Tired of making money for others.Doing it for myself now.
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Smokescreen??? Coming from YOU????? Give us all a break!!!!!
Find a cannabis stock and get some REAL SMOKE!!!
Kelt
Boy are you a cheap date ;)
Kelt
We share the same opinion.
I don't really enjoy reading posts by the "naysayers" but I do sometimes just to keep informed with what the "enemy" is up to.
I do appreciate your posts as well as the other reliable "reputable" posters (I think you know who they are)
I feel like this is an asylum run by the inmates so posts with sense and sanity are refreshing and welcomed.
Your DD is especially appreciated.
Thanks,Kelt
Isn't it so sad to watch (just about) the whole coven of criminals and their cronies so desperately trying to disparage IPIX and it's management in order to keep buyers away and try to cover their "shorts" cheaper.Meanwhile IPIX just keeps marching relentlessly forward to becoming the BLOCKBUSTER company it is destined to be (and very soon).As I said earlier,Leo could be at the table with BP right now working out a deal to his (and the shareholders) satisfaction.
I know he would love nothing more than to catch the manipulators and associated cronies flat-footed and unprepared for a massive gap up in SP.
As the Good Book says "and the blood was up to the horses bridals"
Looking forward to it!!!!!
Kelt
So many people focused on July 10th conference.What is not mentioned is that it takes time to gather the data and format it into a presentation.That said,data has to be in hand very soon if not now to prepare.Now will BP CDA holders be in the dark also until July 10? I think not.They probably already have the data or will have it within days.Leo could already be at the bargaining table working out a partnership deal as we speak.(Leo despises the manipulators as much if not more than many of us do)
Wouldn't it be poetic justice to see a partnership PR on Friday,July 7th after the close or on Monday,the 10th after the close when nobody expects it?
Wouldn't that mess up a lot of shorts?
Sweet revenge.Best served cold.
Kelt
As I said,I don't drink Jack.Maybe you should because everything you say IS JACK.
Kelt
No,Leo didn't bring this on himself,,,you and your shitheads did.Now he will have to dig out by dropping a nuke on you when you least expect it.IT WILL HAPPEN.(I have my sources too)
KELT
No , Leo takes his orders from Dr.B now.Or don't you understand how corporations are set up and operate. , You AH.
KELT
And that doesn't begin to count naked short shares ;)
Kelt
Wait until we start saying "Here comes the $20's,Here come the $40's etc.,etc.,etc.
I'll push the rock back over the hole for some here when the above
happens. :) :) :)
Kelt
Nothing getting "pounded" on such a low volume day so far.
Kelt
1/2 hour in and only 14.6K shares traded.
Buyers waiting for the "bottom" among other things
and sellers don't want to sell at these ridiculous low
prices.
That leaves penny traders and manipulators as the trading
"cast of characters" today.
As is usual on low volume days.
Kelt
Bullshit.
Kelt
I have not heard from Lisa in several years.I've just been keeping my nose to the grind stone and have managed to wait out the storm with CTIX's short attacks.
Increased my position a bit and looking forward to the remainder of this year and 2018.
It should be a wild ride.
I hope you are able to rebuild your position before the SP starts to accelerate into the summer.
Kelt
Great to hear from you,Pete!!!
Hope all is well with you and your's.
Kelt
Same here.But now we can see some light at the end of this tunnel and look forward to great times ahead.I learned a lot over the years here and in the
end,it was worth it.
Looking forward to an exciting 2017/2018 !!!!!
Kelt
Yes,I agree.Irritating but not worried.
As it is written,"For the love of mammon is the root of all evil".
That is on full display in the market daily,especially with the manipulation of companies like CTIX.
Just glad we have the science and management to overcome the gauntlet of
attacks that we have endured.
Hope all is well.
Kelt
bout time
kelt
The higher dose for humans in this trial is most likely derived from (extrapolated from) the doses used in the animal trials.(mg/kg or body mass)
That's my guess and I'm sticking to it ;)
Kelt
From the news letter
"Cellceutix Corp. (CTIX) For those who missed it, in an alert last week, Patrick covered CTIX’s abundance of positive data that sent shares up 15%. Therefore, we will stick to the company’s earnings and financial position in this update. The pre-revenue company reported a net loss of $3.0 million, up from $2.6 million the same time last year. The additional net loss is a result of higher operating and research & development costs, a common condition for an early-stage company. The company’s balance sheet showed a total cash position of $5.5 million, which is down from the second quarter. At the current burn rate, CTIX has enough cash on hand to fund operations for two more quarters. However, since the company has delivered positive data on all three of its therapeutic platforms, we don’t believe securing additional funding will be difficult."
