AmpliPhi Biosciences Corporation (NYSE American: APHB), a clinical-stage biotechnology company focused on precisely targeted bacteriophage therapeutics for antibiotic-resistant infections, today announced a Cooperative Research and Development Agreement (CRADA) with the U.S. Department of Veterans Affairs. The agreement covers individual patient expanded access for AmpliPhi’s investigational bacteriophage therapeutics AB-SA01, targeting Staphylococcus aureus, and AB-PA01, targeting Pseudomonas aeruginosa.
Mark Holodniy, M.D., Professor of Medicine (infectious diseases) at Stanford University and the Veterans Affairs (VA) Palo Alto Health Care System and Director of the Public Health Surveillance for the Department of Veterans Affairs, will be the Principal Investigator leading the collaboration. The CRADA will enable the supply of AB-SA01 and AB-PA01 under single-patient investigational new drug (IND) applications for patients with serious and life-threatening infections, who do not respond to antibiotics and who meet the criteria for treatment under FDA's Expanded Access regulations.
"We are delighted to collaborate with the U.S. Department of Veterans Affairs on the compassionate use of AB-SA01 and AB-PA01 within the VA Palo Alto Health Care System," said Paul C. Grint, M.D., CEO of AmpliPhi Biosciences. "This agreement adds another site to our network of expanded access treatment centers, where we continue to provide potentially life-saving treatments to critically ill patients who have few or no alternative options, while collecting clinical and microbiological data to support the utility of bacteriophage therapeutics. Our objective remains to bring the data to the FDA in mid-2018, obtain feedback on the path to regulatory approval, and potentially initiate a Phase 2 or registrational clinical study as early as the second half of 2018."
About AmpliPhi Biosciences
AmpliPhi Biosciences Corporation is a clinical-stage biotechnology company focused on the development of precisely targeted bacteriophage therapeutics for patients with serious and life-threatening antibiotic-resistant bacterial infections. AmpliPhi’s lead product candidates target multidrug-resistant Staphylococcus aureus and Pseudomonas aeruginosa, which are included on the WHO’s 2017 Priority Pathogens List. Phage therapeutics are uniquely positioned to address the threat of antibiotic-resistance as they can be precisely targeted to kill select bacteria, have a differentiated mechanism of action, can penetrate and disrupt biofilms (a common bacterial defense mechanism against antibiotics), are potentially synergistic with antibiotics and have been shown to restore antibiotic sensitivity to drug-resistant bacteria.
Forward Looking Statements
Statements in this press release that are not statements of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, without limitation, statements regarding: AmpliPhi’s plan to present data from expanded access clinical cases to the FDA in mid-2018, obtain feedback on the path to regulatory approval, and potentially initiate a Phase 2 or registrational clinical study as early as the second half of 2018; and the potential benefits of phage therapy and the potential use of bacteriophages to treat bacterial infections, including infections that do not respond to antibiotics or are associated with biofilms. Words such as "believe," "anticipate," "plan," "expect," "intend," "will," "may," "goal," "potential" and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. Among the factors that could cause actual results to differ materially from those indicated in these forward-looking statements are risks and uncertainties associated with bacteriophage product candidate development, both generally and specifically through expanded access regulations, AmpliPhi’s financial condition, and other risks and uncertainties described in AmpliPhi’s Annual Report on Form 10-K for the year ended December 31, 2016, as filed with the Securities and Exchange Commission (SEC), and AmpliPhi’s subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking...
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