- VLP Therapeutics attains FDA’s clearance over its investigational new drug application
- Post clearance the firm is all set to begin the first clinical trial of VLPM01, its malaria vaccine
In a recent turn of events, VLP Therapeutics declared that the Food and Drug Administration of United States has approved an IND (investigational new drug) application for the firm’s new VLPM01 malaria vaccine’s clinical trial.
According to sources familiar with the development, the clinical trial’s phase I/IIa would start recruiting partakers in the second month of 2019, and has been designed to appraise the immunogenicity, safety, and effectiveness of the VLPM01 vaccine for malaria. Reportedly, the clinical trial would take place at the Walter Reed Army Institute of Research located in Silver Spring, Maryland.
According to a press release by VLP Therapeutics, VLPM01 is firm’s first vaccine contender to get into humanoid clinical trials. The press release also stated that the new vaccine candidate is pre-erythrocytic vaccine providing CSP (circumsporozoite) antigen on company’s patented i-αVLP (inserted alphavirus virus-like particle) vaccine platform.
Clinical trials using mosquito-bite induced CHMI, or controlled human malaria infection, with P. falciparum have been performed in adults who are malaria-naive in an effort to assess the protective effectiveness of malaria vaccines, cite trusted sources.
After vaccinations are conducted, clinical trial partakers would reportedly be exposed to malaria-generating parasites through mosquito bites in controlled lab settings. Controlled human malaria infection will enable researchers to assess a malaria vaccine contender’s effectiveness and acts as a precursor to field researches in malaria-endemic areas globally, claim sources.
Dr. Wataru Akahata, Ph.D., Chief Executive Officer, VLP Therapeutics, was quoted stating that the clinical trial embodies a significant milestone for the firm as the first clinical trial is being initiated and this marks a great accomplishment for VLP’s team. Dr. Akahata further stated that this signifies the culmination of years of efforts by firm’s resources as well as partners and the firm is rather grateful for all the support it has received from its partners, like the U.S. Department of Defense.