Just getting back to civilization and tried to read through many of the posts of the regulars that I know have good understanding of science but was curious on the numbers presented yesterday. To me, they were not as good as I wanted to see, but my hopes were to stick with interim data numbers and I think BK said...that was just not reasonable weeks ago.
But the data is somewhat confusing and I was wondering if anyone could add to my interpretation or correct me:
61 patients were enrolled.
46 patients met the cumulative radiation dose criteria of at least 55 Gy—the minimum treatment threshold for inclusion in the efficacy population
39 of these patients met more strict criteria for inclusion in the “per protocol” study population.
Is there somewhere or will there be somewhere that states what the 'more strict criteria for inclusion' is? I'd like to know why those 7 patients were excluded.
In addition, what happened to the other 15 patients? 61-46=15
Will we ever find out why they were not included? What happens if they were all Placebo and had such bad SOM they dropped out and could not take it? The numbers for Placebo would be much higher in that case?
Or what happens if some of those patients taking B-OM never got SOM and just had to stop treatment because the cancer spread to different areas and they had to move to a different location for treatment or if the patient died? I am just saying with these low numbers some details could really help IPIX.
Overall, the numbers are not bad, but they are not overwhelming unbelievable. I think they are very good and could be possibly REALLY REALLY GOOD if we knew more about the other 15 patients. That is about 25% of the trial population and they are not accounted for.
Since there is no preventative drugs I think this is a grand slam with numbers like 63.2% PREVENTION rates. I mean if I had HN cancer I would absolutely take this if my odds were over 60% less likely to get SOM especially if I only have to swish and spit.!!!
Modified Intent to Treat
(mITT) Population (n=46)
INCIDENCE OF SOM
Brilacidin: 9 of 21 patients (42.9 %)
Placebo: 15 of 25 patients (60.0%)
Per Protocol
(PP) Population (n=39)
INCIDENCE OF SOM
Brilacidin: 7 of 19 patients (36.8%)
Placebo: 12 of 20 patients (60.0%)
Overall reduction in observed severe Oral Mucositis (WHO Grade ≥ 3) in the Brilacidin-OM treatment group from that seen in the control group ([incidence control - incidence active]/incidence control) was: 28.5% (mITT population) and 38.7% (PP population).
Here are the secondary endpoints that we may see data on soon:
Secondary Outcome Measures:
Duration of severe oral mucositis (WHO Grade ≥3) [initial instance duration] [ Time Frame: 11 weeks ]
Duration of severe oral mucositis (WHO Grade ≥3), from initial WHO Grade ≥3 during radiation therapy to the first WHO Grade 2 or lower
Duration of severe oral mucositis (WHO Grade ≥3) [overall duration] [ Time Frame: 11 weeks ]
Duration of severe oral mucositis (WHO Grade ≥3), from initial WHO Grade ≥3 during radiation therapy to the last WHO Grade ≥3
Incidence of severe oral mucositis (WHO Grade ≥3) by cumulative radiation dose [ Time Frame: 7 weeks ]
Incidence of severe oral mucositis (WHO Grade ≥3) at cumulative fractions of radiation therapy
Time to onset of severe oral mucositis (WHO Grade ≥3) [ Time Frame: 7 weeks ]
Time to onset (in days, and in cumulative radiation dose) of severe oral mucositis (WHO Grade ≥3)
Exploratory: Total number of days of severe oral mucositis (WHO Grade ≥3) [ Time Frame: 11 weeks ]
Total number of days (per subject) of severe oral mucositis (WHO Grade ≥3)
Exploratory: Incidence of ulcerative oral mucositis (WHO Grade ≥2) by cumulative radiation dose [ Time Frame: 7 weeks ]
Incidence of ulcerative oral mucositis (WHO Grade ≥2) by cumulative fractions of radiation therapy
Exploratory: Time to onset of ulcerative oral mucositis (WHO Grade ≥2) [ Time Frame: 7 weeks ]
Time to onset (in days, and in cumulative radiation dose) of ulcerative oral mucositis (WHO Grade ≥2)
Exploratory: Duration of ulcerative oral mucositis (WHO Grade ≥2) [ Time Frame: 11 weeks ]
Duration of ulcerative oral mucositis (WHO Grade ≥2)
Exploratory: Total number of days of ulcerative oral mucositis (WHO Grade ≥2) [ Time Frame: 11 weeks ]
Total number of days (per subject) of ulcerative oral mucositis (WHO Grade ≥2)
Exploratory: Area under the oral mucositis-severity versus time curves [ Time Frame: 11 weeks ]
Area under the oral mucositis-severity versus time curves
Exploratory: Incidence of Mouth and Throat Soreness [ Time Frame: 11 weeks ]
Mouth and throat soreness will be assessed daily using Oral Mucositis Daily Questionnaire (OMDQ) Question #2
Exploratory: Quality of Life (QOL) Assessment [ Time Frame: 11 weeks ]
Quality of Life assessed weekly (FACT-H&N)
Exploratory: Incidence of Analgesic Concumption [ Time Frame: 11 weeks ]
Analgesic consumption for pain due to OM
Exploratory: Incidence of Gastrostomy tube (G-tube) use [ Time Frame: 11 weeks ]
Use of gastrostomy tube (G-tube) for nutritional support due to OM
Exploratory: Incidence of Unplanned Office Visits [ Time Frame: 11 weeks ]
Number of Unplanned Office visits, emergency department visits, and hospital admissions due to OM
Exploratory: Incidence of Unplanned Delays in Chemotherapy and/or RT Schedule [ Time Frame: 11 weeks ]
Incidence of Unplanned Delays in Chemotherapy and/or RT Schedule due to OM
