Handful of researchers test disputed compound
By Susie Gran
Tribune reporter http://web.abqtrib.com/archives/cancer/060701_cancer_vital1.shtml
The chemical compound vitalethine has a few well-known supporters who agree with inventors that it is a potent cancer fighter.
How discoverers think it works
Those supporters plan to introduce a nutritional supplement to help the human body produce more vitalethine to stimulate the immune system to attack cancer cells.
Among vitalethine's backers are the principal inventor of Taxol, the billion-dollar drug for treating breast cancer, and an Albuquerque businessman with 22 years in the nutrition business. They have joined forces to develop the new product.
Their venture recognizes vitalethine's importance in stimulating the immune system to find and destroy cancer cells, said Richard Savage of Albuquerque, who sells nutritional supplements.
"Our strategy is to provide a proprietary product to empower the body and allow it to produce its own vitalethine naturally," Savage said. "Vitalethine needs a healthy environment."
The product will include vitamins, herbs and minerals, said Savage, president of Meditrend, an Albuquerque nutritional supplements firm.
Ingredients of the new product will address factors that hinder vitalethine production -- bad nutrition, toxic elements in the environment and a suppressed immune system, Savage said.
These factors have been identified by vitalethine inventor Galen Knight, whom Savage has known for several years.
"I believe Galen is a guy with a world-class discovery," Savage said.
Savage and his business colleague, Taxol inventor David Carver of Colorado, have embraced vitalethine as described and synthesized by Knight and co-inventor Terence Scallen.
Knight and Scallen discovered vitalethine in the mid-1980s in their laboratory at the University of New Mexico and determined it was an immune system stimulant. When they injected synthetic vitalethine into mice with cancer, most of the mice didn't die of the disease.
But they say their vitalethine has not been replicated, developed or marketed. It is tied up in a legal battle in federal court.
Savage said the inventors' work was reviewed by Carver, the prominent chemist involved in the processing and formulation of the anti-cancer agent paclitaxel from Pacific yew trees into a cancer therapy.
Carver is now the president of Hyperquan Inc./MediHerbs Inc., a research, development and manufacturing firm.
"Vitalethine is real and Dr. Carver has confirmed that," said Savage.
Savage said he's aware the University of New Mexico disagrees, based on letters he received as far back as 1997 when he first inquired about vitalethine. At that time, Savage was interested in developing the compound for commercialization. But UNM officials told him Knight's vitalethine was actually beta-alethine, a compound already licensed exclusively to another company.
Dovetail Technologies Inc. of Maryland licensed all the Knight and Scallen compounds from UNM in 1994.
"Basically, they told me they didn't believe Dr. Knight's vitalethine existed and that it was the same thing as beta-alethine," Savage said.
Savage said he was aware of the dispute, but thought it was worth trying to see if he could license Knight's vitalethine, since the university wasn't recognizing it.
Knight and Scallen contend vitalethine is the more potent immune stimulant and likely the active ingredient in beta-alethine. They say the changes UNM made in their patents suppresses the vitalethine technology. They fear the compound will never be developed.
Savage said he wasn't satisfied with UNM's assessment of vitalethine and sought the advice of Carver. In a letter to Savage, Carver concluded that Knight "has performed substantial experimental work that is, at the very least, worth pursuing vigorously."
Savage said his plan to market nutritional supplements based on the inventions of Knight and Scallen is a way "to help people get well" without getting into the middle of the dispute with UNM.
Knight said he has no business relationship with Savage or Carver. "They are very interested in what I'm doing," said Knight, who has advised them at no charge. "We are working together on the best ways to help people get well."
Savage has made a few donations over the years to Knight's nonprofit company, Knight said.
In its lawsuit against Knight and Scallen, UNM claims its chemistry experts who synthesized vitalethine determined the inventors made mistakes in describing the chemical structures of the compound.
UNM made changes to the patent applications to correct the alleged errors.
The inventors protested, saying the corrections were erroneous and destroyed their work. A trial is scheduled June 25 in U.S. District Court in Albuquerque.
In his analysis of Knight's data, Carver said the chemistry is "very sensitive" and must be followed "to the nth degree" to accurately replicate it.
"It is apparent that his work has not been replicated by others due to some less-than-perfect adherence to his chemical procedures," Carver said in a letter to Savage. "Until his work is exactly reproduced, any work that appears to contradict his results and conclusions cannot be justified under the scientific method."
Other scientists familiar with vitalethine include Ron Watson of the University of Arizona and Kathy Mason of M.D. Anderson Cancer Treatment Center in Houston, who used the compound synthesized by Knight.
At the University of Maryland, researchers had a $100,000 grant from the National Institutes of Health to study how vitalethine stimulated the immune system.
The NIH grant manager, Dr. John Sogn, said the investigators didn't doubt vitalethine worked when they embarked on the study. However, the actual compound used in the study was identified by the trade name Betathine, which is what Dovetail calls beta-alethine.
Sogn said it was not unusual for investigators to use a derivative.
Knight's synthetic vitalethine was used in Watson's tests on mice with AIDS and Mason's tests on mice with breast tumors. Both researchers said their testing did not produce any startling data, and they did not continue their studies.
Watson said vitalethine showed modest benefits in a standard immune study and that he was surprised to learn that UNM and the inventors were fighting over the compound. "Somebody must really believe in it to spend that kind of money," Watson said, referring to the patenting costs and legal fees exceeding $200,000.