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SuperGen Inc. gains IND for new Phase II study of obesity pill; new human studies will focus on intermittent dosing.

EMERYVILLE, Calif.--(BUSINESS WIRE)--April 16, 1996--SuperGen Inc. (NASDAQ:SUPG), a development stage pharmaceutical company, announced today that its Investigational New Drug (IND) application with the U.S. Food and Drug Administration for a new Phase II human clinical study of its proprietary antiobesity drug has been cleared.

The drug, "RF 1051," is administered in pill form. RF 1051 currently is in ongoing Phase I/II human clinical studies, under a separate IND, based on a daily dosage schedule. The new IND was filed for concurrent trials with an intermittent schedule of dosing every two days.

The new study will involve approximately 80 patients at two sites, Evanston Hospital in Illinois and the Orlando Clinical Center in Florida.

RF 1051 is an orally administered formulation of a human steroidal hormone which also has been successfully tested in the ob/ob (obese) mouse and the db/db (diabetic) mouse models. SuperGen believes that RF 1051 plays a role in the intake and output of energy, rather than relying on appetite suppression or the stimulation of increased metabolic activity.

Under a Physicians's IND, in a randomized, double-blind crossover study with 17 obese human subjects over a 20-week period, patients lost significantly more weight during RF 1051 administration than during placebo administration. Their weight loss was maintained for an additional 10-week follow-up period.

"While we believe an oral rather than injectable drug will be critical to the success of long-term antiobesity treatment, we also believe the least stringent dosing schedule will have the most advantage," said Joseph Rubinfeld, Ph.D., chairman and chief scientific officer of SuperGen.

"Results from previous human studies suggest that RF 1051 has a serum half-life that may support administration on less than a daily basis, and our ultimate goal is a twice-weekly dosage regimen," Dr. Rubinfeld continued.

"No clinical side effects from RF 1051 have yet been observed. This trial was designed to obtain preliminary efficacy results from intermittent dosage, concurrent with ongoing daily dosage trials, and to help us plan later-stage clinical trials with the optimal dosing schedule."

Dr. Rubinfeld cautioned that, while recently lauded injectable approaches to obesity have garnered enormous public attention even prior to any human data, SuperGen's obesity pill still is in early human studies. He said that results to date are scientifically and clinically encouraging to the company, but long-term patient benefit cannot be established without further trials.

He added that initial results in humans, ob/ob mice and db/db mice have established RF 1051 as a top priority for SuperGen.

Based in Emeryville, SuperGen is a development stage pharmaceutical company dedicated to the development and commercialization of products intended to treat life-threatening diseases, particularly cancer and blood cell disorders, as well as other serious conditions such as obesity.

SuperGen is developing its anticancer portfolio of five generic products and four enhanced or "supergeneric" products. Blood cell disorder products under development currently target anemias associated with chemotherapy and radiotherapy, renal failure and aplastic anemia.

CONTACT: SuperGen Inc., Emeryville

Joseph Rubinfeld, 510/655-1075 x230

Les Stickles, 510/655-1075 x210
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Publication:Business Wire
Date:Apr 16, 1996
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