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A novel platform for the sustained intracellular delivery of therapeutic molecules.

A novel platform for the sustained intracellular delivery
of therapeutic molecules.

With increasing knowledge of genomics and proteomics, many new intracellular pharmacological targets will be achieved. Exploiting these new therapeutic opportunities demands the sustained delivery of active compounds to the interior of the cell. A generic platform will be developed that enables prolonged exposure of intracellular targets to proteins and small molecules. DIATOS' transport peptides will be combined with OCTOPLUS' Dextran-based particulate delivery system. The project is divided in two phases, a feasibility and a development phase. 1. Feasibility Phase: Four approaches will be followed in a stepwise manner: 1a. Controlled release of therapeutic proteins, linked to transport peptides, from Dextran microspheres. 1b. Intracellular controlled release of a therapeutic protein from 500 nm microspheres after loco-regional administration 1c. Intracellular controlled release of a therapeutic protein from nanospheres (100-200 nm) or transport- facilitated liposomes after intravenous administration. 1d. Intracellular controlled release of a gene, coding for a therapeutic protein, from 150 nm nanospheres. 2. Development Phase: From the feasibility study, a choice will be made on the most promising technology. Preformulation and formulation development studies will be carried out to obtain a laboratory bench prototype. Freeze drying development and upscaling will be necessary to prepare for clinical phase 1 and phase 2 production. One of the technological challenges is the sterilization of these protein-containing particulate systems. Safety and efficacy of the drug delivery system will be investigated in a toxicology programme and clinical phase 1 and phase 2 studies. Keywords: drug delivery, therapeutic, biotechnology.
Project ID: 
2 578
Start date: 
01-10-2001
Project Duration: 
64months
Project costs: 
5 020 000.00€
Technological Area: 
Pharmaceutical Products / Drugs
Market Area: 
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