Kelt
The "Cox bounce effect",perhaps?? :)
Kelt
For your reading enjoyment...Pat Cox's write-up.
Kelt
November 17, 2016
Positive Cellceutix Data for All Three Programs and a Legal Triumph
Dear TransTech Reader,
Earlier this week, Cellceutix Corporation (CTIX) presented extremely positive data for all three of its therapeutic platforms. Before talking about the company’s regulatory progress, however, I want to discuss the company’s recent legal victory.
Periodically, I need to explain to readers that the online financial media is a cesspool of misinformation and corruption. The short attack industry utilizes these online forums to manipulate naïve and uninformed traders.
Though I have responded to a few of these scurrilous attacks on biotechs in our portfolio, I try not to. It’s simply too time consuming. Moreover, the companies under attack always refute these attacks themselves. You should understand, by the way, that anything a company publishes is scrutinized by the SEC and FDA. Columnists writing on financial websites, however, have no such oversight and rarely suffer any consequence for slandering their targets.
Personally, I don’t read any of the popular online stock sites because they are so unreliable. The most charitable characterization of these sites is that they give platforms to organized campaigns designed to drive down the stock prices of target companies, generating enormous profits for the well-funded shorters. Some people believe, however, that the websites are participants themselves.
Not being privy to their internal workings, I don’t know what motivates these sites. I wish that WikiLeaks would turn its attention to their activities, but it doesn’t actually matter why they do what they do. The harm they enable is real, whether or not they are directly profiting.
Let me describe a typical short attack on a startup biotech. Some prominent website will feature an article attacking a biotech company. Commenters in forums will pile on with supposedly reinforcing information. Often, other sites will publish similar and apparently coordinated articles attacking the same company.
As a writer, I’m often impressed by the skill of those who pen these attacks. I know good writing, even when it’s employed in the cause of evil, and these people are good. Even educated and skeptical people often fall for these scams.
Following the first wave of disinformation, we often see announcements from law firms in these same publications asking other investors in the target company to join in a class action lawsuit. Even if the ads fail to turn up additional litigants, they accomplish their primary purpose which is to sow fear, uncertainty, and doubt in the minds of investors. When the easily swayed start dumping their stock, the price goes down and the short attackers follow up with additional articles and comments claiming success in foreseeing the company’s decline. This may panic other investors and contribute to a downturn in the company’s capitalization.
The targeted companies and their stockholders may suffer if the reduction in stock price increases the cost of raising further capital. This is true even if the stock price recovers, which is usually the case.
El jefe John Mauldin is one of the primary advocates for legal reform in this area and he writes regularly about it. There’s been some movement toward such reform in recent years as the number of victims mount. Progress, however, has been slow. It may be wishful thinking on my part, but we may have a shot at real change now. President-elect Trump is probably the first president elected with the financial experience and expertise to understand the short attack industry and the harm it does.
Regardless, the website Seeking Alpha published an attack on Cellceutix in August 2015 filled with false statements. Cellceutix immediately issued a letter answering the charges, including the ridiculous claim that Cellceutix was a sham company operating out of an empty office. Given the company’s easily verified affiliations with well-known research institutions and scientists, I find it amazing that anybody could be fooled.
The company’s office, by the way, is located in the enormous Cummings Center of Beverly, Massachusetts. Any serious publication would have sent somebody to the address listed on the Cellceutix website and discredited the entire article. Nobody involved in publishing the article, however, demonstrated any interest in the truth.
Nevertheless, a class action lawsuit was quickly filed by a law firm known for handling similar cases. The obligatory ads looking for other shareholders to join the lawsuit followed.
Typically, in these cases, the targeted company wins the lawsuit and moves on, hoping to recover their lost good will and share price. I’ve talked to multiple CEOs while they endured this sort of attack. Every one of them had been initially furious, promising to track down the attackers and put the hosting websites out of business. As time passed, however, they chose to cut their losses and move on.
