AmpliPhi Biosciences Review of Recent FDA Feedback and Drug Pipeline

NEW YORK, NY / ACCESSWIRE / April 24, 2017 / Traders News Source, a leading independent equity research and corporate access firm focused on small and micro-cap public companies is issuing a comprehensive report with no obligation
on AmpliPhi Biosciences Corporation (NYSE MKT: APHB), a biopharmaceutical company engaged in the discovery, development, and commercialization of phage therapeutics. Currently, AmpliPhi has product candidates for the treatment of S. aureus infections (including Methicillin-resistant Staphylococcus aureus or MRSA), P. aeruginosa infections, and C. difficile infections. AmpliPhi’s most advanced product candidate is AB-SA01, a treatment for S. aureus.

On April 17, 2017, AmpliPhi announced that the FDA provided positive feedback on the company’s proposal to commence a Phase 2 clinical trial for AB-SA01 for the treatment of antibiotic-resistant S. aureus infections in patients with CRS. The FDA also acknowledged that phage therapy is an exciting approach to the treatment of multidrug-resistant organisms and pledged to address the unique regulatory challenges that may arise during product development. The company also disclosed that it has retained H.C. Wainright & Co., LLC, an investment banking firm, to explore strategic alternatives to maximize value for shareholders.

FDA’s positive feedback could be a catalyst for Ampliphi shares READ MORE.

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The primary benefit of using bacteriophages is their ability to disrupt biofilms, external layers of aggregated bacteria and other extracellular components which serve as a defense mechanism. These biofilms, which are present in the majority of infections, can render traditional antibiotics almost completely ineffective. In comparison, bacteriophages can penetrate these biofilms and are highly effective at treating infections. AmpliPhi has multiple product candidates that could make a significant contribution to the global market for treating bacterial infections, and the recent feedback from the FDA regarding AB-SA01 was positive.

AmpliPhi reported fourth quarter and full-year results on March 27, 2017. Revenue for the year ended December 31, 2016 was $0.3 million, a slight decrease from the prior year revenue of $0.5 million. This revenue is related to sub-licensing agreements from the company’s former gene therapy program. AmpliPhi does not expect material revenue from sub-licensing in the future. The company still faces financial hurdles before they can fully develop and potentially market the products in their pipeline.

Ampliphi financials and a full pipeline review are discussed in this full report READ
MORE

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