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thefamilyman

05/02/15 7:10 AM

#100228 RE: FarmaZutical #100227

Good find! I had not seen this mentioned before.

Has the company talked about the ARVO conference that takes place in Denver,CO starting Sunday ?

Brilacidin is being presented tomorrow morning at 8.30:

C0149: The In Vitro and In Vivo Antibacterial Evaluation of Brilacidin
Exhibit Hall
193664
8:30am - 10:15am
Sun, May 03

Regis Kowalski

The Charles T. Campbell Lab - UPMC

From the website:

The Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) is the largest gathering of eye and vision researchers in the world, attracting over 11,000 attendees from more than 75 countries. About 45% of our attendees are from outside the U.S.

www.arvo.org/Annual_Meeting/Program/

- FarmaZuetical

John B

05/02/15 7:20 AM

#100230 RE: FarmaZutical #100227

Nice find! Here is some info from that site:

The In Vitro and In Vivo Antibacterial Evaluation of Brilacidin

Posterboard #: C0149

Abstract Number: 264 - C0149

Author Block: Regis P. Kowalski1 , Eric G. Romanowski1 , Robert M. Shanks1 , Kathleen Yates1 , Francis S. Mah1,2
1 Ophthalmology, The Charles T. Campbell Lab - UPMC, Pittsburgh, Pennsylvania, United States; 1 Ophthalmology, The Charles T. Campbell Lab - UPMC, Pittsburgh, Pennsylvania, United States; 1 Ophthalmology, The Charles T. Campbell Lab - UPMC, Pittsburgh, Pennsylvania, United States; 1 Ophthalmology, The Charles T. Campbell Lab - UPMC, Pittsburgh, Pennsylvania, United States; 1 Ophthalmology, The Charles T. Campbell Lab - UPMC, Pittsburgh, Pennsylvania, United States; 2 Ophthalmology, Scripps-Health, San Diego, California, United States

Disclosure Block:Regis P. Kowalski, PolyMedix (Code F (Financial Support)), PolyMedix (Code F (Financial Support)), PolyMedix (Code F (Financial Support)); Eric G. Romanowski, PolyMedix (Code F (Financial Support)), PolyMedix (Code F (Financial Support)), PolyMedix (Code F (Financial Support)); Robert M. Shanks, None; Kathleen Yates, None; Francis S. Mah, PolyMedix (Code F (Financial Support)), PolyMedix (Code F (Financial Support)), PolyMedix (Code F (Financial Support))

Purpose:Brilacidin (BRI) (PMX30063) is the first anti-infective in a new class of defensin mimetics. The goals of the study were to evaluate the in vitro and in vivo efficacy of BRI as an ocular anti-infective.

Methods:In vitro: MICs using broth dilution were determined for clinical ocular isolates (n = 25 per bacteria) of Ciprofloxacin Susceptible (CS) Staphylococcus aureus (CSSA), Ciprofloxacin Resistant (CR) Staphylococcus aureus (CRSA), CS Staphylococcus epidermidis (CSSE), CR Staphylococcus epidermidis (CRSE), Streptococcus pneumoniae (SP), Streptococcus viridans group (SV), Moraxella Species (MS), Haemophilus influenzae (HI), Pseudomonas aeruginosa (PA), and Serratia marcescens (SM). In vivo: In 24 NZW rabbits, corneal epithelial defects were created OS (abraded corneas), while the epithelium OD remained intact (intact corneas) to determine the effect of drug penetration. The corneas were intrastromally injected with 1000 CFU of MRSA. Rabbits were separated into 4 groups (n=6): A) BRI 0.5%, B) Vancomycin (VAN) 5%, C) saline (SAL), and D) no treatment (baseline CFU). Four hrs after MRSA challenge, topical treatment of one drop every 15’ for 5 hrs was initiated. One hr after treatment the corneas were harvested for CFU. The data were non-parametrically analyzed.

