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Replies to post #40929 on Innovation Pharmaceuticals Inc (IPIX)
We are also actively developing Prurisol, an oral anti-psoriasis drug under guidance from the Food and Drug Administration that a 505(b)(2) approach is acceptable as the active moiety of Prurisol as an approved drug allowing us to skip right to mid-stage trials. Prurisol was planned to enter the clinic in a matter of weeks with the commencement of Phase II Proof of Concept trial in Europe.
Psoriasis is a compelling area and that common consensus is that psoriasis is not cured, only controlled at best. Commercially available products that are widely used today often demonstrate relatively poor efficacy while having side effects that could some times be severe lending to the great need and market opportunity for us.
With the acquisition of PolyMedix assets we have now changed our strategy with Prurisol vis-à-vis Proof of Concept trial. As we have disclosed it was our intention to do Proof of Concept study through attractive licensing partner. Cellceutix is now a bigger and stronger company and we believe the more effective business strategy is to immediately move into a larger FDA Phase II/III trial with Prurisol. This will save us hundreds of thousands of dollars in months of time.
Bringing the drug further along on the regulatory pathway will increase it's value many times to a partner. An FDA approved drug for psoriasis will be an extremely valuable franchise and we're presently preparing the FDA 505(b)(2) application.
Photos of Prurisol are available on this presentation and on our website, showing that the drug essentially removed all traces of psoriasis and clearly outperformed methotrexate one of the most common psoriasis treatment therapies today. Now that the patent has been published one can see that Prurisol is a pro-drug of a very effective and well known drug to treat an autoimmune disease. Psoriasis2 is an autoimmune disease. As to why in lab experience Prurisol was very effective against psoriasis and the parent drug has limited effects, one needs to understand the chemistry. That discussion is for Dr. Menon at scientific conferences.
Dr. Reddy's Laboratories, New York Stock Exchange listed company with a $5.7 billion market cap has already manufactured the Prurisol. Upon FDA permission to begin the trial we will ship the drug and be ready to start.
Again with psoriasis we are very targeted and focused with the value it can bring to a company and it's shareholders. Last month research was published in JAM Dermatology that was conducted through surveys from the National Psoriasis Foundation from 2003 through 2011.
It showed that AbbVie's Humira and Amgen's Enbrel which were both approved to treat psoriasis and generated about $8.7 billion of sales in 2012 patients still forego their treatments because of adverse effects and they don't believe it's effective. Our optimism in Prurisol the desperate need for an effective psoriasis drug and the overall strength of Cellceutix has convinced us to bypass any additional testing and move it straight into more advanced trials.
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