Innovation Pharmaceuticals Inc (IPIX)

[georgejjl]

A MUST READ regarding the Brilacidin OM trial. The Brilacidin OM trial is going as good if not better than expected.

Purpose
Oral Mucositis (OM) is a painful and debilitating side effect of many of the drug/radiation regimens used to treat cancer. This study examines the investigational drug brilacidin and its possible application in prevention of oral mucositis in patients undergoing chemoradiation for treatment of head and neck cancer

The key is that this trial intents to prove that Brilacidin PREVENTS oral mucositis progressing to grade 3 or higher. That is why the Primary Outcome is to record the incidence of grade 3 or higher oral mucositis.

Primary Outcome Measures:
Incidence of ulcerative and severe oral mucositis (WHO Grade ≥3) [ Time Frame: 7 weeks ]
Incidence of ulcerative and severe oral mucositis, defined as grade 3 or 4 on the WHO Oral Mucositis score, experienced during radiation therapy by patients with head and neck cancer receiving a cumulative radiation dose of at least 55 Gy. The WHO Score will be assessed by trained site personnel twice-weekly.

Incidence of Treatment-Emergent Adverse Events [ Time Frame: 11 weeks ]
Reporting of Adverse Events and severity of adverse events

https://clinicaltrials.gov/ct2/show/NCT02324335?term=cellceutix&rank=3

Brilacidin-OM represents a potential significant treatment breakthrough, as there are currently no preventative drugs approved for Oral Mucositis for solid tumors. Limited existing therapies focus on temporarily ameliorating symptoms. Cellceutix’s goal is to show that Brilacidin-OM has dual functionality in not only shortening the duration and severity of OM, but also preventing the onset of the condition, something no other drug developer has been able to achieve.

http://www.cellceutix.com/press-release/2017/1/4/cellceutix-to-present-at-biotech-showcase-2017-brilacidin-for-oral-mucositis-nears-interim-results

Secondary Outcome Measures:
Duration of ulcerative and severe oral mucositis (WHO Grade ≥3) [ Time Frame: 11 weeks ]
Duration of ulcerative and severe oral mucositis (WHO Grade ≥3) experienced by patients with head and neck cancer receiving a cumulative radiation dose of at least 55 Gy.

Duration of ulcerative oral mucositis (WHO Grade ≥2) [ Time Frame: 11 weeks ]
Duration of ulcerative oral mucositis (WHO Grade ≥2) experienced by patients with head and neck cancer receiving a cumulative radiation dose of at least 55 Gy.

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: Use of Gastrostomy tube (G-tube) [ Time Frame: 11 weeks ]
Use of gastrostomy tube (G-tube) for nutritional support due to OM

Exploratory: Number 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

Exploratory: Analgesic Concumption [ Time Frame: 11 weeks ]
Analgesic consumption for pain due to OM

Exploratory: Quality of Life (QOL) Assessment [ Time Frame: 11 weeks ]
Quality of Life assessed weekly (FACT-H&N)

Secondary outcomes are to determine the time that it takes for Brilacidin to reduce the grade of oral mucositis to a lower grade.

Cellceutix’s primary goal is to show that Brilacidin-OM has dual functionality in not only shortening the duration and severity of OM, but also preventing the onset of the condition, something no other drug developer has been able to achieve.

Good luck and GOD bless,

George