KRS L-Asparaginase Used In Study
KRS Global, the preeminent provider of compounded L-Asparaginase in the United States, is honored to have our preparation used in a major multi-site study to test the effectiveness of our product against that of the manufactured product (no longer available) Elspar (Lundbeck LLC, Deerfield, IL). We are extremely pleased with the results as we hope are all of the veterinary oncologists and specialists who utilize our preparation on a daily basis. When the study was conducted between November 2013 and December 2014 KRS offered a non-sterile product but the preparation offered by KRS today is a sterile, lyophilized powder for reconstitution.
Seventy-five canines were treated in the study; 47 with our preparation and 28 with Elspar. No canines treated with KRS product experienced an adverse event attributed to our L-Asparaginase. This was not the case with Elspar. Two animals experienced adverse events which the doctors attributed to the manufactured product.
“The overall response rate was 80% (11 CR and 26 PR) for CLASP (compounded L-Asparaginase) and 59% (4 CR and 12 PR) for Elspar. The response rate for dogs that were naïve to treatment was 83% (11 CR and 23 PR) for CLASP and 71% (3 CR and 26 PR) for Elspar. The response rate for relapsed and refractory cases was 60% (3 PR) for CLASP and 40% (1 CR and 3 PR) for Elspar. Response in dogs previously treated with LASP was PR (n = 2, CLASP), SD (n = 1, Elspar), and PD (n = 2, Elspar).”
“Based on our results, the L-Asparaginase compounded by KRS Global Biotechnology between November 2013 and December 2014 was safe in the treatment of dogs with lymphoma. NO AE WERE ATTRIBUTED TO CLASP. In combination with a corticosteroid, CLASP showed activity against lymphoma with an overall response rate of 80%. As single agents, the reported response rates for corticosteroids and LASP are 48% and 73-79%, respectively.”
The general findings and recommendation of the study authors, specifically our contact, Dr. Nicole Northrup, are for veterinarians to understand what 503b outsourcing facilities are and how their products can usually be relied upon more than compounding pharmacies because of the requirements placed on them by the FDA and their public inspection records.
If you have any questions about KRS products, processes or pricing, we encourage you to reach out to us at any time.