YONKERS, NY, USA I December 22, 2014 I ContraFect Corporation (NASDAQ: CFRX) (NASDAQ: CFRXW) (NASDAQ: CFRXZ), a biotechnology company focused on the discovery and development of protein therapeutics and antibody products for life-threatening, drug-resistant infectious diseases, announced today that the U.S. Food and Drug Administration (FDA) completed the review of its submission and has removed the full clinical hold on ContraFect’s investigational new drug (IND) application for CF-301. This action allows for the initiation of clinical trials, which ContraFect expects to commence in Q1 2015.

Julia P. Gregory, ContraFect’s chief executive officer commented, “CF-301 will be the first recombinant bacteriophage lysin allowed by FDA to advance to human clinical trials, marking a very important step for patients with serious infection. We believe it has great potential to address the global crisis of drug-resistance. CF-301, with its novel mechanism of action and full activity against drug-resistant bacteria and biofilms, is sorely needed to treat these life-threatening infections. We look forward to commencing the Phase 1 trial.”

About CF-301:

CF-301, which was licensed from The Rockefeller University and developed at ContraFect, is a bacteriophage lysin with potent activity against Staph aureus infections. Staph infections occur in both hospital and community settings, and in the United States there are approximately 120,000 cases annually of Staph bacteremia (a bloodstream infection), which causes approximately 30,000 deaths annually. Of further concern, drug-resistant strains of Staph are now evolving and developing additional resistance against standard-of-care antibiotics, which may ultimately result in increased number of cases and mortality from Staph bacteremia. A recent study commissioned by U.K. Prime Minister David Cameron found that without action drug-resistant infections that already kill hundreds of thousands a year globally could exceed 10 million by 2050.

CF-301 is a bacteriophage lysin that has the potential to be a first-in-class treatment for Staph bacteremia. CF-301 has specific and rapid bactericidal activity against Staph. Combinations of CF-301 with vancomycin or daptomycin increased survival significantly in animal models of disease when compared to treatment with antibiotics or CF-301 alone. CF-301 targets a conserved region of the cell wall that is vital to bacteria, thus making resistance less likely to develop. When used in combination with standard-of-care antibiotics, the result is a novel combination therapy that has the potential to combat the high unmet clinical need of Staph aureus infections.

About ContraFect:

ContraFect is a biotechnology company focused on discovering and developing therapeutic protein and antibody products for life-threatening, drug-resistant infectious diseases, particularly those treated in hospital settings. Due to drug-resistant and newly emerging pathogens, hospital acquired infections are currently the fourth leading cause of death in the United States, following heart disease, cancer and stroke. We intend to address drug-resistant infections using our therapeutic product candidates from our lysin and monoclonal antibody platforms to target conserved regions of either bacteria or viruses (regions that are not prone to mutation). ContraFect’s initial product candidates include new agents to treat antibiotic-resistant infections such as MRSA (drug-resistant staphylococcus bacteria) and influenza.

SOURCE: ContraFect