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news.EGEN has received a four-year grant from the US Food and Drug Administration (FDA) for the development of EGEN-001, the company's lead product in development for the treatment of advanced recurrent ovarian cancer.
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The company has successfully completed two Phase I trials of EGEN-001, in which the treatment resulted in good safety, biological activity and encouraging efficacy.
EGEN-001 received Orphan Drug Designation from the FDA in 2005, with its first orphan drug grant of $1,000,000 in 2005, and the latest grant is valued at $1,600,000.
EGEN president and CSO Khursheed Anwer said the company is pleased to receive this FDA support, which has been very useful in the advancement of 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," Anwer added.