Replies to post #116371 on Innovation Pharmaceuticals Inc (IPIX)

[Drano]

You are dead wrong. To give NEW information at this time would be a waste of an opportunity. ANy new information would be lost in the sea or garbage that is being flung now.

Mr. Ehrlich was exactly right to refute but not let his hand be forced into a poorly-timed release of new data.

[nerby]

DF is a tight-lipped outfit. And they should be - they are a preeminent research facility running clinical trials. There's a lot at stake. I'm guessing Leo asked DF yesterday for special dispensation to announce the fantastic news that came out today about K. We'll hear more about later doses, well, later.

[sox040713]

The data must be no good at higher doses. Hence the IRB's decision to enroll 20 more patients just to waste time and money. (Sarcasm)

Because the data is not so good? I believe it is the latter,

[TOB]

I'm stunned and pleased to hear additional initial efficacy data from the Kevetrin trial focusing on the 9 known ovarian cancer patients treated to date. A median increase of 22% of p21 expression indication p53 activation. P53, The 'Holy Grail' of cancer research is showing results in the Kevetrin trial.

We also learned that 4 of the nine ovarian cancer patients achieved stable disease measured at the 3 and 6 month intervals, despite the majority being treated a doses that were previously expected to be below the efficacy range, and only once a week, with three doses in a 4 week period.

This is also partial information, notice the previously reported Ovarian Cancer Spleen Met tumor complete response wasn't mentioned again, nor other such possible results. Nor was information given on the other cancer types tested. We can only guess whatever else may, or may not have been observed.

Why I'm stunned is because this is a trial in progress, and world class research institutes like Harvard's Dana Farber are generally tight lipped prior to study completion and top line results. Even then, there is a tendency to wait for publication in a peer received journal - or at minimum - presentation at a medical conference such as ASCO.

Apparently the CEO pushed the limits on this, perhaps spurred on by the malicious and false hit piece, but I'm certain there is more being held back as that's just SOP for Dana Farber and academia.

Why not crush the opposition? CEO gives new details about response to K: what the heck??!!??? Why not say one word about the higher doses. 4 of 9 stable disease at doses up to 450 for ovarian CA. He knows the data for the higher doses so why not say anything about it?[...] TIAB

That's incorrect, the CEO doesn't know the data for the higher doses. Keep in mind that the P21 testing is done in batches. There is a long wait between batches, it's only been done twice since the Kevetrin trial started in late 2012.

The ASCO presentation included 31 of the 40 patients enrolled as of that date. Presumably, the P21 results for the next nine patients will be included in the next batch assays for P21, along with those from higher dose cohorts.

Note also from the efficacy report today:

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

They are being evaluated for stable disease at their 3 and 6 month follow-up imaging intervals, not 1 or 2 months. The Oncologist investigators have apparently determined this to be a meaningful interval for ovarian cancer, and all had progressive disease before beginning Kevetrin. As you know, the time period to assess stable disease as significant would vary by cancer type and stage.

As of ASCO, there was only one patient treated at a higher dose, 750 mg/m2, and that was for metastatic squamous cell carcinoma of the head and neck, not ovarian cancer which was reported on and received the orphan drug designation from the FDA. We now know evidence of efficacy was included in this application and the company's plan to focus on Ovarian Cancer in the next clinical trial.

The PR announcing the the IRB approving the amended protocol to enroll additional patients past the 40 planned, was announced on May 22, 2015. We know from the update the additional 2 patients in the 11th cohort were being enrolled at that time, the first one has completed two cycles. The remaining two also may, or may not have been ovarian cancer patients, but they certainly haven't passed the 3 and 6 months follow-up imaging.

Thus the CEO couldn't possibly have the 3 and 6 months follow-up data from this higher dose cohort. We know they don't do P21 assays for each cohort, and we know the first patient enrolled in the eleventh cohort was not an ovarian cancer patient.

So there is probably nothing to say at this point about the higher dose 11th cohort, which may or may not have even completed dosing. Were the next two enrolled ovarian cancer patients? Who knows? But we do know the 3 and 6 month imaging data points are yet to occur in the future.

What I find intriguing, is considering the expanded protocol from 40 to add 20 additional patients, a 50% increase, these added patients will all be at the higher doses.

(Note to readers: I always refer to the cohorts as for example "the 11th cohort" which is how Cellceutix reports them. The 11th cohort is actually cohort #10, as the initial cohort is cohort zero, and the second cohort is cohort #1. I wrote about this about 3 years ago. On our board we also use this terminology, so regular readers are familiar with this, but new readers perusing the ASCO poster may be confused)