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

More Articles

More Articles

Amazon.com is pleased to have the Lymphoma Information Network in the family of Amazon.com associates. We've agreed to ship items...

The question ought to be what are myelodysplastic syndromes (MDS), since this is a group of similar blood and bone marrow diseases that...

Merkel Cell Carcinoma (MCC) is a very rare and aggressive skin cancer that usually develops when a person is in his or her 70s. It is...

Radiation Therapy Topics

...

At some point, the Seattle biotech company Cell Therapeutics Inc (CTI) should earn an entry in the Guinness Book of World Records for utter and...

Site Beginnings

This site was started as Lymphoma Resource Page(s) in 1994. The site was designed to collect lymphoma...

Three papers appearing in the journal Blood and pointing towards a regulator-suppressor pill could offer hope to blood cancer...

The US Food and Drug Administration (FDA) has granted a third so-called Breakthrough Therapy Designation for the investigational oral...

The US Food and Drug Administration today has approved an expanded use of Imbruvica (ibrutinib) in patients with...

The U.S. Food and Drug Administration has announced that it has granted "Breakthrough Therapy Designation" for the investigational agent...

According to a new study published in the Proceedings of the National Academy of Sciences, a team from the University of California, San...

Pharmacyclics has announced that the company has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for...

New research suggests that frontline radioimmunotherapy...

Gilead Sciences has announced results of the company's Phase II study of its investigational compound idelalisib, an oral inhibitor of...

Sitemap