Clinical studies on Gynex Pharmaceuticals Inc.'s drug Oxandrin(oxandrolone) have shown that the compound significantlyreduces the mortality rate in alcoholic hepatitis patients withmoderate malnutrition.
The results of the multicenter, double-blind, placebo-controlledstudy on 273 patients, which was conducted by the Departmentof Veteran Affairs, were reported in the current issue of thejournal Hepatology.
In the trials, Oxandrin, which is a testosterone analog that isthought to indirectly stimulate appetite and the immunesystem, among other actions, when combined with a nutritionalsupplement, was able to reduce the mortality in patients withsevere alcoholic hepatitis and moderate malnutrition by 50percent after one month's treatment.
Even after six months, the combined therapy resulted in a 46percent lower death rate among treated patients. Oxandrin hadno effect on mortality in patients with severe malnutrition orthose with moderate malnutrition but inadequate nutritionalintake.
Gynex (NASDAQ:GYNX) of Vernon Hills, Ill., intends to file a newdrug application (NDA) on Oxandrin for this indication with FDAby the end of this year.
In March, Gynex signed a definitive agreement to merge withBio-Technology General Corp. (NASDAQ:BTGC) of New York. Themerger, which is subject to approval by the shareholders ofeach company and regulatory bodies, should be finalized thissummer.
Gynex's stock was up 9 cents a share on Tuesday, to $2.97. --Jennifer Van Brunt
(c) 1997 American Health Consultants. All rights reserved.