I don't think anyone has any real clue what Leo and company are really shooting for and what they expect to accomplish over the next year or two or three.

Keep pushing things out 5 or 10 more years if that excites you.Hopefully for you others will get discouraged by that BS and sell off and fatten your
wallets a little.

That attitude is FOS.

Dr.Menon is not a 35 yr old with all kinds of time to play around.

He wants progress and success a lot sooner than "traders" expect.

And,no,I'm not going to argue with any "eggheads" who want to "dialogue" over it.

Kelt

Thanks Sox. Good comparison .

Kelt

See my post 145282

That PR as well as most others show up in my TD news feed before they get posted by the wire services.

Kelt

It showed up on my TD Ameritrade streamer news feed.(Quite often news shows up there before the wire services posts them)

Kelt

See my last post # 145287


Kelt

Guidelines for Hard-Locking a Clinical Research Database
May 27, 2010 Clinical Research Education
For every clinical research study, there is a beginning, several interim milestones and a definite endpoint. For the clinical research database, the initial milestone is normally finalization of the study protocol. While interim milestones vary by study, phase, indication, endpoint and sponsor; common interim milestones include the following: safety analysis of cohort data in dose escalation studies; interim analysis based on milestones defined in the Clinical Study Report (i.e.: 50% of subject data received or with an endpoint of survival, 50% of study subjects deceased); testing of programming code for the development of draft tables, figures and listings.

The final milestones relate to database closure and are termed ‘database soft lock’ or ‘database freeze’ and ‘database hard lock’. The distinction between these terms is as follows:

Database soft lock also known as database freeze is a milestone defined in the Statistical Analysis Report and is most commonly defined as the point where all case report form data has been input into the database and all known queries are resolved. When soft lock is declared, the edit rights of all data entry and data management personnel are rescinded so that only the Lead Data Manager has the ability to modify the database.

At this point, the QA department will review a random sample of the study data in order to assure that the data is clean enough for analysis and to define the exact error rate. The sample size reviewed by QA is based on the square root of the total number of records. So, for instance, given a database with approximately 950,000 records, 974 of those records will be printed out on a listing for QA to review against the original CRFs. These records are generated using a random seed so that if the listing at some point needs to be regenerated, the seed allows the team to do so. The FDA standard for an acceptable error rate is = .05% or = 1 error every 2000 fields. Once the database passes QA, a QA certificate is generated documenting the actual error rate and hard lock can then be declared.

Once hard lock is declared, all edit rights, including those of the Lead Data Manager, are rescinded from the team. At this point final tables, figures and listings can be generated. Also, if the clinical study was blinded, the statisticians can now generate programs to unblind the data. Unblinding does not take place prior to hard lock in order to minimize the potential for bias.

Once hard lock is declared, the database is considered final and should never be unlocked. Of course there are exceptions to every rule. On rare occasion, even after all queries generated by the clinical and data team have been resolved, a statistical programmer, a statistician or a medical writer on the team will notice an inconsistency in a data value. If the inconsistency is associated with a critical data field, the database may need to be unlocked.

A likely reason for unlocking the database is identification of a difference in the regulatory and clinical databases associated with a serious adverse event. Oftentimes, the reconciliation between these 2 databases is not finalized until the very end of the study. Also, if subjects develop SAEs near study end, they need to be followed for 30 days beyond their official ‘final date on study’ OR until the SAE is resolved OR until the subject begins treatment with another medicinal product. Also, should a female subject or the spouse of a male subject being treated on a clinical trial becomes pregnant, the pregnancy is followed until birth, in order to identify potential SAEs. In this case, data could stream in well after all of the previous data have been received and analyzed; and if an SAE is identified, it should be incorporated into the final tables, figures and listings.

The process for unlocking a ‘final’ database must be pre-defined in the study project plan and must be supported by the sponsor’s relevant SOPS. Also, when the erroneous data is changed, an audit trail will document what data field was changed, who changed it, when it was changed and why it was changed. The database is then re-locked following the same process as noted previous for the first hard lock and generation of final Tables Figures and Listings and the Clinical Study Report are then completed.

For changes to less critical fields, unlocking a ‘final’ database is not warranted. In this case, a memo is generated to the team, and incorporation of the relevant database change can be handled programmatically, with proper documentation.

Erin P. Johnson is a Clinical Research Consultant with 22 years industry experience including data management, quality assurance, field monitoring and project management and all phases of clinical research. She is currently a Clinical Consultant at Supergen, and also teaches Clinical and Data Management topics in the Clinical Research Education and Training Online (CREAT-e) Certificate program offered by California State University, East Bay and ClinfoSource.

