Shares of Cellceutix Corp (OTCMKTS:CTIX) look to have bottomed after announcing that the manufacturing, lyophilization and filling of vials is now complete in preparation for the planned Phase 3 trials of Brilacidin for Acute Bacterial Skin and Skin Structure (ABSSSI) infections caused by Gram-positive bacteria. The excitement here is that Cellceutix is almost ready to make history by becoming the first new class of antibiotic to enter a Phase 3 clinical trial for ABSSSI in more than two decades.The vials of Brilacidin are now in the inspection and quality control (QC) stage. The Company is preparing for submitting the final protocol for the trial per guidance from the U.S. Food and Drug Administration (FDA) received at the end-of-phase 2 meeting. With the vials being filled, a global Contract Research Organization (CRO) selected, and the final protocol nearing completion, the vast majority of the work has been finished in preparation for the pivotal Phase 3 trials of Brilacidin for ABSSSI.This is just the latest accomplishment from CTIX. Cellceutix's anti-cancer drug Kevetrin is currently in a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center. In the laboratory Kevetrin has shown to induce activation of p53, often referred to as the "Guardian Angel Gene" due to its crucial role in controlling cell mutations.Cellceutix is in a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention of Oral Mucositis in patients with head and neck cancer. Brilacidin-OM, a defensin mimetic compound, has shown in an animal model to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo.Cellceutix's anti-psoriasis drug Prurisol is in a Phase 2 trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction.CTIX is ready for the ABSSSI Phase 3 trials. The company has former Durata executive Dr. Ronald Trust as a consultant for the trial, and the Head of Clinical Operations, Edward Walters, is experienced in taking drugs through Phase 3 and getting drugs FDA approved. For the Phase 3 ABSSSI study, CTIX will use a global CRO. In regards to funding all of this, CTIX has enough cash on hand, a commitment from Aspire Capital, and a shelf registration.The lawsuit from the Rosen Law Firm alleges that costs for the trial will be $145 million. We at Insider Financial believe that it will not cost this much. CTIX has always come under budget in its previous studies and has operated at a lower burn rate than comparable drug companies. Overall, we view the Rosen suit as without merit and not a concern for shareholders.Shares of CTIX are also bouncing as traders and investors focus on what's going to happen in 2016. Among the developments we are watching include the start of Kevetrin advanced study in ovarian cancer ; start of Brilacidin ABSSSI Phase 3; start of Brilacidin for Ulcerative Proctitis proof of concept trial (Phase 2); top line data on Kevetrin Phase 1 trial for advanced solid tumors; top line data on Prurisol Phase 2 trial for chronic plaque psoriasis; interim analysis for Brilacidin Phase 2 trial for Oral Mucositis (if enrollment milestone reached); start of Retinoblastoma program, formulation and toxicity studies; additional ototoxicity studies with Brilacidin in different concentrations; gram- negative and anti-fungal progress; and submission of grant application for study of Kevetrin in pancreatic cancer with renowned hospital.
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CTIX is one of the few pharma companies on the OTC markets on the verge of several multi-billion dollar developments. We think this will be the case with CTIX as Dr. Krishna Menon is a real genius. He was the brains behind the development of two blockbuster cancer drugs, Gemzar and Alimta for Eli Lilly & Co.(NYSE:LLY) back in the late 90’s. Now he hopes to do the same with CTIX. We will be updating Insider Financial when more details emerge so make sure you are signed up below to get the latest on CTIX. With all that CTIX has going on, we expect it to be a busy year and many updates to come!
Disclosure: We have no position in CTIX either long or short. We have not been compensated for this article.
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