Cellceutix didn’t follow that pattern. CEO Leo Ehrlich hired The Ashcroft Law Firm, founded by former US Attorney General, Governor, and Senator John Ashcroft. The lead counsel was Michael J. Sullivan, former US Attorney for Massachusetts.
Sullivan moved for dismissal with a “Motion to Dismiss”, which requires meeting the most difficult legal standard for a defense. To grant a Motion to Dismiss, a judge must accept everything the defendant presents as true and the company needs to defend itself with limited defenses such as showing that the case is legally invalid. Dismissal was granted and the plaintiff’s request to replead was denied.
Most other targeted companies in these circumstances would have gladly accepted the outcome and returned to business. The Cellceutix team and Ashcroft Law, however, decided to go after all damages and costs, which are sizable. Now, the shoe is on the other foot and the plaintiff and the law firm behind the frivolous suit against Cellceutix are contemplating serious pain.
Ultimately, we might even see the anonymous author and the publishing website exposed. Ironically, the anonymous author of the attack on Cellceutix followed up by attacking Ocata Therapeutics. He scared some investors into selling, predicting Ocata’s value would go down to zero, shortly before the company was acquired by Astellas Pharma for $379 million.
The Cellceutix lawsuit accomplished two things that we should care about. One, it made it clear that there are risks involved in launching frivolous lawsuits against Cellceutix. Secondly, it sent a message to the entire short attack community.
If the judge rules in favor of Cellceutix for damages and cost, frivolous lawsuits will no longer be a cheap, convenient way to move a target company’s stock price downward. There does, in fact, seem to be a significant drop in the number of lawsuits filed on behalf of short attackers. I believe all biotechs owe thanks to Leo Ehrlich and Cellceutix. If you’d like to read the details of this story, the relevant documents are here on the company website.
Other Cellceutix Progress
Cellceutix has recently brought three pharma industry veterans into the company management team to help with the accelerating clinical trial programs. Most notable is Arthur P. Bertolino, MD, PhD, MBA who now serves as President and Chief Medical Officer. Bertolino previously held positions at Novartis Institutes for Biomedical Research (NIBR), including Vice President of Dermatology and Vice President & Global Head of Translational Medicine for Dermatology. There, he played a major role in the approval of Ilaris (canakinumab) in the United States, European Union, and Switzerland. He also held positions as Senior Medical Director and Senior Director of Dermatology at Pfizer, Inc. where he led clinical programs for various drug candidates.
The Q1 Fiscal 2017 conference call held earlier this week will give you a comprehensive overview of the company’s programs and progress. In fact, I’m not inclined to paraphrase the whole call here because you can easily watch the entire professionally prepared program in less than an hour.
If you’re already an investor, you’ve probably seen it. If you’re not, I recommend watching the video, which includes the presentation PowerPoint. It’s embedded on the company website’s event page or it can be accessed on YouTube.
I will, however, point out that the Trump election seems to be very good for biotech. At the very least, Hillary Clinton’s “war on pharma” isn’t going to happen. Polls indicate that the public is suspicious of profit-killing drug pricing rules. The best evidence comes from liberal California’s rejection of Prop. 61, which would have implemented state drug price controls. Major reform or elimination of the Affordable Care Act is also good for biotech.
Trump has been saying the right things about deregulation and FDA reform, so it’s not surprising to see a hot acquisitions market. With three platforms in clinical trials, Cellceutix is well positioned to benefit from the current environment.
Though the company’s psoriasis drug has produced impressive clinical data, I remain most excited about the antibiotic program. For legal reasons, the company isn’t calling Brilacidin a solution to antibiotic resistant bacteria. Nevertheless, that’s what it is.
The drug utilizes a biomimetic version of defensins, the host defense peptides that effectively kill bacteria, fungi, and many types of viruses. They naturally protect vertebrates, invertebrates, and even plants from infection. Microbial pathogens have never evolved resistances to defensins because these immune system peptides mechanically puncture the cell membranes of their targets. If bacteria evolved cell membranes that couldn’t be punctured, they would no longer function as bacteria. The potential applications are enormous with multiple potential blockbusters.
