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Polish leukaemia preparation in clinical trials in the US

05.05.2017 Health

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In March this year, three centres in the US started clinical trials of Polish acute myelogenous leukaemia preparation, according to announcement at a conference in Warsaw.

This is yet another Polish pharmaceutical drug that proved to be promising enough to launch clinical trials. Earlier, in 2016 the first phase was of trials on melanoma drug developed by specialists from the University of Warsaw was successfully completed.


Potential new drug for acute myeloid leukaemia was developed by the innovative company Selvita from Kraków. Scientific director of the company Dr. Krzysztof Brzózka said at the meeting that the drug used SEL24, a compound purchased in December 2008 from the Diagnostics and Therapy Development Foundation in Warsaw, where it had been developed by a Polish-Italian team of researchers led by Prof. Zygmunt Kazimierczuk.


"Two years ago, we were looking all over the country for a compound that could be used to develop a potential drug" - emphasised Dr. Brzózka. Several thousand versions of this substance were pre-evaluated in computer modelling, and then 800 variants were selected and synthesized. "One compounds, considered optimal, was selected for clinical trials" - he added.


The preparation has been patented in the USA, Europe, Japan and other countries. Its action has been tested in animal studies conducted in Poland: at the Institute of Immunology and Experimental Therapy PAS in Wrocław, the Jagiellonian University in Kraków, the Institute of Hematology and Blood Transfusion in Warsaw and the Medical University of Gdańsk.


The pharmaceutical product ready for clinical trials was licensed to the Italian company Menarini. CEO of Selvity Paweł Przewięźlikowski explained that this was necessary because Selvity did not have the resources to finance expensive clinical trials.


"The license has not yet covered all the costs incurred during the work on SEL24. The profits will only come when we get royalties from the sale of the drug" - he added. To this end, three phases of clinical trials must be completed successfully. The first step is to check if the drug is safe in humans. The other two allow to determine its effectiveness and dosage.


The Polish preparation will be tested in three American clinics: MD Anderson Cancer Center in Houston, Vanderbilt Ingram Cancer Center in Nashville and Northside Hospital in Atlanta. The US Food and Drug Administration (FDA) approved the clinical trials of the drug in August 2015. The first patient was included in March 2017.


Selvity representatives say that this is probably the first case in the history of the Polish biotechnology industry when the original substance developed in Polish laboratories has been administered to patients in clinical trials in American hospitals.


Ireneusz Otulski, clinical trials director at Selvity, said that high hopes were placed in the Polish preparation is because it could be used in the so-called targeted therapy (for a specific tumour cell mutation). Such drug is not yet available in treatment of acute myeloid leukaemia (it is treated with chemotherapy and bone marrow transplants - PAP). At the same time, studies is being conducted of several other potential targeted therapy drugs for this disease.


Przewięźlikowski said that clinical trials of new drugs usually take 6-7 years, and then there is at least a 2-year waiting period before registration. "However, sometimes drugs are approved for use earlier because of their particularly beneficial effects" - he added. The cost of developing a medicine and implementing it in medical practice already exceeds 1.5 billion euros.


In the treatment of acute myeloid leukaemia new drugs are urgently sought because the effectiveness of treatment of this disease is still small. The data presented at the conference show that the five-year survival rate is achieved in only 24% patients. Two times higher effectiveness of therapy is only achieved in younger patients, under the age of 50. This type of leukaemia mainly affects the elderly, the average age of patients is 67 years.


In the work on SEL24, in addition to own funds and funds obtained from the shares issued on the WSE, structural funds granted by the Polish Agency for Enterprise Development and the National Centre for Research and Development were also used.


Zbigniew Wojtasiński (PAP)


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