DBP introduces SA-101, a new drug candidate for the treatment of solid tumors, that is now entering the preclinical stage of development.
DPB announced today that SA-101 has been selected as its next drug candidate. Hereby, SA-101 is officially entering the preclinical phase of drug development, which is the first step for a successful drug candidate towards marketing. SA-101 targets solid tumors and is based on a new drug delivery mechanism.
"We are building a portfolio of several drug candidates for those types of cancers that currently lack good treatments, said company CEO Igor Lokot. Through our broad yet focused product strategy with several oncological drug candidates in the pipeline in different stages of development, we ensure the stability of our work in the future and at the same time avoid typical vulnerability of single-product pipelines”.
SA-101 is based on innovative principles of drug delivery that allow the active pharmaceutical ingredients to the delivered safely and in a controlled manner into diseased organs and protect the rest of the body from toxic effects. The precise indication for the use of the SA-101 will be specified after the in vivo studies in rats, which are planned to start at the beginning of 2017.
Our first product, SA-033, which is targeting liver cancer, is entering the clinical phase of development already next year, which means that it has successfully passed through the entire preclinical development phase and now will be tested for the first time in man. SA-033 has also been granted Orphan Drug status by the European Medicines Agency (EMA), which means that it can be marketed earlier than usual. Our second product, Temodex, acting against brain cancer, is also already designated an Orphan Drug status by the EMA and is, moreover, approved in Belarus as a drug and the first-choice treatment for brain cancer, says Igor Lokot.
More about DBP’s products:
SA-033 is the first drug candidate that DBP has developed based on company’s own innovative drug delivery technology BeloGal®. Using this technology, doxorubicin is accurately and specifically deiivered to the liver, which increases the concentration of the active substance in the tumor-affected target organ (in this case liver), improves efficiency and reduces the toxic side effects that are common in systemic (whole body) chemotherapy. SA-033 enters Phase I clinical trials during the first half of 2017, meaning that it will be tested in humans for the first time. Because SA-033 has received Orphan Drug status from the EMA it may be sufficient with the Phase I and Phase II clinical trials to receive a marketing authorization for this product. This is called Conditional Approval and allows to perform the most costly and time-consuming clinical phase, Phase III, after the drug is allowed to be marketed. The goal is that SA-033 can reach the European market already in 2019.
BeloGal® is DBP’s innovative drug delivery platform that facilitates a simple and controlled distribution of a given drug exactly to the diseased organ.
Temodex, which is a locally acting formulation of temozolomide, was developed by RI PCP in Minsk, Belarus, and is registered for marketing within Belarus since 2014 as the first-line treatment of glioblastoma. Temodex was acquired by DBP in autumn 2015 and is now being prepared to pass through all the tests and trials required for registration within the EU and globally. Find out more here.
Full Company Name: Double Bond Pharmaceutical International AB (publ)
Corporate identity: 556991-6082
Stock short name: DBP B
Share ISIN code: SE0007185525
For more info, contact
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.