Innovation Pharmaceuticals Inc (IPIX)

[ImmunoATX]

How will B-OM stand up to SGX942 -

Obviously, we don't have efficacy data on B-OM, and others have aptly pointed out that fact. However, IF our Ph2 results are anything like the preclinical mouse outcomes, then this should be a no-brainer. Here is my rationale:

1. Dosing regimen - B-OM is given 3x a day, for 7 weeks as an oral rinse. It was mentioned at the meeting yesterday that this consists of a 16mL solution (Mint flavored??? HA!) and is taken at home by the patient. So, which would you prefer...go into the oncology clinic and get set up for IV infusion for an hour on the SGX drug, or swish around some B-OM oral rinse at home a few times a day?

2. Outcomes - it was just reported that average duration of severe OM was decreased by 50% in the SGX Ph2 study, and 67% in the heavy radiation group. While this sounds impressive on first reading, think about what that means....it basically says that almost every one still got a bad case of OM, but the duration went from 30 days to 15 days (on average). That's still 2 weeks of debilitating ulceration in the mouth and throat....or imagine having the worst case of strep throat for 2 weeks. B-OM is believed to help reduce the overall severity of OM, including the duration of symptoms. If you look back at the mouse data, the inflammation in the oral cavity was significantly reduced, to the point that OM scores were at or near their lowest category. If we can achieve even half that result in humans, then the data will be very compelling compared to SGX [IMHO].

3. Study design - I went to clinicaltrials.gov and looked closely at the details of both the SGX study and B-OM, and noticed something that caught my eye. The Primary Purpose of the SGX study is listed as "Treatment" whereas B-OM is listed as "Supportive Care". Here are the definitions from the FDA:

Primary Purpose: Treatment - protocol designed to evaluate one or more interventions for treating a disease, syndrome or condition

Primary Purpose: Supportive Care - protocol designed to evaluate one or more interventions where the primary intent is to maximize comfort, minimize side effects or mitigate against a decline in the subject's health or function. In general, supportive care interventions are not intended to cure a disease.

I'm not savvy enough to understand the differences of these as far as trial design, but I am imagining that the "Treatment" classification might require a higher threshold for statistical significance and different outcomes measures, as compared to "Supportive Care". If so, then this could bode well for CTIX come time to submit the NDA. In other words, B-OM is not intending to "Cure a disease", but rather provide prevention and relief from debilitating side effects of chemo & radiation. SGX on the other hand may be required to demonstrate some clinical effect on the condition itself (think clinical immunology or biomarkers to show treatment effect).

So, this is a long post, but I wanted to provide my thoughts on the potential of B-OM, and how I'm not even sweating the fact that we appear to be slightly behind in the development timeline. In the end, I expect B-OM to be very competitive, and possibly the treatment of choice [if approved].

P.S., yes, I attended the meeting and had some very nice conversations with folks (employees and investors), and came away very impressed. I plan to provide a more detailed account of my experience and takeaways when I have a chance (long flight back to TX last night).