Cellceutix Institutes "Database Soft Lock" on Its Phase 2 Psoriasis Clinical Trial, Top Line Results Anticipated in May; Additional Company Updates

Last update: 19/04/2016 10:30:00 am


Cellceutix Institutes "Database Soft Lock" on Its Phase 2 Psoriasis Clinical Trial, Top Line Results Anticipated in May; Additional Company Updates

BEVERLY, MA--(Marketwired - April 19, 2016) - Cellceutix Corporation (OTC: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to inform shareholders that the clinical database for Prurisol's Phase 2 FDA trial for mild-to-moderate chronic plaque psoriasis has instituted a "Database Soft Lock."

Also referred to as a "database freeze," this step in the regulatory process means all case information has been compiled and put into the database and all known queries have been resolved. Next, the Quality Assurance staff will review all the data points to ensure statistical accuracy in preparation of the dataset's final analysis and confirm that all data points, including PK data, are in-line with the Statistical Analysis Plan.

Additionally, the Company would like to provide the following updates:

FDA Feedback Received for Phase 3 Trial of Brilacidin-ABSSSI

Cellceutix has received a response from the U.S. Food and Drug Administration ("FDA") regarding the Company's Special Protocol Assessment ("SPA") for its Phase 3 Trial of single-dose Brilacidin for the treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI). The FDA reviewed the Company's SPA submission and has requested certain changes be made to the protocol, as is typical procedure (see 'About SPA Agreements' below). Cellceutix will be scheduling a meeting with the FDA to discuss the proposed protocol changes toward finalizing the agreement. Meanwhile, the Company is moving ahead in matters of clinical supply procurement and study sites selection.

About SPA Agreements

Obtaining Special Protocol Assessment (SPA) designation from the FDA is an important step as it reinforces the potential of a promising drug in clinical development. The SPA agreement delineates key statistical and clinical endpoint requirements, streamlining the process toward a product gaining FDA approval should the agreed upon criteria and outcomes be met. The SPA process itself can be iterative in nature. In fact, according to industry data, 78 percent of SPAs require multiple review cycles and an average of three months to finalize the SPA. For more information about the FDA's SPA program, please visit: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080571.pdf.

"We are extremely proud of Brilacidin as it represents the first potential new class of antibiotics to treat serious skin infections in some twenty plus years and very much look forward to the start of the Phase 3 ABSSSI trial as soon as our SPA discussions with the FDA conclude," stated Leo Ehrlich, Chief Executive Officer of Cellceutix. "There is a huge unmet medical need, worldwide, for newer and better antibiotics, with the market likely to gravitate toward single-dose drugs like Brilacidin. Commonly praised by clinicians once introduced to it, Brilacidin is positioned to help fill this void, and in the process, further unlock shareholder value. In addition, we see the ABSSSI clinical trials as a gateway for Brilacidin's use in bacterial biofilm infections and its use in the treatment of diabetic foot infections."

Clinical Advisory Board Addition

Dr. Frances A. Farraye MD, MSc, has joined the Cellceutix Clinical Advisory Board. Dr. Farraye is Clinical Director in the Section of Gastroenterology and Co-Director of the Center for Digestive Disorders at Boston Medical Center. He is also Professor of Medicine at the Boston University School of Medicine. Prior to accepting the position, Dr. Farraye consulted with Cellceutix to help design the protocol for its planned Phase 2 ulcerative proctitis clinical trial. Commented CEO Leo Ehrlich, "We are thrilled to have Dr. Farraye formally join the Celleutix team. His expertise and leadership has been clearly demonstrated throughout his stellar career. Dr. Farraye's experience and knowledge will help us explore Brilacidin's potential in treating other gastroenterological conditions. Brilacidin continues to impress us as we explore its application in numerous clinical areas."

About Dr. Francis A. Farraye, M.D., MSc.

Francis A. Farraye, M.D., MSc, Professor of Medicine, Clinical Director, Section of Gastroenterology and Co-Director, Center for Digestive Disorders, Boston University School of Medicine

Dr. Farraye is a Fellow of the American College of Physicians, American Society of Gastrointestinal Endoscopy, American Gastroenterological Association and the American College of Gastroenterology. He has published over 350 original manuscripts, abstracts and book chapters. He has served on numerous national and international committees including as a member of the ACG Board of Trustees. The New England CCFA named Dr. Farraye Humanitarian of the Year in 2003. In 2009, the ACG awarded Dr. Farraye the William Carey Award for service to the college. Dr. Farraye has been recognized as "Top Doctor" in Gastroenterology by Boston Magazine and U.S. News and World Report since 2010. His newest books for clinicians are Gastrointestinal Emergencies and Curbside Consultations in Inflammatory Bowel Disease and for patients Questions and Answers about Ulcerative Colitis, Questions and Answers about Crohn's Disease and Ulcerative Colitis for Dummies.

