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Ultimate01

05/01/15 8:36 AM

#100080 RE: frrol #100079

Perhaps pursuit of "Orphan Drug" designation.

GO CTIX!!!

bramkers

05/01/15 8:57 AM

#100086 RE: frrol #100079

How about this:
I wonder why they are trying to pursue a dozen indications half-a$$. Why not focus 90% on a big, fat, undeniable launch of Brilacidin and secure and finance our future? And more importantly, create some credibility with the more mainstream and likely less-informed investor, who seems to be losing a bit of confidence.
Instead of announcing all these new (and probably potentially great) drugs. All this does momentarily, is create a "Oh look, there's another one, let's see how long it takes before it fizzles"-vibe.
I'm not one of them, don't get me wrong, I love the widespread potential of the platform, but that's what I'm detecting in the general sentiment of several message boards lately.
Of course, I too believe that we're all singing a far more positive tune here rather soon!!
GLTA!

slcimmuno

05/01/15 9:18 AM

#100092 RE: frrol #100079

More on HDP-Ms as anti-TB and anti-Malarials (rsch has been suspended) per xoc, Ultimate posts; comprehensive PYMX antimicrobial bibliographies, 2013 and 2010 versions (reflective of breadth/depth of research)

So while there is an obv need for TB and Malarial drugs, CTIX is *not* pursuing them -- see Springer link on therapeutics in Suspended / Preclinical / Research. Later confirmed by email. There are lots of articles in the Lit how hard it is to incentivize Rx to spend $ twd developing these "low-return" drugs for neglected 3rd World diseases. Bummer, but money still (always in all ways) talks... Also a function of prioritization----focusing resources. An understandable management decision.

Anyway, perhaps TB/Malarial drugs a future area for a deeper-pocketed Big Rx to pursue post CTIX partnership should one come to pass. (Highly probable IMO.) The HDP-M science, never failing to amaze (per the extensive PYMX pre-clinical work), is there in spades---again, improving on what Mother Nature already does quite well. And those tropical (neglected) disease Priority Rvw vouchers occasionally have been sold for mucho dinero. So who knows. Maybe these compounds will have their moment at some future pt.

http://en.m.wikipedia.org/wiki/Priority_review_voucher

http://www.raps.org/Regulatory-Focus/News/Priority-Review-Voucher/

///

Hi [ ],

Although an anti-malaria drug would be exciting, it would cost way to much for us to develop and thus did not fit in with our plans. In addition it would have to be injected and the WHO is looking for an oral drug. We therefore will not be pursuing malaria.

We are not working on TB and at present have no plans to.

Best,

Leo Ehrlich | CEO |

///

http://adisinsight.springer.com/drugs/800020520

Research programme: defensin mimetic therapeutics - Cellceutix
Alternative Names: Arylamide series - PolyMedix; Bactericidal amphiphilic antibiotic compounds - PolyMedix; Calixarene series - PolyMedix; CTIX 1278; CTX 1807; Defensin-mimetics - PolyMedix; Hydrazide series - PolyMedix; PMX 1408; PMX 1502; PMX 196; PMX 225; PMX 231; PMX 243; PMX-10004; PMX-10033; PMX-10036; PMX-10052; PMX-10056; PMX-10065; PMX-10066; PMX-10067; PMX-10068; PMX-10070; PMX-10072; PMX-10098; PMX-30006; PMX-30016; PMX-30024; PMX-40007; PMX-50003; PMX-519; PMX-60006; PMX-60007; PMX-60014; PMX-70004; PMX-70008; Salicylamide series - PolyMedix
Latest Information Update: 13 Mar 2015

At a glance
Originator
PolyMedix
Developer
Cellceutix
Class
Calixarenes; Small molecules
Mechanism of Action
Cell membrane permeability enhancers; Cell membrane structure modulators; Defensin modulators
Orphan Drug Status
No
On Fast track
No
New Molecular Entity
Yes
Available For Licensing
Yes
Highest Development Phases

Preclinical
Gram-negative infections; Mycoses; Proctitis
Research
Acne vulgaris; Hidradenitis suppurativa; Rosacea
*****Suspended
Anthrax; Malaria; Tuberculosis
Most Recent Events

13 Mar 2015
Early research in Rosacea in USA (unspecified route)
02 Mar 2015
Early research in Acne vulgaris in USA (unspecified route)
02 Mar 2015
Early research in Hidradenitis suppurativa in USA (unspecified route)

///

Magnitude of TB Problem

WHO
http://www.who.int/tb/publications/factsheet_global.pdf
CDC
http://www.cdc.gov/tb/education/corecurr/pdf/corecurr_all.pdf

///
PYMX Deck "Global TB Epidemic, HIV and PolyMedix Solutions" (Sept 2008) // XOC also posted this in his Dropbox
http://files.shareholder.com/downloads/ABEA-4ITCYZ/1410277423x0x502484/04f855bc-78e4-4ea6-a752-24e73f795e01/AIDSSymposiumTBSept262008.pdf

Posted yesterday
Beyond INH: New classes of drug development for the treatment of multi-drug resistant tuberculosis (MDR-TB) and extensively drug resistant tuberculosis (XDR-TB) infections and global vulnerabilities of HIV+ drug users is a determining consideration for the development of defensin mimetics
http://files.shareholder.com/downloads/ABEA-4ITCYZ/0x0x502048/55a1027c-8669-457c-933d-ec94e62b6927/AIDS_2009.pdf

TB Patent
http://patentimages.storage.googleapis.com/pdfs/US20130137706.pdf

Malarial Patent
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=8,796,275.PN.&OS=PN/8,796,275&RS=PN/8,796,275

///

PYMX Antimicrobial Bibliography
(January 2013)
http://files.shareholder.com/downloads/ABEA-4ITCYZ/0x0x497185/6bb17bf6-bd93-452c-a9bc-f056be6c3d45/PYMX_WebDoc_9457.pdf

PYMX Antmicrobial Bibliography (March 2010)
http://www.docstoc.com/docs/38779195/PolyMedix-Antibiotic-Bibliography---March-2010

CallMeCrazy

05/01/15 9:19 AM

#100093 RE: frrol #100079

My guess is that while TB is increasing in the world it is declining in the U.S. First world (US, Europe, etc) drug sales subsidize third world drug sales and, as the ebola crisis revealed, if their are not enough first world patients with a disease (TB) than their is little, if any, financial incentive to develop a drug for it.

http://www.cdc.gov/tb/statistics/default.htm



Data and Statistics

Tuberculosis (TB) is one of the world’s deadliest diseases:
•One third of the world’s population is infected with TB.
•In 2013, 9 million people around the world became sick with TB disease. There were around 1.5 million TB-related deaths worldwide.
•TB is a leading killer of people who are HIV infected.

A total of 9,582 TB cases (a rate of 3.0 cases per 100,000 persons) were reported in the United States in 2013. Both the number of TB cases reported and the case rate decreased; this represents a 3.6% and 4.3% decline, respectively, compared to 2012.