EC grants drug orphan designation for CTCL

Micrograph showing
mycosis fungoides
The European Commission (EC) has granted orphan designation to MRG-106 for the treatment of cutaneous T-cell lymphoma (CTCL). MRG-106 is a locked nucleic acid-modified oligonucleotide inhibitor of miR-155-5p. miRagen Therapeutics, Inc., the company developing MRG-106, is currently testing the drug in a phase 1 trial of CTCL patients. Early results from this trial were presented at the 2016 ASH Annual Meeting. Researchers presented results in 6 patients with stage I-III mycosis fungoides. [Read Article]

Assay available to screen donated blood for Zika

Blood bags
Photo by Elise Amendola
Blood banks in countries that accept the CE mark can now use the Procleix Zika Virus Assay to screen blood donations for the presence of Zika virus. CE marking means a product conforms to relevant legislation for sale in the European economic area. The Procleix Zika Virus Assay, which was developed by Hologic, Inc. and Grifols, is designed to run on the Procleix Panther System, an automated, nucleic acid technology (NAT) blood screening platform. [Read Article]

EMA recommends orphan designation for AML drug

AML cells
The European Medicines Agency (EMA) has recommended orphan designation for Actimab-A, a product intended to treat patients with newly diagnosed acute myeloid leukemia (AML) who are over the age of 60 and are ineligible for standard induction therapy. Actimab-A targets CD33, a protein expressed on the surface of AML cells, via the monoclonal antibody, HuM195, which carries the cytotoxic radioisotope actinium-225 to the AML cells. Actinium Pharmaceuticals, Inc., the company developing Actimab-A, is testing the drug in a phase 2 trial. [Read Article]