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That is certainly the benefit of us having multiple drugs in the pipeline which further decreases risk. I appreciate the efforts of management and fully support the decision making process with the resources we currently have. As the platforms continue to mature, many doors and avenues of exploration will develop. Patients and shareholders will have lots of upside.
It seems the University of Bologna arrangement was simply postponed due to lack of funding. Government funding for health research across the EU has been limited. Hopefully, if a major BP becomes interested as we accumulate more data with the Kevetrin OC trial, it will help fund that study.
I was very pleased to see today's PR about added new information and exploration into AML and potentially blood cancers. This definitely opens up an extremely wide opportunity for the company and patients. Hopefully this added information will inspire University of Bologna and/or large Pharmaceutical companies to help fund this avenue of research.
I want to take the opportunity to wish all my fellow CTIX followers a happy and healthy upcoming Memorial Day weekend.
Got to quickly change my supermarket order for the BIG weekend BBQ: cancel all the beer, hot dogs and burgers, everyone is getting champagne, ribs and wagyu steak.
Very exciting times coming up over next few months!
Spot on biohedge.
I have been following CTIX for over 5 years and consider myself lucky to have come across it. I have both an extensive active clinical medicine as well as research background. Moreover, I have been following the biotech sector for over 20 years.
I have never come across such an exciting opportunity in terms of risk/reward potential as we have with CTIX. The majority of risk is mostly behind us and we are on the brink of finding the true value that may lie ahead.
I am excited for both investors as well as the clinical potential it will offer a wide spectrum of patients across many indications.
It certainly is great having a board certified dermatologist with an extensive research background as part of the management/leadership of CTIX.
Streptococcus mutans is the main bacteria in the mouth that is thought to be responsible and contribute to dental caries (cavities).
Brilacidin as we know has been shown to be quite effective for gram positive infections (staph and strep).
An oral rinse can definitely be effective and quite lucrative.
Had a quick thought regarding another potential use for Brilacidin in GI marketplace to potentially treat clostridium dificile based on its antibiotic and immunomodulatory properties.
Taken from Wikipedia:
Clostridium difficile infection (CDI) is a symptomatic infection due to the spore-forming bacterium, Clostridium difficile. Symptoms include watery diarrhea, fever, nausea, and abdominal pain. Complications may include pseudomembranous colitis, toxic megacolon, perforation of the colon, and sepsis.
Often the antibiotics metronidazole, vancomycin or fidaxomicin will cure the infection.
C. difficile has become the most common microbial cause of healthcare-associated infections in U.S. hospitals and costs up to $4.8 billion each year in excess health care costs for acute care facilities alone.
As mentioned above, vancomycin (usually in oral formulation) is often a common treatment choice.
If Brilacidin can be shown to be effective for this indication, this can be of further interest to a partner that is already marketing this to the GI market for UP/UC conditions.
Eagerly awaiting June 8 conference call, hopefully everyone submitted their questions. Management I believe is sincerely trying to be transparent and keep us updated. Lots of exciting news to come throughout 2017.
I assume any significant news will likely only be released on June 8 conference call. Less than a month away - patience is a virtue and will likely be rewarded.
This would be an extension to the Brilacidin GI platform. Ulcerative colitis and proctitis are inflammatory conditions of the lower GI tract.
If B-UP is found to be successful, another potential avenue of exploration can be its use for GI ulcers in the upper GI tract based on its anti-inflammatory and biofilm properties.
Carafate and/or sucralfate are currently one of the medications that I have seen to be quite effective in both hospital and outpatient settings both to prevent and/or treat gastric and duodenal ulcers.
Similarly to carafate, benefits may include low systemic absorption, excellent safety profile, and easy administration.
Furthermore, a potential phase 2 study should be relatively quick and easy to perform with an oral liquid formulation because the incidence of acid reflux and ulcers is extremely high in the general population (recruitment should not be an issue).
Also, an upper endoscopy to evaluate ulcers is an extremely quick procedure that does not require an extensive preparation for patients in advance (unlike colonoscopy), therefore, patient compliance should be high.
DF can investigate solid tumors while University of Bologna can investigate leukemia, multiple myeloma, and other blood cancers. An oral formulation will very significantly reduce the cost of a clinical trial. The possibilities are endless...
