Herb Derived Drug Fights Head and Neck Cancer (Chapparal)

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Ralph W. Moss, Ph.D. Weekly CancerDecisions.com
Newsletter #153 10/10/04
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THE MOSS REPORTS


This week I begin a two-part discussion of the re-emergence of chapparal, an herbal treatment for cancer which was once considered by mainstream medicine to be nothing but a cruel - and dangerous - fraud.  Now, a derivative of chapparal, M4N, is being tested in clinical trials for the treatment of head and neck cancer, a type of cancer that is notoriously difficult to treat.

In more than thirty years of studying and chronicling developments in the field of cancer therapy I have seen many useful alternative treatments at first mercilessly vilified and driven underground, only to resurface years later when science eventually confirms that the active principle of such a treatment really does have some recognizable, quantifiable effect against cancer cells.  

The fruit of my long career in this field is The Moss Reports, a comprehensive library of guides to both the conventional and alternative treatment of over 230 different kinds of cancer.  For a newly-diagnosed cancer patient there can be few more useful guides and decision-making tools than a Moss Report.

To order a Moss Report please visit our website, or call Diane at 1-800-980-1234 (814-238-3367 from outside the US).

We look forward to helping you.



HERB-DERIVED DRUG FIGHTS HEAD AND NECK CANCER


South Carolina doctors have announced that a drug called M4N shrinks inoperable tumors of the head and neck region. Researchers injected M4N directly into the tumors of eight such patients who were not eligible for surgery. According to press releases, they saw evidence that the agent killed the tumors in these patients, all of whom had advanced, otherwise untreatable forms of the disease (Reuters 2004).

"This study revealed that M4N was generally well-tolerated without direct toxicity," Terry A. Day, MD, told colleagues at the 6th International Conference on Head and Neck Cancer in Washington, DC, August 10, 2004. Dr. Day is Associate Professor and Director of the Division of Head and Neck Oncology Surgery at the Medical University of South Carolina (MUSC). He is the author of over 150 scientific publications and is president of the Yul Brynner Head & Neck Cancer Foundation. The meeting was sponsored by the American Head and Neck Society (http://www.sic2004.org/).

Dr. Day and his colleagues now plan a larger, Phase II study aimed at showing whether, and at what dosage, the drug really works in this intractable kind of cancer.


ASCO Study


Dr. Day's report followed a related one presented a few months earlier at the American Society of Clinical Oncology (ASCO) convention in New Orleans. At this June 2004 meeting, Frank R. Dunphy, MD, and colleagues from the Duke Comprehensive Cancer Center, Durham, NC (one of the top rated cancer centers in the US) presented the results of their study, in which M4N was injected directly into the tumors of patients with relapsed or refractory (i.e., treatment resistant) head and neck cancer (Dunphy 2004).

Such patients generally have a poor prognosis with only a 10 percent two-year survival.  Because M4N has shown activity in laboratory animals when injected intratumorally (i.e., directly into tumors), the same method of administration was used in this trial. The dose was 20 milligrams of the agent per cubic centimeter of tumor, given once weekly for three weeks. Three patients (one woman and two men) were treated. Their ages ranged from 54 to 82, with a median (average) age of 65.

The treatment given at Duke was not without side effects. One patient experienced an episode of heart-block requiring two hospitalizations. Another patient developed a fistula from the trachea to the skin, which necessitated withdrawal from study. All patients experienced pain at the injection site, which was severe enough to require intravenous morphine. (However, as the doctors gained experience with the injection technique, the pain became less severe.)

But the therapeutic results were dramatic: in all three patients "injected tumor volumes were observed to respond by crusting within one week of the first injection, followed within two weeks by necrosis and ulceration."  The two patients who completed the course of three intratumoral injections had "total necrosis of the injected tumor site." This was certainly quite encouraging in a group with such a dire prognosis. Unfortunately, though, this local dying back of the tumor at the injection site was "followed by disease progression outside the boundaries of the injected tumor volume"  (Dunphy 2004).

The Duke authors concluded that "M4N intratumor injection was feasible and showed promising antitumor activity in relapsed-refractory squamous cell cancer."

Both the Duke University and MUSC groups are participating in an NCI-sponsored clinical trial with BioCure Medical, a small drug company based in the Research Triangle Park of North Carolina.

The description of the trial at the NCI's clinical trials website (www.clinicaltrials.gov) is as follows:

"The purpose of this study will be to determine the safety and tolerability of intratumoral M4N. Patients suffering from cancer of the head and neck that is recurrent after primary treatment with surgery, radiation therapy, and/or chemotherapy may be eligible. The design is a Phase 1 dose escalation study of M4N administered intratumorally once weekly, initially for three weeks. Dose will be escalated on the starting schedule to a target of 20 mg/cm3 [milligrams per cubic centimeter, ed.] tumor volume and then, new patient cohorts will have their schedule extended to weekly M4N for 4 weeks. Dose escalation will continue, assuming tolerability, so that cohorts will be treated for 6 weeks, and finally, 8 weeks" (www.clinicaltrials.gov).


Scientifically Validated


Any new drug for this difficult type of cancer would be worth writing about. But what makes these announcements particularly intriguing is that M4N is derived from one of the most controversial herbal remedies for cancer--chaparral. Chaparral tea is a long-standing Native American remedy which originated among the tribes of the desert Southwest. Long derided by medical authorities as both ineffective and dangerous, for the past dozen years its sale has been virtually banned by the Food and Drug Administration (FDA). Yet now chaparral is turning out to be the source of a scientifically validated medicine to fight cancer.

