I am very pleased with today's PR. It gave us a lot of information and highlighted many near term events -
The protocol safety committee met on April 13, 2015 to review data for patients treated in the 450 mg/m2 cohort and recommended that the next cohort receive Kevetrin doses of 750 mg/m2 (a 67% increase in dose and 75x the initial dose).
Further, Kevetrin appears to be having the expected effects on p53 in a number of the patients treated, as measured by increases in the levels of the downstream protein p21 biomarker. According to the latest data, over 50% of patients treated have had increases in the p21 marker. In addition, the effect on p53/p21 appears to be dose-dependent, with patients treated in the cohorts receiving 350 and 450 mg/m2 of Kevetrin showing greater increases in levels of p21. At this time, the Company is saving the full p21 results for an appropriate scientific venue.
We are pleased to report we have been notified that based upon the data from the Phase 1 study, the original protocol has been revised and expanded from what was originally planned to be a Phase 1b study into a Phase 2 trial evaluating Kevetrin as a single agent or in combination with cytarabine in patients with Acute Myelogenous Leukemia (AML).
We anticipate meeting with the FDA for an End-of-Phase 2 meeting in late June 2015. Upon the FDA accepting our proposals, we will commence Phase 3 trials of Brilacidin for ABSSSI.
The FDA accepted our Investigational New Drug application in October 2014 to begin the trial. Since that time, we made modifications to target specific investigator sites having significant experience in conduct of this type of study and ultimately doubled the original number of planned sites to expedite recruitment. We expect subject enrollment in this trial to commence in May.
We hope to initiate a Phase 2 trial in 2015 to expand into the lucrative GI markets, with the potential for additional trials targeting ulcerative colitis, Crohn's Disease and other conditions where today's treatment options are very limited in effectiveness.
We expect enrollment to begin in 2Q 2015. We are engaging the trial at more clinical sites than originally planned and expect to make up for lost time as the manufacturing process took longer then expected. 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 expect enrollment in this study to be completed during 2015.
After careful consideration, we have now cancelled a scheduled May pre-IND meeting with the FDA to discuss initiating a Phase 2 trial for HS. We believe it is a more prudent use of resources to expand upon on our more advanced compounds at this time. After the start of our other Phase 2 trials, and as we can devote more resources specifically to an HS therapy, we will return to advancing this project toward the clinic.
Elsewhere in our extensive pipeline, we and/or our partners have conducted very promising research that supports additional clinical trials that we plan to focus on in the future. Namely, we are developing formulations for ophthalmic, otic and diabetic foot infections. We have a growing body of evidence to the potential efficacy of our HDP mimetic compounds for the treatment of Gram-negative bacteria and fungal pathogens.
Our NASDAQ application is in process. We made our selections and now received confirmation of acceptance of positions for new members to the Company's Board of Directors and committees required to move to the NASDAQ exchange. This information has been prepared in the form of an 8-K filing for submission to the Securities and Exchange Commission (SEC) and is currently being reviewed by our SEC counsel. Under guidance of our legal counsel, we will be publicly releasing this information simultaneously with the 8-K submission.
"There are many exciting developments ongoing at Cellceutix, both at the corporate level and from a drug development perspective," commented Leo Ehrlich, Chief Executive Officer at Cellceutix. "We have always held that the best approach to build shareholder value is to conduct multiple projects concurrently. We are executing efficiently at this business model, targeting large markets with novel drugs, while running a lean operation. In a relatively short period of time, we have grown exponentially and will soon have several Phase 2 trials and a Phase 3 study happening as we stand in the best financial position in the Company's history."
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