In reply to the post that University of Bologna is still interested but lacks the funding. I am hopeful that once Cellceutix is able to create an oral formulation, the cost of doing such a trial will be significantly decreased. I expect many potential trials will be explored creating many potential opportunities.
These past 10 days certainly has been a challenging period for shareholders and fortunately the storm seems to have passed.
I am eagerly looking forward to the horizon which should shortly be bringing news of the final cohort of brilacidin UP phase 2 study. Also, in the next few months we shall likely be hearing news of interim results for prurisol phase 2b. Kevetrin oral formulation and updated phase 2 ovarian cancer information can be released as well.
I remain optimistic, excited, and LONG on CTIX.
I would like to possibly shed some light on the release of interim prurisol data from 2Q to 3Q.
This has been directly quoted from the CTIX press release dated December 19, 2016:
"Interim analysis of 6-week data with readout is anticipated in 2Q2017, with full study top-line results in 3Q2017."
The science is progressing and I am confident that the share price will hopefully reflect that in due time. Management's goals are aligned with long term shareholders and thus I maintain a very substantial position in CTIX which I have been consistently increasing over time.
I have been a strong accumulator and fully LONG, science remains strong with lots of upside potential!
We should all take the Cellceutix pledge, buy 20k shares and hold them, which will hopefully put some pressure on the shorts. Similarly to KarinCa, I have a strong feeling 2017 will be the year of the partnership and we shall all see some nice returns.
I am really happy to hear that some smart investors are basically funding the company $2 million. This will hopefully allow us to finish the brilacidin and prurisol phase 2 trials. Management can negotiate a far better deal with big pharma from a position of strength.
The evolving story of brilacidin as an "anti-inflammatory" in addition to its original intended use as an antibiotic may likely parallel the story of the statins as having anti-inflammatory properties in addition to its benefits as a lipid lowering drug.
I look forward to the day when doctors prescribe a low daily dose of brilacidin, similarly to a baby aspirin, to virtually every patient for a wide variety of indications.
Although today's B-OM initial results are only based on preliminary and limited data, my enthusiasm has greatly increased for many reasons.
In particular, patient recruitment as we know has likely been challenging for possible many reasons:
Patients are aware that there chance of receiving the placebo is 50%, other oral mucositis trials in past have mostly been unsuccessful, current trial is not by a major pharmaceutical company, trial is only a phase 2 with no previous known efficacy, trial sites were initially limited.
However, now that we are armed with initial encouraging results - radiation oncologists, oncologists, and patients can be made aware and this will undoubtedly help recruitment efforts. Moreover, the recent expansion of additional clinical sites should definitely speed along the current trial.
I congratulate and continue to appreciate the efforts of Cellceutix management on behalf of shareholders and look forward to more excellent news!
Copied and pasted verbatim from www.insiderfinancial.com
Here's Why Latest The Cellceutix Corp (OTCMKTS:CTIX) Data Is Important
By Chris Sandburg / in Biotech & Pharma, Momentum & Growth, Momentum Stocks, Stocks / on
Thursday, 23 Mar 2017 12:00 AM / 0 Comment / 132 views
Cellceutix Corp (OTCMKTS:CTIX) has been subject to some pretty harsh criticism as late, and is currently at the center of a legal dispute between it and an anonymous SA blogger called Mako Research surrounding a report it put out that seemingly claimed the company was a sham entity.
We have said in the past that we are more than willing to give the company the benefit of the doubt in this situation, and we base this willingness on some due diligence conducted in response to the initial publication of what seemed to be a short hit piece.
It seems, however, that certain operators are not so willing. We see this unwillingness as misguided, and in turn, see it as an opportunity to take advantage of a misbalanced market response to the company’s fundamental developments. With this in mind, we’ve been on the look out for Cellceutix’s reporting of any such developments, in anticipation of the short pressure weighing heavily enough on the company for the news to not make a difference, and offering up this misbalance as a chance to pick up shares at a discount ahead of the rebalancing.
Well, we just got one, and it’s about as big a news as we could have hoped for. Yet, as predicted, markets haven’t moved the company in its wake.
The news relates to a proof of concept study that the company is currently undertaking in what we might deem its secondary Brilacidin program (although there’s not too much between the primary of OM and the secondary of Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS) – the latter of which is in focus here.
