Development of technology is proposed for the controlled, commercial scale reproduction and rearing of Megathura crenulata, the Giant Keyhole Limpet, for production of Keyhole Limpet Hemocyanin (KLH), an active, non-specific immunotherapeutic adjuvant widely used in biomedical research and specifically in the treatment of certain cancers.
The specific aims of Phase I were achieved by: 1) Developing a method to control spawning; 2) Developing procedures for hatching and rearing larvae through metamorphosis; 3) developing suitable diets for growing adult Megathura in captivity; and 4) demonstrating the quantity and quality of KLH from specimens grow in captivity are comparable to those measured in wild populations. In Phase II we propose to: a) Develop and optimize diets for Megathura post-larvae and sustained KLH production; b) Optimize culture methods and stage-specific aquaculture systems for long-term maintenance of KLH-producing stock suitable for commercial scale production; c) Perfect reliable commercial procedures for non-lethal extraction and purification of KLH from aquaculture stock; d) Develop Standard Operating Procedures and establish Good Manufacturing Practice (GMP) standards for KLH produced from aquaculture; and e) In conjunction with prospective Phase III partners, develop a comprehensive business plan for scale-up of our company to meet forecasted KLH demand.
The proposed research will create a reliable commercial source of clinical grade KLH for use by pharmaceutical producers and the medical research community. Additionally, the research will create a source of live Megathura crenulata for use in the continuing effort to identify and purify new pharmaceutical compounds, and a supply of juvenile Megathura for restoration of the native population depleted by commercial harvest of the resource for KLH production.