Cadila Healthcare Ltd (Zydus Cadila) on Thursday announced a tie-up with IDRI for clinical development of the latter’s visceral leishmaniasis (VL) vaccine candidate, designed to prevent the deadly parasitic disease known as Kala-Azar in India.
IDRI is a Seattle-based non-profit research and product development organisation in the US.
Conducting trials in India, where there are real-life situations of disease exposure, is critical to determining the effectiveness of IDRI’s VL vaccine candidate and ensuring that it is approved and available within endemic countries, Pankaj Patel, Chairman and Managing Director, said.
VL is transmitted by the bite of an infected sand fly. There are over five lakh new VL cases and 50,000 associated deaths each year.
VL is the most severe form of leishmaniasis, affecting vital organs, and, if left untreated, the disease can be fatal. A vaccine is considered essential to control and eliminate the disease.
Currently, leishmaniasis occurs in four continents and is considered endemic in 88 countries, 72 of which are developing ones, with the disease being most common in India, Nepal, Bangladesh, Sudan and Brazil.
Available drugs are expensive and often toxic. To date, a safe and efficacious vaccine to prevent this disease does not exist.
IDRI’s VL vaccine candidate, Leish-F3+GLA-SE, is the product of more than 20 years of research and development supported by the US National Institutes of Health (NIH) and the Bill and Melinda Gates Foundation.
After completion of Phase 1 clinical trial of 36 US adult volunteers to test safety and immunogenicity, the vaccine was shown to be safe and to induce potent immune responses in healthy volunteers.