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That guest should be careful for what they wish for...... We are on borrowed time here in FL, eight years without a direct hit, at some point that will change. While weather is fascinating, no desire to see a Cat 2 or higher up close, I would be long gone before that if I lived right on the coast and in the storm surge zone....
Hi rnn256, I agree with your last paragraph, we do need to take some of these guidelines with a grain of salt. If converting a mouse dose to a HED was simple in terms of determining what the anticipated efficacy should be when comparing efficacy in the mouse to humans, there would be would be few drug failures. Obviously that is not the case. The allometric scaling approach has limitations on the types of drug being tested and factors such as how highly protein bound the drug it, biliary vs renal excretion mechanisms and binding sites all come in to play as noted in the Sharma and McNeill paper.
At the end of the day we are placing faith in Dr. Menon's judgment and that's ok with me. He has a wonderful track record and I think his veterinary background also provides him with valuable insight when it comes to drug effects on differing species. My gut feeling tells me he is a driven "lab geek" who has special clinical skills (the lab geek reference is meant as a compliment). Hopefully we will have our confirmation in early 2015 (although another cohort or 2 would be fine with me). In closing perhaps what the underlying tone of this thread is defining what realistic expectations are. Speaking for myself, I cringe when I see some saying Kevetrin will be the cure for Cancer. While I would love to be wrong, I think it more accurately should be said that Kevetrin will cure some of cancer, very big difference but still a fabulous outcome that we all want at the end of the day for those suffering with cancer. I hope my comments today were not viewed as being a doubting Debby or negative in my hopes for Kevetrin. Time to go finish mowing my lawn in between the afternoon showers in FL. BK I hope you faired well in the recent storms in Hawaii, many years ago my sister lived on Oahu and I spent a summer there between by junior and senior years in high school (Rainbow Towers, Waikiki, I won't say how long ago.....) lots of beauty there.
To further cloud things, if you use Table one in the Sharma.... study you calculate HED by dividing the animal dose, in this case the mouse dose of 200 mg/kg, by 12.3, thus a result of 16.2 mg/kg is HED, conversely you can determine the HED by also multiplying by 0.081 which also yields 16.2 mg/kg. The conversions are based on using the exponent of 0.67 for body surface area in humans. I like the table 1 conversions better!
Hi georgejjl. I believe BK is correct in his statement that one of the uses of referenced BSA formula is for determining "the selection of maximum recommended starting dose in humans for phase 1 trials" as that is one of the points mentioned in the study by Sharma and McNeill here:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2737649/
That said, the earlier study I referenced used the Baur's Mouse model when extrapolating mouse to HED (human equivalent dose) does equivalencies and illustrated the common misunderstanding of such extrapolation by using the Resversatrol example they provided. I use used the formula since I was trying to determining the HED of the mouse dose of Kevetrin for the lung cancer study where it states "Mice were treated intraperitoneally with 200 mg/kg Kevetrin every other day for 3 doses. For comparison, another group of mice were treated with 22 mg/kg
paclitaxel IV every other day for 4 doses. In that study Cellceutix noted a 33% to 111% tumor growth delay compared to controls.
It would appear the current K study did use a variation of the BSA formula to determine the safe starting point. Using the NOAEL for Kevetrin which is 90 mg/kg in Rats, one I believe would calculate a "safe starting point in a Phase 1 study by the formula of 90 (the rat NOAEL)x 6 (the rat K factor) / 37 (human K factor, which yields about 14.6 mg/kg. I believe we started our Kevetrin study at 15 mg/kg so it would appear they used the Baur model to determine the safe starting point.
Again we have to defer to the expertise of Dr. Menon here and thus far I am pleased with what we have seen in the study. I can't fault anything BK stated and admit using the Baur model may not be correct application of the formula when coverting the mouse dosage of 200 mg/kg to HED so you can "expect" to see the same efficacy as was noted in the mice.......
Sorry, hit submit post by mistake - full post below.
