Friday, June 29, 2007

Cytotron Cancer Treatment entering Phase III trials soon.

This Radio Frequency Delivered In A Magnetic Field Is Actually Delivering On Its Promise

A two-year-old experimental treatment for cancer is creating an even greater buzz worldwide. It will enter Phase III trials soon...

Shailaja M.G. had begun marking time during February last year. She was a cancer patient twice over, and was not responding to any treatment. The tumour in her liver was growing despite six courses of chemotherapy, the maximum given to a patient. She was in intense pain. She could not move around. She could not eat without difficulty. She was losing hope.

Her husband G. Pampapathy, an engineer in the PWD in Hosepet near Bangalore, heard about a clinical trial on a new method of treatment for cancer being tried at the Institute for Aerospace Medicine (IAM) in Bangalore. IAM accepted only patients like Shailaja, who had not been responding to the three standard methods of cancer treatment available: surgery, chemotherapy and radiotherapy. IAM treated her for 14 days in April, and then again in September. She has had five courses of treatment so far.

Shailaja still looks frail and somewhat sickly. But she is no longer in pain. She can eat well and move around the house doing her chores at a slow pace. She is not on painkillers or any other drug. The tumour, which has marginally decreased in size, has mysteriously stopped bothering her. It seems that the tumour no longer produces the toxic substances that squeeze and drain all cancer patients. Says Pampapathy: “In February last year, her doctor told us that she had only six months to live. Now she is recovering well.”

For three years, IAM has been trying this method on hundreds of patients. Some results were spectacular. Patients who were on their deathbeds seemingly recovered and went on with their normal lives. Some results were good; patients seemed to live slightly longer than their predicted median period of survival. Some died even before the first course of therapy was completed. The quality of life improved for almost all patients after a few days of treatment. Many patients like Shailaja are still alive. And now this experiment is entering a crucial phase. In about a year or two, we would know what really is going on.

The IAM method of treatment is so simple that few would have endowed it with any therapeutic value. It places the patient in a brief, intense magnetic field and then submits the cancerous tissue to short pulses of radiation.

This radiation is at a frequency and intensity that is not lethal to any living tissue. In fact, it is known to be harmless. We use a similar frequency in our mobile phones. Yet the cancer cells appear to react differently. They are not destroyed, but seem to sputter and stop in their tracks.

This is all we know now. The experiment is yet to produce a statistically significant result on any single cancer type, but the circumstantial evidence is so strong that IAM has decided to put the experiment through multidisciplinary analysis. Cancer surgeon D. Routray and oncopathologist Renu Madan at the Command Hospital in Bangalore are going to assist Radiologist (and principal investigator) V.G. Vasishta at IAM to remove and study tumours after treatment. Some time later, Triesta Sciences, a clinical research firm in the city, may take the tissues and try to understand the phenomenon at the molecular level. Says Vasishta: “The experimental results are encouraging enough for us to go to the next stage.”

The story of this experiment does not proceed in one dimension. It has a main plot, of treating terminally ill cancer patients, and it has several subplots as well. Each of these subplots has the potential to develop into a full story even if the main one ends prematurely. And it is not just IAM that plays a major role here. This institution came into the picture only recently, about two years ago. Before that, there was an organisation called Centre for Advanced Research and Development (CARD).

CARD is in a small building on the outskirts of Bangalore, on a dirt track near a dying lake. It is part of Scalene Cybernetics, owned mostly by engineer-physicist Rajah Vijay Kumar. Rajah set up Scalene in 1992 to develop medical equipment. The company began its life by making and selling ambulatory blood pressure monitors developed by the Hungarian firm Meditech. Scalene’s first indigenous product was a cardiovascular cartograph, an instrument to map out the blood flow in arteries. Cartograph is now installed in 24 places across hospitals in India. On paper, it has the potential to bring about a revolution in cardiac care.

This brings us to the first of our stories. At the moment, cardiologists use angiography to determine the existence and extent of coronary arterial blocks. It is a slightly risky and an expensive interventional technique. The cartograph does not show you the blocks, but shows the blood flow accurately. Since cardiologists are ultimately interested in the blood flow, this machine is purportedly an inexpensive, non-invasive technique to replace angiography. Yet clinicians have not really accepted the machine wholeheartedly. Is it vested interest or lack of faith? We do not know at the moment.

