ContraFect Receives FDA Approval to Initiate Clinical Trials of CF-301 for MRSA Bloodstream Infections
YONKERS, NY -- (Marketwired) -- 12/22/14 --
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."
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.
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.
This press release contains "forward-looking statements" within the meaning of the safe harbor provisions under Section 21E of the Securities Exchange Act of 1034. Forward-looking statements can be identified by words such as "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "projects," "should," "will," "would" or similar references. Forward-looking statements included in this release include statements made regarding the potential that lysins in general or ContraFect's product candidates specifically will develop into commercially available drugs that are efficacious in combating Staph aureus or other diseases. Forward-looking statements are based on ContraFect's current beliefs, expectations and assumptions; however, forward-looking statements are subject to inherent risks, uncertainties and changes in circumstances that are difficult to predict and many of which are beyond ContraFect's control. Actual results may differ from those contemplated by the forward-looking statements. Important factors that could cause actual results to differ include, among others, the cost, timing and success of clinical trials for ContraFect's product candidates, whether such clinical trials demonstrate these candidates' safety and effectiveness, the ability of ContraFect to obtain regulatory approvals required to conduct clinical trials and to commercialize its product candidates, ContraFect's ability to obtain additional financing to support its research and development in a timely basis and on commercially reasonable terms, ContraFect's dependence on clinical investigators and personnel, clinical research organizations and consultants and other factors described in the "Risk Factors" and elsewhere in ContraFect's 10-Qs, 10-Ks and other periodic reports filed with the U.S. Securities and Exchange Commission. Any forward-looking statement contained in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, ContraFect expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time.
Barry Kappel, Ph.D., MBA
SVP Business Development
E-Mail: Email Contact
or visit: www.contrafect.com
Source: ContraFect Corporation
Released December 22, 2014