SA033 is a novel treatment of cancers in liver. It is the first drug candidate that DBP has developed using its first-in-class technology BeloGal® which provides direct targeting of a drug to 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. By this reason SA033 belongs to 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. The Orphan Drug Designation Status for SA033 obtained by, 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 patients suffering from hepatocellular carcinoma (HCC) in year in 2018, HCC being the most frequent type of primary liver cancer in adults.