Replies to post #30298 on Innovation Pharmaceuticals Inc (IPIX)

[TheProgressive]

The original time frame had the POC trial starting roughly right now. However, this estimate was given by management before a visit to Dr. Reddy's revealed that they had found a way to greatly simplify the manufacturing process for Prurisol even further. This would make manufacturing the compound even more simple and substantially cheaper. So now the product has been refined and reformulated one more time, and is in he process of being manufactured for the planned trial.

This moves the start of the trial back a few months, well worth it for all the strategic long term financial cost benefits they will get from the move. So nothing is really delayed, they just hit pause since this newest reformulation would save them even more money and this was the one they wanted to be approved for final use in trials.

[tduggan]

Not new info. Here's the PR predicting Phase 2 trial in 1st qtr 2013:

BEVERLY, MA – November 12, 2012– Cellceutix Corporation (OTCBB: CTIX) (the “Company”), a clinical stage biopharmaceutical company focused on discovering small molecule drugs to treat unmet medical conditions, including drug-resistant cancers and autoimmune diseases, reports that the Company has signed an agreement with a European Union (EU) clinical site for a Proof-of-Concept (PoC) trial of Prurisol™, the Company’s lead drug candidate for the treatment of psoriasis. The trial, a double blind study, is planned for the first quarter of 2013 and will include patient dosing over a 30-day period with follow up visits over the next 30 days. Cellceutix decided on this protocol after discussions with pharmaceutical industry executives and believes this is the quickest path to evaluate the efficacy of Prurisol in humans with the objective of bringing it to market and creating greater shareholder value.

Here's PR dated Dec 31, 2012:

Regarding Prurisol™, our leading anti-psoriasis drug candidate, a Company-sponsored Phase II/III Proof of Concept trial is on target to begin late first quarter/early second quarter 2013. This will be a relatively short trial with only 30 days of treatment and 30 days of follow-up to evaluate the efficacy and safety of Prurisol. Dr. Reddy’s Laboratories Ltd. has condensed the manufacturing process, saving us time and money. Manufacturing of cGMP Prurisol is expected to begin in about a months time. Given the outstanding data from our laboratory studies and the guidance from the Food and Drug Administration that a 505(b)(2) pathway is acceptable, we have high expectations for these trials to support a larger scale, late stage clinical trial. I believe updates on these trials will be quite frequent

So, predictd start date moved back a few months per Dec 31, 2012 PR. I believe delay due to Dr Reddy's making improvements in the Prurisol manufacturing process.