Panacea Biotec is delighted to announce the signing of the agreement with Technology Development Board (TDB), Govt. of India for providing the financial assistance of Rs. 28.99 Crores for the “Development and commercialization of Dengue Tetravalent vaccine (Live Attenuated, Recombinant, Lyophilized)”. Dengue is a mosquito-borne flavivirus disease that has spread to most tropical and subtropical areas globally including India. The disease is caused by four immunologically defined serotypes of Dengue virus. Currently, there are no specific dengue therapeutic options available and the treatment is primarily supportive. The prevention is currently limited to vector control measures only. Panacea Biotec’s collaboration with National Institutes of Health (NIH), USA has led to the development of an advanced Dengue Vaccine in India with proven safety in pre-clinical studies. According to the results from clinical trials conducted by NIH, the candidate Dengue vaccine has been found to stimulate a strong immune response against all 4 serotypes in all age-groups and expected to be a single dose vaccine. Panacea Biotec has obtained Phase I/II clinical trial permission from Drug Controller General of India, New Delhi. Clinical trial lots production is in advanced stages at Panacea Biotec’s cGMP facility and clinical trials will be started by early 2018. Currently some of the vaccine candidates under development elsewhere require 2-3 doses to achieve desired immune response, while the published clinical data of only licensed vaccine outside India has shown a poor immune response against Type-2 strain of Dengue besides being a 3 dose vaccine and protects only the age group of 9-45 yrs. Dengue Viruses are defined immunologically by serotypes, not by genotypes. The vaccine being developed by Panacea Biotec is a live attenuated tetravalent vaccine which express authentic envelop proteins for the induction of immune responses to each serotype and also express non-structural proteins capable of inducing CD4 and CD8 T-cell responses that are both serotype specific and serotype cross-reactive. On this occasion Dr. Rajesh Jain, Joint Managing Director of Panacea Biotec has said “An efficient Dengue vaccine must provide a balanced immune response against all 4 serotypes in all age-groups ideally in a single dose regimen. Panacea Biotec’s Dengue vaccine development program would therefore represent a major advancement in the control of this life threatening disease globally.”
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