Hi Georgejjl - You raise some qood questions regarding dose conversions from mouse studies to humans. The FDA has suggested that it is appropriate to extrapolate animal dose to human dose by normalization of body surface area (BSA), which often is represented in mg/m2. To convert the dose used in a mouse study to a dose based on surface area for humans, one should multiply by 22.4 mg/kg (Baur’s mouse dose) by the Km factor (3) for a mouse and then divide by the Km factor (37) for a human. Since the Kevetrin mouse studies reference 200mg/kg the resultant calculation I believe would be 200x3/37, thus an equivalent dose would be 972 mg/kg when using the referenced formula. A good article on the topic is located here:
http://www.fasebj.org/content/22/3/659.full#ref-20
That said, the study above also notes the formula should be used because pharmacokinetics of absorption, distribution, and elimination parameters are considerations when dealing with also variables to consider when dealing with chemotherapy dosing, that is clearly not the case here, Kevetrin is restoring function of P53. It's above my pay grade to determine if the formula is pertinent with this type drug, thus we are depending on the expertise of Dr. Menon in this case,
I agree whole heartedly though that Kevetrin might best be used as a complementary drug to synergistically enhance efficacy, especially if used earlier in the disease process. Good questions to ponder. I'll close with the upbeat observation that it is extremely promising that disease stabilization/restaging was noted in some patients at low dosages, albiet in a small sample set.
Hi Farrell90, Seems like he has not updated his LinkedIn page since there is no reference to Polymedix which I thought was after his AMAG work. I agree with you/CallMeCrazy is appears he has been retained as a consultant with regards to Brillicidin. That said, I hope they also use his knowledge for the other Polymedix drugs that we acquired since it would make sense (although I could be dead wrong) that he would have been intimately involved in their initial testing as well. Would hate to see another company gobble him up and we could not use him as a consultant, it would boil down to what clauses he put in his contract. I stumbled across the info when researching "defensing mimetics" and was a bit uncomfortable with the fact that the company he works for, ioGgenetics, has a drug under development that would appear to be a competitor to Brillicidin. The info from their web page states:
"IOG-101 s designed to treat Staphylococcal infections including MRSA. It is targeted to enter into Phase 1 for ABSSSI (acute bacterial skin and skin structure infections) in 2015. The MRSA global market size is about $8 billion and current antibiotics continue to develop resistance. This product is clearly differentiated from current marketed products with minimum dosing/duration of administration compared to current products due to its distinguished mechanism of action. It has no/low toxicity and targeted delivery effective at nanomolar level based on in vitro and in vivo data to date. The preclinical in vivo data in animals is showing great promise for both therapeutic and prophylactic applications – offering significant benefit to the patient, as well as to the healthcare system in reducing hospital costs. Since this product can be developed for multiple indications, including pre-surgery prophylaxis, it has block buster potential."
It's notable that they are way behind us in development though.
Hi 58nout - It's our guy. This is the description from the iogenetics page:
http://www.iogenetics.com/about_us/management.html#anchor4
Daniel Jorgensen, MD, MPH
Chief Medical Officer
Dr. Jorgensen is an accomplished physician executive and corporate officer with 16 years of Industry experience, including 10 years at Pfizer. Most recently, he was the Senior Vice President, Clinical Development and Chief Medical Officer at PolyMedix, Inc., where he successfully conducted the first clinical efficacy study on a novel class of immunomodulatory antimicrobial compounds known as defensin-mimetics. At Pfizer, Dr. Jorgensen was the Global Clinical Leader for Zmax (single-dose azithromycin) and the Development Team Leader for dalbavancin (second generation glycolipopeptide). He was named Pfizer’s first Vaccine Development Team Leader and was responsible for the company’s first human vaccine trial (DNA influenza vaccine). He began his Industry career at Pasteur Merieux Connaught, in the area of viral vaccine development. In these leadership roles, he has successfully ushered several products from early clinical development through full regulatory approval, both in the U.S. and abroad, playing a key role in NDA submissions and FDA Advisory Committee Meetings. Dr. Jorgensen is a CDC-trained epidemiologist (EIS Officer), with public health experience at all levels (local, state, national, international), and is the former Chief Medical Officer for the State of Montana. Dr. Jorgensen received his undergraduate degree from Yale, his MD from the University of Wisconsin, his MPH from the University of Washington, and his MBA from Yale. He is board-certified in three medical areas: pediatrics, infectious diseases, and preventive medicine.
Re: Dr. Daniel Jorgenson. In doing some researching about defensin mimetics today and what completion may be out there I came across a company called ioGenetics. They have a drug in development called IOG101 that is targeted towards ABSSSI like Brilicidin. Then I happen to see Dr. Jorgenson is listed as the Chief Medical Officer for them. I know Dr. Jorgenson presented Brilicidin data for Cellceutix at Therapeutic Area Partnership (TAP)last November so I had assumed he had joined Cellceutix since he headed up the research for "B" at Polymedix. I noted we don't list him on the Cellceutic "Our Team" page so is he just a consultant to Cellceutix with regards to Brilicidin? If so too bad I thought he was "on our team" so to speak.
