SOURCE: ContraFect Corporation

ContraFect Corporation

August 11, 2015 07:00 ET

ContraFect Corporation Provides Update on CF-301 Phase 1 Trial

Study Continues as Planned for CF-301, Under Development for Staph Bloodstream Infections, Including MRSA

YONKERS, NY--(Marketwired - Aug 11, 2015) - ContraFect Corporation (NASDAQ: CFRX) (NASDAQ: CFRXW) (NASDAQ: CFRXZ), a clinical-stage biotechnology company focused on the discovery and development of protein therapeutics and antibody products for life-threatening, drug-resistant infectious diseases, today announced that an independent Data and Safety Monitoring Board (DSMB) recommended the continuation of the CF-301 Phase 1 study. Thus far, the study has successfully completed two dose levels out of the currently planned four, and ContraFect expects to complete the study by year-end. If the results of the Phase 1 study in healthy volunteers are favorable, ContraFect plans to advance CF-301 into Phase 2 study next year in patients with staph bloodstream infections, including MRSA.

"ContraFect is pleased to have made progress in this important initial stage of development for CF-301, the first lysin allowed by the FDA to enter human clinical trials, targeting drug-resistant Staph infections, including MRSA," said Julia P. Gregory, ContraFect's Chief Executive Officer. "Novel approaches, like CF-301, with activity against drug-resistant bacteria and biofilms offer great potential to successfully treat these current life-threatening infections."

ContraFect is conducting a single Phase 1 randomized, double-blind, placebo-controlled, dose-ranging trial in healthy volunteers in the United States to evaluate the safety, tolerability and pharmacokinetics of CF-301 alone. An independent DSMB reviews the safety and pharmacokinetic data for each dose level in order to recommend proceeding to the next higher dose. Additional information on the trial can be found at https://www.clinicaltrials.gov/ct2/show/NCT02439359

About CF-301

CF-301 is a bacteriophage lysin with potent activity against Staph aureus infections. CF-301 has the potential to be a first-in-class treatment for Staph bacteremia as it has a new mechanism of action for eliminating bacteria. It has specific and rapid bactericidal activity against Staph aureus and does not impact the body's good bacteria. By targeting a conserved region of the cell wall that is vital to bacteria, resistance is less likely to develop to CF-301. In vitro and in vivo experiments have shown that CF-301 clears biofilm. Combinations of CF-301 with standard of care antibiotics increased survival significantly in animal models of disease when compared to treatment with antibiotics or CF-301 alone. CF-301 was licensed from The Rockefeller University and developed at ContraFect.

About Staph Bacteremia
Staphylococcus aureus ("S. aureus") is a major cause of bacteremia, and Staph aureus bacteremia is associated with higher morbidity and mortality, compared with bacteremia caused by other pathogens. The burden of Staph aureus bacteremia, particularly methicillin-resistant Staph aureus bacteremia, in terms of cost and resource use is high. The risk of infective endocarditis and of seeding to other metastatic foci increases the risk of mortality and raises the stakes for early, appropriate treatment.

Staphylococcus ("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.

About ContraFect

ContraFect is a clinical-stage 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 (methicillin-resistant staphylococcus bacteria) and influenza.

FORWARD-LOOKING STATEMENTS

This press release contains "forward-looking statements" within the meaning of the U.S. federal securities laws. Forward-looking statements can be identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intend," "plans," "potential," "transform," "look forward to," "novel," "if" or similar references to future periods. Forward-looking statements are statements that are not historical facts, nor assurances of future performance. Instead, they are based on ContraFect's current beliefs, expectations and assumptions regarding the future of its business, future plans, strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent risks, uncertainties and changes in circumstances that are difficult to predict and many of which are beyond ContraFect's control, including those detailed in ContraFect's filings with the Securities and Exchange Commission. Specific forward-looking statements in this release include, without limitation, statements regarding anticipated screening and enrollment of healthy volunteers in our Phase 1 clinical trial of CF-301, the data obtained throughout the trial regarding the safety, tolerability and pharmacokinetics of CF-301, the DSMB's review of the trial data, our dosing plans for Phase 1, our ability to advance CF-301 into Phase 2, our ability to develop therapies to combat life-threatening infections, and CF-301's activity against drug-resistant bacteria and biofilms. Actual results may differ from those set forth in the forward-looking statements. Any forward looking statement made by ContraFect 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, whether as a result of new information, future developments or otherwise.

Contact Information

  • Investor Relations Contact

    Barbara Ryan
    Clermont Partners
    Tel: 203-274-2825
    Email: Email Contact

    Avonelle McLean
    ContraFect Corporation
    Email: Email Contact