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It was in last week’s PR. Sorry, iPhone X autocorrect changed OC to OM. It just did it again. The PR was last week. Hope you saw it. In the context of the “K is 4 years out” thread, the typo should be obvious, unless one is clueless about PR content and meaning.
Kevetrin will be monetized long before 2020. The OM primary outcomes, MOA, were successful in demonstrating K’s impact on p53. IPIX won’t take on the cost burden of developing K alone.
B-OM endpoint was that it is the only safe, AE-free drug out there effective in preventing severe OM. Everything else is manufactured controversy. As several pointed out, OM patients need to swish and spit every day anyway, so even the issue of swishing and spitting 4 times a day is overblown as a controversy.
.70 is not “close to all time lows.” It’s 7 times all time lows and double the price from 2011-2012 lows. I’m still at more than double my first entry prices.
Higher concentrations of B-OM, but also increased changes in viscosity for adhesion and increased length of exposure could also do the trick. Another consideration is Brilacidin in water may have increased irritation that a more viscous rinse might ameliorate. Finally, there might also be a topical anesthetic added to the solution that could reduce contact pain.
Treatment isn’t all or none for a rinse and spit. B-OM delayed the onset of SOM as a rinse and spit. Seems logical to use B-OM to delay the onset and then stop treatment if/when severe OM emerges. So, even if there is no increase efficacy through B-OM fine tuning delivery, ease of application and delaying onset should be sufficient to become part of the standard of care. Unfortunately there would still be little or no options once OM became too severe, so things would remain the same for those fewer patients.
I have thought something similar. A sort tune-up prophylaxis. One of the reasons for the OC trial was to better understand K's MoA as well as PK/PD. The powers that be will know more soon, and that question can be answered in the future, most probably after approval.
According to EDGAR filings, there are CDAs with BPs that include guidance for what they want to see which aided in the design of at least 3 trials: B-OM, B-UP and K-OM. I’d say that was jumping at at least 2 drug platforms.
Yes, BP is smart and they start with low all numbers. Leo is also smart and has established a dialogue that informed trials based on what BP wants to see before they sign any contracts with Leo’s numbers.
Good to hear from you KarinCA. Happy New Year to you!
Or, most likely interactions like CDAs, CRAs and NDAs, any and all of which can lead to partnerships. I think we already have some of those mentioned in the Qs and Ks, yes? The Qs and Ks make “interactions” less vague, don’t you agree?
That is just plain bullshit. Leo, Dr B and Dr Menon have completed 8 trials across 6 diseases and 3 drug platforms. They have accomplished that using less money and time than most biopharma startups take to get one drug against one disease into clinical trials.
Complete nonsense. IPIX is in the real business world, it just happens to be biopharma. Compared to so many other biopharma startups, Leo et al has been very frugal. 100% dilution is nothing after 11 years and IPIX is still around only 50%. In the real world, my experience has been and still is that most biopharma startups suffer 1000% dilution at 10+ years and reverse split with one drug in the pipeline in order to finance entering mid-stage clinical trials. Leo has done an excellent job of managing corporate development and survival while now IPIX is on the cusp of revenue producing partnerships.
It’s more likely there will be more details, especially bottom line info not yet released. For example, OM duration and severity reduction could be released, or details for IBD and UP results.
That’s not what I said. Quit putting words in my posts that I didn’t state.
I had always been open about that relationship. The law suit revealed nothing. Beginning summer 2006, I met with Dr Seymour in Kauai and every summer for 7 years. I was always open on the forums about those meetings including the one in 2006. I also met with him after changing my alias, and discussed the meeting as BigKahuna.
Once I was over here at CTIX more often, lots of aliases included “doc” and Dr, so it caused me to rethink my alias. Kahuna (leader, teacher, or holy man) seemed more fitting.
You are correct. There is a lot of speculation and nobody knows all the details outside the onco and the patient. But what I’ve stated (reasons given) was reported by the company.
FWIW, I’m not “Dr.F.” I’m not a doctor in the medical sense and my alias is not Dr.F. It has not been for several years because I don’t want anyone to think I’m a clinical or academic MD which did happen. However, I do have certificates in medical and cultural anthropology.
Of course they use CA 125. It’s a standard in nearly all oncology. That fact does not improve CA 125 reliability. It’s more reliable in some cases and less reliable in others. Why is that nuance completely lost in your argument.
There is ignorance and then there is willful distortion. I’m beginning to suspect the former.
I’m not characterizing any biomarkers as bogus. Those are your words. I’m characterizing biomarkers according to the literature out there. A clinician would know the difference.
At the time of the trial, that particular case was at the early stages and little was yet known about the Kevetrin and human use. The CA 125 number was going up while the lesion was shrinking and no one could yet explain it. CA 125 is also a biomarker for other problems, such as liver damage, so there was also a safety concern in continuing treatment.
