Science - Reuters

Enzyme Shows Early Promise in Fat Melting
Tue Dec 17, 8:02 PM ET Add Science - Reuters to My Yahoo!

By Bill Berkrot

NEW YORK (Reuters) - A tiny Long Island biotech firm is testing a treatment for shrinking fatty tumors that could be the answer to shedding unwanted fat without resorting to stressful dieting and exercise or risky liposuction.

Claims of fat melting by products or treatments have always proved to be too good to be true. But Biospecifics Technologies Corp. of Lynbrook, New York, says it has seen "promising results" in early clinical trials of an injectable treatment for reducing fatty tumors under the skin known as lipomas.

The treatment involves a single injection of the enzyme collagenase, which occurs naturally in the body. The enzyme is dissolved in a saline, or salt water, solution and directly injected into the lipoma.

While animal studies are complete, U.S. Food and Drug Administration (news - web sites)-approved testing on humans is at a very early stage. The first human clinical trials began in June on just 12 patients with lipomas no larger than five centimeters (two inches).

Still, Dr. Zachary Gerut, a Long Island plastic surgeon who is conducting the trial for Biospecifics, was encouraged by what he has seen so far.

"Ten out of the 12 patients had a significant reduction in the size of the lipoma -- at least seven greater than 50 percent reduction," Gerut said in a telephone interview, noting that not all of the data was in.

How might this translate for the average couch potato looking to lose a spare tire around the middle or unsightly love handles?

POSSIBLE 'OFF-LABEL' USE

"It's common knowledge that the fat inside a lipoma is the same as the fat inside the rest of the body," Gerut said.

However, he added: "If it only turns out to be useful for lipomas, that will still be very significant."

Lipomas are very common and while they usually pose no danger, Gerut said many people suffer from multiple, large and sometimes painful lipomas.

"Right now each one has to be removed surgically," Gerut said.

And should regulators eventually approve the treatment only for shrinking lipomas, there is nothing to stop doctors from prescribing it for body fat if they believe it will work. The wide use of Botox for treating wrinkles other than the one for which it was approved is a classic example of popular "off-label" use of a treatment by plastic surgeons.

If the FDA gives the go-ahead for the trials to proceed, Gerut said the next phase would likely involve at least 100 patients.

Biospecifics Executive Vice President Thomas Wegman said extensive blind placebo trials will be necessary and final approval, if it comes, could be "five years down the road."

There are no fat melting treatments currently approved by the FDA, but Wegman believes the agency might look favorably on a noninvasive alternative to surgery or liposuction if results of clinical trials satisfy regulators.

Wegman said Biospecifics would welcome a licensing partner, such as a large drug company, that could provide an infusion of cash to help keep the project on track for reaching the market within five years.

"We're a small company; it's a matter of resources," said Wegman, whose company's share price closed at $1.12 on Nasdaq on Tuesday. "If we got good funding, it could be done."