Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Please break it down for us who all of the insiders are.
Put some "who they are detail" behind your statement.
The safety check passed to move on to cohort C (#3).
They are gathering efficacy now.
You want them to release disease progression before an official efficacy report??
$25 million to $50 million upfront is peanuts for a Pfizer interest in Prurisol, even with milestones along the way. Pfizer paid $5.2 billion for Anacor Pharmaceuticals having $99 million in yearly revenue. The crown jewel was Anacor's Crisabarole which may do $2 billion in revenues by 2022.
Tell me what risk Pfizer is taking on if Phase 2B Prurisol results are duplicated as 2A results?
Is that the avenue they should take before waiting on results of 3-4 trials?
Dr Bertolino was brought on board to intensify the partnership talks and determine the best way to maximize value for deals.
Leo gave way and it was a good decision.
There are small biotechs with websites whose content pages (non news) say they're looking for partnerships....what's the big deal with looking for a partnership even if it takes several years...better to start somewhere and build your strategy by having meetings with other companies to understand who's interested in what and what more they want to see in trials.
Sounds like your not focused on upcoming trial results.
A cohort 2 Phase 2A BUP result end of February/early March.
6 week endoscopy impressed some BPs for cohort 1.
A Phase 2 BOM interim results end of March.
*** BTW they added 2 BOM sites today, total = 13
Fast track designation granted by FDA.
A Prurisol Phase 2B 6 week interim result probably in April.
Prurisol appears to start working already in week 2, based on Phase 2A.
The Prurisol 2A looked comparable to Otezla (projected sales of
$1.5 BILLION in this its 3RD YEAR) with less side effects.
And Kevetrin 2A site initiated, should start recruiting soon.
I'm satisified that Dr Bertolino is running the show!!
He's moving the trials along and has the interest of Big Pharma.
CDAs/NDAs and continued meetings with the BIG BOYS!
Any decent outcome for Prurisol 2B will end up a cash injection.
There are a # of folks on here that just talk FUD. And there time is up soon, lot going on with trials...results will kick in soon.
Why would it drop after even a Prurisol sale of $200 million with promising brilacidin trials waiting in the wings.
Exactly, some folks out there actually get it!!!!
I agree with that, but interim analysis in addition could lead to a license or partnership deal...
Here is a license example :
CAMBRIDGE, Mass. & CARLSBAD, Calif.--(BUSINESS WIRE)--Biogen (NASDAQ:BIIB) and Ionis Pharmaceuticals (NASDAQ:IONS) today announced that nusinersen, their investigational treatment for spinal muscular atrophy (SMA), met the primary endpoint pre-specified for the interim analysis of ENDEAR, the Phase 3 trial evaluating nusinersen in infantile-onset (consistent with Type 1) SMA. The analysis found that infants receiving nusinersen experienced a statistically significant improvement in the achievement of motor milestones compared to those who did not receive treatment. Nusinersen demonstrated an acceptable safety profile in the trial. As a result of these findings, Biogen has exercised its option to develop and commercialize nusinersen globally and paid Ionis a $75 million license fee. Biogen will initiate regulatory filings globally in the coming months.
http://media.biogen.com/press-release/investor-relations/biogen-and-ionis-pharmaceuticals-report-nusinersen-meets-primary-en
I agree that Phase 2a was very encouraging at the 200mg level for moderate patients.
So do you think maybe 200 mg (or 150 mg) was the beginning of therapeutic benefit for efficacy with moderate patients?
If this drug eventually is to work well, then as a psoriasis type drug, it should have an efficacy window, with the outer parameters of that window not as efficacious as the inner area of the that window.
Where do you think this window of efficacy may be?
150mg - 450mg (hence 150 X3)
In your note about mild psoriasis harder to treat than moderate, does this mean 200mg in the 2A has shown only "less than lukewarm" results for mild patients in treating psoriasis?
If the 2B ends up showing 300mg results for moderate as >= 200mg results (2A for moderate), does this mean try at least 300mg for mild patients in a trial and in addition a higher dose than 300mg for mild patients?