For transformational profits,
Patrick Cox
What catalysts are you looking for this year or next?
Kelt
Thank you Daubs for that post!
I only read a handful of posters here now and you are the top of my list!
I'll send you my email Friday as I think we've connected before (maybe facebook?)
I agree with you that there is a lot going on behind the scenes at CTIX and I sense that the end of 2016 won't be as "dull" as some here are expecting.
Again Thanks!
Kelt
Remember what happened when you were a kid in class and the teacher
stepped out of the classroom for a few minutes :0
That's what it's like here when there's no news after a week ;/
Kelt
You're assuming a capability exists to exercise a "thought process" when most likely the next "thought" could very well be a "first".
CTIX will advance no matter what the "bottom feeders" say or do at this point.
Kelt
Per Leo.
Hi,
From the CV...
MASTER OF SCIENCE, CLINICAL PHARMACOLOGY: University of Aberdeen, Scotland, 1992; received Medical
Research Council Award
MASTER OF PHILOSOPHY, PROTEIN BIOCHEMISTRY: University of Leicester, England, 1991
BACHELOR OF SCIENCE (HONORS), BIOLOGICAL CHEMISTRY: University of Leicester, England, 1990
Best wishes,
Leo Ehrlich | CEO |
cellceutix
100 Cummings Center, Suite 151-B, Beverly, MA 01915
Leo@cellceutix.com
www.cellceutix.com
Confidentiality Note:
This message is intended only for the use of the named recipient(s) and may contain confidential and/or privileged information. If you are not the intended recipient, please contact the sender and delete this message. Any unauthorized use of the information contained in this message is prohibited.
On Wed, Aug 3
Hi Leo,I know you must be very busy but can you clarify Jane's title of MP for me?
Is that a Masters of some kind?
Thanks,Jim
P.S.Have a great Labor Day Weekend!!
Thanks Karin,very interesting .If you can,keep me in the loop!
Kelt
Nothing is impervious.
If Sullivan,with his connections and contacts wants the name(s) of the author of the SA article,Mako,et al.He will get them (If he hasn't already).
If he has,now isn't the time to disclose that info or to use it as yet.
Those days are coming and it will catch a lot of crooks by surprise.
Kelt
From where? The "Sales Dept.?
Kelt
Were you there when he said that? (I rather doubt it) So stop treating fiction as fact and use verifiable sources to back your statements.
Kelt (Have a "nice" day)
Figure it out.It is pretty obvious.
(Geesh)
Kelt
Good catch!!!
Kelt
Cellceutix Receives Update on First Patient Enrolled in Phase 2 Proof-of-Concept Study of Brilacidin for Ulcerative Proctitis
Company Encouraged by Investigator Report of Significant Decrease in Symptoms in First Patient in One Week
BEVERLY, MA--(Marketwired - July 18, 2016) - Cellceutix Corporation, (OTCQB: CTIX) ("the Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, antibiotic, and anti-inflammatory applications, is pleased to provide additional information in the ongoing, open-label Phase 2 Proof-of-Concept (P-o-C) trial of Brilacidin for the treatment of ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS). Brilacidin is being evaluated in adults with active, mild to moderate UP or UPS present for at least three months prior to screening with disease extending at least five centimeters, but no further than 40 centimeters from the anal verge, as confirmed by sigmoidoscopic examination.
Cellceutix has been advised that the first patient in Cohort A remains on study. The clinical site administering Brilacidin to this patient has informed the Company, "Both the patient and the site staff have been amazed how the study drug works as all the symptoms decreased significantly within the 1st week of treatment."
While impressed and optimistic about the initial feedback, Cellceutix needs to strongly caution that this is limited feedback from only the first patient in the trial and the initial results may not be durable for the patient or indicative of future outcomes in the study.
"The trial being structured as an open-label study lets us know with certainty that Brilacidin was administered to the patient and not a placebo," commented Dr. Arthur P. Bertolino, President and Chief Medical Officer at Cellceutix. "It's still very early in the study, but this is the type of investigator feedback that is encouraging to hear. While by no means guaranteeing future results, it lends validation to laboratory research that suggested Brilacidin could provide a clinically meaningful therapeutic benefit for patients with UP, UPS and other inflammatory diseases and conditions. We are hopeful that the initial data will translate to durable and repeated results throughout the first cohort and subjects at higher dosing levels to align us for larger trials in the future."
