sox, thanks. No doubt the positive interim results impacted the rate of enrollment. The interim analysis for B-OM revealed 2/9 Brilacidin patients suffered severe oral mucositis with a mean duration of 10.5 days. The duration of severe oral mucositis in the Brilacidin treated group was 3 days for one patient and 18 days generating a not-so-helpful mean duration. I wonder if the 18 day non-responder will appear an outlier after top line results are in or if this is more related to a particularly challenging tumor location and high radiation dosage.
It's also worth noting that one of the placebo patients had severe oral mucositis for 39 days, I'm sure with considerable morbidity.
I've commented several times in the past couple of years how much I like the design of the B-OM trial (Brilacidin vs. placebo in a high risk population) but have also noted that stringent enrollment criteria makes enrollment difficult.
As a preventative treatment for severe oral mucositis, I expect early use of B-OM in a wide range of cancer treatments. Though this trial studies head/neck cancer patients who receive radiation, it should be noted that chemotherapy is fairly nonspecific and targets rapidly dividing cells. Oral mucosal cells are rapidly dividing and especially vulnerable to chemotherapy. An effective preventive therapy will be widely adopted well beyond head/neck radiation induced oral mucositis. One example is bone marrow transplant patients where about 75% experience oral mucositis.
On a different note, perhaps we'll hear about completion of Kevetrin Cohort 1 and Data Monitoring Committee recommendations for Cohort 2.
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