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Cellceutix Corp (OTCMKTS:CTIX) Could Be In Line For A Big Pharma Partner

Cellceutix Corp (OTCMKTS:CTIX) Could Be In Line For A Big Pharma Partner
Written by
Chris Sandburg
Published on
October 11, 2016
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Cellceutix Corp (OTCMKTS:CTIX) just put out some early stage data from a phase II in one of its lead assets, and markets are pretty flat on the release. Interpretation of the numbers seems a bit uncertain, but the release will likely bring in some speculative volume. Beyond that, however, we think the numbers offer up a pretty strong buy thesis, and that the drug in question's potential makes Cellceutix an attractive candidate for a big name partnership.Before we get into the data, let's start with a brief introduction to the company.Cellceutix is a development stage biotech with a focus on oncology and inflammatory disease. The company has a pretty robust pipeline and development program for a company of its size, and its three lead assets are Prurisol, Kevetrin and Brilacidin. The latter is the most advanced candidate, and as per the result of an end of phase II meeting with the FDA, Cellceutix is about to kick off a pivotal investigating its efficacy in acute bacterial skin and skin structure infections (ABSSSI) at some point early next year.It's this latter asset we're focusing on for the purposes of this discussion, although in this instance it's targeting ulcerative proctitis, which is basically the same as ulcerative colitis (inflamed intestine lining that causes ulcers, pain and digestive issues) but in the rectum (as defined by the last six inches of the large intestine).From an MOA perspective, Brilacidin is a synthetic molecule designed to mimic the actions of what are called host defense proteins (HDPs). HDPs are a sort of front line of attack in our bodies, floating around as part of the immune system identifying and killing pathogens. They also modulate inflammation, and this is the idea behind their use as an anti inflammatory (in conditions like the UP that it targets as part of the data we are discussing).So, the numbers.The data is very limited, with only four of the six patient first cohort having completed the study to date.Of the four, at day 42, two of these patients achieved a full response (defined as 100% reduction in inflammation) and the other two achieved a 50% of more reduction. These numbers derived from only a partial analysis, however. Specifically, the final analysis was supposed to involve a full MMDAI, but one patient wouldn’t allow a physician to perform an endoscopy (we don't know why) so the actual data is only based on three patients. Unfortunately, the patient that didn’t consent was one of the 100% responders as part of the partial MMDAI, so this skews the data a little.The drug was generally well tolerated, so safety doesn’t look like it's going to be an issue as the cohorts expand.What does all this mean?We can sum up the results like this: they are indicative of clinical benefit, and bode well for the coming cohorts as the doses expand. The highest dose is a four times multiple of the dose these patients received, so we're looking for some degree of correlation between efficacy and dosing as indicative of potential. It's an open label trial, so we expect the company to put out information on each cohort as and when the numbers come in. This means we can piece together a pretty solid picture of how the drug is performing ahead of final data collection.As far as a partnership is concerned, we think there are probably some big names interested in the drug right now, but they are probably waiting to see how things play out once the dose escalates before taking action. At worst case, we've got 100% reduction in 33%, and at best, 100% reduction in 50% and a 50% reduction in the remaining. For a target market as large as inflammatory conditions, that's exciting.We're going to follow this trial closely and interpret the data as it plays out. Subscribe below and we'll keep you in the loop!Disclosure: We have no position in CTIX and have not been compensated for this article.

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