Innovation Pharmaceuticals Inc (IPIX)

[TOB]

Cellceutix released efficacy data for Kevetrin, its cancer drug in Phase 1 Clinical Trials at Dana Farber.

This is a stunning revelation for CTIX investors, this remains the #1 most read board for days, and yet most of the discussion is about a pathetic short blog post that is not only packed with lies, but has already been completely refuted.

Then the talk about suing the ambulance chasing law firm, the SEC, and more gibberish. LOL, all just words and without any action or benefit from action. But the impression to the reader is of a company under attack and in trouble.This is a false image. Rather we have a buying opportunity due to an artificially manipulated share price. Kevetrin has shown clear indications of efficacy!

Among these nine patients with ovarian carcinoma enrolled in the Cellceutix Phase 1 study, the median change in p21 expression in peripheral blood lymphocytes was an increase of 22% after the first dose of Kevetrin.

During Kevetrin treatment, four of the nine patients with advanced ovarian carcinoma were documented to have stable disease (by radiographic examinations) for 3 to 6 months while receiving Kevetrin - Link

The p21 expression is a secondary endpoint of the trial and indication of MOA and efficacy, an indication of activation of P53, the 'Holy Grail' of cancer research called the 'Guardian of the genome and policeman of the oncogenes' for its importance. This was observed in the pre-clinical mouse studies, which showed both efficacy against a variety of cancer types and increased p21 expression. WE ARE SEEING DOCUMENTATION OF THE FIRST OF THE POSITIVE RESULTS IN THE MOUSE STUDIES OCCUR IN THIS HUMAN CLINICAL TRIAL!

Stable disease in Stage 4 Ovarian Cancer patients who were enrolled with progressive disease, with their cancer growing rapidly and spreading to other parts of their bodies is a tremendously positive indication for Kevetrin.

This is at low Kevetrin dosage, and only once a week and three weeks in 4. PK data of Kevetrin in humans already indicates more frequent dosing is appropriate and will guide the trial design of the Phase 2 efficacy study. The safe dose of Kevetrin is already likely 750 mg/m2, the highest dose any of the 4 Ovarian Cancer patients received is 450 mg/m2. That was one patient. The others started at 10 mg/m2, 50 mg/m2, 75 mg/m2, and 350 mg/m2. Presumably they moved to higher doses, but none of those reported with positive results at doses above 450 mg/m2... yet.

This is the best news we're received to date in the Kevetrin trial. It adds context to the report of the Stage 4 Ovarian Cancer patient treated with Kevetrin who had a Spleen metastatic tumour disappear and a period of stable disease. Now we know this was not a fluke, nearly 50% of the Ovarian Cancer patients in the Kevetrin clinical trial have achieved periods of stable disease. This is not a case of "I feel better", these are documented responses based upon objective radiographic examinations such as MRI.

For those not familiar. These are all patients whose ovarian cancer is growing and spreading to other parts of their body. They all had progressive disease and had exhausted all available treatment options, with nothing working for them.

Kevetrin at low doses and once a week gave these patients with stage 4 refractory Ovarian Cancer periods of stable disease in which their cancer stopped spreading and rapid growth. As a result CTIX will conduct a Phase 2 Clinical Trial for Ovarian Cancer in which the dose and frequency of dosing will be optimized. Kevetrin has received FDA Orphan Drug designation for Ovarian Cancer, which brings certain advantages. We now know that efficacy data was submitted with the application which received a rapid positive approval from the FDA.

The next Kevetrin Phase 2 clinical trial of Ovarian Cancer will likely be an adaptive design, intended to speed up the trial, give interim looks at efficacy, and morph into a Phase 3 trial. We could be looking at an early halt for efficacy if this trend of stable disease holds with a larger number of patients and is judged an improvement in well known historical Progression Free Survival (PFS) rates. PFS is emerging as a surrogate endpoint for the approval of cancer drugs to speed their development. It is faster than waiting for Overall Survival (OS) data.

Of course the results could be even better, as indicated by the Ovarian Cancer patient with the metastatic Spleen tumour disappearance (complete response). The Phase 2 patients could see tumours shrinking, both primary and mets, and by definition stable disease requires no new tumours or metastatic spread of tumours to other organs and parts of the body. Cancer generally kills by tumour growth and metastasis.

In fact, with up to 20 more patients to be enrolled in the ongoing Phase 1 clinical trial at Dana Farber, all at the higher doses, we could see a more results with any Ovarian Cancer patients enrolled, or other tumour types. This is still at a dose and frequency which is yet to be optimized.

I didn't even mention the antibiotic Brilacidin. It is entering Phase 3 Clinical Trials with a high probability of success. It was proven safe and effective against MRSA, and now needs confirmation with a larger patient population.

Phase 3 Clinical Trial stage biotechs generally get a boost in their share price and increased institutional buying. The same is true of positive trial results. What we've heard indicates the Kevetrin Phase 1 Clinical Trial will end reporting positive results.

The market will catch up with these events, not to mention the trials for Psoriasis and Oral Mucositis which are both up and running and recruiting. The pending NASDAQ up-listing will help also, but is itself a mouse relative to the elephant of positive clinical trial results and increasing number of clinical trials.

I feel sorry for the suckers who sold cheaper due to fear or stop loss orders triggered by this anonymous hit piece which is full of lies and has been completely refuted. Some have bought back chasing the share price up, already touching the level before the hit piece, and settling up ~+20%.

Short-term the share price will do what it does, who knows? But considering what we've just learned about Kevetrin efficacy, and what we know about Brilacidin efficacy, and the advancement and increase of clinical trials, does anyone not believe we're going to see not only the CTIX share price recover, but make new highs?

Upon successful clinical trials, drug approvals, partnership, buy-out, up-listing, and any of a number of possible major catalysts for CTIX, we're not just talking about 'new highs' for the CTIX share price, we're talking about many multiples of increase.

So seriously, enough of the crybaby stuff about the short blog post full of lies and distortions. Enough of the sinister conspiracies and painting the company as under attack. Who cares about the bloody ambulance chasing lawyers? They float these trial balloons right and left, it's what they do. Let's focus on the facts, which are all positive.

Be thankful that the share price dropped due to lies and fear mongering, not facts. Be thankful the share price has nearly recovered the next day. Cellceutix is a well funded company with a multitude of promising clinical trials. We just heard the best news of efficacy for Kevetrin after a nearly three year wait.

I suggest the discussion shift to facts, which are overwhelmingly positive for CTIX, and stop focusing on the lies which have been already proven laughably false.

I know they lied. Everyone knows they lied. Nothing will be done. Meanwhile, as I read the board last two days, moslty the first line of posts, I get depressed. What will new investors think when they read the board? -TheDane

Exactly.