Cellceutix considers this early study information important as the Company has made a significant investment in studying the anti-inflammatory and immunomodulatory properties of Brilacidin for several different indications. Due to the pathogenesis of UP and UPS, Cellceutix views this data as strongly encouraging evidence of the anti-inflammatory and immunomodulatory properties of Brilacidin in the clinical setting. The data are pertinent with respect to not only inflammatory bowel conditions, but also to the ongoing, double-blind Phase 2 trial of Brilacidin-OM, where the combination of these properties is expected to deliver a clinical benefit to prevent and treat oral mucositis in patients receiving chemoradiation for head and neck cancer.
UP/UPS Trial Design
The primary objective of the P-o-C trial is to assess the frequency of clinical and endoscopic remission with Brilacidin administered per rectum in subjects with active UP or UPS after 6 weeks of treatment. Secondary objectives include evaluation of safety and tolerability of Brilacidin when administered per rectum, evaluation of clinical remission at Week 2 and Week 4, assessment of systemic exposure and/or pharmacokinetics of Brilacidin when administered per rectum, assessment of the efficiency of Brilacidin by biomarker evaluation of biopsy samples for interleukin (IL)-6 and IL-1beta, and estimation of statistical power for subsequent trial(s) in UP and UPS.
The P-o-C trial will include 18 patients divided evenly into three cohorts. Cohort A is receiving 50 milligrams (mg) of Brilacidin once daily for 42 days. Dosing will be increased to 100mg and 200mg once daily for 42 days for Cohort B and Cohort C, respectively. Endoscopic evaluation of the rectum and mucosa up to 40 cm from the anal verge will be performed at screening and at the end of treatment/Day 42 (+/- 3 days). Per protocol, a safety committee will review safety and retention data (clinical laboratory findings, vital signs and adverse events) after 21 days of therapy for all six patients in each cohort before proceeding with initiating enrollment in the subsequent cohort.
Alerts:
Sign-up for Cellceutix email alerts is available at
http://cellceutix.com/email-alerts/ - sthash.CRfqSmmY.k6MzKBo8.dpbs
About Cellceutix: Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol "CTIX". Cellceutix is a clinical stage biopharmaceutical company developing innovative therapies in multiple diseases. Cellceutix believes it has a world-class portfolio of compounds and is now engaged in advancing its compounds and seeking strategic partnerships. Cellceutix's anti-cancer drug Kevetrin concluded a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, and Cellceutix is now preparing its application for a Phase 2 study. In the laboratory Kevetrin has shown to induce activation of p53, often referred to as the "Guardian Angel Gene" due to its crucial role in controlling cell mutations. Cellceutix is in a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention of Oral Mucositis in patients with head and neck cancer. Brilacidin-OM, a defensin mimetic compound, has shown in an animal model to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix's anti-psoriasis drug Prurisol completed a Phase 2 trial and is now setting up a Phase 2b study. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Top-line data have shown a single dose of Brilacidin to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy for certain multi-drug resistant bacteria (Superbugs). Cellceutix has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. More information is available on the Cellceutix web site at www.cellceutix.com.
Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause Cellceutix's actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. Cellceutix has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are Cellceutix's need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that Cellceutix's compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in Cellceutix's filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Cellceutix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
INVESTOR AND MEDIA CONTACT:
Cellceutix Corporation
Leo Ehrlich
info@cellceutix.com
(MORE TO FOLLOW) Dow Jones Newswires
July 18, 2016 10:00 ET (14:00 GMT)
You want us back?
Back us up when we go after the bastards.
Kelt
Cellceutix Phase 2 Trial of Prurisol for Mild to Moderate Psoriasis Meets Primary Endpoint
Last update: 24/05/2016 10:00:00 am
Cellceutix Phase 2 Trial of Prurisol for Mild to Moderate Psoriasis Meets Primary Endpoint
BEVERLY, MA--(Marketwired - May 24, 2016) -
-- 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
Cellceutix Corporation (OTC: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, antibiotic, and anti-inflammatory applications, is pleased to inform shareholders that topline data from the Company's Phase 2 FDA trial of orally-administered Prurisol in the treatment of mild to moderate chronic plaque psoriasis have been compiled and reviewed. The trial successfully achieved its primary endpoint, further validating Prurisol's potential as a novel oral treatment for psoriasis.