Great post CallMeCrazy. What sets Cellceutix apart is the multiple drugs/platforms they are developing, they are not a one trick pony. This reduces investment risk but it will take time to come to full fruition. "K and B" are both unique in their approach. To date nobody has introduced a drug (without undue toxicity) to fully restore P53. Similarly "B" offers a unique approach by cell wall destruction or defensin mimetics.
I think most are here for "K" as it offers incredible opportunities for use considering wild/mutant P53 is implicated in so many cancer types. It's exciting to see we have not had serious safety setbacks thus far and are now in the range where true therapeutic utility is anticipated. Couple that with the suggestive benefit to a small sample set of patients at low doses (restaging of patients) definitely gets us excited since the results were with advanced 4th stage patients. Intuitively repair of P53 might best be achieved by use of the drug earlier in the disease process (stage 1/2) so there is less of a tumor burden and before the patients immune systems are not as compromised as those who have gone thru several types or rounds of debilitating chemotherapy. I think this might ultimately be the best use for "K" however that question will require further "targeted" trials down the road. Consider that tamoxifen, a prophylactic use drug during it's heyday was about a 600 million per year advocated for just specific types of breast cancer patients. P53 is implicated in multiple (50%?) types of cancers, thus the potential applications are staggering. The fact that Cellceutix also has "B" and "P" in the pipeline is what sets Cellceutix apart. Those that are patient will be rewarded in my opinion, it will take multiple years to fully see the potential but the potential is so mind boggling assigning a future value is almost impossible. Saturday afternoon ramblings......
Apparition - We understand your views on who is "paying/sponsoring" the trial and the frustration with not having more "meaty" data updates during the trial. That said, if you think a sponsoring company like Cellceutix can waltz in to DF, one of the pre-eminent cancer research institutions in the world and demand to have an unfettered say in what gets released and when, then I believe you are very mistaken. DF would respectfully say to the sponsoring company - there is the door, our reputation, knowledge about how a trial should be designed and run (thousands of trials) and desire to do get it right, comes first. It's my opinion the info clamp down came after the R&R 2013 powerpoint presentation revealed so much about the initial cohort results, including the tumor reduction/stabilization and P21 expression at 20-30 mg dosage. I think DF had a pow wow with Menon/Erlich and it was mutually agreed there would be no more detailed info released until the end of the study, just cohort progression, dose etc. but not the same level of detail. Too much at stake. So while Cellceutix is sponsoring, it's strongly my opinion DF definitely has a say and what is made public during the trial. I think it was a real "come to Jesus" meeting and its been a much tighter ship since then. Just my opinion, DF is arguably the best at running oncology trials and I believe they definitely have a say in what is going to be released and when. Hopefully cohort progression news on the big K in coming weeks followed by good Brilicidin results. I think brilicidin can be a gold mine, drug resistant bacteria strains are just going to get worse, we a re in the right spot at the right time....
I believe the final Russell list is to be released 3pm pacific, so 6pm eastern.
I'm a lifelong Rangers fan, cannot wait for Wednesday but the competition will be stiff. Hope XXII can go on a run like the Ranger have....
Watching a bit of the Stanley Cup playoffs eh.....
Is that you Chauncy?
"The Dane" Thanks "Chauncy" LOL
If you are 6'5" no issues LOL
I don't think the PRs reflect a "frustrated CEO", I think he is just trying to keep the shareholders informed of future opportunities the company is aware of. I would rather have information overload and plenty of PRs than not any info but that's just me.
Actually knew a guy by that name - what were his parents thinking, poor SOB. Makes me think of the old song a man named Sue.....
"septmike09" - "Frankly it gets tiring listening to all those other great deals. Why doesn't Leo step up to the plate and make one?" Because patience is needed (in my opinion) to maximize the return on the deal. Make a deal now before "B" results are realized (probably by years end or 12 mo.) and not get "full monies worth, or wait until the results are in and maximize the returns on the deal when we know what we have (assuming positive). In my opinion you wait until you have results since we have the money available to last another year (and then some). It all boils down to confidence in the drug. If you think you have it you play your cards accordingly. Thus patience is needed. I believe the quantum leap in appreciation is next year since we will have much greater clarity on many fronts.
"tombrady12nh" - So by your logic we should be judging the value of the acquisition on near term "B" approval as opposed to the Phase 2B study underway in which we should have results in the fall? You must live minute by minute and have no long term perspective. The price could drop in the next month or two, makes no difference to me as all understand the final value of the acquisition will be based on the study results, not next weeks/months potential orphan designation. Your comments make no sense at all. It appears your playing the self validation game, you sold (some/all don't remember) and now your trying to validate the decision by trying to instill doubt in others. You need to bring a lot more rational perspective to the table than that. I have no problems with anyone selling and hoping to reenter at a lower price but Ii loose respect when some soft bash which is how your comments come across. That said, I wish you the best of luck regardless.
