Innovation Pharmaceuticals Inc (IPIX)

[MinnieM]

There is a trial with multiple sites for those wanting to try Brilacidin for Oral Mucositis. Fifteen sites are currently recruiting in the hopes of preventing OM or reduction of severity. The encouraging interim results recently reported will likely speed up recruitment for this trial.

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

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.

Cellceutix Reports Very Encouraging Interim Analysis of Phase 2 Drug Candidate Brilacidin for Severe Oral Mucositis (OM) in Head and Neck Cancer Patients; High Potential for Preventative Treatment

http://www.cellceutix.com/press-release/2017/4/3/cellceutix-reports-very-encouraging-interim-analysis-of-phase-2-drug-candidate-brilacidin-for-severe-oral-mucositis-om-in-head-and-neck-cancer-patients-high-potential-for-preventative-treatment

INTERIM ANALYSIS

Preliminary efficacy and safety data from 19 patients who met the criteria for evaluation were reviewed. To be included, patients needed to have reached or passed the planned visit at the end of 5 weeks on study, and have received a cumulative radiation dose of at least 55 Gy. Patients receiving Brilacidin, as compared to patients on placebo, showed a markedly reduced rate of Severe OM (WHO Grade ≥ 3). Additionally, Brilacidin was generally safe and well-tolerated.

Primary Efficacy Results Incidence of Severe OM (WHO Grade ≥ 3)

• Active Arm (Brilacidin): 2 of 9 patients (22.2 percent)
• Control Arm (Placebo): 7 of 10 patients (70 percent)

Secondary Efficacy Results Duration of Severe OM (WHO Grade ≥ 3)

• Active Arm (Brilacidin): Mean 10.5 days (Range 3 to 18 days; 2 patients)
• Control Arm (Placebo): Mean 14 days (Range 3 to 39 days; 7 patients)

Safety and Tolerability Profile

• Brilacidin administered as an oral rinse was generally well-tolerated by patients
• Safety findings were typical for patients with Head and Neck Cancer being treated with chemoradiation; no treatment group differences were apparent on vital signs and clinical laboratory safety tests
• Six patients (2 in Active Arm, 4 in Control Arm) experienced at least one adverse event categorized as serious. Nine Serious Adverse Events (SAEs) were reported for these 6 patients, and all were classified by the Investigator as Not Related to study drug
• Incidence of Treatment-Emergent Adverse Events (TEAEs)
o Majority of the TEAEs reported (Active Arm, 164 TEAEs; Control Arm, 143 TEAEs) were related to chemoradiation or the underlying study indication
o No TEAEs were classified as Likely Related or Definitely Related to study treatment

Pharmacokinetics

• Plasma samples from 6 patients treated with Brilacidin were analyzed and all concentrations of Brilacidin were below the lower limit of quantification (i.e., < 10 ng/mL)

“These interim results suggest the potential for an even greater effective therapeutic response as formulation and dosing is further optimized,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Cellceutix. "There currently is no existing preventative treatment available for OM patients in this population, with only limited therapies focusing on symptom relief. Already under Fast Track designation, should Brilacidin earn FDA approval for the treatment of Oral Mucositis, countless patients may no longer have to suffer from this horribly debilitating condition as a side effect of cancer treatment. The use of Brilacidin to prevent the onset of OM could even lead to an entirely new standard of care in this area as we strive to bring this drug to market.”

Cellceutix, over the past months, has added additional clinical sites to this study. Completion of the clinical trial is expected before year-end.

In Reply to 'govorchin'
CTIX was supposed to be able to really speed something up if at 36 participants that had good results came up. what was that? they must have 36 by now. how mean could anyone be to not let these people with horrible sores choose to try this.