Study Background
Enrolling 115 patients, the placebo-controlled, randomized, double-blind trial tested the efficacy and safety of three separate, twice-daily, dosing regimens of Prurisol-50 milligram (mg) (50mg QD), 100mg (50mg BD), and 200mg (100mg BD). All patients were assessed via the 5-point Investigator's Global Assessment (IGA) scale, ranging from a score of 0 ("clear") to a score of 4 ("severe"). The IGA scale is preferred by the U.S. Food and Drug Administration (FDA) and is comparable to the older and more commonly used Psoriasis Area and Severity Index (PASI) in evaluating psoriasis severity of patients, with many dermatologists preferring it in the clinical trial setting. Generally, an IGA score of 0/1 demonstrates a strong association with a PASI 90 score.
For more information comparing the IGA and the PASI psoriasis scoring systems, please see the link immediately below. Two additional links have been provided summarizing recent dermatological studies by Regeneron and Anacor that used the IGA scale.
-- http://www.ncbi.nlm.nih.gov/pubmed/24354461
-- http://newsroom.regeneron.com/releasedetail.cfm?ReleaseID=963078
-- http://investor.anacor.com/releasedetail.cfm?releaseid=921668
Entry criteria for the study required: a total Body Surface Area (BSA) affected by plaque psoriasis of 10 percent to 20 percent; a baseline IGA score of 2 ("mild") or 3 ("moderate"); and the identification of a target psoriatic lesion with a score greater than or equal to 3 based on a different (than the IGA) lesion-specific 5-point scoring scale. Clinical signs that psoriasis is clearing typically are more noticeable in patients with a greater severity of symptoms. This translated into a rigorous and aggressive study design for the Prurisol trial.
The primary endpoint assessed was the percentage of patients achieving at least a 2-point improvement from baseline on the IGA 5-point scale as measured by visual inspection of patient lesions at the end of the 84-day (12-week) treatment period. In effect, given the entry criteria, participants had to at least obtain an IGA score of "clear" or "almost clear" skin, dropping to 0 or 1 after starting from a baseline of 2 or 3. Secondary endpoints included additional improvement measures tied to degree of patient response at various time intervals.
Results Summary
The Phase 2 Prurisol trial, while not powered to demonstrate statistical significance, was conducted to inform any future fully-powered Phase 3 trial(s) that might be merited. As a result, the study's main goal was to provide indications of efficacy, safety and tolerability upon treating patients with mild to moderate plaque psoriasis via oral delivery.
Overall analyses showed Prurisol, which is being developed under the FDA's 505(b)(2) program, to be superior to placebo in the 200mg arm. Pharmacokinetics/Pharmacodynamics (PK/PD) further revealed an early (by week 8) dose-related response that improved as treatment duration increased.
Evaluating the primary endpoint at 84-days (week 12) in the 200mg arm, 35.0% of the patients receiving that dose of Prurisol demonstrated clinically significant improvements compared with 16.7% of patients on placebo only. This percentage includes patient data from one site where investigator non-compliance may have occurred. Were that site to have been excluded from overall data analysis, as is done in some clinical studies (refer to the journal article linked to below, published findings from another psoriasis study), 43.7% of patients in the 200mg Prurisol arm would have met the primary endpoint. Patient responses in the 50mg and 100mg arms were statistically comparable to the placebo arm.
-- http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4229025/
For purposes of direct comparison, the Prurisol trial outperformed a similarly designed Phase 2b trial in the treatment of mild to moderate psoriasis conducted in 2011 by Anacor Pharmaceuticals in which a topical anti-inflammatory compound was assessed. See the link below.
-- http://investor.anacor.com/releasedetail.cfm?releaseid=587511
Sub-population analyses further showed greater efficacy demonstrated in patients who had a baseline IGA score of 3 ("moderate") as compared to those with a baseline score of 2 ("mild"). Some of these patients even experienced a 3-point reduction in their IGA score, going from "moderate" to "clear." This suggests Prurisol may be more effective in treating moderate to severe psoriasis patients to a greater degree than those patients who exhibit less severe symptoms. In moderate to severe psoriasis studies, the placebo response also tends to be lower.