On March 21, the company put out a release detailing positive topline findings as part of an interim analysis from the above mentioned PoC study. It’s a phase II, and it’s investigating the impact of an enema administration form of Brilacidin in patients suffering from UP/UPS. The primary focus of the data that the company released was two cohorts from the trial (which we reiterate, is ongoing) – cohort A and cohort B. A received 50mg active compound, while B received 100mg.
As per protocol, the patients had 6 weeks, 42 days, of daily treatment with Brilacidin, and were assessed at the end of the six weeks as per two endpoints – the first, the primary, looked at remission based on endoscopic findings, while the secondary, used what’s called MMDAI (an industry standard severity measurement scale) to measure subjective impact.
As per the interim analysis, all twelve patients from both cohorts experienced a beneficial response as measured by the just mentioned MMDAI scoring parameters.
Clinical remission was defined as an improvement in stool frequency from baseline, a rectal bleeding sub score of 0 (so, in other words, no rectal bleeding) and endoscopy findings of mild, normal or inactive disease. This was the primary, and 6 patients across both cohorts (so, 6 out of 12) achieved this endpoint. That’s means that 50% of patients basically had their condition cured. The other 50% had at least two of the three improvement points ticked, and were classed as partial remission as per the study protocol.
It’s difficult to understate how good these results are. Some of the standard of care treatments don’t achieve remission rates this good, and these are the SOCs that cause side effects and that totally lose their therapeutic effect in a large number of patients; the SOCs that Cellceutix is trying to offer an alternative to.
So as not to get too carried away, it’s worth noting that this is PoC, albeit phase II PoC, and that Cellceutix has a number of other programs on which to focus (and in turn, on which it needs to spend cash). The potential for dilution is real, and this could weigh on the value of a position taken on the back of these numbers.
That said, and even with the potential for dilution in play, we would expect at least some loading up on the back of these numbers. If PPS is anything to go by, and of course, it is, these expectations haven’t materialized.
We will be updating our subscribers as soon as we know more. For the latest updates on CTIX, sign up below!
Disclosure: We have no position in CTIX and have not been compensated for this article.
New press release on company website regarding Brilacidin Potential for inflammatory diseases.
Cellceutix Phase 2 Brilacidin Trial Progresses to Highest Dose Cohort for the Induction of Remission of Mild-to-Moderate Ulcerative Colitis
BEVERLY, Mass., Feb. 22, 2017 -- Cellceutix Corporation, (OTCQB:CTIX) (“the Company”), a clinical stage biopharmaceutical company developing innovative therapies with dermatology, oncology, anti-inflammatory, and antibiotic applications, today announced progression of its ongoing Phase 2 clinical trial of Brilacidin to the third cohort (highest dose) for induction of remission of mild-to-moderate ulcerative colitis after satisfactory safety of prior cohorts was reported by the study’s Safety Committee. Patients included those with Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of Inflammatory Bowel Disease (IBD).
The ongoing Phase 2, open-label, proof-of-concept trial comprises three sequential cohorts (6 patients per cohort), with progressive dose escalation by cohort—50 mg, 100 mg, and 200 mg, respectively. Treatment with Brilacidin by daily enema administration is performed for 42 days.
Patients continued to tolerate the treatment well in Cohort B, echoing comments from patients in Cohort A by reporting improvements in quality of life. Even with the dose doubling from the first cohort (50 mg) to 100 mg, drug concentrations in plasma remained in a favorable range, averaging 200 ng/mL maximum concentrations across the six patients in Cohort B.
Efficacy data are currently being analyzed and patients for Cohort C (200 mg group) are now being enrolled.
Congratulations to the LONG and STRONG Cellceutix shareholders. We survived the "fake news" Mako short attack.
Hopefully, the only person who got tricked into selling today was Aruda;)
As we have all witnessed over the past several months in the general news media, there is plenty of "fake" news. Although Mako may be correct that CTIX did raise cash from Platinum in the early forming of the company history prior to access to Aspire funding, there is certainly no evidence of fraud by Cellceutix itself. This is another attempt on Mako part to rattle shareholders by misleading information. I personally am holding very strong, the clinical trials are all progressing and I am eagerly awaiting trial results. To have 3 drugs in active clinical trials with multiple indications - is an extremely favorable risk/reward valuation. Moreover, with the CTIX teams focus on partnership in the near future, I am confident that we may likely see a return of many multiples on our initial investments (even for those that may have bought at the peak). Stay LONG and STRONG!
