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Antitumor Ferrocene Preparations

#0464


Development of new Antitumor Ferrocene-based Compounds.

Tech Area / Field

  • MED-DRG/Drug Discovery/Medicine

Status
3 Approved without Funding

Registration date
31.10.1995

Leading Institute
Ultrasan Corp., Russia, Moscow

Supporting institutes

  • INEOS (Organo-Element Compounds), Russia, Moscow\nMoscow State University / Department of Chemistry, Russia, Moscow\nMoscow Oncology Research Institute, Russia, Moscow

Collaborators

  • White Eagle International Technologies L.P., USA, FL, Palm Beach Gardens

Project summary

The basic goal of this project consists in the development of a new effective ferrocene-based antitumor preparation. The introduction of this preparation into clinical practice will provide a possibility of contributing to the solution to one of the pressing problems of present-day cancer chemotherapy - creation of the drugs, combining the high effectiveness with low toxicily.

Preliminary studies on the mechanism of the alkylferrocene-regulated burning of composite solid propellents based on ammonium per chlorate were the starting point of the investigation of the possibility of using this compound derivatives for creating antitumor preparations. As a result of these investigations, the antitumor activity of ferrocenylalkylazoles was found. The further study of (he specific activity for a number of fcrrocenylalkylazole derivatives allowed us to determine a group of compounds displaying a compromise between the activity and toxicity suitable for the pre-clinical development. The Ultrasan Research Corporation (Russia) together with While Eagle International Technologies (WEFT L.P..USA), Moscow State University Chemical Department, Moscow Oncology Research Institute, and Nesmeyanov Institute of Organoelement Compounds (Russian Ac ad. Sci.) intend to solve the following problems within the context of this project:

- to perform concluding experiments, which will enable us to select the most promising preparation for the pre-clinical trials that are necessary for presenting the preparation to the Pharmacology Committee of Ministry of Health and Medical Industry of Russia (analog of Food, Drug, and Cosmetic Committee);

- to carry out pre-clinic trials of the preparation selected, including the examination of its general and specific toxicity, specific activity and the pharmacokmetics;

- to carry out the analytical and technological developments that are necessary for compiling the Temporary Pharmacopeial article and a full range of standardizing-technical documentation;

- to conduct the first phase of clinical trials;

- to investigate the molecular mechanism of the antitumor effect of the preparation;

- to develop the deposited drug form (capsules, microcapsules) and the technology of the drug release under the action of low-power ultrasound.

Expected Results:

- the development of a new effective low-toxic cheap preparation will allow us to initiate its direct introduction into clinical practice, to establish a pilot plant (together with WEIT L.P.) based upon the "Soyuz" Research and Industry Association (Lyubertsy) with the following commercialization of the preparation;

- the preparation of encapsulated medicinal form with the low-power-ultrasound" controlled release of the drug. With this part of the work completed, the possibilities for malignant tumor chemotherapy, and in addition, vascular disease therapy and anesthesiology will be increased;

- new treatment schemes, including both the novel preparation and known cylostalics, will make it possible to create new methods of the malignancy treatment and may raise the effectiveness of the combined treatment of patients with malignant tumors;

- a study of the molecular mechanism will allow us to pass to the purposeful development of next more effective preparations.

Potential Role of Foreign Collaborators:

WEIT L.P. will take part in the development of a new antitumor preparation, organizing and financing laboratory tests beyond the Russia territory. The goal of this work is the independent verification of the data obtained by Ultrasan in Russia and attracting the attention of American experts to the preparation under development. WEFT L.P. will carry out patent researches and will patent new technical solutions in the USA territory. At present, the provision of experimental investigations and pharmaceutical industry in Russia does not fit the international standards. Therefore, WEFT L.P. will conduct marketing investigations to determine the difficulties and possibilities for the preparation commercialization in the USA territory and will try to invoke new investors, who are capable of financing the entire complex of the works, including pre-clinical and clinical trials, and the arrangement of the preparation production in accordance with the requirements of GLP and GMP and with the FDCC standards.


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