis fully responded. She remains free of cancer 17 months later. Typically, in conventional chemotherapy, remissions last 6 to 8 weeks. A 61 years old woman with myeloblastic leukemic condition in terminal status receiving frequent transfusions underwent weekly low-dose carboplatin therapy with FAN-C for just three weeks. Her blood count stabilized without transfusions and her remission has lasted 19 months. None of the above patients experienced any side effects from carboplatin despite the strong effect it had on the patient's cancer in every instance. In fact, patients tolerated chemotherapy well when FAN-C® was used and even an 82 years old woman underwent FAN-C® chemotherapy with weekly carboplatin without any symptoms. A 59 years old breast cancer patient with a huge liver full of hundreds of metastases underwent alternating weekly carboplatin and gemcitabine therapy with FAN-C®. After only a few cycles, the CT X-ray showed her liver looking like Swiss cheese with multiple holes where liver metastases had been. FAN-C® protected all classes of white blood neutrophil cells so that rather than chemotherapy slowly shrinking tumors such as in conventional chemotherapy, neutrophils liquefied all the cancer cells damaged by chemotherapy. The radiologist had never seen anything like it; it was indeed historic. The response rate in the most recent series of patients undergoing carboplatin chemotherapy with FAN-C® has been 100%. Above are not results selected from among poorer ones. Above cases represent a consecutive series of patients worldwide. LATE BULLETIN FROM FAN-C ADMINISTRATION The FAN-C Clinical Trial Administration is quite aware of what above results mean for cancer patients and for the world. The Administration has already revised this “clinical trial” into the status of Provisional Therapy. Unlike in ordinary trials where some patients are not given the investigational medicaments, all patients accepted at Ensenada are given FAN-C medicaments. The scale up of this work so that more than a few patients can be treated at a time is quite challenging since the production of FAN-C medicament is still limited. We must ensure that every patient accepted at Ensenada is someone the Baja Center can help in a relatively short time since most of our applicants must travel from Europe, South Africa, and Australia. The patients who have achieved these astonishing long-term remissions were predominantly no more advanced than “Early” Stage IV with no bone metastases, no brain metastases, and no extensive lung involvement. Cancer, even in early Stage IV, is almost always fatal, with conventional chemotherapy able to achieve mostly only short term remissions; we are astonished with the achievements of our early Stage IV patients and we would like to give more such patients an opportunity to be treated with FAN-C. The primary reason the FAN-C Clinical Trial Administration authorized Baja Cancer Institute to become the first global center to monitor patients undergoing FAN-C therapy is Dr. Guillermo Aguirre Condit, whom Dr. Matsumura describes as one of the most brilliant and kind physicians he has come to know over the past seven years. As Baja Center has recently added an American and a South African patients with extensive, advanced colon cancers, the FAN-C Administration is very pleased with Ensenada, Mexico as a center that is visa-accessible to patients from ALL countries. Medical care is a right not a privilege and it is important to FAN-C administrators that terror-concern not be a reason for a visa rejection and delay where days make a life or death difference. We have seen a derogatory blog comment by a patient who was offended by our inability to accept her due to the extremely advanced stage of her cancer. While the Baja Center is not able to accept a large number of patients, who fall outside the strict criteria of the study protocol, please know that new protocols are being developed that will shorten the treatment period of even advanced Stage IV cases. The fulfillment of the criteria for inclusion into the study is measured at the time of arrival of a patient in Ensenada, not before. It is regrettable that many patients fulfill their requirements when they first write, but by the time many patients wait to see if their current therapy at home will work, they are shocked to find their cancer dramatically advanced, falling outside the criteria for inclusion at Ensenada. The South African patient wrote the Baja Center and decided to seek enrollment after only a single reply from the Center and arrived in Ensenada only ten days later. His case was far more advanced than our new criteria, but was accepted because he was felt to have such a positive attitude about the therapy, enough to assure the doctors that he would undertake a far lengthier therapy than was necessary in previous cases. His positive attitude is reflected in his statement that every morning he awoke and thanked the staff of the Baja Center and Dr. Matsumura in California for a therapy in which he felt not one side effect while his tumors shrank. Baja Center is not one of those alternative cancer centers that will accept every patient who arrives. We are able to accept few patients because each patient becomes a large investment of our time and funds. In addition to strict adherence to the study inclusion criteria, the Baja Center must feel assured that the patient is completely comfortable with every aspect of the therapy, including the appreciation of the fact that they cannot receive the toughest quality controls practiced at this distinguished, elite Mexican institution even if they went to the best cancer institutions in the United States, Europe or Austrasia. What other institution re-tests their cancer drug for potency shortly before they are used in their patients? Recapitulation Nota Bene: If cancer recurs in a distant organ like the liver, it is fatal almost always, sometimes rapidly so. We hear from too many patients who think the therapy their local doctor started may save them. They wait a few months and they write us again when it has become hopeless, even for FAN-C therapy. Please note that we are now enrolling only early stage 4 cases.

What causes chemotherapy side-effects?