Let's keep kardashian in mind for the psoriasis commercials when it comes approval time:)
Prurisol trial now viewable on clinical trials.org
Congratulations to cellceutix and it's legal team on a major monumental accomplishment that will benefit cellceutix shareholders and the investment community at large.
Clinical trial design is complex and especially more so for a small biotech company that needs to be balance finances. Proof of concept trials are often done with smaller groups of patients to expedite the process at a more affordable cost. We are not privy to all the details involved in the decision analysis. Hindsight is often 20/20. I have been patiently following this company as a shareholder from inception and have thus far been overall satisfied with management and trial progression. I have both a medical and scientific background and have actively been following small biotech companies for the past 20+ years. I have a strong understanding of the complexities of the process. I strongly believe the next 2 years will be very rewarding for those that patiently wait for future progress!
In regards to the much anticipated prurisol data, I think we also need to entertain the most likely possibility that the prurisol data will be equivocal at best. This is a small phase 2 trial where it will not be easy to demonstrate statistical significance (each trial arm has relatively small numbers of patients). I will be happy to learn that there are no side effects and hints of efficacy which should hopefully compel the FDA to allow a larger phase 3.
Perhaps Aruda has stopped selling and is actually buying:)
Does anyone have any information or speculation regarding the brilacidin ulcerative proctitis trial that was mentioned to be scheduled for March 2016?
From Wikipedia:
Boeheim had prostate cancer in 2001, and subsequently became a major fund-raiser for Coaches vs. Cancer, a non-profit collaboration between the NABC and the American Cancer Society, through which he has helped raise more than US$4.5 million for ACS's Central New York chapter since 2000. In 2009, Boeheim and his wife, Juli, founded the Jim and Juli Boeheim Foundation, to expand their charitable mission to organizations around Central New York concerned with child welfare, as well as cancer treatment and prevention.
As per cellceutix website, tomorrow is the start of the prurisol phase 2 trial. If and when that news gets disseminated, news can be another tool to support price.
I have refrained from posting over past several weeks, because I think we all need to let the trials progress as needed.
I am more than confident that over the next 2 to 3 months, there will be more news flowing from the trials and at that point we will likely get an uplisting.
In the meantime, anyone interested in joining my campaign to place a buy order at $3.00/share to support the share price against the shorts. I pledge $5,000.
If kevetrin is determined to be as safe as aspirin, perhaps one day we will all be taking a small dose of "kevetrin a day to keep the cancer away".
I am very excited to hear we are going to be utilizing adaptive trial design for B-OM, this can definitely save time and money.
I am hoping that kevetrin phase 1 trial ends quickly with the next 1 - 3 cohorts, and we also utilize adaptive trial design for phase 2/3.
Ultimate results are still 2 to 3 years away, but I believe within the next year, we can all be confident we have at least one very successful effective drug and possibly 3 drug platforms covering many diseases.
I truly believe the best is yet to come and we are getting closer and closer.
I have refrained from posting comments over the past few months, despite my overwhelming passion for this company, simply because I try to limit my comments to areas of my expertise, which include both current active medical research and clinically practicing as a physician.
I have been accumulating a very strong and steady financial position over the past 5 years and truly believe the best is yet to come. The largest investors, the founders of this company, have obviously the most to gain, their interests as fellow shareholders, are aligned with ours. Let them do their jobs at advancing the trials based on the latest information and resources they have available - they see and have the whole picture. Our requests and impatience may ultimately cause harm to ourselves.
I am a firm believer in capitalism, and respect everyone's right to make a few pennies on swing trades, however I am personally looking for my investment here to comprise a very significant component of my retirement planning.
We are fortunate to have many drugs in upcoming clinical trials, the data thus far all seem promising to date. The risk always remains high in biotech, however, the likelihood of success with our multiple drug platforms lowers the risk for me, and with our current market valuation, I truly believe we will be seeing exponential growth over the next several years.
Thanks for listening and let's all try to stay patient. I have no doubt, the best is yet to come.