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Pitting viruses against bacteria
December 1, 2014   
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Cracow-based biotechnology company IBSS Biomed is working on a new drug containing bacteriophages—or “good” viruses that infect and destroy bacteria—for treating patients with burns and diabetic wounds as well as cancer patients prone to infections after radiotherapy.

The new drug is particularly aimed against bacteria such as Staphylococcus aureus that commonly colonize wounds and are often resistant to antibiotics, Biomed says. The drug, available in the form of a spray or gel, would be applied to an open wound or under the dressing.

Biomed is working on the drug as part of a zl.8 million project co-financed to the tune of zl.3 million by the National Center for Research and Development (NCBR) under the InnoMed program. Biomed is contributing the rest from its own funds.

The project, called Onkofag, is the first step toward “creating a new standard in the treatment of infected chronic wounds,” says the project’s manager, biologist EwaOlchawa, Ph.D., who is the director of Biomed’s research and development center.

For now, under the Declaration of Helsinki—a set of principles developed for the medical community by the World Medical Association (WMA) that are widely regarded as a cornerstone document on human research ethics—pharmaceuticals containing bacteriophages can only be used on patients for whom all other methods have failed. Such pharmaceuticals cannot be registered in the European Union, so they are not treated as drugs, with the exception of Slovakia, where a preparation known as phage lysate is available, according to Olchawa.

Olchawa believes that in the future bacteriophage treatment will be used as a routine clinical practice. Currently, such treatment is being used as a medical experiment at the Polish Academy of Sciences’ Institute of Immunology and Experimental Therapy in the southwestern Polish city of Wrocław.

The new phage-based drug could be a potential breakthrough in modern medicine, according to Olchawa. As part of the project, research and development work will be carried out to select the right type of phages for therapy, develop the drug, test it in the laboratory and conduct clinical trials. A further step will be going commercial with the research results and patenting the drug. The project will last five years and will be completed in 2019.

The new drug will be cheaper than most antibiotics commonly used to treat bacterial infections in patients, says Olchawa. “The production of phage preparations is not expensive,” she adds. “With antibiotic treatment now in crisis around the world, there has been a return to research into phages. This is associated with the high possibility of using them to fight bacterial infections, particularly those resistant to antibiotics.”

To carry out the Onkofag project Biomed has established a research and industrial consortium in which it teamed up with the microbiology department of the Jagiellonian University Medical College in Cracow. The two partners have been working together for some time. The ongoing research on phage therapy follows up on an earlier exchange of experience and know-how and joint development of medicinal products.

A Jagiellonian University Medical College team led by Prof. MałgorzataBulanda is scrutinizing bacteria on which bacteriophages are propagated for various stages of research. The phages are being cultured on a medium that contains live bacteria in a specific growth phase. The phages “eat” the bacteria. In laboratories phages can be cultured in glass containers. However, on an industrial scale, this is done in bioreactors.

On markets abroad, there are already drugs available that contain unpurified bacteriophages in the form of phage lysate. These are available in Russia, Georgia and Slovakia. However, they contain many impurities that come from the culture medium and from the residue of phage-host bacteria, according to Olchawa.

“Our product will be purified and contain phages scrutinized in detail in biological and genetic terms,” Olchawa says.

Internationally, five companies are currently conducting clinical tests on purified phage preparations under the aegis of the U.S. Food and Drug Administration and the European Medicines Agency, according to Olchawa. Already available is information on clinical trials testing the use of phage preparations for the treatment of diarrhea in children, burns, leg ulcers, and inflammation of the ear. But none of these is directly intended for the treatment of infections in patients with reduced immunity, including those suffering from cancer, Olchawa says.
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