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Crab's Collagenase for Burn Treatment

#1034.2


Collagenase Production from Crab Hepatopancreatic Tissues for Burn Treatment

Tech Area / Field

  • MED-DRG/Drug Discovery/Medicine

Status
8 Project completed

Registration date
01.08.2000

Completion date
29.10.2004

Senior Project Manager
Pobedimskaya D D

Leading Institute
Russian Cardiology Research Center / Institute of Experimental Cardiology, Russia, Moscow

Supporting institutes

  • Research Center of Toxicology and Hygienic Regulation of Biopreparations, Russia, Moscow reg., Serpukhov

Collaborators

  • Novus Molecular, Inc., USA, CA, San Diego\nChemicon Int. Inc., USA, CA, Temecula

Project summary

The goal of project "Collagenase from Crab hepatopancreas for Treatment of Burns" is to develop a pharmacological preparation based on collagenases from the hepatopancreas of the crab Paralithodes Camtschatica for the treatment of burns at the first (purulent-necrotic) stage.

According to the work plan approved by ISTC and collaborators, at the first stage of the project a substance (mixture of collagenases from crab hepatopancreas) has been prepared and its physico-chemical and enzymatic properties, stability and behavior in combination with antibiotics, surface-active compounds and anesthetics have been investigated.

The pharmacological preparation (lyophilized powder for an ex tempore solution preparation) has been developed on the basis of these investigations. The method to prepare Enzycol and laboratory protocol for its production have been worked out. In vitro and in vivo assays have been designed. The minimal effective concentration of preparation for uninfected and for infected wound provided wound cleansing were estimated. In comparison with trypsin, a compounds that provides a similar effect, the debridement period for the preperation-treated burns is 2-day shorter. Safety of the preparation’s therapeutic concentration was confirmed by acute toxicity, local irritation and cytotoxicity tests.

New positive effect of the preparation has been revealed: in contrast to trypsin, it facilitates the formation of small, moist, pale-pink granulations, thus providing a higher therapeutic effectiveness. It was demonstrated that at the end of the debridement a treated wound is filled by granulations up to its edges.

Based on the results obtained, it is reasonable to expect that a combination of collagenase isoenzymes from crab hepatopancreas will be developed that would provide the maximum necrolytic and stimulating activities.

At the next stage of project the investigation of the new more effective enzymes combination will be performed at the same time with the analysis of the developed preparation for mutagenicity, embryotoxicity, teratogenicity, allergogenicity and immunomodulating activity. It is supposed to submit documentation to the Russian Federation Pharmacological Committee for permission to start the first stage of clinical trials and to prepare documentation for the preparation patenting.

The possibility of achieving these goals is determined by successful fulfillment of the firs stage of the project, which consists in production and tests of the preparation from hepatopancreas. There is equipment and experience in tests of medical preparations and materials on animal models.

Successful accomplishment of this work will allow us to start toxicology analyzes of new enzyme combination. In the case of receiving of permission to start the first stage of clinical trials will be possible to start production of drug for clinical trials and confirm that the preparation possess higher therapeutic activity than trypsin, chymotrypsin, chymotrypsin and Iruxol. This will allow one to reduce the period required for debridement of the third B and fourth degree burns, to reduce the preparation period for grafting, to provide formation of a more delicate scar due to formation of fine granulations and shorter period before grafting.

The project will provide the researchers and engineers of Research Center for Toxicology and Hygienic Regulation of Biopreparations at Ministry of Public Health of the Russian Federation, who have been working for the Defense Ministry, to apply their experience to the development of a new drug in terms of market-based economies and creating long-term prospects for their integration into the world scientific community.


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