Replies to post #212897 on Innovation Pharmaceuticals Inc (IPIX)

[cabel]

Plenty,

I just received an additional comment from Leo,

I was hoping you could comment,..

I had seen their PR a few weeks back. Although they had written in the PR (which I believe they accidentally wrote incorrectly) "in the overall incidence of SOM through 60 Gy of radiation", it is different than what is stated on clinicaltrials.gov which states:

Primary Outcome Measures :
Duration of Radiation Induced Severe Oral Mucositis per WHO Criteria, Through a Minimum of 60 Gy IMRT Delivered to the Tumor [ Time Frame: Minimum of 60 Gy administered to tumor, approximately 30 IMRT fractions, which is estimated to be 6-7 weeks. ]
Evaluate and compare the duration of severe OM, as assessed from the first determination of ≥ Grade 3 OM to the first instance of non-severe OM (≤ Grade 2), without a subsequent instance of ≥ Grade 3.

https://clinicaltrials.gov/ct2/show/NCT02508389?term=GC4419&rank=3

[F1ash]

I would like your opinion on something.

Is this other company lying? Why are they not being pursued by the FDA if they are lying?

For those wondering why it has not turned up on their searches, it was approved as a device, not a drug.

They claim that by incorporating cross linked polymerization they took a drug which was ineffective in treating OM (sucralfate) and turned it into a product that can completely eliminate OM and can even cure it once it has begun within three days.



“Mueller Medical, a life sciences company in Storrs Connecticut, has entered into a partnership with 193 Walgreens Specialty Pharmacies and 85 Specialty Pharmacy field’s representatives, to launch a nationwide campaign against oral mucositis due to chemo-radiation. The partnership challenges the notion that there could never be a credible Anti-Mucositis Protocol of all oncology practices and bone marrow transplant units. The Phase IV post-market surveillance data on ProThelialTM gives a real-world experience of cancer treatment patients who are suffering from oral mucositis. It chronicles a different notion. The Phase IV data shows that if prescribed in a timely fashion, ProThelialTM will rapidly reduce to 2-3 days, the typical 84 day standard course of oral mucositis. Additionally, ProThelialTM can prevent it altogether. These observations are unprecedented.


http://muellermedical.com/news/press_release3.pdf




See page 9 and page 13 at the following link.

(Page 14 mentions Brilacidin)

http://www.jbento.mucositisrelief.org/pdfpapers/ExpertReviewsOfMedicalDevices2014.pdf


It’s owned by a private company, perhaps that is why no one is pursuing them for making false claims?

Shouldn’t IPIX at least test a “paste” formulation to see if it improves the efficacy of B-OM?

In the preclinical work, less frequent dosing of Brilacidin was ineffective for OM.

Doesn’t that indicate that increasing the surface retention time could greatly improve the chance of preventing OM with an improved B-OM delivery vehicle?