VGX-3100, a therapeutic DNA vaccine, achieved a 25% or greater reduction in high-grade HPV-16/18 vulvar squamous intraepithelial lesion in 63% of patients at 6 months after treatment with the agent, according to co. conclusions from open-label phase 2 clinical trial (NCT03180684) announced in a press release from INOVIO Pharmaceuticals, Inc.
“These phase 2 efficacy results are promising non-surgical advances for relapsing disease that typically require repeated ablation and excision procedures to achieve disease reduction and risk reduction, and may be ‘offering patients a safer, more tolerant and more effective treatment option,’ they said. Robert Edwards, MD, Professor Milton Lawrence McCall, and Chair, Department of Obstetrics, Gynecology & Reproductive Sciences, University of Pittsburgh, lead investigator of the study, in a statement.
In addition to HPV-16/18 HSIL-associated vulvar, treatment with VGX-3100 resulted in HSIL vulvar solution in 3 out of 20 patients with histology data. No HPV-16/18 virus was ever detected in the treated area. On the other hand, there was only a 2% spontaneous solution of HSIL vulvar. Vulvar cancer was not observed in any patients in the trial.
Adverse events were observed in the study, with the most common being injection site pain. The majority of cases of injection site pain were moderate to severe. Treatment was not stopped due to the emergence of AEs, but 5 patients withdrew from the study. Patients enrolled in the study will continue for safety for 18 months after their last dose of VGX-3100.
“Reducing predictive disease offers a significant improvement in the management of this devastating disease and is a step towards advancing women’s health care,” said Prakash Bhuyan, MD, PhD, senior vice president and head of HPV Therapeutic Clinical Development, INOVIO Pharmaceuticals, Inc.
A phase 2 study of VGX-3100 included 24 female patients between 22 and 70 years without comorbidities. Characteristics of patients examined at the time of study showed that 80% of the population had intraepithelial vulval neoplasia (VIN) 3, and 88% showed a history of at least 1 recurrence.
Patients were eligible for enrollment because they were at least 18 years old with HSIL of the vulva caused by HPV16 / 18 infection. The study excluded different VIN women confirmed by biopsy , previous treatment for vulvar HSIL within 4 weeks before screening, had an allergy to 5% imiquimod cream or an inactive ingredient in 5% imiquimod cream, were pregnant or breastfed, had immunosuppressants such as resulting in subluxation. illness, or there was a major or ongoing illness.
VGX-3100 is currently under study in 2 phase 3 clinical trials (REVEAL1, NCT03185013
and REVEAL2, NCT03721978) for the prevention of HPV-16/18-associated high-risk predictive lesions. The aim of both studies is to reduce the risk of patients developing cancer.
Information:
INGIO’s VGX-3100 demonstrates advanced stage 2 efficacy in the treatment of precancerous vulvar dysplasia induced by HPV-16/18. Press release. INOVIO Pharmaceuticals, Inc. 6 January 2020. Accessed 6 January 2020. https://bit.ly/2XiyEcG