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.