A Scorpion’s Poison Antivenin R&D+i Project Case from a Mexican Public University – Anascorp FDA 2011 approval

A Scorpion’s Poison Antivenin R&D+i Project Case from a Mexican Public University - Anascorp FDA 2011 approvalIn 1999 the Health World Organization (HWO) launched a general invitation to the world’s scientific community to get a solution for the need of antivenins in Africa. During 2001 UNAM’s BTI scientific team formed by Alejandro Alagon, Lourival Domingos Possani and Roberto Pablo Stock developed the project. In 2004 the first essays at the African Republic of Benin were carried on presenting excellent results. Due to successful of Alacramyn at Sub Saharan Africa, since 2005 the HWO issued an invitation to UNAM’s BTI and Bioclon scientists’ team to help finding the solution for other notable poison animal’s problem existing at the Maghreb zone. They worked together more than four years developing antivenins for North Africa and the Middle East. Similarly to what happens in Mexico, there are about 200,000 scorpion stings per year, majorly to children at the Maghreb Zone, 20% corresponding to Morocco. Today Alacramyn has the certification and approval of the Morocco Pasteur Institute. Responding to international market requirements, Alacramyn has three relevant characteristics: immediate reaction time, it is safe and easy to conserve owing to it is able to storage bellow 37°C without refrigeration. Medical doctor of some North Africa and Middle East countries as Senegal, Algeria and Tunisia have also validated the product.
The antivenin research collaboration between UNAM’s BTI and Bioclon scientists has also crossed the Mexican border. There are about 800 scorpion stings in Arizona per year and this situation is considered a public health issue.
As result of 12 years collaboration between Alagon Cano and Jose Lever from Arizona University with Bioclon, they obtained at the second half 2011 the Federal Drugs Administration (FDA) approval for Anascorp Scorpion antivenin (the USA commercial nomination for the Mexican Alacramyn) performing the testing and clinical evaluation required by the Agency’s protocol. (News Medical, 2011; Boletln UNAM-DGCS-458 Ciudad Universitaria, 2011). The clinic essays were conducted by Dr. Leslie Boyer, Director of the Venom Immune Chemist, Pharmacology and Emergency Response Institute (VIPER) at the University of Arizona (UA) applying the antivenin antidote to about 2000 patients from Arizona and Nevada who got healthy without secondary effects. Through this field research experience UNAM and Bioclon scientific team guaranteed the fabrication processes required to comply with the USA standards.
Investigation was financed by the Orphan products development Office of the FDA and mainly conducted in the UA’s Medical Center and the Tucson’s Medical Center. The spectacular results reported by Boyer et al., showed that using the Anascorp antivenin in a double blind placebo study, the critical neurological syndrome solved in patients more rapidly among recipients of the antivenin than among recipients of placebo, diminishing the dose of concomitant midazolam for sedation and the quantitative levels of scorpion’s venom in plasma, all of these just four hours after administrating the drug.
Today Bioclon is continuously performing biological and pharmaceutical R&D and emerged as a world leader in the research field also, development and production of antivenin for stings and bites of poisonous animals, creating innovations as the main recourse for competitiveness. (Instituto Bioclon, 2011). Bioclon actually has following granted patents: MEXPAT 30257 and USAPAT 6,709,655 (Pharmaceutical composition of antibody fragments F(ab’)2 and process for the preparation thereof). Their products include coral snake, pit viper, central and South America snakes, African snakes, scorpion and black widow antivenin.

Tags: , , ,