On December 14, 2017 AmpliPhi Biosciences Corporation (NYSE American: APHB), a clinical-stage biotechnology company focused on the development of therapies for antibiotic-resistant infections using bacteriophage technology, reported its progress in 2017 and near-term strategic goals and initiatives (Press release, AmpliPhi Biosciences, DEC 14, 2017, View Source [SID1234522649]).
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2017 Corporate Highlights
In April, AmpliPhi received positive feedback from a U.S. Food and Drug Administration (FDA) Type B meeting in which the FDA "acknowledged that phage therapy is an exciting approach to treatment of multi-drug resistant organisms and expressed a commitment to addressing the unique regulatory challenges that might arise during product development." The FDA also stated that "the clinical safety and effectiveness data collected during development, including from emergency case studies, could inform future discussions for clinical development and ultimately, the regulatory pathway to approval."
In August, AmpliPhi announced the first-in-human administration of its therapeutic candidate AB-PA01 targeting Pseudomonas aeruginosa (P. aeruginosa) under an Emergency IND allowed by the FDA. AmpliPhi provided AB-PA01 for a patient suffering from a life-threatening multidrug-resistant P. aeruginosa lung infection. Multiple doses of AB-PA01 were administered intravenously and by inhalation through a nebulizer and were well tolerated.
In September, AmpliPhi announced the first-in-human intravenous administration of its therapeutic candidate AB-SA01 targeting Staphylococcus aureus (S. aureus) under the Special Access Scheme of the Australian Therapeutic Goods Administration. AmpliPhi provided AB-SA01 for a patient suffering from a life-threatening S. aureus endocarditis. AB-SA01 was administered intravenously over a two week duration and was well tolerated.
A total of seven patients, suffering from serious and life-threatening infections who were not responding to antibiotic therapy, have been treated with AB-SA01 or AB-PA01 in 2017.
Raised $9.4 million in net proceeds from an equity securities offering in May, and received a $2.0 million Research and Development Tax Incentive cash rebate in September from the Australian Tax Office based on the Company’s R&D spending in Australia during 2016.
Continued to raise awareness of the Company’s bacteriophage development programs through presentations and participation in various scientific and medical meetings, including: 2017 Australian Society of Otolaryngology Head and Neck Surgery Meeting in March, Solutions for Drug-Resistant Infections Meeting in Brisbane in April, and "Bacteriophage Therapy: Scientific and Regulatory Issues" workshop sponsored by the FDA and the National Institutes of Health in July.
In December, the Company engaged Ladenburg Thalmann & Co. Inc. to assist the Company in exploring strategic alternatives in an effort to maximize shareholder value. The Company has not set a timetable for completion of this exploratory process and cannot provide any assurances that the process will result in the consummation of a strategic transaction of any kind, or that the Company will not abandon the process. The Company 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 the Company otherwise determines that further disclosure is appropriate.
Potential Milestones and Initiatives for the First Half of 2018
In early 2018, the Company plans to present topline results from the treatment of seven patients with serious and life-threatening infections, not responding to antibiotics, completed under the Company’s single-patient expanded access program in 2017.
The Company intends to continue its expanded access clinical strategy in the first half of 2018, present data from approximately 25 expanded access clinical cases to the FDA in mid-2018 and initiate a Phase 2 or registrational clinical trial as early as the second half of 2018.
The Company will present an overview and update of its current business activities at the 9th Annual Biotech Showcase Conference on January 8, 2018 at 9:30 a.m. PT being held in San Francisco.
"AmpliPhi has made tremendous progress throughout 2017," said Paul C. Grint, M.D., CEO of AmpliPhi Biosciences. "To date, under the expanded access program, we have dosed seven patients in dire need, who were suffering from serious and life-threatening infections and were not responding to antibiotic therapies. We look forward to presenting topline results in early 2018. We have set a goal of dosing approximately 20 additional patients during the first half of 2018. We continue the dialogue with the FDA and key thought leaders in the infectious disease community regarding design of Phase 2 and registrational clinical studies of our bacteriophage therapies."