ASV Production and Clinical Trials

In a continuous effort to produce locally a quality Snake anti venom (ASV) and transfer of internationally accredited technology the project could bring it’s first test ASV in December 2013. It took almost a year and half to acquire WHO described quality parameters and the product was put under WHO registered clinical trials  during September to October 2015. The results were amazing and highly encouraging. The entire six patients treated in 2nd phase of clinical trials at District Hospital Mithi district Tharparker provided positive results with minor adverse effects commonly found even in the most purified ASVs in the world because of antigenic behavior of foreign protein of equine origin. The trials were conducted by an approved panel of experts as per technical plan approved by Institutional Review Board and Ethical Committees, duly accepted by WHO Iran office through Iranian Registry of Clinical Trials (IRCT) Tehran. The trials were directly observed, supervised and monitored by six Professors (Heads of their relevant department) of Peoples Medical University Nawabshah, Sindh University Jamshoro and Sindh Agriculture University Tando Jam and a number of Associate Professors, Assistant Professors, Post graduate Research Scholars and various subject matter specialists to note and analyze various safety and efficacy parameters of the newly manufactured ASV as well as to ensure possible high skilled medical and clinical assistance to meet any acute emergency in case of any drastic reaction, adverse effect or unwanted consequence. So far almost 50 patients are treated as part of phase III of the cited clinical trials. The results are same as of phase II with no life threatening situation so far and each patient of Echiscarinatus Sochureki treated with Sindh ASV required only one vial as against the Indian ASV needing as much as 20 vials to treat similar case and 4-6 vials of NIH Islamabad ASV. In sequence of this WHO registered clinical trials it is firmly anticipated that during March 2016 a comparative study of 48 cases of snakebite will be conducted to compare the efficacy and safety of Sindh ASV against the other ASVs available in the market. To best perception of the project such WHO registered clinical trials are conducted first time in Pakistan for any genuine product of Pakistan.

Besides leveling the decades old shortage of ASV in Pakistan and responding the demand of masses, Sindh project could bring the most updated technology of Caprylic Acid Fractionation in the region which other neighbor countries are still lacking. It can be awesome to note that parallel with Horse ASV the Sindh Project could produce Camel ASV and has tested it in vitro and in small animals. The results are more encouraging than Horse ASV and so far the Camel ASV is proved two time more efficient, 200 C more heat stable, more soluble and having higher affinity for snake venom than Horse ASV. It is anticipated that the commercial supply of Camel ASV in the local market likely to happen in 2016 may tag Pakistan the second country of the world after Costa Rica using Camel ASV on mass level.