AmpliPhi Biosciences announces positive feedback from FDA on phase 2 development proposal.
AmpliPhi Biosciences Corporation, a global developer of therapies for drug-resistant bacterial infections using bacteriophage technology, announced that the U.S. Food and Drug Administration (FDA) provided positive feedback on the company’s previously submitted detailed development proposal to commence a phase 2 trial with its proprietary bacteriophage cocktail AB-SA01 for the treatment of antibiotic-resistant Staphylococcus aureus (S. aureus) infections in patients with chronic rhinosinusitis (CRS).
The FDA’s feedback followed a Type B telephonic meeting held with AmpliPhi on February 21, 2017. In the official minutes from the meeting, the FDA acknowledged that phage therapy is an approach to treatment of multidrug-resistant organisms and expressed a commitment to addressing the unique regulatory challenges that might arise during product development.
AmpliPhi also announced that following a review of the status of its internal programs, resources and capabilities, the company has begun to explore a range of strategic alternatives and retained H.C. Wainwright & Co., LLC to advise the company and its board of directors.
“I’m extremely proud of the entire AmpliPhi team, including academic collaborators, clinical investigators and consultants, for their efforts in successfully positioning our phage technology to enter the phase 2 development stage, which we expect will open additional strategic opportunities for our company,” said M. Scott Salka, CEO of AmpliPhi Biosciences.
“Over the past two years we have opened the world’s first cGMP facility dedicated to producing drug-quality phage cocktails and produced the phage materials used to complete two phase 1 trials, both of which generated favorable results, paving the way for the start of efficacy trials in patients who fail to respond to conventional antibiotics,” he added. “We are also pleased to be working with the highly-experienced team at H.C. Wainwright & Co. and to tap into their expertise in identifying and evaluating opportunities.”
AmpliPhi does not have a defined timeline for the exploration of strategic alternatives and is not confirming that the process will result in any strategic alternative being announced or consummated. AmpliPhi said it does not intend to discuss or disclose further developments during this process unless and until its board of directors has approved a specific action or otherwise determined that further disclosure is appropriate.
(Source: Business Wire)
Filed Under: Drug Discovery
