Some things from the 10-Q, Part 1 In vitro and
Post# of 72446
Posted On: 05/09/2016 6:35:51 PM
Re: takingabath #22192
Some things from the 10-Q, Part 1
In vitro and in vivo animal studies evaluating combinations of Kevetrin and various chemotherapies used in treatment of ovarian cancer have been completed and are supportive of the approach planned. The clinical trial protocol is planned for submission to FDA in May 2016.
We are now engaged in discussions with the hospital [Beth Israel Deaconess] as to the logistics and costs, net of grants, to move this project forward into Phase 2 studies of renal cell carcinomas. At this time our priority is to advance Kevetrin in the treatment of ovarian cancer.
[MD Anderson] also wish to study our other cancer compounds against a broad array of Multiple Myeloma cell lines that are resistant to today's FDA-approved chemotherapies. MD Anderson is covering the expenses of the research, with Cellceutix only supplying the drugs. In May 2016, we sent requested Phase 1 pharmacokinetic data to MD Anderson.
Given that psoriasis is a chronic condition with limited effective therapies that the National Psoriasis Foundation lists as affecting 125 million people worldwide, we see a tremendous market opportunity for an effective new oral treatment. We have completed enrollment and expect topline data approximately in May 2016.
Brilacidin-OM: 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 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.
In vitro and in vivo animal studies evaluating combinations of Kevetrin and various chemotherapies used in treatment of ovarian cancer have been completed and are supportive of the approach planned. The clinical trial protocol is planned for submission to FDA in May 2016.
We are now engaged in discussions with the hospital [Beth Israel Deaconess] as to the logistics and costs, net of grants, to move this project forward into Phase 2 studies of renal cell carcinomas. At this time our priority is to advance Kevetrin in the treatment of ovarian cancer.
[MD Anderson] also wish to study our other cancer compounds against a broad array of Multiple Myeloma cell lines that are resistant to today's FDA-approved chemotherapies. MD Anderson is covering the expenses of the research, with Cellceutix only supplying the drugs. In May 2016, we sent requested Phase 1 pharmacokinetic data to MD Anderson.
Given that psoriasis is a chronic condition with limited effective therapies that the National Psoriasis Foundation lists as affecting 125 million people worldwide, we see a tremendous market opportunity for an effective new oral treatment. We have completed enrollment and expect topline data approximately in May 2016.
Brilacidin-OM: 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 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.
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