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Vopec Pharmaceuticals has received the NOC (no objection certificate) and license to develop and test its new anti cancer drug as a new chemical entity (NCE), which also offers a promising therapeutic option for COVID-19.
It inhibits Angiotensin-converting enzyme-2 (ACE-2) and Nonstructural protein-15 (Nsp-15). The NCE, according to the company, has the ability to target lungs to eliminate cancer stem cells (CSCs) and also treat COVID-19 infection.
The DCGI approval also includes testing and analysis of the NCE. The company also applied for a US patent for the same.
“We would approach DCGI to conduct the required bioequivalence clinical trials in India and also seek strategic private investments or government aid to commercialize this product, subject to all regulatory approvals and trials. We are being represented by Cooley Group, one of the foremost leading Pharma Attorneys in the US, for the patent approval,” Ramakrishnan Karnan, director, Vopec Pharmaceuticals told Pharmabiz.
The Chennai-based company funded by Agastiya Biotech, USA reported that the molecule has been tested for safety in animal models which exhibited no signs of discomfort or cardiovascular or respiratory disease throughout the study period. There was no change in body weight monitored for a period after drug administration. It has the ability to activate CD4+ helper T cells and CD8+ cytotoxic T cells and generate an immune response in the body to protect against viral infections, noted Karnan.
For the first time, we have made a breakthrough molecule that complies with US FDA standards. Initially, our small molecule was intended for different forms of carcinoma including advanced pancreatic and colon cancer. In vitro and in vivo studies have demonstrated encouraging results in eliminating the CSCs, especially in the lungs. This molecule has the ability to target lungs to eliminate the CSCs and also treat COVID-19 serious issues, he added.
The R&D team identified that the small molecule inhibitor of ACE-2 has the potential to block corona virus entry into the host cells. This was documented by Simulation of Structural Interactions. The candidate compound was identified by molecular docking studies utilizing advanced computational models, which underwent testing to confirm the prediction.
The results suggested that the compound blocks 3 targets that are important for COVID-19 replication and infection. These are the viral spike interaction point, helicase, and protease which prevent the entry and viral replication in the host cells.
We are constantly pushing to stay ahead of this virus and are looking to provide meaningful solutions to the current pandemic situation at the earliest. Based on initial research outcomes our management and R&D team will decide further stages of development, said Karnan.
All research work was carried out by East West Integrative Medicine and Research Center, a sister concern of Vopec Pharmaceuticals, Chennai. Vopec was founded by M. Kannan, former Director of Tamil Nadu Drugs Control department.
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