The problem with chemotherapy agents is that they have poor focus and end up destroying many normal dividing cells along with the cancer cells found in a patient's body. Invariably, patients suffer side effects. When bone-marrow cells are damaged patients suffer fatigue and become susceptible to infections. Many patients also suffer nausea and vomiting from the damage done to gastrointestinal cells.

What have physicians done traditionally to eradicate chemotherapy side-effects?

Traditionally scientists have tried to address the issue of side-effects by designing methods to deliver chemotherapy agents only to cancer cells. These methods of selective targeting have been employed with limited degrees of success. The reasons for the limited success are varied, but by in large, the failures reflect one simple fact -- all cancer cells are not identical. If all targeted cells are not identical, it is very difficult to target them for direct delivery of the chemotherapy agent.

In addition, there are several other therapies offered for the reduction of side-effects, but their success is limited.

How do the new medicaments help eliminate chemotherapy side-effects?

Berkeley Scientists have discovered a means whereby chemotherapy agents can be administered more safely and effectively. This technology is called Focused Anti-Neoplastic Chemotherapy (FAN-C™).This technology allows doctors to reduce or eliminate the toxic effects of chemotherapy agents on normal tissues found in bone marrow and the gastrointestinal tract by using the principals of selective targeting.

Read on to learn how side-effect free chemotherapy works and use our interactive graphic for help.

Chemotherapy agents are like poisons. They have antidotes that can reverse the poisonous effects if given quickly after the agent is administered. Doctors commonly use some of these antidotes to rescue patients from overdose of cancer drugs. However, giving patients antidotes without targeting their delivery completely reverses any capacity the agent has to destroy cancer cells.

Berkeley Scientists have developed a way of targeting antidote delivery and selectively protecting only normal dividing cells in the body from cancer drugs. Antidote is not delivered to cancer cells leaving them vulnerable to cancer drugs.

Step 1

Antidote is placed in a drug delivery system called a dendro-microspherule. These dendro-microspherules are chemically programmed to target only normal dividing cells.

What is a dendro-microspherule?

Dendro-microspherules are tiny microspheres made of harmless substances that can be designed to target different cells in the body.

What is the antidote made of?

Many antidotes for chemotherapeutic agents are edible plant extracts or medicines that have been in use in humans for decades. One antidote, monosodium glutamate (MSG), is used as a flavor enhancer and are found in large amounts in common vegetables. MSG is an antidote for the powerful group of cancer drugs called vinca alkaloids. These cancer drugs form part of a cocktail that have cured certain types of cancer. Vinca drugs are very effective in treating breast cancer, but has harsh side effects particularly to the bone marrow. By using MSG in specially-formulated dendro-microspherules that target bone marrow and gastrointestinal cells, vinca drugs can be used with much less side effects. Other antidotes include leucovorin and mesnex, both U.S. FDA approved for many years. Mesnex is an antidote for many cancer drugs in the class called 'alkylating agents.' Drugs such as cisplatin, carboplatin, thioTEPA, cyclophosphamide (Cytoxan ®), ifosfamide, and BCNU, are just a few in this class. Scientists affiliated with Baja Cancer Institute have developed side effect reducing agents for virtually all cancer drugs, including paclitaxel (Taxol ®), methotrexate, doxorubicin (Adriamycin ®) and many others.

Can you tell me more about the vinca alkaloids?

There is a new and powerful vinca drug called vinorelbine. This member of the vinca family is quickly becoming a premier, single agent drug against such forms of cancer as breast cancer.

Step 2

Once the normal cells are protected with the antidote, cancer drugs can be administered without causing harm to the healthy dividing cells.

Step 3

The cancer cells do not receive any antidote, so they are effectively damaged and destroyed by the cancer drugs.

Could you please summarize the benefits?

• First, side-effects of the chemotherapy agent are substantially reduced because the healthy cells suffer no harm.
  
  
• Second, cancer cells are effectively damaged and destroyed because they are not protected by the antidotal agents.
  
  
• Third, chemotherapy need not be interrupted to allow recovery of damaged bone marrow or gastrointestinal tract cells. This means that cancer can be more aggressively treated.
  
  
• Fourth, because the healthy white blood cells have been spared the damaging effects of chemotherapy, they actively seek out and destroy damaged cancer cells that could otherwise recover.
  
  
• Fifth, studies have shown that with this technology it might be possible to use much higher doses of cancer drugs than was possible before. Scientists have always believed that higher doses can eradicate cancer cells more completely.
  
  
• Sixth, cancer is usually treated with multiple drugs simultaneously, because of the side effects. In conventional chemotherapy, any one drug cannot be used in sufficient dosage to be curative as a single agent and treatment usually involves multiple agents. Only time will tell if a single drug, when used with side-effect eliminating agents such as FAN-C™, can be powerful enough to act as a cure when used at dosage levels never thought possible.

FAN-C™ technologies will be offered only in regional cancer centers where health professionals undergo rigorous education and training in the technique. Baja Institute is the first cancer center to be able to monitor patients using FAN-C™ medicaments.

For more information or to enroll in the trial, write: medical@bajacancer.org.

To read more about the clinical trial and the Baja Cancer Institute, click here

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