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Tuesday, February 09, 2016 6:25:14 AM
The Phase 3 ABSSSI program would include two Phase 3 ABSSSI studies, as required by FDA Guidance (October 2013), of approximately 700 subjects in each study. The two studies may enroll subjects simultaneously. In addition, the first study would include an interim analysis after a portion of the patients has been enrolled. This would provide an early assessment of both safety and efficacy.
The Company is now engaged in activities necessary for beginning the Phase 3 study. Manufacturing of Brilacidin has been completed and is presently undergoing quality control and stability testing
Brilacidin -- Ulcerative Proctitis / Colitis and Hidradenitis Suppurativa
We have also identified inflammatory gastrointestinal disease (ulcerative proctitis) and inflammatory skin disease (hidradenitis suppurativa) as indications for treatment with Brilacidin or our other HDP mimics. The Company plans for a Phase 2 proof of concept trial for ulcerative proctitis to begin in March 2016.
Big K talking about the refrigeration/freeze/ "room temperature" formulation. Imagine the durability that will have world wide.
Brilacidin for Topical Applications and Otic Infections and Related Formulation Work
Cellceutix is formulating and conducting preclinical experiments on topical Brilacidin for use in topical skin applications such as diabetic foot ulcer infections, and for ear-related infections, such as otitis externa or draining otitis media. On July 14, 2014, the Company announced that a significant breakthrough had been made in the formulation of Brilacidin. Previously, Brilacidin was stored in a refrigerated state. The Company has now developed the formulation of Brilacidin to be stable at room temperature. However, further formulation work is still needed for each indication. Upon developing optimal formulations, the Company plans to advance these drugs into the clinic. The Company believes this work, though challenging, is very important.
This will be a very quick revenue generator imo. Each indication is important. Someone googles an indication and whala, leads them to brilacidin for the treatment. Very cool.
Funding isn't an immediate issue, consider the grant and sponsorship potential. Kevetrin has very good support already for 2 indications (in the form of FDA support and possible grant support). Of course there is Aspire and the shelf reg as well. Prurisol is in motion. Data pending for kevetrin. I'm thinking there's plenty to be excited about as far as a start up bio with solid integrity moving forward.
btw, chose this one to reply to so you can edit a couple links. The Spoke link needs to be manually updated to bring up CTIX, imo they are just repetitive and not really needed on your DD post.
http://www.spoke.com/search?utf8=%E2%9C%93&q=Cellceutix+Corp
The Alexa site gives a little competitive data but is really just an amusing time killer unless you're a paid subscriber.
http://www.alexa.com/siteinfo/http://www.cellceutix.com#
Either way Hound, keep up the GREAT work you're doing keeping all the info together for the board!!
Go CTIX!!
And at this level? I see some mention of a weakening sector possibly adding to the bearishness of Cellceutix. Quite the opposite imo. More opportunity as many other WEAKER companies are now at an even keel PPS wise that we now have an even better chance for visibility. Competition should be on notice.
all imo
"Perfection is not attainable, but if we chase perfection we can catch
excellence." Vince Lombardi
Do your research! Play the TA. All posts are my opinion.
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