"I am pleased with the results of this pioneering phage study in patients suffering from CRS"
SAN DIEGO--(BUSINESS WIRE)--AmpliPhi Biosciences Corporation (NYSE MKT: APHB), a global leader in the development of bacteriophage-based antibacterial therapies to treat drug-resistant infections, today announced that Peter-John Wormald, MD, Professor of Otolaryngology Head & Neck Surgery at the University of Adelaide, commented on the favorable results from the Phase 1 trial of AmpliPhi’s AB-SA01 in patients with chronic rhinosinusitis (CRS). On December 19, 2016, AmpliPhi Biosciences announced that AB-SA01, its proprietary investigational bacteriophage cocktail targeting Staphylococcus aureus (S. aureus) infections, met the Phase 1 trial’s primary endpoints of safety and tolerability in patients who had failed standard of care treatment, including previous sinus surgery. Additionally, all nine patients enrolled in the study experienced a reduction in the quantity of S. aureus infecting their sinuses, with some patients showing complete eradication of the bacterial infection.
“I am pleased with the results of this pioneering phage study in patients suffering from CRS,” said Dr. Peter-John Wormald, the trial’s principal investigator. “I have long believed that phage therapy has the potential to treat recalcitrant infections in the portion of CRS patients who do not respond to conventional treatment. We have seen significant improvements in both symptoms scores and on nasal endoscopy providing evidence of the efficacy of phage treatment. Based on my experience treating these patients and the outcomes I witnessed in this study, phage therapy warrants continued evaluation as a means to treat CRS patients whose infections return following sinus surgery.”
A video of Dr. Wormald discussing bacteriophage therapy, AB-SA01 and the Phase 1 trial is available at http://investor.ampliphibio.com/events-and-presentations.
“We saw decreases in S. aureus bacterial load in all patients treated with AB-SA01 in our Phase 1 trial, which is particularly encouraging since most patients also reported improvements in symptoms,” added M. Scott Salka, CEO of AmpliPhi Biosciences. “CRS is a serious condition with patients reporting quality-of-life scores that are often worse than those suffering from congestive heart failure or chronic back pain. An estimated 300,000 sinus surgeries for this condition are performed in the United States each year with the condition returning in approximately 20% of these patients post-surgery. We plan to initiate a Phase 2 trial of AB-SA01 in patients with CRS in the second half of 2017, bringing us closer to our goal of providing these patients with an effective and non-invasive treatment option.”
Conference Call and Webcast
As previously announced, AmpliPhi Biosciences will hold a business update conference call today, January 4, 2017 beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time). The conference call dial-in number is (877) 287-2401 for domestic callers and (216) 562-0057 for international callers, and the passcode is 30920092. A live webcast of the call will be available on the Investor Relations section of www.ampliphibio.com.
A recording of the call will be available for 48 hours beginning approximately two hours after the completion of the call by dialing (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. Please use passcode 30920092 to access the recording. A webcast replay will be available on the Investor Relations section of www.ampliphibio.com for 30 days, beginning approximately two hours after the completion of the call.
Bacteriophages, or more simply “phages,” are the natural predators of bacteria and are thought to be the most abundant life form on earth, outnumbering even the stars in our universe. Over eons, phages have evolved an incredible diversity of specialist strains that typically prey upon just one strain of bacteria, enabling a phage-based therapeutic to precisely target a pathogenic bacterial population while sparing the beneficial microbiota. Phages can effectively infect and kill bacteria, regardless of whether they are antibiotic-resistant or not and even when they have formed protective biofilms. Such biofilms are a major line of defense for bacteria that phages are able to penetrate to produce strong local therapeutic effects without the side-effects commonly associated with conventional antibiotics.
About AmpliPhi Biosciences
AmpliPhi Biosciences Corporation is a biotechnology company focused on the development and commercialization of novel bacteriophage-based antibacterial therapeutics. AmpliPhi's product development programs target infections that are often resistant to existing antibiotic treatments. AmpliPhi has reported final results from two Phase 1 clinical trials of AB-SA01, one for the treatment of S. aureus in chronic rhinosinusitis patients and one to evaluate the safety of AB-SA01 when administered topically to the intact skin of healthy adults. AmpliPhi is also developing bacteriophage therapeutics targeting Pseudomonas aeruginosa (P. aeruginosa) and Clostridium difficile (C. difficile) in collaboration with a number of leading organizations focused on the advancement of bacteriophage-based therapies. For more information, visit www.ampliphibio.com.
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 about the potential advancement of AB-SA01 into a Phase 2 trial in 2017, the potential use of bacteriophages to treat bacterial infections, including infections that do not respond to antibiotics, the potential benefits of phage therapy, and AmpliPhi’s development of bacteriophage-based therapies. 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 AmpliPhi’s business and financial condition, risks and uncertainties inherent in the development of product candidates and the other risks and uncertainties described in AmpliPhi’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, as filed with the Securities and Exchange Commission (SEC), and other filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and AmpliPhi undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.
Media Relations (U.S.)
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Media Relations (Europe and ROW)
Gemma Howe/Sue Charles
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