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 NASDAQ
in full National Association of Securities Dealers Automated Quotations
U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :SUPG SUPG Streamline Upwind Petrov Galerkin ), 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 Evanston Hospital is located Evanston, Illinois, near the campus of Northwestern University. The hospital is run by Evanston Northwestern Healthcare, which owns Glenbrook and Highland Park Hospitals, as well as a number of outpatient facilities. 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 ran·dom·ize
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment. , double-blind crossover study A crossover trial also referred to as a crossover study is one where patients are given all of the medications to be studied, or one medication and a placebo in random order. These studies are generally done on patients with chronic diseases to control their symptoms. 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 in·ject·a·ble
Capable of being injected. Used of a drug.
A drug or medicine that can be injected. 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 Side effects
Effects of a proposed project on other parts of the firm. 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 renal failure
Acute or chronic malfunction of the kidneys resulting from any of a number of causes, including infection, trauma, toxins, hemodynamic abnormalities, and autoimmune disease, and often resulting in systemic symptoms, especially edema, and aplastic anemia aplastic anemia
or anemia of bone-marrow failure
Inadequate blood-cell formation by bone marrow. Pancytopenia is the lack of all blood-cell types (erythrocytes, leukocytes, and platelets), but any combination may be missing. .
CONTACT: SuperGen Inc., Emeryville
Joseph Rubinfeld, 510/655-1075 x230
Les Stickles, 510/655-1075 x210