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The Brilacidin-OM trial was a great success, despi

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Post# of 72446
(Total Views: 474)
Posted On: 11/29/2019 12:24:30 PM
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Posted By: Drano
The Brilacidin-OM trial was a great success, despite the lies of the bashers who are trying to pretend that it wasn't. Does anyone really think that the FDA would approve continuing clinical trials, and (in recent news) grant a waiver for pediatric trials, if the trial had not been a success?

Here is a good summary of how impressive the Brilacidin-OM results were. And remember, in this trial the dose and dosing frequency were not optimized.

Quote:
The Company’s Brilacidin oral rinse demonstrated a strong therapeutic benefit in patients receiving the aggressive chemotherapy regimen (cisplatin administered 80-100 mg/m2, every 21 days), which currently is in common use. In this patient population, incidence of Severe OM (WHO Grade ≥ 3) was reduced to 25.0 percent in the modified Intent-to-Treat (mITT) population, versus 71.4 percent of placebo patients . In the Per Protocol (PP) patient group, incidence of Severe OM dropped to 14.3 percent for patients receiving Brilacidin, compared to 72.7 percent among those receiving placebo.

The completed Phase 2 study (see NCT02324335) met its primary endpoint, showing a reduction of Severe OM incidence versus placebo, as well as beneficial treatment effects in reducing the duration of Severe OM and in delaying the onset of Severe OM. Furthermore, Brilacidin showed a favorable safety profile and ­was well-tolerated.

http://www.ipharminc.com/press-release/2018/1...-mucositis



If the mentally ill basher again posts the claim that the Brilacidin-OM trial was not a success, the above quote is proof that he is either a liar, or mentally ill, or unable to understand clearly-written text, or all of the above.


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