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What a rough day. As others have mentioned I think this was the wrong trial design for B. Was at a conference this past weekend and heard Dr Peter McCullough speak and a tidbit sticks out. There was talk about Remdesevir and how it's use in late stage covid illness was illogical because the replication phase for the virus was already past when it's typically given in a hospital, advanced illness case (replication phase is 8 days or so). Can't help but wonder if B is given earlier, during the replication phase, would there be a benefit? Regardless we need to focus in areas previously shown to have great promise. This was a hail mary usage with a dog of a drug (remdesevir) in moderate/severe covid patients (e.g. advanced stages of the covid). Very saddened at the results but not shocked.
Hi Windansea. I understand your concerns but I think one also needs to weigh the potential benefits with the downfall of potential bacteria resistence over time (assuming it could be used for periodontal applications. There could be unseen benefits. There has been some studies I believe that suggest a correlation between development of heart disease and periodontal disease. Your concerns are valid though, just "talking out loud" about the wide range of conditions that could possibly be investigated down the road, but one step at a time.....
I guess you are not familiar with the products already out there. Best to keep an open mind...... As an example:
OraVital® Antibiotic and Antimicrobial Rinses and Creams
Periodontal disease can be challenging to treat because pathogens are protected within an oral biofilm that is difficult for antimicrobials to penetrate. Mechanical removal of biofilm is typically only partially effective because biofilms can rapidly reorganize. Thus using an antibacterial rinse as an adjunct to mechanical removal of plaque and calculus is a significantly more effective way of dealing with oral biofilm infections.
Antimicrobial rinses are most often used to complement mechanical therapy to aid in controlling plaque buildup. Antibiotic rinses include low-dose antibiotics in colloidal suspensions - these rinses can impact pathogens up to 4,000 times more effectively than systemic antibiotics, with immediate treatment onset and without systemic implications. Since infected gum tissue is typically swollen and may have pockets around the teeth, medicated rinses are able to enter the sulcus and are drawn into the depth of these pockets by a reduction in crevicular fluid pressure (the Venturi Effect). Particles dissolve over several hours.
I had actually had the same thought. What if it could be used as a daily mouth wash for treatment/prevention of periodontal conditions since bacteria/inflammation are drivers of that disease process.
Hi "BigKahuna" Tke heart, here in Jacksonville Florida we have had 25 days in a row of temps of 90 or above (and the next 7 days they predict 97-100 for daily highs) with high humidity as well. Definitely in the summer doledrums as far as markets are concerned as well but I've never been more optimistic for the long term prospects of CTIX. It's amazing reading the board sometimes with all the negativity, I call it the "mayfly effect" since some investors seem to have an investment horizon that is only equal to a mayflies life span....... biotech is a marathon.
Hi Karen, the LD Micro Investor web page states, for those interested in attending, please contact David Scher for more information at david@ldmicro.com.
By the way, note track 1, June 8th at 8:30 is another company you previously had some interest in as well (XX--, not sure if you still own shares)
Hope you have the opportunity to speak with Leo.
Can't compare the move based on 2 phase 111 studies that were designed to demonstrate efficacy with our more limited Phase 11 study, apples and oranges. Those who don't see the significance of the positive results today should not be investing in biotech (not saying you but others on the board who want instant gratification, its a slow slog).
Yup, contrary to what some claim, I am Earthbound....
Sometimes it's better to remain silent and thought a fool than to speak up and remove all doubt.
"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."
Source: http://blog.clinfosource.com/guidelines-hard-locking-clinical-research-database/
I think it's crazy to say the price per share impact is backed in considering much more explicit information will be released with the full reports. I think you minimize the potential for a very favorable PPS response from the full report for the first drug to clear the toxicity hurdle and which has been shown to induce activation of p53. Dana Farber BI are not mom and pop cancer treatment centers. My opinion is we will see a very good pop on the release of the full reports. The point is I state it's my opinion, I don't throw out stuff saying they are facts.
Phteven C - There is a distinct difference between "facts" and opinions. You have offered opinions. The actual Purisol P2 start is obviously not a hard date, thus you may be correct, but its an opinion. With regards to the opinion the current stock price already reflects B P3 and K P1 results, that's even a bigger stretch and definitely an opinion and not a fact. Keep it real.
