Detroit, Dec 18th, 2018, (PENNYSTOCKS.NEWS) Innovation Pharmaceutical (OTC: $IPIX), announced yesterday that U.S. Food and Drug Administration (FDA) and the company completed the end-of-phase 2 meeting that is related to the ongoing development of Brilacidin oral rinse to decrease incidence of SOM (Severe Oral Mucositis) in patients of Head and Neck Cancer (HNC) receiving chemoradiation. For Oral Mucositis (OM), Brilacidin oral rinse is being developed under Fast Track Designation of FDA.
When cisplatin is administered in the higher concentrations about 80 to 100 mg/m2, and at the lower level about 30 to 40 mg/m2 conducted weekly as the part of chemoradiation regimen, both parties are agreed to an acceptable pathway of Brilacidin Phase 3 development including studying Brilacidin oral rinse effects on SOM.
Once an official meeting received from FDA, the company is expecting to release more about the planned phase 3 trials of Brilacidin as the novel oral SOM treatment. According to the guidance of FDA, the meeting was conducted, studies will aim to gratify the requirements for New Drug Application and for obtaining the market approval of Brilacidin for SOM. Additionally, the management intends to seek the international regulatory bodies for expanded registration globally.
Arthur P. Bertolino, MD, Ph.D., MBA, President, and Chief Medical Officer said at the Innovation Pharmaceuticals that:
“Our interactions with the FDA have been highly collaborative and constructive, providing us with clear guidance to help inform our Phase 3 development plans,” and he said:
“We are in alignment as to necessary key pivotal trial design features and Phase 3 clinical outcomes needed to support an NDA filing. We look forward to continuing working closely with FDA on our Brilacidin oral rinse program as we prepare to enter the pivotal stage of clinical evaluation.”
The CEO of Innovation Pharmaceuticals
Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals, said that:
“This is an extremely exciting moment for Innovation Pharmaceuticals and its shareholders,”
Moreover, he also said:
“In Brilacidin oral rinse, we now have a Phase 3-ready drug candidate targeting an area of large unmet need—comprising a worldwide annual market opportunity estimated to approach $1 billion—for which currently there are no FDA-approved treatments. Brilacidin is further advantageously differentiated from the two other OM drug candidates in Phase 3 testing which require being taken intravenously, whereas Brilacidin is easily administered as an oral rinse and conveniently packaged in sachet form, similar in design to a sugar packet. With a sachet, patients simply would mix the contents of the Brilacidin sachet with water for a quick-and-easy treatment at home or on-the-go.”
Additionally, Mr. Ehrlich said:
“This result further validates the breadth of the Brilacidin franchise. Our novel defensin-mimetic drug candidate is anchored with mid-and-late-stage trials in three clinical indications—oral mucositis, inflammatory bowel disease, and serious skin infections—and planned extensions into dermatological diseases, such as atopic dermatitis and acne. Effectively, we have a multi-indication drug platform in Brilacidin, now planning for Phase 3 testing for the first indication, thus moving us a significant step closer to bringing Brilacidin to market.”
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About Brilacidin Phase with the other OM drugs in development:
The Brilacidin oral rinse of Company expressed a substantial therapeutic benefit in the patient receiving the aggressive chemotherapy regimen that is commonly used. In this population of the patient, the incidence of severe Oral Mucositis was reduced about 25 percent in a population of modified Intent-to-Treat (mITT), compared to 71.4% of placebo patients. In a group of patients of Per Protocol (PP), the incidence of Severe OM is reduced to 14.3% for Brilacidin’s patients, versus 72.7% among the patients that are receiving placebo.
The study of completed Phase 2 connected its primary endpoint, displayed the reduction of Severe OM compared to placebo and the effects of beneficial treatment in delaying the onset of Severe OM and in reducing the time of Severe OM. Additionally, Brilacidin displayed the favorable safety profile and well-tolerated.
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