Business
ORAGENICS INITIATES PHASE IIA CLINICAL TRIAL SITE ACTIVATION
FIRST SITE INITIATION VISIT COMPLETED IN AUSTRALIA SARASOTA, Fla., March 12, 2026 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a clinical-stage biotechnology company pioneering brain-targeted therapeutics through proprietary intranasal delivery technology, today announced it has completed the first site initiation visit (SIV) for its Phase IIa clinical trial of ONP-002 in Australia. The visit marks the formal launch of clinical trial operations at the first of three planned trial s
About this update from Oragenics Inc.
[{"type":"image","alt":"Oragenics, Inc.","displaySize":"","headline":null,"caption":"Oragenics, Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":114,"url":"https://media.zenfs.com/en/globenewswire.com/02a218ac180e2bd4098942c8c71e4535"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/EJO5t_9yeEA4D97YiOoXog--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTE2MDtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/02a218ac180e2bd4098942c8c71e4535","width":300,"height":114}},"lazy":false},{"type":"text","content":"FIRST SITE INITIATION VISIT COMPLETED IN AUSTRALIA","length":50,"tagName":"p"},{"type":"text","content":"SARASOTA, Fla., March 12, 2026 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a clinical-stage biotechnology company pioneering brain-targeted therapeutics through proprietary intranasal delivery technology, today announced it has completed the first site initiation visit (SIV) for its Phase IIa clinical trial of ONP-002 in Australia. The visit marks the formal launch of clinical trial operations at the first of three planned trial sites in Australia, including completion of site staff training, protocol orientation, and site regulatory documentation.","length":569,"tagName":"p"},{"type":"text","content":"The remaining two clinical trial sites are currently completing their Research Governance Office (RGO) reviews — the final administrative step required following Human Research Ethics Committee (HREC) approval before each site can activate to begin patient enrollment and dosing. The Company expects these reviews to be completed in the near term, at which point all three sites will be positioned to enroll patients.","length":417,"tagName":"p"},{"type":"text","content":"The Phase IIa trial initiation follows the Company's receipt of HREC approval earlier this year, which represented the final regulatory clearance required to commence clinical site contract finalization, activation, and onboarding.","length":235,"tagName":"p"},{"type":"text","content":"PHASE IIA CLINICAL TRIAL OVERVIEW","length":33,"tagName":"p"},{"type":"text","content":"The Phase IIa trial is a randomized, placebo-controlled study evaluating the safety, tolerability, and preliminary clinical signals of ONP-002 in patients presenting with acute concussion and mild traumatic brain injury. Key design parameters include:","length":251,...