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Re: noretreat post# 136346

Monday, 01/11/2016 9:31:59 PM

Monday, January 11, 2016 9:31:59 PM

Post# of 403742
Summary of presentation

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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