Oncor to develop gene therapy for obesity Treatment's human trials at least 1 to 4 years away

Biotechnology

March 26, 1996|By Mark Guidera | Mark Guidera,SUN STAFF

Oncor Inc., the Gaithersburg-based biotechnology company, said yesterday that it is entering the race to develop a way to control obesity by targeting one of its genetic causes, in this case a mutation in a gene that controls how calories are stored.

"We believe this holds major revenue opportunities for testing and therapeutics," said Stephen Turner, Oncor's president and chief executive officer.

Oncor joins a growing list of biotechnology and pharmaceutical houses, such as Amgen and Hoffman-LaRoche, which are attempting to develop anti-obesity treatments based on discoveries about the role of the body's many complex biological mechanisms that control appetite and weight.

Company executives at Oncor's subsidiary, OncorPharm -- set up to develop gene therapies -- said they could launch limited human trials on the obesity therapy within one to four years. However, developing and getting approval to market such a therapy for obesity in the United States could take eight to 12 years.

The company also hopes to develop a test for the genetic mutation. That could be available in one to three years depending on regulatory approval, company executives said. The company also hopes to make money from licensing out information about the mutation to companies developing treatments for other ailments.

Still, it's the potential market for a therapy correcting the gene mutation, that holds the most promise for profit.

An estimated 4 million Americans -- 6.4 percent of the population -- have the mutation.

The mutation occurs in what is referred to as the beta-3 adrenergic receptor, a molecule that is found on the surface of tissue lining the stomach and intestines. It controls the rate at which the body metabolizes calories.

Research has found that people who have the mutation burn fewer calories as heat and store more as fat, said Dr. William Ryan, president and chief executive officer of OncorPharm.

He said the genetic therapy company scientists hope to target the mutation by injecting a small molecule made of DNA, the basic material of all cell nucleuses.

The molecule would then seek out and bind with the kink or break in the mutated receptor affecting how calories are stored and burned. Enzymes in the body, whose job it is to correct such kinks and breaks, would be alerted by the molecule to repair the mutation.

No one has yet developed a genetic therapy that has been clinically proven to work, though many researchers say that in 20 years gene treatments will be available, if not common.

Dr. Ryan said the therapy, if ever developed and approved for marketing, would be given only to overweight people whose families have a clear history of obesity and the complications it can cause, such as high blood pressure.

A patient probably would have about 40 injections of the molecule therapy over a year's time at a estimated cost of $10,000.

"That may seem expensive, but in the long-term it would save a lot of money by avoiding the many medical complications and expenses caused by obesity," said Mr. Turner.

The receptor mutation was discovered by Dr. Alan Shuldiner at the Johns Hopkins University School of Medicine. Oncor struck a licensing agreement with Dr. Shuldiner and the school.

The agreement calls for Oncor to provide an undisclosed up-front payment and undisclosed royalties to Dr. Shuldiner. Oncor also will fund his research on the receptor for five years, said Mr. Turner.

OncorPharm's Dr. Ryan said the gene mutation that Oncor has licensed is one of what scientists say is a group of between 30 and 40 genes and other biological elements that contribute to obesity, a disease on which Americans spent millions of dollars last year.

For example, British researchers announced in January that they had found the protein that tells the brain when the body should stop eating. The discovery of the protein's role in suppressing appetite came on the heels of a discovery of a hormone, called leptin, which controls body weight.

Such discoveries are the focus of intense research at major pharmaceutical and biotechnology companies attempting to develop anti-obesity drug treatments.

For example, Amgen, the California-based biotechnology company, has launched early human clinical trials of a leptin injection aimed at controlling weight gain in overweight people.

OncorPharm's Dr. Ryan said the genetic therapy the company hopes to develop "may very well be used to complement other obesity therapies," such as the one Amgen is developing.

Pub Date: 3/26/96

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