ContraFect Submits Complete Response To FDA To IND Clinical Hold For CF-301

(RTTNews) - ContraFect Corp. (CFRX, CFRXW, CFRXZ), a biotechnology company, said it has submitted a complete response to the U.S. Food and Drug Administration or FDA. The complete response addresses all of the issues identified in the Investigational New Drug Application or IND clinical hold letter issued by FDA. The IND is for ContraFect's most advanced program, CF-301, and is for the combination of CF-301 and antibiotics for the treatment of Staphylococcus bacteremia, including infective endocarditis, caused by methicillin-sensitive and methicillin-resistant S. aureus.

Julia Gregory, ContraFect's chief executive commented, "This submission achieves a very important milestone for ContraFect this year. While FDA will make the ultimate decision regarding whether our clinical trial may proceed, we have addressed all of their questions. CF-301 has the potential to make a major impact on the important unmet needs of treating Staph blood stream infections and addressing the global crisis of drug-resistance."

CF-301 is a bacteriophage lysin with potent activity against Staph aureus infections.