The pre-clinical toxicological development of SA-033 is now completed
DBP has now completed the final part of the toxicological studies required to apply for clinical trials of SA-033 – drug candidate against cancers in liver. SA-033 is a novel self-navigating formulation based on the known cancer drug doxorubicin.
The final part of the pre-clinical development was comprised of a toxicology study performed in accordance to GLP-standard (i.e. the highest standard) where the ordinary doxorubicin was compared with the SA- 033 formulation. The purpose of this part of the toxicology program was to develop a detailed profile of SA-033 toxicity. The results show that the damage to liver, kidneys and immune system caused by doxorubicin as substance are much less pronounced after use of SA-033 compared to the use of ordinary doxorubicin form. The study and all the tests have been conducted in accordance with the plan that was previously discussed with the Swedish MPA.
"The study shows that the toxicity of doxorubicin is reduced when applied in the form of SA-033, which is consistent with the results we have obtained in previous studies," comments Stellan Swedmark, Director of Preclinical Development / Regulatory Affairs at DBP.
"Thanks to these results, we can now proceed to the initiation of clinical trials. We have thus taken a major leap forward towards our goal to provide the market and liver cancer patients with a more safe and efficient medicine, "commented Igor Lokot, president of DBP. – As soon as the manufacturing of the GMP-copmliant batch of SA-033 is completed, we can submit the application to perform clinical trials to the respective authorities and initiate the last preparations at already selected clinical sites for the dosing of the first patients."
About our products:
BeloGal® is DBPs innovative drug delivery platform that allows to control the biodistribution of the drug in the body, and send it exactly into the organ where the drug needs to be active.
SA-033 is the first drug candidate that DBP has developed with the help of its innovative drug-delivery technology BeloGal®. The innovative formulation allows for a controled delivery of doxorubicin into the liver, resulting in a higher concentration of the active substance in the desired target organ and dramamtically lower in the healthy organs, which improves the efficiency and reduces the toxic side effects that are common in systemic (whole body) chemotherapy.
More info about our products : www.doublebp.com
This information is information that Double Bond Pharmaceutical International AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 18 of April 2017.
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: Double Bond Pharmaceutical International AB (publ)
Corporate identity: 556991-6082
Stock short name : DBP B
Share ISIN code : SE0007185525
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Igor Lokot, CEO
Information on Double Bond Pharmaceutical International AB
DBP is a pharmaceutical company with the primary focus on development of therapies against cancer based on the company’s own developed drug delivery technology BeloGal®. The company was granted Orphan Drug Designation status by European Medicines Agency (EMA) in June 2015 for its first product, SA-033, for treatment of hepatoblastoma. DBP acquired rights to Temodex, a drug registered in Belarus for treatment of brain tumours, in October 2015. The company was granted Orphan Drug Designation status by EMA for Temodex in July 2016.