Results:In vitro: Data is expressed as MIC50, MIC90, and Range of MICs in µg/ml. CSSA (0.25, 0.25, 0.125-0.5); CRSA (0.25, 0.5, 0.125-1.0); CSSE (0.125, 0.25, 0.03125-0.25); CRSE (0.125, 0.25, 0.03125-0.25); SP (1, 1, 0.5-128); MS (4, 64, 0.5-128); HI (8, 8, 2-32); PA (4, 4, 0.5-8); SM (8, 32, 0.25-32). In vivo: For abraded corneas, VAN and BRI produced similar reductions in MRSA CFU, and were less than saline (P<0.05, K-W). However, only BRI demonstrated a 99.9% reduction compared to baseline CFU. For intact corneas, VAN significantly reduced CFU compared with BRI which demonstrated a slight but significant decrease vs. SAL (P<0.05, K-W). BRI reduced CFU in abraded corneas significantly more than intact corneas (P<0.05, M-W) suggesting the corneal epithelium acts as a barrier for penetration. There was no difference in CFU in abraded and intact corneas with VAN (P>0.05, M-W) suggesting high penetration through the corneal epithelium.

Conclusions:BRI demonstrated broad spectrum in vitro activity against ocular pathogens. BRI was equally efficacious as VAN in a MRSA keratitis model only when the corneal epithelium was removed.

F1ash

05/02/15 8:26 AM

#100233 RE: FarmaZutical #100227

I posted the link on March 30th. I don't think they are playing it up yet because the current formulation won't effectively cross the Cornial epithelium. It seems to be great on the surface of the eye though. I was hoping one of our eye doctors could comment on the importance of it crossing this barrier. I have no idea what part of eye harbors most infections.

Ultimate01

05/02/15 8:49 AM

#100234 RE: FarmaZutical #100227

GREAT FIND!!! Looks like ophthalmic conditions on the horizon. And as far as I'm aware, NO, they have not announced this.


GO BRILACIDIN!!!

slcimmuno

05/02/15 9:40 AM

#100242 RE: FarmaZutical #100227

Thx for flagging this. My guess: unaffiliated research tied to the PYMX days of yore - a decade back. The same lead researcher out of Pittsburgh. Kowalski.

See
http://www.businesswire.com/news/home/20061113005507/en/Data-PolyMedixs-Antibiotics-Presented-40th-Annual-Meeting#.VUSxzFJOKnM

http://eyemicrobiology.upmc.com/2006Abstracts/Abstract%203.htm

http://ophthalmology.medicine.pitt.edu/personnelDetail.asp?pid=2372&id=127&ptype=2&pnavcat=2

I've forwarded to CTIX in case it's not on their radar. The attribution currently is tied to PolyMedix not Cellceutix, which makes me think they're not---maybe both parties... Ie folks not knowing CTIX acquired the IP portfolio -- and a few chairs -- post bankruptcy.

While Brilacidin was unable to penetrate wall, per the new abstract, the earlier 06 data had them testing other HDP-Ms (pmx30006, pmx30016, pmx70004). So perhaps other compounds could be "tweaked" (I know, that dreaded word) for greater efficacy. Welcome any docs/expert opinions.

cascott

05/02/15 10:00 AM

#100245 RE: FarmaZutical #100227

looks like all of these presenters are from university of pittsburgh medical center, could a research collaboration be in the works for brilacidin and opthamology maladies with a research hospital?

alwaysdreaming

05/02/15 10:08 AM

#100247 RE: FarmaZutical #100227

Yea baby, nice to see my hometown boys getting into the Brilacidin coming out party!

Go Pitt/CTIX

CallMeCrazy

05/02/15 11:19 AM

#100263 RE: FarmaZutical #100227

Nice find. I expect this to be included, hopefully, in Monday's PR, if we get one.

