Took some notes. Some of this is my summary and so
Post# of 72446
Posted On: 06/08/2016 9:58:24 AM
Took some notes. Some of this is my summary and some I typed real fast as he was speaking.
He says Bril-OM is going for FDA drug designation, not "device" designation. Current attempts at OM treatment are "devices" -- substances intended at coating the lining of the mouth. Have new Contract Research Organization to recruit more patients faster. Have made changes to exclusion criteria so should be easier to recruit patients now.
Brilacidin ABSSSI trial will be international -- conducted overseas and analyzed in U.S. Making sure they get agreement with FDA before proceeding with trial, so that FDA won't come back and change conditions after they've started the trial. Because it's multi-national worldwide study it's complicated.
Bril is "a gateway drug because it has many other beneficial properties." "WE HAVE INITIATED A TRIAL" for Bril-UP overseas. It's been shipped to clinical sites and expect it to commence near term. Gateway for Crohn's disease etc.
Antibiotic coating for implants: encouraged that big pharma studies have placed more than one order for Bril. CTIX doesn't know but thinks it bodes well.
Dermatology drug development: Prurisol "the dark horse" has really come into its own in the past weeks. Prurisol has a new chemical entity patent. It's easier to see improvement in a more severely affected patient. Enrolled patients with some "pretty resilient psoriasis." Used IGA scale which only ranges from 0-4. The PASI scale is much wider. Used IGA scale because patients could have a rating of no more than 3. Mild patients had to drop to zero because of 2-point drop endpoint. People thought we were crazy but we were confident and wanted to set the bar high. P successfully treated 35%, including 1 site where investigator non-compliance is suspected because data were very different than all other sites. Excluding that, 46.1% were successful with largest dose.
Comparing Otezla at same point in their trials, Prurisol meets or exceeds their efficacy at a similar point. Want to approach the efficacy of biologics with an oral medication, no one has done that before. Avoids all the known side effects of biologics. MENTIONS PSORIATIC ARTHRITIS "we intend to explore."
Also talks about HS and eczema -- meeting with the FDA is scheduled for THIS MONTH.
Leo says a shareholder told him why shareholder is so loyal -- it's because of the pipeline.
He says Bril-OM is going for FDA drug designation, not "device" designation. Current attempts at OM treatment are "devices" -- substances intended at coating the lining of the mouth. Have new Contract Research Organization to recruit more patients faster. Have made changes to exclusion criteria so should be easier to recruit patients now.
Brilacidin ABSSSI trial will be international -- conducted overseas and analyzed in U.S. Making sure they get agreement with FDA before proceeding with trial, so that FDA won't come back and change conditions after they've started the trial. Because it's multi-national worldwide study it's complicated.
Bril is "a gateway drug because it has many other beneficial properties." "WE HAVE INITIATED A TRIAL" for Bril-UP overseas. It's been shipped to clinical sites and expect it to commence near term. Gateway for Crohn's disease etc.
Antibiotic coating for implants: encouraged that big pharma studies have placed more than one order for Bril. CTIX doesn't know but thinks it bodes well.
Dermatology drug development: Prurisol "the dark horse" has really come into its own in the past weeks. Prurisol has a new chemical entity patent. It's easier to see improvement in a more severely affected patient. Enrolled patients with some "pretty resilient psoriasis." Used IGA scale which only ranges from 0-4. The PASI scale is much wider. Used IGA scale because patients could have a rating of no more than 3. Mild patients had to drop to zero because of 2-point drop endpoint. People thought we were crazy but we were confident and wanted to set the bar high. P successfully treated 35%, including 1 site where investigator non-compliance is suspected because data were very different than all other sites. Excluding that, 46.1% were successful with largest dose.
Comparing Otezla at same point in their trials, Prurisol meets or exceeds their efficacy at a similar point. Want to approach the efficacy of biologics with an oral medication, no one has done that before. Avoids all the known side effects of biologics. MENTIONS PSORIATIC ARTHRITIS "we intend to explore."
Also talks about HS and eczema -- meeting with the FDA is scheduled for THIS MONTH.
Leo says a shareholder told him why shareholder is so loyal -- it's because of the pipeline.
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