Recoly developed a novel patented "platform" technology for the prolongation of protein and peptide half-life and efficacy by formulation with proprietary liposomes. The delivered proteins/peptides are neither encapsulated in the intraliposome aqueous phase nor inserted into the lipid bilayer but rather associated with the liposomes in a specifically high affinity manner without loosing their activity. In addition, a screening method to test interaction of any protein/peptide with the liposomes was developed. The technology and approach was extensively developed for liposome formulation for FVIII protein. This protein has a half-life of 10-12 hours in humans and participates in the clotting cascade. Experiments in hemophilic mice indicate that the half-life and clotting efficacy of liposome-formulated FVIII is significantly enhanced over those of free FVIII and that formulation with liposomes leads FVIII to high concentrations in organs. Results of a multi-center, patient blinded phase I/II clinical trial indicate significantly higher efficacy of liposome-formulated FVIII and support the concept of the technology.

The concept of liposome-formulated protein/peptide

  1. Protein/peptide formulate with liposomes by mixing liposome solution with the protein
  2. Manufacturing process of the protein/peptide unchanged.
  3. The protein/peptide binds non-covalently to liposomes.
  4. The protein/peptide properties improved: Higher efficacy and reduced frequency of injections.
 

Potential advantages of liposome-protein/peptide

  1. Higher efficacy due to high concentration in various organs and longer half-life.
  2. All the rotein/peptide is therapeutically available.
  3. Reduced frequency of injections. Since the protein/peptide is formulated with the liposomes simply by hydrating the dry protein concentrate with the liposome solution, there is n o need to change the production process