Proteo completes phase 1 trial of intravenous Elafin to treat inflammatory disease

By E. Janene Geiss

Philadelphia, Dec. 13 - Proteo Biotech AG said Tuesday that the first phase in the clinical trial of the newly developed drug Elafin has been successfully completed.

Elafin, a recombinant human protein, is intended for the treatment of inflammatory diseases and is administered intravenously. The trial aimed to assess the safety and tolerability of the drug, according to a company news release.

Elafin has been tested on 32 healthy male volunteers over the last few weeks, officials said.

All intravenously applied doses were well-tolerated. No severe adverse events occurred, officials said.

"The successful conclusion of this trial demonstrates that the therapeutic use of proteins of human origin for these therapeutic purposes is associated with good tolerability. For further development of Elafin, we see a range of indications in the area of inflammatory diseases, particularly in circulatory and lung disorders," Birge Bargmann, chief executive officer of Proteo, said in the release.

Proteo said it owns the rights for the production and exploitation of recombinant Elafin. In humans, it is produced in the skin, lungs and mammary glands and protects the Elafin-producing cells from destruction by the immune system, officials said.

Some organs, particularly muscles and blood vessels, do not express Elafin and are thus more susceptible to immune attack, officials said. Elafin's ability to block the enzymes elastase and proteinase 3, both of which are involved in tissue damage during inflammatory reactions, makes this protein a promising agent for the treatment of inflammatory lung disorders or severe reperfusion injury occurring after heart attacks, wounds or organ transplants, officials said.

Proteo Biotech, based in Kiel, Germany, researches, develops and markets substances for biological and medical research, as well as for use as pharmaceuticals, with a focus on production methods for active agents in inflammation research.

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