Monday, January 11, 2016 9:31:59 PM
Very professional ,well documented presentation by Dr Jorgensen
High point was the narrative which clarified management's future plans for their products.Several new points delivered.
Leo's introduction...Presentation outlines path to a multibillion dollar company.
Brilacidin
-new class of antibiotics
-lower risk of resistance due to multiple factors including new class, - single dose, short half life
-single dose makes follow up visits less critical
-effective against stationary and rapidly dividing bacteria and biofilm
-rapid clearing of bacteria is also a factor in lowering risk of resistance
-clinical response in 48-72 hrs
-QIDP approved
-SAE's reduced with lower dose, which proved to be effective
-lower BP than Daptomycin in trial
-Brilacidin is also immunomodulary
-Ulcerative Colitis and Ulcerative Proctitis trial is planed
-possibly a safer treatment than Prednisone for inflammatory bowel disease
Brillacidin for Oral Mucositis
- quick FDA phase 3 possible at completion of phase 2
-Fast track by FDA
-impressive preclinical results
-leading researcher "given results unethical to not study"
-high incidence of OM in head and neck cancers 80-100%
-OM high levels of morbidity: sepsis; hospitalization; gastric feeding tubes
-trial arms for prevention and treatment
-10-20 sites
-oral rinse tid x 7 weeks
-quick trial
-Interim report at 37 weeks
Defensin-mimetic Host Defense Proteins
-skin and mucus membrane disease
-CTIX 1807 gram neg disease; low MICs against CRE,Carbapenem-resistent Enterobacteriaceae
-Antifungal agent high response rate
Kevetrin
-effective against wild and mutant p53
-increases P21 biomarker
-57% of all pt increased P21;70% of ovarian cancer
-low toxicity
-no SAE's due to Kevetrin
-large therapeutic index
-several with stable disease
- one patient treated X 6 courses and is still being treated
-short half life
-simple manufacturing process
-complimentary to radiation in Head and neck Cancers
-Retinoblastoma orphan drug designation and pediatric rare disease
designation. FDA trial being planned
- drug resistant Ovarian ca awarded orphan drug status FDA trial being planned
-AML trial being planned
-???Renal Ca trial being planned [I think had trouble hearing]
Prurisol
-505[2] pathway will expedite trial
-Ester of Abacavir which is an AIDS drug with 15 yr track record of safety
- FDA has accepted the previous FDA trial safety results of Abacavir which will shorten the trial
From my quick and dirty notes feel free to add or correct.
GLTA Farrell
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