Is the scenario possible at times that mild patients need a higher dosage than moderate patients to treat psoriasis?
The Prurisol 2A trial was for mild to moderate psoriasis.
Hence, the lower 50mg 100mg in addition to the 200mg.
Prurisol 2B trial is a moderate to severe psoriasis trial range, which most phase 2's for psoriasis finish up as.
Now we see if the start of efficacy was 200mg or maybe it was in between 150mg-200mg. Anyway they are going higher to 300mg and 400mg, because some promising efficacy was seen for moderate patients at the 200mg level.
This is a larger trial and time will tell. Interesting times ahead.
Thanks for this early catch - open label too :)
Yes, welcome. Don't know when they started. This poster was displayed January 3rd. Someone asked about the trial on January 15th thru facebook comments.
RunningGirl,
The South Bend site on Facebook shows an initial advertisement on timeline photos of January 3rd for the psoriasis trial.
https://www.facebook.com/SBCCenterforResearch/
You must click on the photo ad for the psoriasis trial to see the date.
Karin,
The time layout of the Prurisol 2B 6 week interim results will be interesting. Should they be released at week 10, perhaps this means at that point management has the unblinded patient case reports for 80+ % of the patients in this Prurisol 2B trial. And can make a fair deduction how its going compared to the Prurisol 2A. Maybe this also is the time when big pharma and biotechs named in any CDA and NDA agreements for Prurisol get a peek at 80+ % unblinded finality shown to them.
I agree, perhaps 18 BOM patients out of the 36 interim analysis patients will suffice. The trial has been blinded since the start. But the placebo was water.
CTIX (I believe) has added 2 new BOM sites in the past 3-4 months,and around this time they gave a milestone of BOM interim analysis being done probably 2Q 2017, which now appears likely early or mid 2Q.
Can anyone out there verify if I'm in the ballpark on my statements above.
Maybe they didn't want to add too many sites before waiting what the FDA says about how much more patient recruitment for Phase 2 after interim analysis is analyzed.
As to your question about efficacy, some folks here projected that ctix would proceed with the BUP trial based on what BOM anti-inflammatory properties were reading out in the trial. CTIX had finished at least 24 patients in the BOM trial, when the BUP trial proceeded. That's all I can say.
I'm interested in BOM results as well.
It is quite an unmet need and a significant health cost saver as a preventative if it shows it.
Maybe the lengthy BOM trial (of finding head and neck cancer patients) along with possibility of outstanding results, would move the FDA to shorten up the Phase 2 or finish it altogether and move on to a Phase 3.
We'll see if there BUP recruiting went thru the path of bringing on people who failed at other drug options.
How does Celgene's oral Otezla work to be approaching $1.5 BILLION in sales in its approval time of currently year 3? In its Phase 2B and Phase 3 (two trials) trials, it didn't come close to being in the territory of the biologics.
An interesting result in the BUP trial would be what other drugs the trial patients have taken in the past to remedy their Ulcerative Proctitis. And for a good majority of them, is Brilacidin the drug that performed quite better for them? Hope there is something communicative, relayed by patient survey outcomes identifying this.
RunningGirl, I hope your right. One mention though is there are quite more exclusion criteria in this trial than the 2A. That being said, they are using a top dermatology CRO this time for the 2B. The original clinical site count needed was 30, but ctix has only required 23/24. Maybe this has meaning toward a fast enrollment. For phase 2A, ctix finished a month ahead of schedule.
Let's hope your right on it being soon.
RunningGirl,
You mean psoriasis under Current Studies is no longer on the web page, but was there before.
Was this site one of the first eight sites for Prurisol (now 23 sites)??
Excellent work George. So this seems common for psoriasis trials. Thanks for giving The Truth and not The Street (AF is a manipulator).
Expand significantly on this if you will.
Sound reasonings / logic from you would be nice.
So do you believe if the company were sold today its worth $4 per share?
Or less than this?
No interest at all for any of their drugs?
