CF links in study debated Foundation urges caution after Martek research with mice

Biotechnology

October 23, 1998|By Mark Guidera | Mark Guidera,SUN STAFF

The senior medical director for the Cystic Fibrosis Foundation said yesterday that he is concerned about Martek Biosciences Corp.'s announcement that a nutritional supplement made by the Columbia-based company had a beneficial effect on mice genetically altered to mimic symptoms of the disease.

But the foundation is intrigued by the findings and plans to support a follow-up study to gather information about what role the nutritional supplement might have in treating the inherited, deadly disease that affects more than 30,000 Americans.

"The bottom line is it's early -- way too early -- for people with CF to go out and buy this product," said Dr. Preston Campbell, executive vice president for medical affairs at the Bethesda-based national Cystic Fibrosis Foundation and a pediatric pulmonologist at the Johns Hopkins Medical Institutions in Baltimore.

One of Martek's senior scientists, David Kyle, said the company shares the foundation's concerns that the findings not be overblown, but that it wants to move the supplement into clinical trials quickly so a determination can be made about its benefits for CF patients.

"We think the key here is not to wait on this. The right approach is to get this into well-controlled clinical studies in humans as quickly as possible so we can get some answers," said Kyle, senior vice president for research and development at Martek.

He said the company was "very surprised" at the researchers' findings, which triggered Martek to issue Monday's announcement.

The company has been following up on a number of scientific studies that show long-chain fatty acids appear to aid brain and eye development in fetuses and newborns. But the company has never studied whether the substance might have a benefit in treating cystic fibrosis.

Monday's news release said a team of researchers in Boston had "reversed lung and pancreas symptoms" in genetically altered mice by feeding them high doses of Martek's Neuromins tablets.

Campbell said that statement is a bit misleading since the researchers did not observe any symptom changes, but rather examined tissue samples for a specific biochemical change in the lung and pancreas that might be tied to controlling inflammation problems in CF patients.

The release also quoted Henry Linsert Jr., chairman and chief executive officer of Martek.

"Martek is very excited about these results because, to our knowledge, no drug or therapy has ever reversed CF symptoms in this mouse model," Linsert is quoted as saying.

He also urged caution, saying "We don't want to give anyone any false hopes since research now needs to be conducted directly in CF patients. There can be no assurance as yet that Martek's Neuromins-DHA will have the same effect that it did in mice."

The nutritional supplement at issue contains a naturally occurring long-chain polyunsaturated fatty acid, DHA (docosahexaenoic acid). Martek markets the tablets as a brain-power-boosting supplement, and has deals with several vitamin and nutritional supplement companies to market DHA tablets under their own labels.

DHA is also a key ingredient in Martek's infant formula additive, ,, which is approved for marketing overseas, but not in the United States.

Martek and the foundation's interest centers on an experiment conducted by Dr. Juan Alvarez and Dr. Steven D. Freedman of Beth Israel Deaconess Medical Center in Boston. The findings of their experiment were presented last weekend at a cystic fibrosis conference in Canada.

According to an abstract published on the experiment, the researchers theorized that DHA might be therapeutic for cystic fibrosis sufferers, because earlier research pointed to a deficiency of the fatty acid in lung and pancreas tissue membranes of people who suffer from the disease.

On the other hand, those membranes show higher-than-normal levels of another fatty acid, AA (arachidonic acid). High AA levels trigger inflammation of the lung and the abundant mucosal secretions that plague CF patients.

CF patients suffer from mucous buildup in the lungs; bacterial lung infections; and poor digestion and food absorption due to mucous buildup in the pancreas. The disease is due to a gene defect that inhibits the body from making a protein responsible for transporting salt and chloride in and out of tissue cells in organs, such as the pancreas and lung.

The mice were given 40 milligrams of Neuromins daily for two weeks and then killed. Lung and pancreas tissue samples were then taken for testing. The researchers found that the supplement brought the DHA-AA levels back into balance.

"This is encouraging and the first in a number of steps that could lead to a new therapeutic strategy," said Campbell. "But we don't yet know what a comparable equivalent dosage for a human might be, and it could be a dangerous leap of faith for someone with CF to buy this product and take too much of it."

He said the foundation has sent out advisories to physicians and medical centers nationwide that treat CF patients so they will be aware of the study if patients ask about Neuromins and DHA.

Alvarez and Freedman are so concerned about their findings being over-emphasized or misinterpreted that they are declining be interviewed, a Beth Israel hospital spokesman said.

In a statement issued through the hospital, the doctors said, "While the work we have done is encouraging, it is important to emphasize that it is preliminary and was done in mice under carefully controlled conditions.

"Although this therapy has been tested and proven effective in ++ our mouse model, a comparable formulation has not yet been developed for humans with cystic fibrosis or tested in humans for safety."

Pub Date: 10/23/98

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