Replies to post #223903 on Innovation Pharmaceuticals Inc (IPIX)

[KMBJN]

Yes, trials discount subjects who don't receive the minimum cumulative radiation dose (typically 50-60 Gy of IMRT), since these subjects are less likely to develop severe OM.

https://clinicaltrials.gov/ct2/show/NCT02508389

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. ]

They reported mITT, based on receiving mimimum 60 Gy, just like we are doing.

BTW, their drug reduced SOM incidence from 70% (placebo) to 46%.

and their drug required a 60 minute IV infusion every day before radiation

Brilacidin sure looks favorable compared to Galera's drug.

[PlentyParanoid]

Chronic, cutoff is a cutoff. Protocol specifies minimum dose, accepting less is protocol violation. FDA does not like protocol violations. PERIOD.

And how do you know that Galera reported ITT results? As far as I know Galera has so far reported the size of trial and a set of results, but has not said that the numbers are for the reported trial population. Don't assume that. Biotech press releases are high art of deception by omission.

While we at the topic of Galera. Galera's trial filing at ClinicalTrials.gov specifies

Duration of Radiation Induced Severe Oral Mucositis per WHO Criteria, Through a Minimum of 60 Gy IMRT Delivered to the Tumor

and

Planned radiation fields in all 3 arms must include at least two oral sites (buccal mucosa, floor of mouth, tongue, soft palate) with each site receiving a dose of at least 50 Gy.

Galera putting 60 Gy in their press is nice in decorative sense. The important number is minimum cumulative radiation dose into oral cavity. For Galera's trial minimum was 50 Gy or 5 Gy less than in IPIX trial. SOM incidence rate starts to pick up significantly around 45 to 50 Gy. And that is the reason why Soligenix and IPIX put minimum at 55 Gy. Galera did not see it that way, they clipped closer.

Furthermore, you may have noticed that Galera was supposed to present the results at

2018 Multidisciplinary Head and Neck Cancers Symposium being held February 15-17, 2018, at The Westin Kierland Resort & Spa in Scottsdale, Ariz.

They said so in their press release. Somehow that did not happen, presentation was withdrawn. Funny that Galera did not make press release out of that. Maybe they had some family problems like not finding a babysitter. Or maybe the reason was scientific excrement starting to hit their corporate fan.

We don't know. But dropping out from important symposiums is seldom good news.

And, please, do not introduce the FDA's BTD for GC4419 as important achievement. At this stage FDA is willing to grant that on any compound provably reducing SOM incidence rate more that 10 %.It is that desperate.