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Wednesday, May 09, 2018 11:26:42 PM
falcon74, I agree.
I've modified ipix's display of todays pr by replacing designations with a capitalized letter, and enumerated the subsets associated with them(A2,B1,C2,etc) in the event I need to refer to them.
Agree.
A. Reduced Incidence of Severe OM (Primary Endpoint)
1. Placebo 60.0%, reduced to Brilacidin 42.9% [Modified Intent to Treat (mITT) Population].
2. Placebo 60.0%, reduced to Brilacidin 36.8% [Per Protocol (PP) Population].
B. Delayed Onset of Severe OM (Secondary Endpoint)
1.For those patients in the Brilacidin group who did experience Severe OM, onset occurred generally later during radiation therapy.
C. Reduced Duration of Severe OM (Secondary Endpoint)
1.Severe OM median duration was 0.0 days for Brilacidin (mITT and PP Populations), indicating that more than half of all patients on active treatment did not experience Severe OM.
2.Overall Severe OM median durations for placebo were 3.0 days and 5.5 days for the mITT and PP Populations, respectively.
D.Reduced Incidence of Severe OM, 21-day Cisplatin Regimen subset
1.Placebo 71.4%, reduced to Brilacidin 25.0% [mITT Population] (p=0.048).
2.Placebo 72.7%, reduced to Brilacidin 14.3% [PP Population] (p=0.025).
E. Delayed Onset of Severe OM, 21-day Cisplatin Regimen subset
1.The time to onset of Severe OM was delayed with Brilacidin treatment compared to placebo, even more markedly in the 21-day cisplatin regimen subgroup.
Quote from Dr. Stephen Sonis relevant to his advisory role with another OM company:"Concomitant chemo-radiation induced oral mucositis remains a significant unmet medical need. Probably 60 to 70 percent of patients with cancers of the oral cavity, oral pharynx, hypopharynx, and nasopharynx, develop severe mucositis of such severity as to require increased hospitalization, emergency room visits, or breaks in treatment," explained Dr. Sonis. "The mechanism of action of EC-18 supports its use as a potential intervention in mucositis, as well as other radiation-induced injuries such as dermatitis, enteritis and pneumonitis."
The referenced company, who filed their 84 patient ph 2 study with clinicaltrials in June, 2017, is not yet recruiting(go get em tiab).
Baystreet considers them, and us, top contenders:
http://www.baystreet.ca/stockstowatch/2658/A-Billion-Dollar-Market-Just-Waiting-for-a-New-Oral-Mucositis-Drug-Five-Companies-That-Want-It
Today's pr was the best they have ever put out, and backed by FACTS.
p.s A breakthrough therapy designation can be assigned to a drug if "it is a drug which is intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition" and if the preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development."[5][7]
Re-read Sonis statement about the inability to eat or drink because of severe OM.
Good night Irene.
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