Inovio Initiates Phase II Study On Pipeline Drug VGX-3100
Zacks Investment Research | May 22, 2018 12:01AM ET
Inovio Pharmaceuticals, (NASDAQ:INO) has initiated a phase II study to evaluate the efficacy of its pipeline candidate VGX-3100 on adult men and women with human papilloma virus (HPV)-related anal dysplasia. This will be the third indication that VGX-3100 will be evaluated for. It is already being evaluated to treat HPV-related vulvar and anal precancers.
In the phase II study, VGX-3100 will be administered by intramuscular (IM) injection with CELLECTRAdelivery system in adult men and women who are human immunodeficiency virus (HIV) negative with histologically confirmed anal or perianal high-grade squamous intraepithelial lesions (HSIL) associated with HPV-16 and/or HPV-18. The study is expected to enroll 24 patients and will administer at least three doses of VGX-3100. In a phase II study for cervical dysplasia, VGX-3100 demonstrated a systemic response (versus localized surgery) and clearance of cervical lesions and eliminating the underlying HPV infection in many patients.
Anal HSIL or dysplasia is the precursor to anal cancer, which is estimated to cause more than 1,100 deaths in the United States in 2018. Currently the only treatments for anal dysplasia are surgical excision and electro-cautery or laser therapy. However, more than 50% treated with these current treatments experience recurrence of the disease. VGX-3100 has potential to be the first approved treatment for HPV infection of the cervix and the first non-surgical treatment for precancerous cervical lesions.
Year to date, shares of Inovio have rallied 16.5% against the Zacks Investment Research
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