Innovation Pharmaceuticals Inc (IPIX)

[TOB]

Yes, I do know the approximate dates.

have not had the chance to look back over the ASCO report to see about the timing of doses but I would guess that there is at least a couple of 750 mg ovarian CA patients who have had 3 month scans, but maybe not 6 month scans

But I do not know

Do you know the cohort dates?

I could not agree more that some response at lower doses is EXCELLENT -TIAB

The first patient of the 750 mg/m2 cohort was for metastatic squamous cell carcinoma of the head and neck. We see in the PR the CEO was only reporting about Ovarian Cancer patient's results. Also only data already provided to the FDA as part of the orphan drug application.

The approval by the IRB to add patients beyond the 40 in the protocol was announced on May 22nd. Then they began the screening for enrollment process.

Even if one or two of those completing the cohort were Ovarian Cancer and began dosing immediately, at best they would have had a three month imaging follow-up. (But unlikely given the time-frame to enroll and time to report to the company). Note the CEO was using 3 and 6 month imaging to determine stable disease. It certainly hasn't been 6 months.

I also note the CEO was reporting data passed to the FDA, and no data on other patients. Previous information had referenced stable disease, so only the numbers and specifics were revelations. So I think this was all part of the rational to risk upsetting the apple cart at Dana Farber. Something he's done a couple times already.

Cellceutix needs to stay in Harvard's good graces as a journal article is expected, and likely another ASCO presentation once the trial is complete. Harvard's Beth Israel Deaconess is also standing by to do a combo test with Kevetrin for renal cancer, and the wrap-up stage of this Phase 1 at Dana Farber looks to have some interesting features. The Phase 2 may well be at Dana Farber as well.

I could not agree more that some response at lower doses is EXCELLENT -TIAB

Great stuff indeed. Really looking forward to:

1. The results for the 50% additional patients that will be dosed at the higher levels.

2. The Top-line results and then the full clinical report when the trial wraps up which will include all cancer types tested.

3. The results from the Phase 2/3 when they start on dose and frequency optimization.

I try not to get overly excited by preliminary data points, or even full results from Phase 1 trials, but these Ovarian Cancer details are indeed compelling.

Progression Free Survival (PFS) is emerging as a surrogate end point as these cancer trials are being accelerated. Stable Disease in metastatic Ovarian Cancer in a Phase 2 trial with a larger population size could result in an early trial halt for efficacy, or form the basis for an adaptive trial to morph into a Phase 3 trial, also with the possibility of an early halt for efficacy.