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Mabion obtains permission from Croatia, Bosnia and Herzegovina, Serbia & Poland authorities to begin trial in lymphoma patients

Lodz, Poland
Wednesday, November 26, 2014, 16:00 Hrs  [IST]

Mabion SA, a leading biotechnological Polish company, announced that the company has obtained the consent of appropriate regulatory authorities in Croatia, Bosnia and Herzegovina, Serbia and Poland to perform the clinical trial in patients with Diffuse Large B-cell Lymphoma.

The study will be carried out in four clinical centers in each the above mentioned countries in cooperation with Altiora d.o.o. Simultaneously Mabion is close to obtain approval to conduct clinical trial in: Bulgaria, Romania, Moldova, Ukraine, Georgia and Hungary.

The study regarding lymphoma will be executed jointly at more than 140 patients. The basic study performed by the company is a multicenter study which takes place in 9 European countries with participations of about 700 patients with heumatoid rthritis – it is the main study required in the registration process of the drug MabionCD20.

In May 2014, Mabion signed the agreement for the implementation of the clinical trial MabionCD20 in patients with diffuse lymphoma in 10 different European countries. Additionally, Mabion has expanded an agreement with Altiora concerning clinical study on MabionCD20 in patients with rheumatoid arthritis. As a result, around 10 new medical sites will be involved in the study in Poland.

“Clinical trial in patients with lymphoma is supporting study with the participation of only 140 patients. Its purpose is to demonstrate clinical biosimilarity between MabionCD20 and  MabThera. We have not hurried with the start of this study because it does not require such a long observation, as in the case of RA. Due to extension of the  agreement with Altiora – we are optimistic with assumptions regarding the recruitment of patients, and thus the initiation of research within the prescribed schedule” – said Maciej Wieczorek, CEO of Mabion SA.

In May 2014 Mabion SA obtained over 53 million PLN from issue of stock. The capital stock will be used including: adaptation and certification of the new Science and Industrial Complex Medical Biotechnology to the requirements of the FDA (American Food and Drug Administration). Additionally, Mabion signed a letter of intent with Regulatory Compiliance Associates, which provides a comprehensive solution for regulation and compliance with the requirements of the FDA. Among the highly qualified employees of RCA there(?) are people  Involved in the past in the activities of the FDA. Signed letter of intent includes among others: identification of potential risks and providing solutions to minimize them in order to  start production in Industrial-Scientific Complex of Medical Biotechnology in Konstantynów Lódz in defined time. established term.

Mabion intends to register MabionCD20 on all global markets where reference drug is sold. Geographically, it can be divided into three major regions: the United States, European Union countries and other countries of the world, where the registration is less strictly regulated. The company intends to register MabionCD20 across the European Union on its own.

On August 29, 2014 Mabion SA presented to the Data and Safety Monitoring Board (DSMB) – an independent committee composed of experts in the field of rheumatology, pharmacology and biostatistics – the clinical and safety data from about 62% of the total number of patients needed to complete the study, including 44,4% of patients who have already completed required procedures. Commission – likewise after the first two meetings (in August 2013 and in February 2014) – very positively assessed research process.. According to the issued opinion, procedure of the clinical trial does not require any modification. The current patient recruitment runs smoothly and asforeseen. The opinion of DSMB allows for the continuation of clinical trials in accordance with the protocol.

With regard to regions with a less strictly regulated system of registration - such as Africa or Asia - Mabion SA is planning both, implementation of sales and the entire registration procedure conducted by local leading pharmaceutical companies.

The process of  production will be carried out in Mabion’s Scientific-Industrial Biotechnological Complex  in Poland, and the company will have shares in he revenues from the sale of drugs by foreign distributors. By now Mabion has signed: An agreement with the  pharmaceutical company LYFIS for the territory of Iceland; An agreement with the Ukrainian pharmaceutical company Farmak in relation to Ukraine, Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Turkmenistan and Uzbekistan; An agreement with the Turkish pharmaceutical company ONKO referring to the territory of Turkey ; An agreement with the Moroccan pharmaceutical company Sothema Laboratories for countries of North Africa (Morocco, Algeria and Tunisia); An agreement with the Argentine pharmaceutical company LKM SA in relation to South America (Argentina, Colombia, Venezuela, Peru, Chile, Paraguay, Ecuador, Bolivia and Uruguay); A letter of intent with a pharmaceutical company from Lebanon in relation to the Middle East; A letter of intent with a pharmaceutical company from Croatia in relation to the Balkan countries.

Mabion SA is a leading biotechnological Polish company focused on development and implementation of new generation biosimilar drugs based on humanized monoclonal antibodies and therapeutic proteins.


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