Finally, you don’t seem to understand end-of-life care and issues. At stage 4, cancer patients in the New England region are already in end-of-life care and counseling making decisions about how those final days are spent. That care and counseling include discussions about how to go out including whether or not to allow invasive final treatments. The oncologist is part of that counsel.
It’s not a matter of giving up, it’s a matter of feeling better than one has in a long time due to what could be a very rare spontaneous remission or the treatment. I’m sure there were other considerations, but the elevated CA 125 along with wanting to enjoy the renewed energy and reduction in debilitating pain were mostly responsible.
That study isn’t irrelevant. Induced apoptosis is cytoreduction. If you read the entire report much of it is relevant to the K clinical study and the use of AC 125 data.
Your post is the worst kind of absolutism. All I did was cite a key study. Induced apoptosis is cytoreduction. Dana Farber et al were correctly collecting AC 125 data to be included in a full data set, not examined in isolation as a single preliminary data point. Not to understand that every biomarker in clinical use is only one element in the diagnostics process is a key flaw in any clinician.
I haven’t been a moderator for more than a year.
No one said CA 125 is a bogus biomarker. Those are your words. All the literature states that the assay has limitations, as does any biomarker assay. The literature and published studies going back to the 1990s and as recently as 2014 state that its reliability rages from the high 90 percentages to as low as 72% to 78% and recommends AC 125 not be used for decisions regarding cytoreduction therapies where it is least reliable, and inducing or correcting apoptosis mechanisms is cytoreduction. That’s just the reality of biomarker a. All have multiple uses and all have these varying issues depending on use. It’s a valuable tool, I keep saying that, but like all biomarkers it is not 100% and should be part of a full data set.
My father recently succumbed to bladder cancer. He was in his 90s and much more clearly end-of-life stage. He elected to do an experimental, noninvasive therapy. His oncologist feels it added several months to my dad’s life, but quality months.
The week before he passed he was on a 9 hole pitch and putt. He hit a short drive to the green but felt a sharp pain in his gut. He still walked to the green to hole out, but missed the putt because of a second sharp pain. What pissed him off was that he missed an easy birdie.
He drove himself directly to his oncologist, who told him this was it. Surgery, with a 50/50 survival, catheter life, and probably not more than 6 more months; or palliative care, extreme pain management and no further treatment with a DNR. I was glad he lived in a state that allows patients to choose their own path, with counseling, to the other side. Dad could just as easily have chosen to fight for every last breath of precious life, but that wasn’t his choice.
His gallows humor came through the day after his dicision to take no extraordinary or invasive measures. He said to me, “Another six months but without golf? What kind of life is that? Just wish I’d got that last birdie.”
Frankly, that mindset is exactly the doc I want in emergency care. “All life is precious. Do everything possible to preserve and save all life.” In the absence of a DNR order, assume all want to live no matter the outcome. But, in oncology often dealing with end life situations, there is a different passion and compassion required.
From a very selfish view of how that woman dropping out affected the trial outcome regarding any indications of efficacy, well I wish she had completed the protocol. With what little I know, I have to accept the decision as the right, personal choice.
No one forced her to do anything. You clearly have no end-of-life experience in your practice.
As a good oncologist, the doctor consulted with the patient. Together, they made the decision for whatever reasons. Doctors without end-of-life experience can’t conceive of not extending life if their entire mindset is only to “save lives.” End-of-life care involves more than just extending life as long as possible. It includes assessment of quality of life as well as the wishes of the patient. All the patients in the study were end-of-life, extremely ill, elderly, and platinum resistant. Platinum resistant means they were all highly treatment experienced, meaning all had exhausted treatment options, chemo and possibly radiation. Sometimes another factor is just that patients get tired of being poked by needles and taking pills that cause more discomfort.
I didn’t allege malpractice. It was a trial using a new moiety with not yet known outcomes. Among other factors and considerations the oncologist made a recommendation based on his understanding of ca 125 and its implications. These patients were stage 4 and very, very sick. One of the inclusion criteria was that there be no other options for treatment. The doctor consulting with the patient, together, made a decision to withdraw from the study. It was a study with many unknowns, not a standard of practice.
It wasn’t a misinformed decision. It was based on the oncologist’s understanding of ca125, a clinical trial testing a new moiety with not yet known outcomes, a stage 4 patient whose vast improvement allowed her to return to (at least temporarily) a normal life, and a huge improvement in quality of life during end of life. There was nothing ignorant about the decision.
None of what you are arguing is based in the reality of clinical trial situations and all the unknowns that those involved need to deal with. None of your points have anything to do with the reality of ca 125 in clinical practice. Yes, it’s a valuable tool, no it’s not 100% reliable just because Dana Farber uses it. And, as shown in the study I cited it has well recognized lower reliability during treatments involving cytoreduction.