M4N stands for tetramethyl-O-nordihydroguaiaretic acid. It is a derivative of a powerful antioxidant called nordihydroguaiaretic acid (NDGA), which is found abundantly in chaparral. NDGA was first isolated in 1942 by scientists at the University of Minnesota, among them Dr. J.M. Zamora. NDGA is considered the most prominent and active chemical component of chaparral. Dr. J.M. Zamora later wrote his dissertation at the University of Auburn, Alabama, on how NDGA attacks bacteria, yeast, viruses, fungi, and cancer cells. He reputedly reported that it does not produce the side effects of other chemotherapeutic agents (Zamora 1984).

M4N was first explored as an antiviral agent, and was tested as an anti-HIV treatment in China (Chen 1998). It was later found to arrest the growth of cancer cells as well. It was certainly a good idea to expedite the testing of this promising agent. In the late 1990s, Ru C. Chi Huang, PhD, of Johns Hopkins's celebrated biology department, raised $2.5 million to conduct pilot trials in four locations in Asia, including the large Regional Cancer Centre (RCC) at Thiruvananthapuram, India.

But then all hell broke loose. The American group had failed to secure institutional review board (IRB) approval for the Indian study from Baltimore-based Johns Hopkins, or to secure informed consent from Indian patients. The university assumed this had all been taken care of on the Indian end. But a scandal broke out when the head of radiobiology at the RCC, Dr. V. N. Bhattathiri, and another doctor, claimed that the RCC's Director, Dr. M. Krishnan Nair, had sanctioned the M4N trials without informing patients that they would be given a new medicine (Bidwai 2001). It was also claimed that surgery was in some cases delayed while patients took M4N, and that the drug itself had not been properly screened for toxicity.

In India this became a big political issue, and the trial was denounced by some as a scam and a violation of human rights (Bidwai 2001). Some people felt that a rich American university had come to test a potentially dangerous new drug on Third World people, without providing the same elementary protections that would be afforded North Americans. Demonstrations at the RCC forced cancellation of the trial-and dealt a major setback to M4N testing.

A company spokesperson later claimed that medical rivalries at the RCC led to the uproar. However, in a news release at the time, Johns Hopkins University tried to cast the blame on Dr. Huang and reported that she had been directed to cease all activities related to the study in question (JHU 2001). Dr. Huang still remains on the JHU faculty and lists M4N as among her major research interests.

The scandal was complicated by questions surrounding patents and the financing of the drug's development. Dr. Huang and her colleagues assigned their patents on the medical use of M4N to Hopkins itself (as frequently happens with university-based research). According to one such patent, the US government is also a financial stakeholder since Dr. Huang and John Gnabre, a postdoctoral fellow, first identified the potential use of chaparral derivatives while working under an NIH grant.

The relationship between Hopkins and BioCure (the drug company that is now assisting in clinical trials of M4N) seems close. Dr. Jonathan Heller, a former graduate student of Dr. Huang, currently serves as director of technologies at BioCure. In June, 2000, while visiting Hopkins, Singapore real estate billionaire Ang Tiong, a member of the board of directors of Houston-based MetroCorp Bancshares Inc., offered to finance development of M4N. He has invested in the Raleigh-based company and offered to pump anywhere between  $15 million and $25 million into the venture, enough to keep it in business until mid-2005.


The Transformation of a Folk Remedy


It seems ironic that the US government now has a financial interest in M4N, since it has done so much over the years to discourage the exploration of chaparral as a cancer treatment. First, the effectiveness of chaparral was denigrated. Then, based on toxicity concerns, it was virtually banned by an agreement between the US Food and Drug Administration (FDA) and the food supplement industry.

So far, however, the chaparral derivative in question does not appear to cause the kind of systemic toxicity that is mentioned in the scientific literature.  Initial tests on patients showed that, when it was injected intratumorally, it did not cause the serious liver damage sometimes associated with systemic use of the plant extract.


What is Chaparral?


The term "chaparral" actually refers not to a particular species but to a community of plants, indigenous to the American West and Southwest, that is dominated by evergreen shrubs. Chapparal is also called greasewood, creosote bush or Mediterranean scrubland and grows in dense thickets to a height of four to eight feet. Chaparral is made up of thorny plants including ceanothus, manzanita, chamise, and various evergreen oaks. In most scientific discussions, however, the word usually refers specifically to two particular species of the genus Larrea, L. divaricata and L. tridentata. Some years ago I drove from Phoenix, AZ to San Diego, CA as part of a cross country trip and well remember seeing acre upon acre of chaparral for the length of that 350 mile journey. Despite efforts to ban its sale, chapparal is still available over the Internet and, given its abundance, is very inexpensive. A pound of the stuff sells for under $10!

Chaparral tea is an old Indian and folk remedy for many ailments. It is considered a very effective detoxifier. Chaparral was the main ingredient in the original and controversial "Jason Winters tea" formula. It has also been used in many "black ointment" salves, some of which are associated with toxic skin reactions (Moss 1998).

In his monumental study, Plants in Use Against Cancer, the late Jonathan Hartwell, PhD, of the National Cancer Institute, reported the ethnobotanical use of chaparral against stomach cancer. Chaparral remains a popular remedy for a wide variety of illnesses. It was propounded as an American remedy for cancer over half a century ago and is used for the same purpose in at least one other country, Argentina (Anesini 2004).



(TO BE CONCLUDED, WITH REFERENCES, IN NEXT WEEK'S NEWSLETTER.)



--Ralph W. Moss, PhD

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IMPORTANT DISCLAIMER

The news and other items in this newsletter are intended for informational purposes only. Nothing in this newsletter is intended to be a substitute for professional medical advice.



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