Replies to post #108620 on Innovation Pharmaceuticals Inc (IPIX)

[MilesTeg]

Great questions, better answers.

Thanks for this, BK.

[TheHound]

I'm happier than a bearded clam. Thanks BK. I really appreciate ur time.

[DoubleJ23]

Thanks for asking these questions and posting his response. Much appreciated.

[DaubersUP]

Great email and response! He is clear!

[Chemdeps]

This is going to be very interesting....Additional sites will be coming on line regularly as we want to complete this trial ASAP.....I wonder if we can expect some type of interim update on this trial later in the fall? If this works.....look out!

[Chemdeps]

Thanks BK....great stuff!

[Phoenix300]

Informative, thank you Bk.

[Amatuer17]

BK - thank you for the unofficial update. Appreciate it.

[WILD_4_IPIX]

YOU ROCK BK ! Always have. Great questions and great answers IMO. Thanks for the value you bring to this board and all of us shareholders. Aloha indeed !

GO CTIX !

[tduggan]

Thank You good Sir and Aloha :)

[farrell90]

Great...thanks for posting.
Farrell

[youssef]

Bk thanks for posting , I don t know if I mention this before that my sister doctor overseas who is mdanderson graduate met with ctix pcyc and merk in Paris to see if he can start a trial overseas only Merck agree to sell them keytruda to try on my sister case for lymphoma cancer the last session I sent her was last Thursday her situation improved 80% for a month after she did 6 session we had to pay for them $66000 and 2 days ago she relapse and cancer came back stronger then ever destroy her lungs and her heart beat increase to 330 per minute, the person who had stomach cancer , he s pretty much cure from the keytruda , I believe ctix will do very well and I trust Leo and I have no worry on daily price share

[scottsmith]

His response to the FDA question is very understated, especially in comparison to BK's question. Hopefully this turns into an under-promise, over-deliver situation.

[Astavakra]

Thanks BK. So, we know there are at least 8 sites lined up for the trial, and the possibility exists for more. What's a WAG regarding end date for enrollment? If all goes well for both the patients and the company, the follow-up period for primary EPs will be brief.

[Drano]

BK, thanks for this information. (eom)

[frrol]

Thanks BK. He did not fully answer the question about Brilacidin fast-track. Either:

A. They haven't applied yet and are waiting to do so depending on the FDA meeting outcome and the FDA's posture
B. They applied within the last 59 days and are awaiting word
C. They applied and got denied.

His non-response is disappointing, but perhaps it's smart not to announce application for fast-track, in case it gets denied. Any informed opinions out there?

[Snowy_Owl]

Great questions! Thanks BK.

[BaartP]

Aloha, looking good BK, thanks. Late July it is.....

[slcimmuno]

thx for posting BK--is nice to hear tidbits straight from the top... lots in the hopper for sure. im personally expecting good news following the FDA meeting for Brilacidin Ph III. guess we'll hear more mid-July.

some ABX reading.

Antibiotics Not Given Same Research Attention as Rare Diseases, Says Report
http://www.dddmag.com/news/2015/06/antibiotics-not-given-same-research-attention-rare-diseases-says-report

Full Report (see pgs 13-23, good info inc ABX patents)
NovaBiotics mentioned... has a similar MOA to HDP-M/Def Mimetics (synthetic/rationally-designed antimicrobial peptides... their tagline: "Taking Nature's Lead in Antimicrobials")
http://www.marks-clerk.com/MarksClerk/media/MCMediaLib/PDF%27s/Reports/Life-Sciences-Report-2015-From-rare-to-routine.pdf

NovaBiotics
http://www.novabiotics.co.uk/technology

[Rkmatters]

Thank you for asking such great questions. Very insightful. Extremely refreshing to see how open and honest our CEO is. Thanks again!

[rr50]

B.Kahuna...Thanks for contacting Leo and relaying his answers. Positive stuff on a lot of fronts!

[TOB]

Much appreciate you sharing your email exchange with the CTIX CEO.

Excellent and informative questions and answers. Good to see everything is on-track, and especially that they are taking steps to accelerate the Brilacidin-OM trial. If the Brilacidin-OM results are good, we will have a surprise home-run. I don't think a penny of Brilacidin-OM is priced into the current share price.

Very intriguing about the Kevetrin clinical trial at Harvard Cancer Centers. Something is clearly in the works to speed-up the conclusion of the trial methinks. But I'm happy to wait for the actual details in the coming update.

Personally I'm also happy if they just continued the Kevetrin trial with higher doses. But they must have some basis for wanting to move faster to a next stage clinical trial. No question a positive Phase 1 Clinical Trial primary outcome measure is all but certain at this point. This has been the case since I first wrote that... was it a year ago? When the Kevetrin trial had proven safety into the range believed therapeutic. It only becomes more likely factual as higher doses are proven safe.

IMO additional indications of Kevetrin efficacy adding to those we've heard about, and PK data suggesting more frequent dosing is needed for full therapeutic effect are the only reasons there would be interest in wrapping up the trial without pushing to the highest doses. I can't imagine any other explanation for the below quote. Without indications of efficacy I'd think they'd want to keep trying higher doses.