This is what I was getting at: even though in clinical testing CA 125 is monitored, in that capacity it has low sensitivity and poor reliability when used in context of cytoreduction and apoptosis. Primary example is low reliability for the Phase 1 woman with the disappearing lesion. Though her stage 4 tumor all but disappeared, her CA 125 became so elevated that her oncologist recommended she leave the study. This is why the full data set and all metrics have to be used and not just CA 125 in isolation.
A better reference than the lay article I provided yesterday.
“This study showed that CA 125 had 73% sensitivity and 78% specificity in predicting optimal cytoreduction, and other studies have yielded similar results.15,16 The relatively low sensitivity and specificity of CA 125 in this capacity have precluded its routine use in surgical decision making for newly diagnosed patients.”
http://www.gotoper.com/publications/ajho/2014/2014dec/ca-125-and-epithelial-ovarian-cancer-role-in-screening-diagnosis-and-surveillance
As we discussed revisiting ca 125, the numbers can be meaningless at best and misleading or even purposely misinterpreted at worse if not in context of full results. That is probably the main reason for not inclusion, if it is even available. I can imagine the “investor reaction if ca 125 often is elevated, “CA 125 is a cancer signal, omg, it gives people cancer!” I’m sure Leo has a very good reason for not prematurely releasing those numbers, up or down.
Objective spin? Hilarious. A new oxymoron.
What irrefutable proof? You mean the proof that shows your assertion happened 2 years before Leo took over? You mean the proof that what you claimed was Leo was actually George Evans, the CEO fired from CTIX/IPIX? You mean that proof?
You mean this proof all dated 2008?
“10.1.1 Security Agreement, dated as of May 7, 2008, between Cellceutix Corp. and Putnam Partners, White Star LLC, and Dahlia Nordlicht, filed with the Company’s Form 10-KSB with the Securities Commission on September 24, 2008
10.2.2 Convertible Promissory Note dated as of May 7, 2008, between Cellceutix Corp. and Putnam Partners, White Star LLC, and Dahlia Nordlicht, filed with the Company’s Form 10-KSB with the Securities Commission on September 24, 2008
10.3.4 Guaranty in favor of Putnam Partners, White Star LLC, and Dahlia Nordlicht dated as of May 7, 2008, filed with the Company’s Form 10-KSB with the Securities Commission on September 24, 2008
All those were under George Evans. You are smearing Leo and current management 2 years before they took over. Also, you said 2013, those were 5 years earlier. Glad I didn’t go chasing them.
Go find them and prove they are true. No evidence, it’s just not there. Prove me wrong. Why should I go on a wild goose chase based on your accusations? The burden of proof is on you.
Smear the company and it’s officers and ignore all of the progress. Really nice tactic. 9 trials and no failures. They've done this on minimal dilution. If the current officers were really scamming, they would have spent more than 12 million a year since inception and done a reverse split like the one the first CEO wanted to do.
Yes, it’s not one of the outcomes, though it is (or should be) one of the markers followed during treatment. So, there is no reason to report ca125 unless it is relevant to one of the outcomes or observations during treatment or post-trial analysis.
Yes, there are other causes for changes in ca125, and that is precisely the reason for full analysis of data and not release those numbers in preliminary data. CA125 is only one diagnostic tool, though it’s an important screen. Clinical trial staff would know this, while it seems a GSW doc might not.
Leo had nothing my to do with Saliva Diagnostics until 2007 (if I recall the exact year correctly) and all damage to the company had been done by previous CEOs. He lead the company for only one year before his hire by CTIX/IPIX. Leo took over then CTIX after George Evans drove CTIX into a ditch and was unable to start clinical trials due to financial and funding issues. Within 2 years Leo took the company out of that ditch and started the first clinical trial. Five years later there are now 9 completed trials, all achieving and meeting all outcomes and all clinical successes.
CA125 is a complicated assay that can lead to misleading numbers, false diagnosis and misinterpretations. During treatment, CA125 often becomes elevated for a number of chemos (Doxil and Hycamtin for examples) this in spite of positive treatment outcomes. There are also other reasons for elevated CA125, and not just Ovarian Cancer. “A number of benign conditions can cause elevations of the CA 125 level, including pregnancy, endometriosis, uterine fibroids (benign tumors), pancreatitis, normal menstruation, pelvic inflammatory disease, and cirrhosis of the liver. Benign tumors or cysts of the ovaries can also cause an abnormal test result. (https://www.medicinenet.com/ca_125/article.htm#what_is_ca_125_test_what_is_a_tumor_marker)
There are very good reasons for delaying ca125 data release until other markers and data allow a fuller understanding of what normal, elevated and even lower ca125 might mean or not mean for Kevetrin treatment.