ASCO questions - To the more scientifically savy on the board. I know someone in the pharmaceutical industry (oncology background too) who I hope will be attending since they are close by. If you had a list of questions to present to CTIX (or Shapiro if he is doing presentation) what would they be? No promises but worth a shot...
LOL, best laugh of the day..... had tears in my eyes. Hope you are doing well Keltoi, don't post much but familiar with your circumstances/story. You must be ready for spring, it's been a tough winter up there. Currently reside in FL but grew up in NE and still have a small home in western MA in the Berkshires, miss it.
Best to you and thanks for the chuckle!
Hi "thefamilyman"
The potential uses are endless. I was equally excited seeing the potential use on PVC pipes. I work in the Env. Consulting world and perform Legionella/Waterborne Pathogen assessments in hospital settings. If this coating can effectively reduce biofilm formation it could potentially reduce the incidence healthcare associated infections. I have also wondered if it could be applied to filtration material for point of use filters...... the possibilities are endless. Montana State University has a good biofilm engineering lab........., Leo when you have some spare time...
Hi Ebuilder,
Your post is a good reality check for all here on this board as to what is important. We all get caught up in dreaming about what the price may be at a given future date but we should not loss sight of those that have previously or are still fighting the big C. For those this investment has a whole different meaning. I spent month than 2 months on a cot in a BMT center (University of Chicago) over Christmas in 92 while my first wife battled breast cancer so that acronym struck a cord. For those fighting the battle such as yourself, Citrati, Keltoi and others, keep up the fight and my prayers for all of you.
With regards to your comment about "odds" I wanted to pass along something I read long ago that put things in perspective. While medical science has to rely on numbers it should be noted what the definition of an average is (like the average response to a give treatment), an average is nothing more than a statistical accumulation of anomalies, predicting where youfall on the bell curve is another matter since people are individuals, not numbers. Thus why not strive to be that "outlier" on the right hand side of that bell curve?
Think about all of the artificial spinal disk replacement surgeries too. Lots of plates, cages and screws there that would benefit with an antimicrobial coating.
Working my way through today's post so forgive me if this has already been addressed by a later post.
This was referenced in the 11/24 news release from Leo.
"Looking to Brilacidin, the lead drug candidate in the Company’s definsin-mimetic platform, Cellceutix has signed an agreement with a division of one of the largest U.S. pharmaceutical companies for testing Brilacidin as a component of certain implanted devices as a means to prevent infection. This potential prophylactic use was not part of Cellceutix’s strategic plans for Brilacidin, but given the compilation of clinical and laboratory data, it is a logical application that could potentially add millions of dollars of revenue to the Company. The material transfer does not cover the pharmaceutical use of Brilacidin for treatment of infections or other diseases. A final contract can only be entered into if and when Brilacidin receives Food and Drug Administration (FDA) approval."
- See more at: http://cellceutix.com/cellceutix-december-to-be-momentous-month-in-companys-history/#sthash.pzrmBupe.dpuf
The ABSSSI numbers looked "too good to be true" so did a quick check. I came across this reference from an article in August this year.
"Orbactiv is the third drug approved by the FDA this year that targets acute bacterial skin infections commonly known as ABSSSI. Roughly 5.2 million people in the U.S. and Western Europe are treated each year for the infection and often involve intravenous therapies that require hospitalization." Reference here:
http://online.barrons.com/articles/SB50001424053111904329504580077553463725926
I also doubt 2,500 per treatment but even using that number and 15% penteration for US first (Lets assume 4 million cases for US) that's 600,000 cases or 1.5 billion, not 6.75 billion. Didn't Leo mention its a billion dollar market for ABSSSI? I agree the potential is staggering but it's easy to get a bit carried away when crunching numbers.....
Hi "Biodoc", My daughter is a neurosurgical nurse and they use vanco powder as well. I wondered if "B" could be manufactured as a powder so I did some research on the use of "vanco" as a powder in open incisions/cavities during operations. I found I believe an Italian study (can't locate right now) that showed no statistical benefit when it came to infection rates. Kind of dashed my hopes for "B" being used for that purpose. I do remember the company we bought "B" from did have successful use of defensin mimetic technology on sutures (called Polycide). The potential uses of this platform are mind boggling...
Hi KMBJN, geat supporting links, thanks for the post with them, good reading. I agree "cautiously optimistic" is the right mindset.
