Panacea Biotec Bolsters Business Momentum: Commenced Phase III Clinical Trials

On August 14, 2024, Panacea Biotec Limited, a leading pharmaceutical and biotechnology company, announced in an exchange filing that it had started a Phase III clinical trial of its tetravalent dengue candidate vaccine, DengiALL, in India with the Indian Council of Medical Research. The trial commenced after receiving approval from the Drugs Controller General of India (DCGI). The clinical trial would involve 10,335 participants across 19 sites in India, the company further stated.

With the licensing and transfer of novel attenuated tetravalent strains of dengue virus between Panacea Biotec and the National Institutes of Health, USA, the development of DengiALL got underway at Panacea Biotec in 2006. Panacea Biotec has conducted Phase I/II clinical trials for the Indian population. A three-year safety follow-up will be finished in 2020. Then, in March 2022, Panacea Biotec and ICMR signed a memorandum of understanding for Phase III clinical trials to be conducted in India.

On the occasion, Dr. Rajesh Jain, Chairman and Managing Director at Panacea Biotec, said, “DengiALL vaccine development has a long way since it was initiated in 2006 in collaboration with the National Institute of Health USA. We are excited to announce that our dengue vaccine candidate has successfully entered the penultimate Phase 3 clinical trials in India in collaboration with the Indian Council of Medical Research. This milestone brings us one step closer to providing a safe and effective solution for preventing dengue fever, a disease that poses a significant public health challenge. We are committed to ensuring that this vaccine meets the highest standards of safety and efficacy, and we are optimistic about its potential to make a meaningful impact on the lives of millions.”

About DengiALL®

DengiALL® is a tetravalent recombinant live attenuated tetravalent candidate vaccine that targets all four serotypes of Dengue that are prevalent worldwide. Attenuated strains are designed to closely mimic natural infection to stimulate the immune system to recognise and fight the virus if the person is later exposed to wild-type dengue strains.

About Panacea Biotec Limited

Panacea Biotec Limited is a leading pharmaceutical and biotechnology company with established research, manufacturing and marketing capabilities. Panacea Biotec has played a vital role in Polio eradication in India by delivering over 10 billion doses of oral polio vaccines.

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