Industry News (Therapy)

Advanced Ovarian Cancer Orphan Drug Designation Granted

Published in Cancer Weekly, October 16th, 1995

RGene Therapeutics, Inc., The Woodlands, Texas, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to RGene's RGG0853 gene therapeutic for advanced ovarian cancer that overexpresses the HER-2/neu oncogene. Elevated levels of HER-2/neu are highly correlated with extremely poor survival of women with ovarian cancer.

RGG0853 consists of DC-Cholesterol, RGene's lipid-based gene delivery system, complexed with E1A, a tumor suppressor gene. DC-Cholesterol is the only non-viral gene delivery system that has demonstrated to date, in two published human clinical studies, effective gene delivery and biological activity.

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Source: Cancer Weekly (1995-10-16)

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