CDSCO Panel Nod To Phase I Clinical Trial of Anticancer Drug Bevacizumab by Jeevan Scientific
New Delhi: Noting that the drug product is approved in the country of origin, the Subject Expert Committee (SEC), functional under the Central Drugs Standard Control Organization (CDSCO), has granted permission to Jeevan Scientific Technology to conduct a Phase I clinical trial of Bevacizumab Injection 400 mg/16 mL.
This came after the firm presented the proposal for a grant of permission to conduct a Phase I clinical trial titled “A Phase 1, double-blind, randomized, two-treatment, two-arm, single-period, single-dose, parallel, comparative pharmacokinetic study, of BE1040Vinjection 400mg/ 16ml of AryoGen Pharmed., Iran comparing with Avastin 400 mg/16 ml concentrate for solution for infusion of Roche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany in normal, healthy, adult, human subjects under fasting condition."vide Protocol No.: 25-025, Version No. 01 date: 10 Apr 2025 for export purposes.
The firm also presented data from the Phase III clinical study conducted in Iran, including safety data.
Bevacizumab is a monoclonal anti-vascular endothelial growth factor antibody used in combination with antineoplastic agents for the treatment of many types of cancer.
There is a great deal of evidence indicating that vascular endothelial growth factor (VEGF) is important for the survival and proliferation of cancer cells. VEGF plays an important role in angiogenesis, lymphangiogenesis, and tumor growth, which are all factors that contribute to its attractiveness as a therapeutic target for anti-cancer therapies.
In 2004, bevacizumab gained FDA approval for specific types of cancer and became the first antiangiogenic agent introduced to the market. It is a humanized monoclonal IgG antibody and inhibits angiogenesis by binding and neutralizing VEGF-A.
Bevacizumab is generally indicated for use in combination with different chemotherapy regimens which are specific to the type, severity, and stage of cancer. Bevacizumab was approved by Health Canada on March 24, 2010 and by the European Commission on April 21, 2021.
The firm submitted supporting data from a Phase III clinical study conducted in Iran, which included safety findings. The committee noted that the product is already approved in its country of origin.
After detailed deliberation, the committee recommended for the grant of permission to conduct the Phase I clinical trial as per the protocol presented by the firm.
