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Adress

Via Fiorentina, 1
53100, Siena
(Tuscany)

Telephone

+39 0577 1916204

Fax

+39 0577 43444

World Wide Web

www.toscanalifesciences.org

Research and Development

Molteni Therapeutics

Description

Molteni Therapeutics is a special pharma company which is active in research and development of innovative antibacterial and antifungicidal agents. In recent decades, it has acquired international expertise in the application of the photodynamic therapy (PDT) against bacterial fungicidal and also antibiotics-resistant infections. Molteni Therapeutics has test models available for infections in vitro (e.g. bacterial biofilms) and in vivo (e.g. infected wounds), in order to be able to test the efficacy and compatibility of its derivates. In addition, the company has specialists in the fields of bioanalysis, ADME/PK and formulation development of topical products, which are necessary for the optimisation of the therapeutic protocols.

Aim

In recent decades, as a result of increasing bacterial and antibiotic resistances, new therapeutic strategies became urgently necessary. In order to be able to cover this new requirement, Molteni Therapeutics has a pipeline with new chemical compounds, which have been patented; for bacterial and fungicidal infections, also multiple-resistant germs, these agents are very powerful and with a comprehensive effect. In addition, it was established that the bimodal approach with the photodynamic therapy does not lead to bacterial resistances. The innovative key substance RLP068 from Molteni Therapeutics is currently in the clinical testing phase on humans (first in human) in Great Britain; 2010 the test phase 2A takes place.

Externautics

Description

This project includes the identification of new tumour markers in order to be able to develop diagnostic and therapeutic tools. In order to reach this goal, modern techniques in the fields of genomics, proteomics and bioinformatics are used. A polyclonal antibody library is used for this, which is produced by immunisation of experimental animals with recombinant human proteins; the proteins are selected on the basis of their named affinity to the protein classes of the cell membrane or from secret databanks. The selection in silico was additionally filtered by taking proteins, which are noted as hypothetical and/or only noted marginally in scientific studies. The antibody library currently lists about 1 700 antibodies and is used to review which selected proteins are selectively present in the tumour tissues. In detail, a screening and the identification of tumour markers by the analysis of clinical samples on tumour patients are carried out. Thereby the TMA method (tissue microarray) is used. Proteins with selective or hyper expression in the tumour tissues are researched in detail to be able to validate markers thus; this comprises also the description and establishment of their relevance for tumour diseases. The first validation phase includes the confirmation of the altered marker for a large number of patients in order to fix thus the statistically significant frequency values. The presence of markers is determined by markers in the blood and urine of the patients. The analysis is particularly important as tumour markers, which are demonstrable in body fluids, have a high trade value. Moreover, specific monoclonal antibodies for markers are developed, which were identified and developed so that markers in cells can be recognised selectively by applying immunohystochemistry techniques, confocal microscopy, cytofluorometry and other immunological methods. The markers are then sub-divided after their clinical usage and, depending on the possible application as diagnosis and/or prognosis tool (e.g. a marker, the presence/absence of which does not alter the neoplastic course, but the presence /absence of which is clearly linked to the type of tumour, or its natural course, or its as a consequence of a therapy) differs from the markers suitable of the development of antitumoral medications. The identification of the markers for therapeutic use requires several test phases. Initially the appearance of the identified markers on the surface of tumours taken from the patients or on tumoural cell lines is confirmed. Thereby techniques are used such as cytofluorometry and confocal microscopy. Therafter follows a study of the phenotypic and functional changes of the cell as a result of the change to the marker caused by a necessary gene manipulation. This gene manipulation requires the use of genetic inactivation techniques (by means of antisense-oligonucleotide, ribozyme or siRNA) or over-expression techniques by means of transfection of coded constructs for the markers by applying representative cell models of the tumour classes. In a later project phase, also transgenetic organisms are used such as knock-out and knock-in mice, the relevant gene expression of which was selectively modified to be able to modify the effect of the changed expression to the physiological and morphological parameters of the organism. Finally the monoclonal antibodies for the selected markers are analysed for their ability to stop the in-vitro growth of the tumour lines or to retard or prevent the tumoural development for in-vivo-test models.

Aim

Tumours are one of the main causes of death of human beings. A careful and early diagnosis, together with an effective therapy could lower the death rate for this disease enormously. The most important factor is the identification of specific molecular components (markers), which can be used clinically, based on their selective presence in tumour tissue, for the tumour diagnosis and prognosis and for antitumoral therapies and the development of new molecular therapies. The project includes the identification of new tumour markers. Thereby the method used is an innovative immune-proteomic approach with the aim of developing diagnosis and therapy tools. The project is a high-grade innovative and important project for the industry, as it enables new diagnosis and therapy tools to be developed in oncology. The results expected from this project can be used in various areas, both in basic research and also in the field of clinical diagnosis and prognosis of tumour diseases. In the research area, new tumour markers enable new insights regarding the biology of tumours to be obtained. Moreover, this leads to a better definition of the molecular components, whereby the neoplasias of the patients differ. Finally the antibodies offer against the markers more specific alternatives to the researchers in order to examine the role of the proteins in oncogenesis and in the tumoural course. In the medium term, the results can be valuable for the production of antibodies for diagnostic and therapeutic use and for the generation of diagnostic and prognostic kits. New therapeutic agents are created on the basis of the markers identified. They serve to develop targeted cancer therapies with better and more individual treatment of the patient. These are based on the specific molecular classification of the neoplasma of the patient. Externautics wishes to develop some particularly interesting markers for this project in order to take these forward to the clinical development phase. Thereby still further national and international partners from industry and/or the universities should participate.