ContraFect Corporation Completes Successful Pre-IND Meeting With FDA
(firmenpresse) - YONKERS, NY -- (Marketwire) -- 12/14/11 -- , the company that is pioneering the use of recombinant proteins for the treatment of drug-resistant bacteria, completed a face-to-face pre-IND (Investigational New Drug) meeting with the FDA on December 9, 2011 to discuss the development plans for CF-301, a biologic antimicrobial therapy for acute bacterial skin and skin structure infections. CF-301 is a first-in-class investigational drug with potential to have a major role in the treatment of infections caused by MRSA (drug-resistant staphylococcus) and streptococcus. The FDA addressed the Company's questions and provided guidance on the requirements to file an IND to initiate clinical trials. The IND is expected to be submitted mid-2012.
"The completion of our pre-IND meeting with the FDA is a milestone for ContraFect," remarked ContraFect CEO and Chairman . "We now have confirmation that we are on the right path and are preparing our IND package in manner that will be acceptable to the FDA. We remain on target to initiate our first-in-human Phase I clinical trial in Q3 2012."
CF-301 is an investigational first-in-class therapy for the treatment of infections caused by staphylococcus and streptococcus. CF-301 is a bacteriophage lysin that acts immediately upon contact with the bacterium, causing a pore to form in the cell wall and resulting in lysis (death) of the target bacteria. The unique mechanism of action of CF-301 makes it active against all forms of staphylococcus and streptococcus infections, regardless of existing resistance to current antibiotics, including methicillin (MRSA) and vancomycin (VISA and VRSA) resistant strains.
ContraFect Corporation is a biotechnology company pioneering the use of Lysins and Monoclonal Antibodies to treat life-threatening infectious diseases. ContraFect's initial products include agents to treat diseases such as MRSA (drug-resistant staphylococcus bacteria), other serious bacterial infections, and influenza.
Our scientific approach is based on the following principles:
Monoclonal Antibodies for the treatment of life-threatening bacterial and viral diseases
Lysins for the treatment of drug-resistant gram positive bacteria, such as staphylococcus (MRSA), streptococcus and intestinal infections
Transition from conventional monotherapy to a combinatorial approach using multi-therapy antibody and Lysin treatments
The growing challenge of drug-resistance and therapy escape mechanisms used by pathogens
Safe Harbor Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein that do not describe historical facts are forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. The Company assumes no obligation to update or supplement any forward-looking statements whether as a result of new information, future events or otherwise.
For more information, contact:
Barry Kappel, Ph.D., MBA
VP of Business Development
Tel: 914-207-2302
E-Mail:
or visit:
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Datum: 14.12.2011 - 08:13 Uhr
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