![](http://investorshub.advfn.com/images/default_ih_profile2_4848.jpg?cb=0)
Thursday, March 14, 2019 1:29:49 PM
Brilacidin
BEVERLY, Mass., March 14, 2019 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals, (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to inform shareholders that necessary documentation has been completed for the European Medicines Agency (EMA) March 15, 2019 submission cycle requesting Scientific Advice to advance Brilacidin oral rinse in a Phase 3 program for the prevention of severe Oral Mucositis (OM) in Head and Neck Cancer (HNC) patients receiving chemoradiation. The documentation is being submitted to the EMA through IPIX Pharma, Ltd., the Innovation Pharmaceuticals Irish subsidiary.
As is customary, the Company is seeking Phase 3 scientific guidance from the EMA regarding the Brilacidin OM program. In December, Innovation Pharmaceuticals completed an End-of-Phase 2 Meeting with the U.S. Food and Drug Administration (FDA), during which an acceptable Phase 3 development pathway was agreed upon to advance Brilacidin.
For the Phase 3 program, the Company anticipates international clinical trial enrollment, with participating sites located in the U.S. and in Europe. EMA advice is integral to this plan by helping to ensure that the program meets European standards.
“Our Company is now at an inflection point, emerging as a global leader in new OM therapies. The combination of scientific advice from the FDA and the EMA will leave us well positioned to move forward into Phase 3 development with the goal of Brilacidin becoming the first effective and conveniently administered drug approved by both agencies for decreasing the incidence of OM in HNC patients,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals.
Recent IPIX News
- Form 8-K - Current report • Edgar (US Regulatory) • 02/01/2024 01:30:25 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/05/2023 09:25:58 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/20/2023 09:05:44 PM
- Form NT 10-Q - Notification of inability to timely file Form 10-Q or 10-QSB • Edgar (US Regulatory) • 11/15/2023 01:00:19 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/30/2023 08:15:25 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 09/28/2023 01:00:08 PM
North Bay Resources Announces Composite Assays of 0.53 and 0.44 Troy Ounces per Ton Gold in Trenches B + C at Fran Gold, British Columbia • NBRI • Jun 18, 2024 9:18 AM
VAYK Assembling New Management Team for $64 Billion Domestic Market • VAYK • Jun 18, 2024 9:00 AM
Fifty 1 Labs, Inc Announces Acquisition of Drago Knives, LLC • CAFI • Jun 18, 2024 8:45 AM
Hydromer Announces Attainment of ISO 13485 Certification • HYDI • Jun 17, 2024 9:22 AM
ECGI Holdings Announces LOI to Acquire Pacific Saddlery to Capitalize on $12.72 Billion Market Potential • ECGI • Jun 13, 2024 9:50 AM
Fifty 1 Labs, Inc. Announces Major Strategic Advancements and Shareholder Updates • CAFI • Jun 13, 2024 8:45 AM