Innovation Pharmaceuticals Inc (IPIX)

[georgejjl]

Brilacidin for prevention and treatment of oral mucositis

Drug: Brilacidin
Oral Rinse used 3 times daily for 7 weeks

The treatment time frame is just 7 weeks

The Primary Outcome is the prevention of grade 3 or 4 oral mucositis during the 7 week treatment time frame.

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

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

Preventing the incidence of grade 3 or 4 oral mucositis is not easy. Most subjects with head or neck cancer treated with RT (radiation therapy) develop grade 3 or 4 oral mucositis. See the graph below.

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.

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)

The Secondary Outcomes are related to treatment with Brilacidin and the duration of the any grade of oral mucositis and quality of life benefits during the 7 weeks of treatment and 4 weeks after the 7 weeks of treatment with Brilacidin.

The addition of 4 weeks after the 7 weeks of treatment is to see if the benefits from the 7 weeks of Brilacidin treatment extend for at least another 4 weeks after the treatment ends.

Goo luck and GOD bless,

George