Cellceutix clinical trials on Clinicaltrials.gov:

https://clinicaltrials.gov/ct2/results?term=cellceutix&Search=Search

About Brilacidin

Brilacidin is the first of a completely new class of antibiotics called defensin-mimetics. Modeled after the body's innate host-defense response, Brilacidin kills bacteria quickly and efficiently, penetrating bacterial cell wall membranes. Given this mechanism-of-action, resistance is much less likely to develop. Beyond its robust antimicrobial properties, Brilacidin also functions in an immunomodulatory capacity, lessening inflammation and promoting healing.

Alerts:

Sign-up for Cellceutix email alerts is available at http://cellceutix.com/email-alerts/#sthash.CRfqSmmY.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 FDA application for a Phase 2 ovarian cancer 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 is in a Phase 2 trial. 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

Email contact

(MORE TO FOLLOW) Dow Jones Newswires

April 19, 2016 10:30 ET (14:30 GMT)

FLASH NEWS REPORT:

We have discovered that Leo has made some striking changes around the CTIX compound as of late.
First is that he has upgraded his lunch from PB&J to pastrami on rye.
He has had some very impressive signature pens designed and crafted from some wood off the bow of the US Constitution (very pricey) and
he has bought some very stylish seating and placed them around his desk.
CTIX now has a full service Jewish Deli on the 1st floor and they have installed a "chip and put" course out front.
As he was finishing up a round of golf out front,we asked him if all this was a display of his confidence of near term events soon to happen.He just smiled and as he walked away he could be heard humming that famous Sinatra tune "I did it my way".


News as it never happened,,,or did it?

Kelt

To use your term "class members",that would have to be determined through depositions to determine if they were "similarly situated"and that there were enough of them to make a class action worth while before the class would be certified.

Kelt

Yes but there aren't enough "listed" complainants (named plaintiffs) to proceed as a class action.If there were,then the "unnamed"injured parties would be automatically included unless they specifically opted out.

Kelt

In my experience with a class action against Fedex in Maine,the court would only "certify" the case as a "class action" if there were enough "complainants" to justify a class action.If not then the "complainants" would have to file individual suits.

The judge here does not have to certify it as a class action based on only one complainant.There would have to be many who could show they were "similarly situated"like the lead plaintiff.

If it is not certified,then Zagami could proceed with Rosen or another lawyer individually.(not worth much to an attorney).

That might be a way for the judge to get rid of the case without actually dismissing it.

Kelt

Now you're speaking my language ;)

Kelt

Yes,Blizzy.
I followed the exact same protocol.

(when it got to 18 drops per 8 oz it started tasting like bleach but I just guzzled it down :)

And like it says,don't take it at bedtime because you will have so much energy you won't be able to sleep.

Kelt

They were going to use that also with me but even if they did,there could still be some "escapees".I opted for the chemo and surgery.
I would still use the Peroxide anyway as my roommate in the hospital had had bladder cancer,then colon cancer,and then lung cancer.

I think the Peroxide therapy as a regular daily maintenance regimen would be useful to prevent re-occurrence as well as discouraging new developments elsewhere .

Kelt

My Dr.at the Maine Cancer Center in Scarborough,Maine did downplay it but that didn't stop me from continuing the therapy.
What he didn't do (or couldn't do) was to be able to explain to me WHY I SHOULDN'T continue with it.

Kelt

Although Matt's book "One Minute Cure" may appear to be "too good to be true",the science behind it is sound.
Medical professionals will downplay it or worse but remember that it is very inexpensive (no profit margins) and you can't patent it being a naturally occurring molecule .

Flooding tissues with oxygen also boosts the immune system and helps decrease inflammation which is why I believe I recovered so fast.

This is not to diminish the work of CTIX and others in the cancer arena but to give cancer patients a chance to do something for themselves besides just waiting and hoping on others to help them.I couldn't just sit there and do nothing and feel helpless.

Kelt

When I was diagnosed with bladder ca.I started being pro-active and started a regimen of Peroxide therapy.(Not the peroxide you buy in the store).I bought 35% food grade peroxide at Amazon.com and followed the directions as outlined by Matt Cavanaugh in his book "One Minute Cure".
I went through Chemo without any side effects.(No hair loss or nausea to everyone's surprise)And I still had Robotic Neo-bladder surgery.When they sent the tissues to the Path lab,to my Dr's amazement,the report came back that they found no evidence that there was ever any cancer in the bladder.
This after 3 cystoscopy exams showing numerous cancer growths in the bladder)

My recovery was super fast as they expected me to be in the hospital for at least a week or more but I recovered so fast I was released 2 1/2 days after surgery.

I don't know about others but Oxygen therapy with Peroxide sure worked for me.
The nice thing is that it doesn't conflict with Chemo as you are merely flooding your tissues with oxygen making a very inhospitable landscape for anaerobic pathogens as well as cancer cells.