In any case, CARD is now taking the machine to developed countries, and we will know the denouement in a few years. Meanwhile, the machine gave the company revenues of around Rs 3 crore in four years. Scalene also started working on another machine, the cytotron, by 1995. Rajah’s research interests lay at the junction between electronics and biology. He had done his PhD on Osteogenesis (regeneration of bones or cartilage) using electric and magnetic fields. Lack of computing power limited the potential of this technique in those days. “The rapid increase of computing power has enhanced the potential of this method,” says Rajah.

He also thought of a few novel ideas. The most interesting one was to use the frequency band between I khz and 10 mhz. This band has never been tried in healthcare so far. He had known that many biochemical processes depended on the electric potential of the cell membrane. He deduced, using modelling and simulation, and taking cues from recent research literature, that altering the membrane potential could make a mature cell divide again. The technique was called Rotational Field Quantum Magnetic Resonance (RFQMR), and the machine was called the cytotron. Rajah teamed up with the IAM to put this idea to test.

The ability to make a mature cell divide again is of great benefit to people with degenerative diseases. IAM decided that the best way to test this hypothesis is to try it on arthritis patients whose knees have degenerated. There were serious ethical issues involved here since the radiation was at a frequency that was proven to be harmless. The experiment that started about two years ago is still continuing. Patients now queue up at IAM for this treatment (now, the waiting period is one year), as the results seem to be encouraging. Patients can walk after a week of treatment. MRIs show some regeneration of the knee after treatment. Vasishta and Rajah published the results of this experiment in the Indian Journal of Aerospace Medicine.

Promising Hope: Rajah Vijay Kumar
Here comes our second story. Is this treatment a viable alternative to knee replacement? Would doctors recommend this cheap alternative to a surgery? Just like in the case of the cartograph, we will have to wait and see. But Rajah continued to experiment. The ability to alter the membrane potential could have other uses, he reasoned. He knew that cancer cells have a particular potential, around 70 millivolts. He reasoned — again through theoretical methods — that suddenly raising it to about 100 millivolts can stun these cells. And this is what links us to our main plot.

Let’s skip the intricacies of Rajah’s hypothesis, while remembering that it is still a hypothesis. Ethics demanded that IAM take patients who were terminally ill. Of the 106 patients treated so far, more than 50 per cent are still surviving. About 20 per cent seem to have recovered completely. These results are not still good enough for the regulators. “Cancer patients often feel better for some time if they are taken off chemotherapy,” says Shekar Patil, an oncologist at the Bangalore Institute of Oncology. The experiment has thus yet to produce what is known as a statistically significant result. Which means that a significant proportion of patients of a given cancer type has to survive well beyond the median life expectancy for that cancer type. We have to wait for these statistics to be available till we pass final judgement on RFQMR.

We wouldn’t have told you this story in normal circumstances. Scientists take a discovery seriously only when it is peer-reviewed and published in a journal. To them, the IAM procedure is still an experiment that will take two or three years to yield results. There is still a lot left for the researchers to do. More patients have to be studied over longer periods of time. Clinical data has to be collected and analysed thoroughly. In particular, the tests have to produce statistically significant results for specific cancer types. The molecular basis of the changes in the cancerous tissue has to be understood. Yet there are reasons to look at the experiment now. Cancer treatment is an area where big claims are made with regularity. Most of them last only a few months, if at all. The IAM clinical trial has lasted for more than two years, and still looks promising. Yet Rajah and Vasishta are still treating it as an experiment. It deserves attention, particularly because the results are so fascinating. Terminally ill patients have a right to know the truth, and quickly too.

There are aspects of the RFQMR method that are intriguing. Cancer cells are of several types. Even the best anti-cancer drugs work only on certain types of cancer, while the cytotron seems to act on every type of cancer. This generality actually creates more doubt than hope. In fact, the machine seems to be useful in treating a variety of diseases like arthritis, cancer, macular degeneration and so on.

We mentioned earlier that the cancer treatment is only part of the story. CARD could strike it rich in ways more than one in days to come. Its cartograph could become a best-seller. Even if the cancer story falls by the wayside, cytotron could be a great way to treat osteoarthritis. And if it fails on both counts, the machine could open up other ways of looking at diseases and their treatment.

Treatment facilities are currently operating in India, Malaysia and Kosovo with new Cytotron facilities on the drawing board now.

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