Regarding Prurisol's safety profile, only a single Serious Adverse Event (SAE) was reported in the study, that being in the 50mg arm, with the type and the rate of occurrence of additional Adverse Events (AEs) similar and evenly distributed across all the three dosing arms and the placebo arm.
Additional detailed data review and analysis is underway and an end-of-Phase 2 meeting with the FDA will be requested to help determine the dose(s) and design for future studies, which may include higher dosing regimens to determine Prurisol's maximum therapeutic effect. The Company plans to release other summary findings from this trial in the coming months, with full results anticipated to be submitted for journal publication and presentation at a future medical congress.
Investigator Comments
Cellceutix would also like to share some observations and comments from Principle Investigators (PIs) overseeing different participating clinical sites in the trial. Numerous PIs noted patients expressed a desire to have access to Prurisol following the study's conclusion. Moreover, the Company learned that some patients were previously unsuccessfully treated with other therapies, including biologics and apremilast (Otezla(R)).
Included below is a sampling of responses that were authorized to be published:
-- "Well designed study, patients were pleased, minimal to no side effects."
-- "Good tolerability was shown with very few AEs reported. Good compliance
and good patient satisfaction."
-- "Overall impression of the study is very positive, as well as the
patients' satisfaction."
When asked, "Why would you choose Prurisol (should it be approved) over another oral compound for psoriasis?" and "Why would you choose Prurisol over an injectable biologic?" responses included:
-- "Because [Prurisol] does not cause any severe side effects. Patients
dislike needles and injections because they cause pain and discomfort."
-- "Patients overall prefer oral medications over injectable medication. Our
experience with injectable studies for other indications has been that
many subjects do not like taking them and those studies tend to be
difficult compared to oral medications to recruit subjects."
-- "Because of [Prurisol's] low side effect profile."
-- "Patients prefer oral treatments."
Sponsor Comments
Cellceutix believes that the results from the Prurisol Phase 2 trial are extremely encouraging, especially for the 80 percent of psoriasis sufferers exhibiting milder symptoms of the condition. These people are more likely to switch between therapies or be off treatment altogether. Planning is underway to explore Prurisol's potential in the treatment of moderate to severe psoriasis and eczema, a skin condition experienced by up to 30 percent of children and 10 percent of adults. The Company is hopeful Prurisol may one day become a leading treatment for psoriasis regardless of disease severity.
Leo Ehrlich, Chief Executive Officer of Cellceutix, commented: "We had always wanted to explore Prurisol's clinical merit, as it had excellent results in laboratory studies. We put it to the test under some of the most demanding conditions, with respect to the IGA versus PASI scoring systems; short treatment duration; low dosing levels; enrollment that included patients who were previously treated with biologics; and evaluation in mild to moderate psoriasis patients, where it can be more difficult to achieve a meaningful therapeutic effect. To see such a strong response among patients, achieving clear to almost clear skin without serious side effects -- the downside of biologics -- in such a short period of time, is exceptional. We would like to thank patients and investigators who participated in the study. Prurisol has taken a key step towards potentially becoming only the second oral treatment approved by the FDA for psoriasis in decades."
Leo Ehrlich continued: "More broadly, these outstanding results are the first of what we hope are more to come as the Cellceutix pipeline continues to progress. With our three lead drugs, Prurisol, Brilacidin, and Kevetrin, now in later-stage FDA trials, each a possible first-in-class treatment, we are thrilled with what the future holds."
About Psoriasis
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May 24, 2016 10:00 ET (14:00 GMT)
That is plausible but also the "worst case scenario" if things get stretched to the n'th degree.
Kelt
You have my agreement on that!!!!!
Kelt
Interesting you say that.If they impact anything it's increased buying by individuals.Maybe not enough to move the price up much but enough to help support or stabilize the SP.The more "they" show up,the more the "astute" investor sees it as a strong "Buy" signal.
That being said,"their" efforts become counter productive.
Kelt
Depends on whether you're referring to the folks listening to the inane comments or the folks making the inane comments ;)
Kelt