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Here's What You Need To Know About The Latest Cellceutix Corp (OTCMKTS:CTIX) Numbers

Here's What You Need To Know About The Latest Cellceutix Corp (OTCMKTS:CTIX) Numbers
Written by
Chris Sandburg
Published on
March 28, 2017
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Just last week we took a look at Cellceutix Corp (OTCMKTS:CTIX) as part of this piece. Our thesis on the stock was simple: forget the negative attention surrounding the company, and focus on the science.Well, we just got some fresh news related to one of the company's lead development assets, and the company is running up on the release. Here's a look at how the latest development plays in to our view of Cellceutix, and what it means for the company and its shareholders going forward.For those new to this one, Cellceutix is a development stage biotechnology play with a focus on a pretty wide scope of target indications, ranging from cancer to psoriasis to bacterial type conditions. Its three lead development assets are Prurisol (psoriasis), Kevetrin (anti-cancer) and Brilacidin (oral mucosis, anti infection, IBD).The one we're looking at here is the Brilacidin asset in the oral mucosis indication.Cellceutix just put out data from a phase II study investigating the asset in the prevention and control of OM in patients receiving chemoradiation for treatment of head and neck cancer. OM is one of the more prevalent (and the more debilitating) side effects of the chemotherapy that these patients receive, and it's characterized by inflammation and ulceration that often renders patients unable to speak with trouble eating, as well as increasing the chances of infection. Severe cases generally result in hospitalization (outside of the hospitalization required for the cancer) and the condition brings with it costs of close to $25,000 for the portion of the 500,000 patients that suffer from OM on the back of this cancer, and that need to be hospitalized.Analysts expect the market for this condition to exceed $1 billion annually before the close of this decade, and it's this market that Cellceutix is going after with Brilacidin in this indication.So what did the data tell us?The study is double blind, and the data is interim, looking at 19 patients that have passed a predefined marker that sees them having reached or passed the planned visit at the end of 5 weeks on study, and received a cumulative radiation dose of at least 55 Gy. Of the 19 that meet these criteria, 9 are on the active arm (so, receiving Brilacidin) and 10 are on control (so, receiving placebo). The idea is that, after the patient has had the chemotherapy, they swill with a concentration mixture of Brilacidin, then spit it out. This swill administration is – according to the company's hypothesis – supposed to reduce the chances of OM developing, so the endpoint of the study falls in line with this reduced chance of development. Specifically, how many patients developed severe OM (classed as WHO grade higher than or equal to 3) across a seven-week period of chemoradiation treatment.Here's what matters:In the active arm, the percentage portion of patients that developed OM was 22.2%, or 2 of the 9 patients. In the active arm, this number came in at 70%, or 7 out of 10 patients. Additionally, as part of a secondary efficacy analysis, the OM in the active arm lasted an average of 10.5 days, whereas the OM in the control arm lasted an average of 14 days.Safety also came out pretty clean (as clean as can be expected for sufferers of this cancer type, undergoing chemo) and none of the TEAEs were classified as likely related to, or definitely related to, study treatment.So what does this mean?Well, that the drug seems to no only work, but work well. This is a real unmet right now, and any drug that can reduce incidence from 70% to 22% with nothing more than an mouthwash admin, and not add to safety concerns, is a shoo in for an FDA green light. Of course, these are just interim data, and to remains to be seen whether the numbers will remain as convincing when the trial closes.And that's what we're looking at next. The study is expected to complete during the fourth quarter, at which point we should see topline. If the data falls in line with the numbers just released, expect the stock to run (as success here also implies success in other inflammatory and bacterial type indications) as Cellceutix carries forward into registration.We will be updating our subscribers as soon as we know more. For the latest updates on CTIX, sign up below!Disclosure: We have no position in CTIX and have not been compensated for this article.

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