While researchers seek genetic solutions for obesity, aprivately held company in Emeryville, Calif. said italready is in clinical trials with a fat pill.
Joseph Rubinfeld, chairman and chief scientific officer ofSuperGen Inc., said his four-year-old company receivedFDA approval for the Phase I/II trial last Friday. Thedrug, RF 1051, is an orally administered form of a humansteroidal hormone.
Rubinfeld said the synthetic hormone was effective intrimming pounds off the ob/ob mouse, which is theoverweight murine mutation researchers used to isolatethe obesity gene licensed by Thousand Oaks, Calif.-basedAmgen. The gene is considered one of the keys tounderstanding the polygenic nature of obesity.
In studies published in the July 28 issue of Science,Amgen researchers and others demonstrated that ob/obmice shed their weight when given the protein they lackbecause of the ob gene mutation. Amgen said humantrials may begin in 1996 with the ob protein, which hasbeen named leptin.
Rubinfeld said hormonal therapy has been studied foryears as a treatment for obesity, but added that RF 1051has demonstrated it can reduce weight in preclinical andpilot clinical studies.
In animal trials, he said, the drug slimmed not only theob/ob mouse, but also the db/db mouse, another obesemutant strain of mice being studied by researchers.
In addition, Rubinfeld observed, clinical studiesconducted under a physician's investigational new drugapplication in 1993 showed obese patients receiving RF1051 lost more weight than those who received a placebo.No side effects were reported. Rubinfeld also said asubsequent tolerance and safety study, conducted bySuperGen in 1994, showed no adverse effects from thehormone treatments.
The current Phase I/II trials, Rubinfeld said, will involveabout 8 patients who are immensely obese. If thosestudies are successful, SuperGen will conduct Phase IItrials in subjects more representative of overweightpeople in the general population.
The hormone's mechanism of action is not known, hesaid. "It may utilize fat more inefficiently in the energycycle," he speculated. "It may cause the body to use twiceas much fat to make the same amount of glucose. Or itmay stop fatty acids from accumulating." n
-- Charles Craig
(c) 1997 American Health Consultants. All rights reserved.