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Technology for photodynamic therapy of tumours

Patented drug formulations of a phthalocyanine photosensitiser based on microfludised lipids in a gel are being developed for photodynamic therapy of tumours together with non-coherent and coherent light sources suitable for the market.

The project will follow two branches in an effort to improve the following fields of interest: A) BIOTECHNOLOGY - i.e. research on pharmaceutical forms of photosensitisers for the photodynamic treatment of cancer diseases resulting in their optimalisation. B) LASER TECHNOLOGY - i.e. coordinated development interconnected with the development of photosensitisers and new light sources for the photodynamic therapy of tumours. AIMS We intend to develop industrial manufacturing of new formulations of photosensitisers for photodynamic therapy (PDT) of tumours based on hydrophobic derivatives of phthalocyanine, for which a Czech patent was awarded and PCT (Patent Cooperation Treaty) patent applications were submitted (authors Jezek, Nekvasil, Pouckova). We will adapt the patented procedure with the regulations of Good Manufacture Practice (GMP) according to the European Union rules in the case of microfluidisation procedures. We will deal with the prevention of lipid oxidation during the procedure and test liposomal stability in gel formulations; we shall optimise the size of the microfluidised particles and optimise the form and size of entry particles of phthalocyanine powder and its coating, adjust doping with certain nano-particles, etc. In the second part, the refinement of the product will take place in procedures, where the existing product will be mixed with antineoplastic drugs, or will be based on an advanced photosensitiser from the new generation of photosensitisers, or combined in a pharmaceutical form with nano-particles for the delivery of oxygen. The purpose will be increased penetration through interstitial spaces of capillaries or improvement of the pharmaceutical form quality. The proposed project aims to integrate all these efforts and develop hydrophobic derivatives of phthalocyanines for industrial-scale and obtain approvals from the Czech National Agency (SUKL) for up to phase 2B of clinical testing, following the implementation phase. To achieve this, there is a need: 1) To develop up to phase 2B of clinical testing, industrial formulations of novel hydrophobic phthalocyanine derivatives for PDT of basaliomas, inoperable melanomas and other skin tumours or actinic keratosis. 2) To involve and go through the approval process for more indications such as colorectal carcinomas. 3) To develop new combined drug formulations and patent their coverage in the EU and the main industrial countries worldwide. The advantage of the suggested drug formulation (FCIII) lies in its instant use - irradiation therapy can be done only 5 to 10 min after application, whereas with preclinical testing on human tumours implanted in nude mice 100% disintegration efficiency has been reached even for vital tumours such as colorectal carcinoma (Nekvasil et al.,Drug. Develop. Res. 2007.in press) SKEDULE for A), for FCIII (phthalocyanine): * 2009: Development of industrial prototype drug formulation; preclinical testing and toxicity tests, stability tests of the sole drug; development of an industrial manufacturing procedure; * 2010: Finishing of tests of industrial formulations, adaptation of the developed mixing procedure and microfluidisation procedure according to the development; further development of industrial manufacturing and drug formulations; * 2011: Start of approval procedure phase-1/2A for clinical testing of PDT on inoperable basaliomas and inoperable melanomas; * 2012: Receiving approval for phase-1/2A of clinical testing; Industrial-ready preparation; approval application for phase-2B clinical testing for PDT on basaliomas, inoperable melanomas, actinic keratosis and breast carcinomas. MEDICOM & Italian partners will lead part B) Laser technology and optics as follows: they will design a coherent or non-coherent radiation source with specific wavelengths suitable for photo-activation of porphyry dyes and their derivatives with the possibilities of combinations with endoscopes, and implementation of a clinical assessment/clinical trial. Special attention will be paid to the optimisation of the optical flux density used and depth of the penetration of radiation applied. In the use of photo-dynamically active substances, the therapeutic effect depends on the penetration of radiation of a relevant wavelength through the tissue and on spectral characteristics of the sensitising agent. SCHEDULE for B), * 2009: studies of photosensitiser photophysics; relevant design; optimisation; * 2010: construction of a prototype of coherent and non-coherent light sources; * 2011: preclinical testing of light sources; * 2012: testing, licensing and marketing. Keywords: tumour therapy, drug manufacturing, liposomal gel.
Acronym: 
PDT-TECH
Project ID: 
4 511
Start date: 
01-01-2009
Project Duration: 
48months
Project costs: 
4 500 000.00€
Technological Area: 
Medical technology
Market Area: 
MEDICAL / HEALTH RELATED

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