Objective
Objectives :
The primary objective of this demonstration project is to verify the anticancer clinical activity of Ecteinascidin-743 (ET-743), a new marine entity harbouring a novel mechanism of action. Clinical activity will be verified against six solid malignant tumor types for which available therapies have no or limited effects.
The selected tumor types are melanoma, lung cancer, ovarian cancer, breast cancer, renal cancer and prostate cancer. The clinical plan has been implemented on the basis of results emerging from appropriate experimental models which show ET-743 to be highly potent with a unique profile of activity when compared to standard anticancer agents. Mechanism studies have identified ET-743 as a novel DNA interacting agent, acting at the minor groove with specificity for guanine rich regions. It is therefore expected that this novel mechanism of action may be translated into a novel spectrum of anticancer activity. The studies will be conducted under Good Clinical Practice guidelines with separate clinical protocols for each tumor type. The number of patients to be entered in the studies is defined by the statistical requirements to verify the tumor response rate. The project milestones are based on the statistical analysis for each tumor type. On verification of activity in the early studies, further confirmatory studies are carried out. The clinical studies will involve three partners which provide a balance between the pharmaceutical industry and innovative clinical research units. The partners are structured to provide European wide involvement which ensures rapid evaluation while retaining strict logistical management to ensure the results are to regulatory standards. The partnership also ensures that the use of the compound is exposed to prominent members of the medical oncology community as well as to the European regulatory authorities.
The compound is fully covered by patent (until the year 2007 in Europe) and supplies are readily available to conduct clinical studies. The economic effect of the project includes the rapid evaluation of a potentially new anticancer agent minimising the time to market with additional benefit to the European biotechnology industry. The social implication is the availability of an additional therapy for the treatment of life threatening cancers which may improve quality of life in cancer patients as well as providing potential benefits in reducing costs in the healthcare system.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
- medical and health sciences clinical medicine oncology prostate cancer
- natural sciences biological sciences genetics DNA
- medical and health sciences clinical medicine oncology lung cancer
- medical and health sciences clinical medicine oncology skin cancer melanoma
- medical and health sciences clinical medicine oncology breast cancer
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Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Topic(s)
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Call for proposal
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
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Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Funding Scheme
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Coordinator
28760 Tres Cantos - Madrid
Spain
The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.