Innovation Pharmaceuticals Inc (IPIX)

[farrell90]

While it was very good DD to calculate the the results of the weekly dosed cis platinum, the higher dose 3 week data does show Brilacidin OM has a significant treatment advantage over placebo.

m ITT 71.4% pbo ..... 25% BOM
PP 72.7% pbo ..... 14.3% BOM

This coupled with the fact the higher dose 3 week treatment is preferred by many oncologists {see the recent ASCO editorial below} had to be a key consideration in the FDA decision to support the stage 3 Brilacidin OM trial.

The comparison data with the other listed trials in the graph published by IPIX shows in the preferred higher dose cis platinum 3 week dosing shows a superior treatment benefit for Brilacidin OM even if one substitutes the different placebo rates from the other trials which ranged from 82 % to 46%.

The bottom line is after the end of phase 2 FDA review IPIX is moving forward with the stage 3 Brilacidin OM trial.

GLTA Farrell

http://www.ipharminc.com/new-blog/2018/9/24/brilacidin-for-oral-mucositis-at-a-glance-comparative-data-presentation-with-other-investigational-om-drugs

Brilacidin-OM was more effective in decreasing the incidence of SOM in Head and Neck Cancer (HNC) patients receiving the more aggressive chemotherapy regimen — cisplatin administered in a higher concentration (80-100 mg/m2), every 21 days — as compared to lower concentrations of cisplatin (30-40 mg/m2) administered weekly.

http://ascopubs.org/doi/full/10.1200/JCO.2017.76.8614

"The benefit of adding concomitant high-dose cisplatin to adjuvant radiotherapy (RT) for resected head and neck squamous cell carcinoma (HNSCC) was established in two large seminal trials, EORTC 22931 and RTOG 9501.1-3 In these studies, cisplatin was administered at a dose of 100 mg/m2 on days 1, 22, and 43 during radiation. Subsequent large robust trials in the postoperative setting exploring alternative chemoradiation regimens such as weekly dosing of cisplatin have been lacking."

"The results of the trial of Noronha et al,5 with all the caveats discussed, do not support the replacement of high-dose cisplatin given once every 3 weeks with weekly low-dose cisplatin when administering postoperative radiation for HPV-negative HNSCC in routine clinical practice or as the control arm in clinical trials."
© 2018 by American Society of Clinical Oncology