FDA Awards EGEN, Inc. Orphan -Drug Grant for Clinical Development of EGEN-001 for Treatment of Ovarian Cancer
HUNTSVILLE, Ala., Feb. 2, 2011 /PRNewswire/ -- EGEN, Inc. today announced that the Food and Drug Administration (FDA) has awarded the company a four-year grant of $1,600,000 to assist in the Phase II clinical development of EGEN-001, the company's lead product. EGEN-001 is under clinical development for the treatment of advanced recurrent ovarian cancer. EGEN has successfully completed two Phase I trials of EGEN-001 in ovarian cancer patients. In the first study, EGEN-001 was administered as monotherapy in platinum-resistant ovarian cancer patients and in the second study in combination with carboplatin/docetaxel chemotherapy in platinum-sensitive ovarian cancer patients. In both studies, EGEN-001 treatment resulted in good safety, biological activity and encouraging efficacy. EGEN-001 received Orphan Drug Status from the FDA in 2005 and its first orphan grant of $1,000,000 in 2005.
"This is a significant milestone and accomplishment for the company," commented Dr. Khursheed Anwer, President and CSO of EGEN. "We are pleased to receive this FDA support, which has been very useful in the advancement of our novel EGEN-001 product in the clinic for the treatment of recurrent ovarian cancer. The product utilizes the Company's proprietary TheraPlas® delivery technology and is composed of interleukin-12 (IL-12) gene formulated with a biocompatible delivery polymer. IL-12 is a potent cytokine which works by enhancing the body's immune system against cancer and inhibiting tumor blood supply."