SA033 is a novel treatment for cancers in liver. It is the first drug candidate that DBP has developed using it’s first-in-class paradigm-shifting technology BeloGal® which provides direct targeting of a drug into the selected organ, which in case of SA033 means targeting doxorubicin directly to the liver.
Doxorubicin is one of the most well known and proven anticancer drugs and it is the active pharmaceutical ingredient used in the SA033 formulation. Doxorubicin is packed into a BeloGal® technology-based carrier and programmed to be delivered to the liver. After a simple intravenous administration and a safe transport of the formulation to its organ of destination, doxorubicin is released and provides its strong local therapeutic action without harming healthy organs.
Treatment with SA033 is therefore designed to significantly increase the success of liver cancer treatment and dramatically reduce systemic (whole body) side effects of chemotherapy. SA033 is a new generation of anticancer drugs.
Double Bond Pharmaceutical AB (DBP) has been granted Orphan Drug Designation for SA-033 by the European Medicines Agency for the treatment of hepatoblastoma (HB), which is a primary malignant liver tumour and the most common type of liver cancer that affects children. The aetiology of HB is unknown but it is found in greater incidence in children with low birth weight, and has also been associated with Beckwith-Wiedemann syndrome and familial adenomatous polyposis. Five-year survival is about 63% after diagnosis of HB and there is therefore an urgent need for more effective and safer therapy for these children. Orphan Drug Designation for SA033 obtained by DBP for treatment of HB gives ten years of market exclusivity for the indication and various kinds of support from EMA to further facilitate and accelerate the development of the product. DBP is planning to start a Phase I trial of SA-033 in 2017 in patients suffering from hepatocellular carcinoma – the most common type of primary liver cancer in adults.