On November 15, 2018 Oragenics, Inc. (NYSE American:OGEN), a leader in the development of new antibiotics against infectious diseases and effective treatments for oral mucositis ("OM"), reported it has received clearance to enroll patients residing in Germany from the Paul Erlich Institute and patients residing in the United Kingdom from the Medicines and Healthcare products Regulatory Agency (MHRA), into its Phase 2 clinical trial of AG013, a live biotherapeutic product for the potential prevention and treatment of OM (Press release, Oragenics, NOV 15, 2018, View Source [SID1234531372]).
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"We are pleased with the receipt of regulatory Health Authority approvals in Germany and the United Kingdom. These approvals provide us with the opportunity to expand the number of clinical trial sites from which we can draw patients to participate in our clinical trial of AG013," stated Alan Joslyn, Ph.D., president and CEO of Oragenics, Inc. Dr. Joslyn continued "The approvals of Germany and the United Kingdom, further enhance our ability to complete the clinical study in 2019."
The ongoing Phase 2 trial is a double-blind, placebo-controlled, two-arm, multi-center trial, in which approximately 200 patients will be randomized in a 1:1 ratio to receive either AG013 or placebo. The purpose of the study (NCT03234465) is to evaluate the safety, tolerability and efficacy of topically administered AG013 compared to placebo for reducing the incidence and severity of OM in patients undergoing traditional chemoradiation for the treatment of head and neck cancer. Key measures include duration, time to development, and overall incidence of OM (using a World Health Organization scale) during the active treatment phase, which begins from the start of chemoradiation therapy and ends two weeks following its completion.
AG013, which has been granted Fast Track designation with the U.S. Food and Drug Administration and orphan drug status in Europe, is an Intrexon Actobiotics therapeutic candidate formulated to deliver the therapeutic molecule, human Trefoil Factor 1, to the mucosal tissues in the oral cavity in a convenient oral rinsing solution. Trefoil Factors are a class of peptides involved in the protection of gastrointestinal tissues against mucosal damage and play an important role in these tissues subsequent regeneration. The compound was designed by the company’s strategic partner, Intrexon Actobiotics NV, a wholly-owned subsidiary of Intrexon Corporation (NYSE: XON) whereby Oragenics, Inc. holds an exclusive world-wide license