ARVO 2015 Annual Meeting Abstracts
111 Antibiotics and anti-microbial agents Sunday, May 03, 2015 8:30 AM–10:15 AM Exhibit Hall Poster Session Program #/Board # Range: 264–287/C0149–C0172 Organizing Section: Immunology/Microbiology Contributing Section(s): Clinical/Epidemiologic Research, Cornea, Eye Movements/Strabismus/Amblyopia/Neuro-Ophthalmology, Physiology/Pharmacology, Retinal Cell Biology, Retina
Program Number: 264 Poster Board Number: C0149 Presentation Time: 8:30 AM–10:15 AM The In Vitro and In Vivo Antibacterial Evaluation of Brilacidin Regis P. Kowalski1, Eric G. Romanowski1, Robert M. Shanks1, Kathleen Yates1, Francis S. Mah1, 2. 1Ophthalmology, The Charles T. Campbell Lab - UPMC, Pittsburgh, PA; 2Ophthalmology, ScrippsHealth, San Diego, CA. Purpose: Brilacidin (BRI) (PMX30063) is the first anti-infective in a new class of defensin mimetics. The goals of the study were to evaluate the in vitro and in vivo efficacy of BRI as an ocular antiinfective. Methods: In vitro: MICs using broth dilution were determined for clinical ocular isolates (n = 25 per bacteria) of Ciprofloxacin Susceptible (CS) Staphylococcus aureus (CSSA), Ciprofloxacin Resistant (CR) Staphylococcus aureus (CRSA), CS Staphylococcus epidermidis (CSSE), CR Staphylococcus epidermidis (CRSE), Streptococcus pneumoniae (SP), Streptococcus viridans group (SV), Moraxella Species (MS), Haemophilus influenzae (HI), Pseudomonas aeruginosa (PA), and Serratia marcescens (SM). In vivo: In 24 NZW rabbits, corneal epithelial defects were created OS (abraded corneas), while the epithelium OD remained intact (intact corneas) to determine the effect of drug penetration. The corneas were intrastromally injected with 1000 CFU of MRSA. Rabbits were separated into 4 groups (n=6): A) BRI 0.5%, B) Vancomycin (VAN) 5%, C) saline (SAL), and D) no treatment (baseline CFU). Four hrs after MRSA challenge, topical treatment of one drop every 15’ for 5 hrs was initiated. One hr after treatment the corneas were harvested for CFU. The data were non-parametrically analyzed. Results: In vitro: Data is expressed as MIC50, MIC90, and Range of MICs in µg/ml. CSSA (0.25, 0.25, 0.125-0.5); CRSA (0.25, 0.5, 0.125-1.0); CSSE (0.125, 0.25, 0.03125-0.25); CRSE (0.125, 0.25, 0.03125-0.25); SP (1, 1, 0.5-128); MS (4, 64, 0.5-128); HI (8, 8, 2-32); PA (4, 4, 0.5-8); SM (8, 32, 0.25-32). In vivo: For abraded corneas, VAN and BRI produced similar reductions in MRSA CFU, and were less than saline (P<0.05, K-W). However, only BRI demonstrated a 99.9% reduction compared to baseline CFU. For intact corneas, VAN significantly reduced CFU compared with BRI which demonstrated a slight but significant decrease vs. SAL (P<0.05, K-W). BRI reduced CFU in abraded corneas significantly more than intact corneas (P<0.05, M-W) suggesting the corneal epithelium acts as a barrier for penetration. There was no difference in CFU in abraded and intact corneas with VAN (P>0.05, M-W) suggesting high penetration through the corneal epithelium. Conclusions: BRI demonstrated broad spectrum in vitro activity against ocular pathogens. BRI was equally efficacious as VAN in a MRSA keratitis model only when the corneal epithelium was removed. Commercial Relationships: Regis P. Kowalski, PolyMedix (F); Eric G. Romanowski, PolyMedix (F); Robert M. Shanks, None; Kathleen Yates, None; Francis S. Mah, PolyMedix (F) Support: Industry - PolyMedix