On March 4, Dezhan Health announced that on March 3, 2021, the company received a letter of notification from the company’s subsidiary, Oriental Strategy, that Oriental Strategy’s US partner Inovio announced a DNA treatment jointly developed by it and Oriental Strategy.
The positive results of the first phase III clinical trial (REVEAL1) of the combination of the drug VGX-3100 and the device CELLECTRATM5PSP in the treatment of HPV-16/18-related high-grade cervical squamous intraepithelial lesions (HSIL), reached the clinical level in all evaluable subjects The primary endpoint of efficacy and all secondary endpoints
VGX-3100 is a key cooperative development project between Orient and Inovio in the field of DNA immunotherapy.
It is used to treat precancerous lesions caused by human papilloma virus (HPV).
Orient has products in Greater China (Mainland China, Hong Kong, Macau, Taiwan) have the exclusive rights of development, production and commercialization.
Currently, the Phase III clinical trial approval of China CFDA has been obtained, and Phase III clinical trials are being carried out simultaneously in China
Once VGX-3100 is approved for marketing, it will be the world's first non-surgical treatment developed to treat HPV-related precancerous lesions (cervical precancerous lesions, anal precancerous lesions, vulvar precancerous lesions, etc.
), and it is also the world's first DNA drugs
Globally, these three indications currently have no treatment other than surgery, and drug treatment is temporarily blank
Currently VGX-3100 is carrying out two international multi-center phase III clinical trials, including REVEAL 1 (critical phase III trial) and REVEA L2 (confirmatory phase III trial), aiming to evaluate and verify the safety and resistance of VGX-3100 Receptivity, immunogenicity and effectiveness
REVEAL 1 is a randomized, double-blind, placebo-controlled clinical study.
This clinical trial enrolled 201 patients with HPV-16/18-related cervical high-grade squamous intraepithelial lesions
In this REVEAL1 study, a total of 201 subjects (ITT) were enrolled, of which 8 subjects fell out, and no final data was obtained.
The number of evaluable subjects was 193 (mITT)
The primary endpoint was the ratio of HSIL lesion histological outcome and HPV16/18 virus clearance at the same time at the 36th week
In the population of evaluable subjects, the result was 23.
7% (31/131) in the treatment group and 11.
3% (7/62) in the placebo group, which was statistically significant (p=0.
022; 95%CI: 0.
5) , Reached the main endpoint
The secondary endpoints of clinical efficacy have also been achieved, including: a) cervical HSIL lesions turned into normal tissues and HPV16/18 virus clearance; b) cervical HSIL lesions only; c) cervical HSIL lesions turned into normal tissues; d) Only HPV 16/18 virus is cleared
In terms of safety, the number of serious adverse reactions related to treatment is zero, and most subjects with adverse reactions can relieve themselves, which can be classified as mild to moderate, which is consistent with early clinical trials