However I will say our optimism on Kevetrin is unchanged and we want to move into Phase 2 ASAP. When I update on Brilacidin I will do a complete corporate update as well. - CTIX CEO Leo Ehrlich

[TheDane]

Who's your daddy... "figure by mid -late July i'll be able to update shareholders with the results of the meeting."

This is almost a quote from one of my posts. Leo...stop plagiarizing! ;-)

[georgejjl]

So Leo has confirmed that I was right. Cellceutix has potential for multibillions of dollars in yearly sales which gives Cellceutix a multi billion dollar market cap valuation.

Good luck and GOD bless,

George

[F1ash]

I have to join the chorus of thanks BK.
I remember the first time GI inductions were mentioned, some were disgruntled, saying that the company was trying to go in too many directions at once. This helps make it clear that it is simply part of a plan to build upon the unique properties of this new class of antibiotic. I have to agree that there is little to none of this huge potential currently reflected in the share price. I haven't really looked at GI diseases but Leo seems to be very excited about the prospects.

Thanks again for posting his reply.

Did a quick GI disease search and I see infection and inflammation mentioned several times.

"Pancreaticobiliary Disease Treatment

Gallbladder Disease — the gallbladder is a sac (located near the liver) that stores bile produced in the liver. Conditions that slow or obstruct the flow of bile out of the gallbladder result in gallbladder disease, such as:

Gallstones (cholelithiasis)
Inflammation of the gallbladder (cholecystitis)
Infection
Obstruction

Pancreas Disease — the pancreas produces and releases insulin and glucagon into the bloodstream to keep blood sugar levels within a normal range. The pancreas also produces enzymes to aid in the digestion of fats, proteins and carbohydrates in the intestine. Disease of the pancreas include:

Pancreatitis (acute and chronic inflammation of the pancreas)
Solid tumors (malignant and non-malignant)
Cystic tumors (may be benign, pre-malignant or malignant)
Pseudocysts (a fluid collection of pancreatic enzymes)
Strictures (blockages)

Bile Duct Disease — bile ducts carry bile from the liver to the intestine, where it aids in the digestion of food. Bile duct diseases include:

Stones (choledocholithiasis)
Strictures (narrowing of a duct that prevents bile from draining)
Tumors (malignant and non-malignant)
Cysts
Cholangitis, an infection of the bile ducts

[Tails]

Many thanks BK for the great Q&A.

It is hard to stop laughing after reading Leo's answers. There's been so much cr*p thrown around recently on this board. Hope no one has folded their hand - I think Leo is doing his best to tell us we have a spades royal flush.
The way he takes question #5 and first throws out the caution message.... and then names the 5 cards he/we are holding wink wink.

CTIX is a better buy today then it was 3 years ago at $.60!! Just WOW.

Go CTIX!!

[warrenthomas4001]

Thank you, BK for your diligent work and for sharing this information with all of us. Leo's replies were terrific, but your questions were exceptionally informative in their own right. Kudos for building such a quality rapport with Leo. One invests not only in the company, but in the company it keeps. I sleep soundly with this gem in my portfolio AND knowing the caliber of my fellow shareholders.

[TheDane]

I'm guessing Leo means previously untreated for OM??? It's a little confusing.

"As we engaged in discussions and visited the hospital, we learned that most patients with Head and Neck cancer had been previously treated elsewhere (ineligible patients). We always need untreated patients for this study and those patients often first go to a local hospital. In addition for the few newly diagnosed patients there was a competing trial ongoing at the hospital. To learn all this took some time."

[JUST 10-11-12]

thanks

[xoc]

Thanks BK, Leo is very excited about the potential GI applications of Brilacidin. I can see this both in his response to your questions and in his response to a recent query of my own about an old PR. LEO RESPONDED as below:

Last week I was traveling and  I am now catching up on emails.  At this time we are focused on Kevetrin and our defensin mimetics for creating additional  applications.  For example Brilacidin as an anti inflammatory would be a significantly greater market than as an antibiotic.  Think GI diseases!  Thats why we are anxiously waiting to see what happens in the OM trial.


Best,


Leo Ehrlich | CEO |  

cellceutix

[John B]

Thanks BK. I really appreciate you sharing the email from Leo.
Thank You!

[Chemdeps]

After thinking about this further it appears they are extremely confident in the outcome for B-OM to indicate that they want the trial to be completed ASAP. Does anyone have a good handle on the length of time this trial will take? I know the official clinical trials site indicates Dec 2016 as an end date, but that seems awfully long if they have three sites already active and five more in the wings, especially if treatment is only for 7 weeks (if I remember correctly). Could we have interim results sometime on September or October or is that way too optimistic?

[cabel]

Thanks for that BK,... great job!

[CallMeCrazy]

Thanks for sharing your very informative and insightful email to Leo. Although Leo didn't give a direct answer to question #5:

[/

5) One last one just for fun, some have speculated that a buyout might mean $1.5 billion for CTIX, or $10 a share. Would you accept a $1.5 billion offer at this point?

b]

Allow me to give my succinct interpretation of Leo's very long answer: Hellllllll no!

[BonelessCat]

I remember that, yeah. I thought it was a huge break not to be tied to MDA and their time line. I was happy to get an elaboration and even happier to learn of the large number of trial sites.

[AlanC]

Awesome questions and loved the responses! Go CTIX!!!