InvestorsHub Logo

TheDane

02/03/14 7:29 PM

#53468 RE: TheProgressive #53467

It made sense to me...Thanks!

TheProgressive

02/03/14 7:32 PM

#53469 RE: TheProgressive #53467

A snippet of Dr Paul Ambrose's bio, it sounds like they got the perfect lead and expert team to evaluate all the prior PK/PD data to help ensure a truly optimized dosing regimen that would be successful in the imminent 2B trial. Really a shame for PYMX shareholders because scientifically, it really does seem like they did everything in a top notch way, its just the finances that were grossly mismanaged and killed Brilacidin while it was at Polymedix. PYMX's loss is now CTIX's very big gain.

Here is the snippet:

"Our team’s expertise ranges from the microbiology laboratory, with in vitro PK-PD infection models, to the animal laboratory for PK-PD studies, through the Phase 1 Unit for healthy-volunteer and patient studies, into Phase 2 through 4 clinical trial design, to pharmacokinetic and PK-PD mathematical analyses to support regulatory and commercial efforts.

More specifically, our team’s mathematical expertise includes pharmacokinetic and population pharmacokinetic modeling, PK-PD analyses, Monte Carlo simulation, and epidemiological analyses of drug use and antimicrobial resistance.

We are interested in novel PK-PD-based clinical trial design, which serve to better describe the time-course of drug effect. The use of PK-PD-based clinical trial endpoints can have a significant impact on sample size power calculations and thereby hold the promise of reducing the total number of patients required to demonstrate therapeutic efficacy.

Dr. Ambrose is the author of over 60 peer-reviewed scientific publications and approximately 100 scientific abstracts. Dr. Ambrose has served as an Editor for four textbooks, most notable the 1st and 2nd Editions of Antimicrobial Pharmacodynamics in Theory and Clinical Practice."

cabel

02/03/14 7:35 PM

#53470 RE: TheProgressive #53467

Thanks for sharing that very informative post with us!!

petemantx

02/03/14 7:56 PM

#53473 RE: TheProgressive #53467

I had the same report written up on my computer and luckily had not posted it yet or it would have looked like a duplicate. LOL.

Your DD and passing along the information you derive is a real bonus to the board and is why everyone eagerly awaits your posts.

Thanks for another great post.

sox040713

02/03/14 8:28 PM

#53479 RE: TheProgressive #53467

TP, excellent analysis! Your post is Seeking Alpha worthy. All you needs is a title. =)

vip1999

02/03/14 9:48 PM

#53483 RE: TheProgressive #53467

since Dapto is brought up, I decide to learn a bit from googling it. Found a wiki page...

http://en.wikipedia.org/wiki/Daptomycin

Even though it was known to have problems with quite a bit of areas, FDA still approves it for Adult use...

The rights to LY 146032 were acquired by Cubist Pharmaceuticals in 1997, which following U.S. Food and Drug Administration (FDA) approval in September 2003 for use in people older than 18 years began marketing the drug under the trade name CUBICIN. Cubicin is marketed in the EU and in several other countries by Novartis following its purchase of Chiron Corporation, previous licensee



In July 2010, the FDA issued a warning that Daptomycin could cause life-threatening eosinophilic pneumonia. The FDA said that it had identified seven confirmed cases of eosinophilic pneumonia between 2004 and 2010 and an additional 36 possible cases. The seven confirmed victims were all older than 60 and symptoms appeared within two weeks of initiation of therapy.



---------

Nearly 13 years before FDA issued such a warning... I can only imagine how busy they must be. On the other hand, if B is safer alternative, I think FDA would want to fast track it!

WILD_4_IPIX

02/03/14 10:08 PM

#53484 RE: TheProgressive #53467

TP....you ARE and have ALWAYS been DA MAN ! Seriously, that was educational AND awesome ! Thanks Pal and Three words....

Seeking Alpha Article ! : )

GO CTIX !

BonelessCat

02/03/14 10:17 PM

#53485 RE: TheProgressive #53467

that's a pretty expansive and comprehensive bottom line.

My bottom line regarding B for ABSSSI: B = good, but how good?

incubus-now

02/04/14 12:11 AM

#53493 RE: TheProgressive #53467

Worldwide cancer cases expected to soar by 70% over next 20 years

New cancer cases expected to grow from 14m a year in 2012 to 25m, with biggest burden in low- and middle-income countries

Sarah Boseley, health editor
theguardian.com, Monday 3 February 2014 08.02 EST

Cancer cases worldwide are predicted to increase by 70% over the next two decades, from 14m in 2012 to 25m new cases a year, according to the World Health Organisation.

The latest World Cancer Report says it is implausible to think we can treat our way out of the disease and that the focus must now be on preventing new cases. Even the richest countries will struggle to cope with the spiralling costs of treatment and care for patients, and the lower income countries, where numbers are expected to be highest, are ill-equipped for the burden to come.

The incidence of cancer globally has increased in just four years from 12.7m in 2008 to 14.1m new cases in 2012, when there were 8.2m deaths. Over the next 20 years, it is expected to hit 25m a year – a 70% increase.

The biggest burden will be in low- and middle-income countries. They are hit by two types of cancers – those triggered by infections, such as cervical cancers, which are still very prevalent in poorer countries that don't have screening, let alone the HPV vaccine, and increasingly cancers associated with more affluent lifestyles "with increasing use of tobacco, consumption of alcohol and highly processed foods and lack of physical activity", writes the World Health Organisation director general, Margaret Chan, in an introduction to the report.

Lung cancer is the most commonly diagnosed among men (16.7% of cases) and the biggest killer (23.6% of deaths). Breast cancer is the most common diagnosis in women (25.2%) and caused 14.7% of deaths, which is a drop and only just exceeds lung cancer deaths in women (13.8%). Bowel, prostate and stomach cancer are the other most common diagnoses.

"Despite exciting advances, the report shows that we cannot treat our way out if the cancer problem," said Dr Christopher Wild, director if the International Agency for Research on Cancer and joint author of the report. "More commitment to prevention and early detection is desperately needed in order to complement improved treatments and address the alarming rise in cancer burden globally."

Alcohol, obesity and physical inactivity are all preventable causes of cancer along with tobacco, the report says. Its authors call for discussion on ways forward, which could include taxes of sweet calorific drinks.

http://www.theguardian.com/society/2014/feb/03/worldwide-cancer-cases-soar-next-20-years

John B

02/04/14 6:31 AM

#53496 RE: TheProgressive #53467

TP, Nice post as always!
Thanks!

WILD_4_IPIX

02/04/14 7:40 AM

#53505 RE: TheProgressive #53467

Thanks for the message Pal !

GO CTIX !

Talc Moan

02/28/14 11:18 AM

#55367 RE: TheProgressive #53467

Great Post.... I feel extremely Happy to have made a decision to enter CTIX long term....