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Innovation Pharmaceuticals and FDA Agree to Waive Initial Pediatric Study Plan Requirement Regarding Brilacidin for the Prevention of Oral MucositisBEVERLY, Mass., Nov. 25, 2019 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage pharmaceutical company, is pleased to inform shareholders the Company received notification from the Food and Drug Administration (FDA) that a waiver has been granted eliminating the need to study Brilacidin, for the prevention of Severe Oral Mucositis in Head and Neck Cancer (HNC) patients receiving chemoradiation, in pediatric populations. The granting of this waiver now enables the Company to develop Brilacidin in a more focused manner in adult patient populations where Oral Mucositis has the greatest impact. In other news, the Company will provide shortly an update on continuing clinical development of Brilacidin for Inflammatory Bowel Disease, including the status of planned clinical work in Ulcerative Proctitis/Ulcerative Proctosigmoiditis. Alerts About Innovation Pharmaceuticals Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning the future execution of a definitive agreement with a global pharmaceutical company and the anticipated terms thereof, our future drug development plans, other statements regarding future product developments, and markets, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks, uncertainties and assumptions that could cause the Company’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. The Company has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are the Company’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock under securities purchase agreements; the fact that the Company’s licensee(s) may not successfully complete pre-clinical or clinical testing and the Company will not receive milestone payments, or the fact that the Company’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in the Company’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. The Company undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation. INVESTOR AND MEDIA CONTACT |