Orphan Drug Designation Given to Potential AML Treatment

Biopharmaceutical development company BioLineRx is announcing that the U.S. Food & Drug Administration (FDA) has granted Orphan Drug Designation to the company's investigational agent BL-8040 as a therapeutic for the treatment of acute myeloid leukemia (AML).

Said Dr. Kinneret Savitsky, Chief Executive Officer of BioLineRx:

We are very pleased to have received Orphan Drug Designation for BL-8040, which will facilitate the development process of one of our key clinical stage assets. Currently, AML treatment options, especially in patients with a relapse of the disease, are extremely limited. BL-8040 has the potential to be a significant addition to the drug arsenal for this disease, especially when considering its promising pre-clinical results, unique biological mechanism and ability to synergize with other drugs already approved for this disease. Therefore, we are eagerly looking forward to the partial results of BL-8040's Phase 2 study expected towards the end of 2013.

According to BioLineRx, BL-8040 is a clinical-stage drug candidate for the treatment of acute myeloid leukemia, as well as other types of blood cancers. It is a short peptide that functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis, metastasis and cell survival.

Source: MarketWatch