Hi KMBJN, I agree with most of your post and while I do think we need to temper expectations with regards to the pancreatic cancer patients response to Kevetrin, I believe statistics you mention regarding PFS could be a bit misleading. While I take you at your word that those numbers are accurate for pancreataic cancer patients, they probably refer to initial treatments and not for those who failed a treatment and then started a second form of treatment and thus their cancer is growing again. Since one of the requirements for inclusion in the Phase I Kevetrin trial is:
either refractory after standard therapy, or for which no effective curative or surgical treatment options are available
There is a resonable chance that the panceratic cancer patient who had the 4 month stabilization was someone who had already gone thru standard/earlier treatment and now had refractory disease and then achived a second 4 month stabilization. That is the aspect that would make it notable if indeed the patient had failed earlier treatment. No way of knowing but hopefully that's the case.
Hi PinkieSwear, I've noted IHUB typically links to after hours trades as opposed to end of the normal trading day, often results is differing gains or losses from say Scottrade although I have not looked to see if there has been any afterhours activity today.
Cabel/Dane
Interesting theory and fun to postulate but since the other one that had the big move only had 60K traded today doubt its related. If we assume half was due to swing traders that only means 30K impact, doubt that was the reason CTIX droped over 20 cents on about 460K traded. But fun none the less to toss it out there when some are sweating the day to day fluctuations. Big picture still unchanged.... Best to all from FL
Hi Govorchin - Excellent question considering the Rodman Renshaw presentation on 9/9/13 stated:
Evidence of stable disease by radiological examination in 6 cases, which includes head and neck cancer, ovarian cancer, liposarcoma and clear cell carcinoma. Slide 9.
And the "another tumor marker, CEA, was decreased and the tumor size remained stable over 4 months in a pancreatic carcinoma patient." Sept. 24, 2014 Update to Shareholders.
Both of those diseases are often diagnosed in late stages so I thought the results noted in stage 4 patients are possible indicators of what future trials may target.
Hope you get a good response!
So sorry to hear that KarinCA. I agree with your statement about the odds being high for the pancreatic patient having previously failing earlier treatment. I pray Kevetrin can be of use for future pancreatic cancer patients since they typically are diagnosed at an advanced stage (similar to ovarian cancer patients) and the disease is so refractory to the current treatment options. I found it interesting that they mentioned "CEA, was decreased and the tumor size remained stable over 4 months in a pancreatic carcinoma patient" since CA19.9 is the most widely used biomarker for diagnosis of pancreatic cancer. I am not certain if CA19.9 is also the most accurate biomarker for treatment efficacy. It would be interesting if they ran a test for CA19.9 for the pancreatic cancer patient if that is the best biomarker for efficacy of treatment. Ii am sure the researchers have it covered though. I hope future trials include more pancreatic cancer patients to see if Kevetrin can be of benefit. Enjoyed your article today, you are always thorough and illuminating.
Aloha BigKahuna- I hope so as well. Considering that acceptance in the current trial entails "locally advanced or metastatic, either refractory after standard therapy, or for which no effective curative or surgical treatment options are available", it's very possible the pancreatic cancer patient in the trial might very well have already tried/failed other treatments such as Gemcitabine. This begs the question, what are the statistical probabilities for achieving a 4+ month stabilization in that scenario? Ii really hope "K" can be of help to pancreatic cancer patients because there are no real effective treatment options if the disease is advanced.
Hi Yooper61, yea it is about time for another "Ella Update" enjoy reading her research. I hope the upcoming UOB trial start is delayed just a tad more to enable them to perhaps use cohort 8 dosage, if it is deemed safe but perhaps they are comfortable with the cohort 7 dosage based on talks with Dr. Menon as he believed it to be in that dosage range where efficacy would be anticipated/probable.
I did some quick checking tonight about the 4+ month period before disease progression period for the pancreatic patient and noted this from a study back in 2000. I bolded sections.