Kelt

Hi Az!
I have not given up on NN*C but they will still need to show clinical trial results and they are still building their foundation.That said,CTIX is also a monster in the making and with all the clinical trials in progress and the promising progress so far I believe they will produce great returns before NN*C does.When that does happen (and it will IMO) I will then turn my attention back to NN*C as well as a couple of others.
Leo and Dr.Menon are "priceless".Don't let the share price fool you.They have been through their share of short attacks as well but as Leo has said,he will let the science drive the share price.

Kelt

I know.I haven't even met them and I see how valuable they are.I can just imagine what it would be like after meeting them.
Aznavour is a great lady I know from another board.I know you'll help her a lot.

Kelt

Hey Az!! You'll be very interested in CTIX.Youssef is a great source!

Kelt

Something has to "leak" at some point :0

Kelt

I would love for it to be "Compassionate Use" but wouldn't that also be announced in a PR?
(If it is,,,,,KA-BOOOOOOMMM!!!!!)

Kelt

I think the importance of this update is summed up in what Leo said in the preface.

" With all the expected near term events, this is an opportune time for us to engage this analyst community and introduce our company to an important audience."
Based on that statement,I surmise that,knowing what he knows about the progress of the trials and the data that he does have that he is now comfortable in bringing CTIX out of the "shadows" and getting on the "radars" of influential financial leaders.
Leo must have a lot of info that he can't release yet but that doesn't mean he can't act on it.

With sponsors like Johnson & Johnson , there must be a good audience.

The only thing lame about this update are short-sighted readers.

Kelt

I do have L2 through TD Am.

Kelt

You're welcome :)

Kelt

Any more than I need posters downplaying CTIX with FUD and encouraging "investors" through discouragement to sell and give up.

Kelt

To each,his own.

Kelt

To all the "so called" impatient "investors" out there who don't understand "Long Term",look at Apple that took over 8 years to "grow feet" and Intercept (ICPT) who took almost 17 years before they blossomed.
All in all,I think CTIX will be way ahead of those time frames and I've been invested since the $.50's
If you just can't see the longer term potential with confidence,then you shouldn't be investing $ that you can't afford to leave long term.Today's SP doesn't matter in the big picture.

Anything short of that and call yourself a trader but not an investor.

Kelt

I'm glad you're enjoying the pizza recipe.Goes great with football,especially when CTIX is moving back up!!

Kelt

That it did :)

Kelt

Unless Leo has more news to release next week and wants to spread it out.

Kelt

I don't feel bad then.I got 1700 @ $.97 :)

Kelt

With Pfe and Roche,Celgene and other Pharma "eyes" watching,if Kevetrin keeps performing things could really heat up in 2016/17 :)

And that's just on the K front.

Kelt

Interesting also that Roche is involved.

Kelt

Same to you Karin.
Have a blessed Christmas and a Happy and Safe New Year!!
Thanks for all your input and efforts over the year!!!

Kelt

The last part of the last sentence in the update tells a story also.

" we then have an additional two weeks, until March 21st to Respond, if we think it is necessary".

It appears to me from my experience in a class action court hearing,that if this judge is anything like our judge,she just sent a little "birdie with a message" to Rosen by limiting the 60 days to just 3 weeks.

In effect she is hinting that she doesn't like the "smell" of this case.

One would have to be in the courtroom but quite often judges telegraph their attitudes and it seems to be showing here.

"if we think it is necessary"seems to indicate that the judge seems to be favoring Sullivan's position and that Rosen needs to take the hint.

Courts can be fickle but that's the way it looks (to me) at the moment.

Kelt

"Lawyer's fees" ;)

Kelt

Only if it puts pressure on Rosen to settle without the court hearing the "dirty details".
Remember that Rosen could ask Sullivan to settle ie: drop the case,but Sullivan doesn't have to accept.The sword cuts both ways you know.

Kelt

As far as tomorrow's court hearing is concerned,remember that common sense is not necessarily at play here.It is "Procedure,Procedure,Procedure".I was involved in a high profile class action suit (Me.Drivers vs Fdx).It took 4 years for the court to get to where they could have gotten in 6 mos.

Judges prefer that the lawyers settle out of court instead of having to decide the case.It took our judge 4 years to get the lawyers to do just that.Meanwhile it was all about allowing the "Procedures" to play themselves out.

The judge in this case (CTIX/Rosen) could very well know already who will lose but that won't stop her from following established procedures and practices.She could very easily step in and say case dismissed but she will most certainly make sure her "ducks are in a row"before she does.That is because Judges also hate having their decisions brought up before an appeals court which threatens their judicial "record" if overturned.

She will want to make sure that if she renders a decision that it will be "invincible" before an appeals court.In this case,it doesn't matter what she decides,someone will file an appeal.Count on it.

That's one of the reasons why courts seem to drive 100 miles to reach a destination 2 miles away.

Kelt

It may be that recruitment remains open as long as the trial is still active.BWDIK

Kelt