Brilacidin Update We have received back from FD
Post# of 72446
Posted On: 05/09/2016 7:32:58 PM
Brilacidin Update
We have received back from FDA comments and considerations for incorporation into our study design. An additional round of review and/or a formal meeting is anticipated, both of which can extend the review period and be beneficial in reaching agreement with the FDA on design elements. Based on the FDA's feedback, we may reach final agreement with FDA or may decide to incorporate the advice into the design of the Phase 3 clinical study without undergoing additional rounds of review. FDA's assessment of the SPA request, and all related feedback, will be very valuable in our planned Phase 3 clinical study for the development of Brilacidin for ABSSSI. The Company can offer no assurance that a SPA agreement will be reached with FDA.
Trial recruitment is slower then what was projected by the hospitals we engaged. We believe this is happening because there are numerous competing trials for a limited patient population of Head and Neck cancer patients who meet the strict trial inclusion and exclusion requirements. To help hasten the completion of the study we have replaced our previous contract research organization (CRO) with another who has a proven track record in clinical trials for this indication. In addition, we brought on Dr. Steven Sonis, an expert in the treatment of OM as an advisor, and have authorized the opening of additional sites, to help us complete this trial.
We have identified inflammatory gastrointestinal diseases such as Ulcerative Proctitis, Ulcerative Colitis, and Crohn's disease as potential indications for treatment with Brilacidin. We will begin with treating ulcerative proctitis. The Company plans for a Phase 2 proof of concept trial for ulcerative proctitis to begin in May 2016. Cellceutix is now awaiting the country's Ministry of Health permission so it may begin exporting Brilacidin into the country and directly to the clinical sites.
We have also identified an inflammatory skin disease, hidradenitis suppurativa, as an indication for treatment with Brilacidin. Based on detailed discussion with multiple experts in the field of Dermatology, in April 2016, the Company reactivated a request, for a Pre-IND (investigational new drug) meeting with FDA to discuss the clinical path forward. The meeting is expected to occur in June 2016.
The Company has engaged a university for the testing of different concentrations of Brilacidin for ototoxicity. Testing is scheduled to begin in June 2016. Should testing be successful, we intend on advancing this program to develop ear treatments for Methicillin-resistant Staphylococcus aureus (MRSA) infections.
https://www.sec.gov/Archives/edgar/data/13552...ix_10q.htm
We have received back from FDA comments and considerations for incorporation into our study design. An additional round of review and/or a formal meeting is anticipated, both of which can extend the review period and be beneficial in reaching agreement with the FDA on design elements. Based on the FDA's feedback, we may reach final agreement with FDA or may decide to incorporate the advice into the design of the Phase 3 clinical study without undergoing additional rounds of review. FDA's assessment of the SPA request, and all related feedback, will be very valuable in our planned Phase 3 clinical study for the development of Brilacidin for ABSSSI. The Company can offer no assurance that a SPA agreement will be reached with FDA.
Trial recruitment is slower then what was projected by the hospitals we engaged. We believe this is happening because there are numerous competing trials for a limited patient population of Head and Neck cancer patients who meet the strict trial inclusion and exclusion requirements. To help hasten the completion of the study we have replaced our previous contract research organization (CRO) with another who has a proven track record in clinical trials for this indication. In addition, we brought on Dr. Steven Sonis, an expert in the treatment of OM as an advisor, and have authorized the opening of additional sites, to help us complete this trial.
We have identified inflammatory gastrointestinal diseases such as Ulcerative Proctitis, Ulcerative Colitis, and Crohn's disease as potential indications for treatment with Brilacidin. We will begin with treating ulcerative proctitis. The Company plans for a Phase 2 proof of concept trial for ulcerative proctitis to begin in May 2016. Cellceutix is now awaiting the country's Ministry of Health permission so it may begin exporting Brilacidin into the country and directly to the clinical sites.
We have also identified an inflammatory skin disease, hidradenitis suppurativa, as an indication for treatment with Brilacidin. Based on detailed discussion with multiple experts in the field of Dermatology, in April 2016, the Company reactivated a request, for a Pre-IND (investigational new drug) meeting with FDA to discuss the clinical path forward. The meeting is expected to occur in June 2016.
The Company has engaged a university for the testing of different concentrations of Brilacidin for ototoxicity. Testing is scheduled to begin in June 2016. Should testing be successful, we intend on advancing this program to develop ear treatments for Methicillin-resistant Staphylococcus aureus (MRSA) infections.
https://www.sec.gov/Archives/edgar/data/13552...ix_10q.htm
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