"Patients with locally advanced and metastatic pancreatic carcinoma have a poor prognosis and suffer debilitating disease-related symptoms. Historically, single-agent 5-fluorouracil (5-FU) has been a frequently used treatment that has produced tumor response rates in the range of 0–19% (since 1985 when computed tomography [CT] assessment of tumor response became standard) and a median survival of 4.2–5.5 months.1 A review of the literature on investigational new drugs (28 Phase II trials involving 25 agents) showed that, to date, there has been no improvement in patient outcome, with a median objective response rate of 0% (range, 0–14%) and a median survival of 3 months (range, 2–8.3 months).2
Gemcitabine (GEMZAR; Eli Lilly and Company, Indianapolis, IN) is a novel nucleoside analog with activity across a broad range of solid tumors.3 The activity of gemcitabine in pancreatic carcinoma was assessed in early Phase II trials. In a United States study of 44 patients, Casper and colleagues reported an objective response rate of 11% and a median survival of 5.6 months.4 In a European study of 34 patients, Carmichael and colleagues reported a tumor response rate of 6.3% and a median survival of 6.3 months.5 Both study groups reported symptomatic improvements in their patients that were greater than suggested by the objective tumor response rates.
I believe it's likely, although we cannot conclude, the pancreatic patient in the Kevetrin study may very well have previously used 5FU and/or Gemcitabine. Thus the additional 4+ months of stable disease/no progression was significant, especially for them. I know we cannot make predictions based on a single patients response but I also think they would really look at this particular patients tumor characteristics (DF is good at tumor DNA sequencing/mapping) to see if future studies should include more pancreatic cancer patients with similar tumor characteristics.
BooDog/Yooper61 - Thanks for the kind words. I try to keep my emotions in check but there is so much good info coming out of the current trials of both Kevetrin and Brilacidin. I think it was BK who also commented on the favorable response of the pancreatic cancer patient. That is one of the most treatment resistent/unfavorable response rates of all cancers. To have 4+ months of stable disease I believe is a great achievement. The potential uses for Kevetrin are endless, we will just have to wait and see how the trial results pan out but thus far the results seem to correlate to the earlier cell line and mouse/rat studies. There will be many, many future studies here for sure. I also think UOB would not be starting their combo study with Cytarabine unless they have had an opportunity to "peak under the hood" so to speak. I think there has been some informal information exchange with DF and they feel it is worth while to start now. Since it's on UOB dime, that's a big step forward.
I also can't wait to see the unblinded results of the Brilicidin trial, I think they will be all we had hoped for. Exciting times, feel like a kid waiting to come down the stairs Christmas morning.
Hi George,
I’ll take stab here at what I believe the issue is here. While some posters may believe Kevetrin will have miraculous results as a single agent, I think the disconnect is when this optimism is expressed in the sense that it will “cure cancer”. I believe it does have the potential to “cure” some of cancer, saying it will “cure cancer” is s broad statement. That said I do believe “K” has the potential to cure some of cancer and it may be in the form as a single agent. I look at Kevetrin as currently being in bottom of the 1st or 2nd inning of a ballgame. The current study does not meet statistical significance when trying to deal with issues of efficacy, however significant important data can be gleaned from the small sample size just the same. Info that will enable Cellceutix to refine future directions in the use of Kevetrin. We certainly cannot conclude Kevetrin cannot be utilized as a single agent in the future from the current study, especially one in which the patients are 4th stage patients who have advanced, refractory disease and who typically have very compromised immune systems and other problems due to the advanced nature of their disease. The current study is not designed to answer what the response might be if “K” was used earlier in the disease process where patients are not as compromised, the tumor burden is less and where they have not developed more refractory disease via more mutations, etc. That is a significant aspect when trying to determine efficacy in a patient population. If used earlier (stage 1 or 2) it may very well meet or exceed current treatment options, we just don’t know. In my opinion future studies will be performed both as a single agent and in combination because P53 mutations are present in so many cancers. In addition, Kevetrin may very well be proven highly effective when conventional treatment has resulted in no detectable disease and oncologists opt to use afterwards to prevent recurrence or extend cancer free status if the patient had P53 mutations in their tumor type to begin with.
In closing much more study is needed before we conclude optimal uses for “K”. I agree 100% that I think it will be highly effective when used in combination but I disagree when you conclude that “K” is unlikely to be utilized as a single agent at this time, more study is needed. I think we should all try to remain open minded, we all want “K” to succeed and I thinks it’s best to not endlessly debate/focus on whether it’s as a single agent or in combination with treatment modalities, we all hope is successful for those who unfortunately are dealing with any form of cancer.
Best to all from sunny Florida.