PRESS RELEASES
EVENTS AND PRESENTATIONS
BLOG
EMAIL ALERTS
May 24, 2016
Cellceutix Phase 2 Trial of Prurisol for Mild to Moderate Psoriasis Meets Primary Endpoint
Prurisol
- Clinical efficacy demonstrated in the highest dose (200mg) comparator arm
- Compound shown to be safe and well-tolerated with a dose-related response
- Oral delivery often preferred among patients, increasing adherence to treatment
- Additional studies planned in moderate to severe psoriasis and eczema
George,
At the end of Prurisol 2A, they indicated as well looking at Prurisol for eczema along with Brilacidin as a topical for eczema.
Thanks, for the medical infos this weekend.
Shares of the company (NASDAQ:CELG) were still down slightly at midday.
As widely expected, the company released preliminary revenue and financial guidance, maintaining its 2020 revenue target of exceeding $21 billion.
Preliminary total product sales for 2016 are expected to reach nearly $11.2 billion, a 22 percent growth year over year. Sales of Revlimid (lenalidomide) totaled nearly $7 billion, a 20 percent jump over 2015 sales, while Pomalyst (pomalidomide) sales reached $1.3 billion, a 33 percent jump over last year. Sales of Abraxane (nab-paclitaxel) reached nearly $1 billion – $973 million – and sales of Otezla – despite being only in its second year on the market, noted CEO Mark Alles – topping $1 billion and growing by 116 percent over 2015 sales.
If Otezla took 20% of psoriasis market with 1.5 - 2 billion in 2017 sales at PASI 75 of 33% in 3 years,
IMO ctix has a fairly good negotiation position of auction type, if post phase 2 oral Prurisol results are superior to Otezla.
The partner chatter is cuz CTIX could have an otezla type drug (comparable to otezla) or an otezla+ type drug (superior to otezla),
possibly safer too.
We get an early interim peak in April about this possibility; final results in July.
Otezla may be doing 1.5 - 2 billion of sales in 2017 and 2018.
Worth the wait it seems!!
Handle RDunn88,
You seem to never mention the deals recently for other psoriasis drugs and which one of those series of deals ctix may be capable of duplicating.
Otezla for psoriasis is a billion dollar blockbuster and ctix results may well end up being superior or noninferior. Add more logic to your reasoning before completing your thoughts. Pay attention to the deals that have been done in the psoriasis arena and the fact that ctix could be only the 2nd effective, oral treatment if approved. If your so concerned, printout all your posts here for Leo and get the fat for us why Leo won't have a deal for Prurisol.
Back it up with substantial reasons.
Did CTIX receive initial verbal offer(s) after Prurisol Phase 2A, but are waiting on a Prurisol Phase 2B to strengthen(INCREASE THE VALUE OF THE OFFER) the offers in written form.
So partnering is not based on top quality of a drug and comparisons of what's out there already and what is sorely needed, just the cash is only consideration. Big companies are out to fulfill needs with promising drugs.
Look at the xenoport deal for psoriasis. They were shedding this asset.
Not nearly as effective in their phase 2 for psoriasis.
If Prurisol 2B is similar to 2A, some kind of deal can be done....Period...IMO. (whether buyout/license/partnership)
Your missing the big picture.
It seems like they are waiting the outcome of Prurisol 2B to see how to play their cards. It's possible to play partnerships on both B and P with the same Big Pharma.
You be our partner for P, and we'll seriously consider your favorable offers to partner B with us.
I would like to see a 40-50% royalty on both B and P. So if 3 years down the road, a second Big Pharma is interested in buyout, they will have to pay for ctix's 50% share on each of B and P when considering a buyout price.
ctix is not a one trick pony for deals.
3 patients a month, should have it done by 1st half of 2017.
I'm looking for BUP update by next week (IMO) and "more updates"
along the way at the 1/2 way point of each cohort and the finish of each cohort. (IMO)
Hmmmm who would be selling, LT shareholders know major trial results upcoming and holding. Must be the players again.
By mid February we'll be closely approaching results of OM, BUP, and Prurisol.
Anybody care to play short then??
That's great news Mike.
May God's best be found in you and keep you happy and loved in your life ahead.