Scientists from the Butantan Institute, the State University of São Paulo (UNESP) in Botucatu and the Vital Brazil Institute have advanced in the development of a serum against poisoning caused by the sting of the Africanized bee (Apis mellifera).
The serum is expected to enter Phase 3 clinical trials later this year.. The product is patented and obtained promising results in phases 1 and 2 of the studies, disclosed in the journal Frontiers in Immunology. The researchers are excited about the project.
According to researcher Daniel Pimenta, from the Butantan Biochemistry Laboratory, one of the patent holders, the new medicine is intended for people who suffer multiple bee stings, that is, they receive a large amount of venom.
The toxins of the “killer bee”, as the species is known, can cause bleeding, pressure drop, dizziness, nausea and tachycardia. The main target of the poison is the kidneys and the patient can have kidney failure and die as a result.
The idea of producing a serum against bee poisoning came up in Butantan more than 10 years ago. The first step was to carry out the biochemical characterization of the venom in order to understand its composition and think about making the serum production feasible.
The phase 1 and 2 clinical study involved 20 adult volunteers, with an average age of 44 years. The number of bites ranged from seven to 2 thousand. No serious adverse effects were observed and all patients improved, according to the scientists.
Tech
10 Mar
Tech
09 Mar
Now, the researchers are designing the phase 3 protocol, which should last five years, to be submitted for approval by the National Health Surveillance Agency (Anvisa). Brazil records about 20,000 accidents with bees and 50 deaths annually.
If approved by Anvisa, the serum can be produced at the Vital Brazil and Butantan Institutes. The objective is for the medicine to be made available in the future in the Unified Health System (SUS), as well as the other hyperimmune sera produced by Butantan.