No offense taken, I also cringe when I see folks saying "K" will be a cure for all cancers. Hopefully it will cure some but in my opinion no single drug/treatment will ever "cure" all cancers (regrettably). It's a complex disease. That said, as a scientist (environmental, not medical) I am excited to see the progress we have made on many fronts, especially brilacidin which I think will be of enormous value to Cellceutix. We will just have to wait until trial results are fully reviewed and vetted before we know more. It would be interesting to know the breakdown of cancer types in the study thus far and responses (e.g. is this the only pancreatic cancer patient in the study thus far). Keep the faith, we have had no significant setbacks in the pipeline yet.
I understand and agree with your statement but that can be said with most outcomes in this trial due to the small sample size. That said, this result may prompt them to targeted studies down the road. The result is notable though, pancreatic cancer is so resistant to any treatment stabilization of the tumor for 4 months is big.
I agree Romad Diver. Pancreatic cancer is the 4th leading cancer cause of death and it has the highest mortality rate. Any treatment that could extend life expectancy would be major news for those with that disease.
I did a quick check on the pancreatic cancer patient response since I know pancreatic cancer is one of the most difficult to treat and has such a poor prognosis. Interesting the stabilization lasted more than 4 months. My quick research indicates "the average life expectancy after diagnosis with metastatic disease is just three to six months". Reference is from this site.
http://www.pancreatic.org/site/c.htJYJ8MPIwE/b.5050503/k.40C9/Pancreatic_Cancer_Facts.htm
I would say the pancreatic cancer patient response is very notable.
Fabulous, thanks so much noretreat. I knew I would get a response faster than I cold find it! Will post later tonight.
Sorry, Kevetrin
Cohort breakdown. Could someone here provide the number of patients in each cohort. Is it 3 or 4? I seem to recall Govorchin had a summary a time back but may be mistaken. Doing some preliminary research on comparing earlier oncology drugs that also had combined safety/efficacy end points for Phase 1 studies.
ROMAD Diver - You made me "snort" with laughter while eating a brownie, damned near choked but it was worth it!
Thanks for the links KMBJN - it would appear from the abstracts they don't think BSA is the end all either and feel "alternatives based on fundamental principles of clinical pharmacology" are more appropriate. Lots of variables....... With regards to the vancomycin use, my daughter confirmed they use it a lot for back surgeries but not brain since there are concerns about ototoxicity. A study I read about vancomycin powder concluded "it doesn't cut infection post spine surgery as noted here:
http://www.empr.com/vancomycin-powder-doesnt-cut-infection-post-spine-surgery/article/324883/
But who am I to say....... maybe it makes the docs feel better that they are being "thorough".......
Hi biodoc, excellent observation! Never considered the serum level differences between intraperitoneal vs intravenous. Great first post, stop in more often.
Hi KMBJN - Not sure if the question was directed at me but since I have been in this thread today in response to your question, the 200mg/kg mouse dosage amounts are what Cellceutix shows on their web page when it concern tumor response in lung, breast, colon and head and neck cancers, no dosage amounts are provided for the prostate and retinoblastoma studies. The questions arose from converting the mouse doses to HED by using the Baur BSA formula which is more correctly used for determining starting points for Phase I studies as opposed to direct conversions of dosages for human efficacy. I agree with "trusting Menon's expertise" and it is very evident many factors are involved in conversions. In additions these conversions are typically used for drugs that directly impact tumors by various mechanisms, so are they valid for a drug that restores P53, which in turn impacts tumors? With all the questions this process brought up I go back to the observed effects we have seen thus far, some patients having restaging/tumor arrest and multiple cycles/cohorts for multiple patients, thus a benefit was observed to those patient. That is important, (plus increased P21 expression in lymphocytes).
To end on an upbeat note tonight I wanted to pass along some interesting info regarding brilicidin. Recently Cellceutix said "B" is stable at room temp., I am not sure if that is in liquid or powder form. My daughter is a neurosurgical nurse and they routinely use Vancomyacin both in solution (mixed with saline by the nurse) and interestingly also in powder form within open incisions/surgical sites (mostly in back/neck surgeries I believe but perhaps other types of surgeries too) prophylactically. I wonder if "B" could also be used in this manner? Perhaps one of the posters who has a good history with correspondence with Leo (WildforCTIX) could pose the question if "B" can be used in powder form, just another potential use to consider.