The drug major on Sunday said it has received DCGI approval to initiate Phase III clinical trials of its Covid-19 vaccine ZyCoV-D.
The company announced that it will be starting Phase III clinical trials of it plasmid DNA vaccine to prevent COVID-19, ZyCoV-D after having received permissions from the Drugs Controller General of India (DCGI).
The firm will be initiating Phase-III clinical trial in around 30,000 volunteers. ZyCoV-D was found to be safe, well tolerated and immunogenic in the Phase I/II clinical trials, as per the company's disclosure filed on Sunday, 3 January 2021.
The Phase-II study of the vaccine ZyCoV-D had been conducted in over 1,000 healthy adult volunteers as part of the adaptive Phase I/II dose escalation, multi-centric, randomized, double-blind placebo-controlled study. The vaccine was found to be safe and elicit a strong immunogenic response. The trial has reviewed by an independent Data Safety Monitoring Board (DSMB) and reports were submitted to Central Drugs Standard Control Organisation (CDSCO) regularly for the update on safety outcome.
Pankaj R. Patel, the chairman of Zydus Group, said: "We are reaching a critical milestone in our vaccine development programme and towards our goal of helping people fight the pandemic with an indigenously discovered, safe and efficacious vaccine. The launch of the Phase 3 trial will determine the efficacy of our vaccine in preventing COVID-19 which continues to pose a major threat, the world over."
The company's consolidated net profit soared 411% to Rs 423.60 crore on 16% jump in net sales to Rs 3,762.30 crore in Q2 September 2020 over Q2 September 2019.
Shares of Cadila Healthcare rose 0.75% to Rs 482.10. Cadila Healthcare is a global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies.
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