Hi JamesK101,
I had a good laugh at your reply regarding keeping things in perspective. With regards to turning ugly people in to super models, already covered - it's called "last call for alcohol at closing time" everything looks different at that point in time - just having some fun folks, last comment was for laughs.
GLTA
Hi "sox040713"
After closer review I agree, not our study.
Hi "morecoffee"
Just checked the Roche site, RO5429083 was developed by Roche and is not related to Kevetrin from what I see. What are everyone's thoughts about the Roche drug trial duration though (55 months), would out Kevetrin trial be similar length?
Just looked on the Cellceutix site and they reference the UOB study as follows:
The University of Bologna in Italy plans on testing Kevetrin for efficacy against Acute Myelogenous Leukemia (AML). The planned Phase 1B is a multi-center, open-label, dose optimization trial with Kevetrin, administered intravenously with Cytarabine administered either subcutaneously or intravenously. The University of Bologna will source the funding for this trial and plans to initiate the trial once a higher MTD is achieved in the Phase 1 trial conducted at Dana-Farber.
So they are sourcing the funding, so anyone can be the "funder"..
Still not certain the referenced study on the UOB site is indeed the Kevetrin study, why not just say Kevetrin?
I have not gone back to research, was our study sponser Phizer?
"eventhelosers"
This is the cut/paste from the referenced study (it is 55 months duration) if it is the correct one.
Overview
Research Study Summary
A clinical research study of RO5429083 and cytarabine for the treatment of Myelogenous Leukemia, Acute
Research Study Title
Open Label, Multicenter, Dose Escalation Phase 1a/b Study of RO5429083, Administered as Intravenous Infusion Alone or in Combination With Cytarabine in Patients With Acute Myelogenous Leukemia (AML).
Purpose
This multi-center, open-label study will evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of RO5429083 alone and in combination with cytarabine in patients with acute myelogenous leukemia. In Part A, patients will receive multiple escalating doses of RO5429083 intravenously. In Part B, patients will receive RO5429083 plus up to 4 cycles of cytarabine (1000 mg/m2 iv daily for 5 consecutive days). Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
Phase
1
Gender
Both Male and Female
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Hoffmann-La Roche
Duration
55 Months
Facility Type
N/A
"CallMeCrazy" I think you are correct. Looks like two sites in France, three in Germany and one in Italy. Study duration 55 months.
Hi Steelyeye - I think they will have a full board/uplisting completed before they entertain collaborative agreements with a partner. To me that would be a better bargaining position, especially if some of the prospective board members are from the pharma/biotech industry. That said, concurrently offering a board seat to a prospective suitor during the uplisting/BOD appointment, if simultaneous, is also an attractive bargaining chip.
I think later in the summer/early fall makes sense as I believe it would more than likely involve brilicidin and it appears preliminary data from that study will not be available until that timeframe unless they want to offer a board suit for Kevetrin, the crown jewel in their basket (not that the other jewels are shabby).
Hi Korogi, I think the delayed approach Ehrlich has taken with regards to adding independent board members makes very good sense from a fiscal standpoint. Even if we had all the board members in place right now if I understand the NYSE and NASDAQ requirements we could not uplist at this time due to share price (and perhaps other factors), thus paying for the board members at this time is premature. That said, I also think Leo probably has already had several interviews with potential board members and it may very well be a case of as soon as we meet the other criteria we will sign the candidates and then make the application for uplisting at the same time. In this manner the costs for the board are delayed until the other criteria for uplisting are met, makes good sense to me. I also don't have any heartburn about the other issues that come to light recently like the salary increases. Lets be honest, either we trust management or we don't. Thus far I have not seen anything that raises big red flags. Ultimately Menon and Ehrlich have the most skin in the game and as of now its their locomotive and they are the conductors, we the passengers are in the caboose but more than willing at this point to have a ticket for the ride. Also uplisting will not shelter us from orchestrated short attacks, just look at NNVC, DNDN, overstock.com and others, uplisting did not shield them from manipulation. For now I am fine with where we are, which is light years ahead of where we were 15 months ago when I first purchased. Lets hope we get an updated ASCO slide this year similar to last years but this times is updated to include multiple patients with tumor reduction, still no SAE or dose limiting toxicities or confirmed p21 biomarker expression. Then its off to the races.
Ah heck I Need Help, now you went and spoiled the pitty party and hand wringing crowd with some darned common sense comments - what were you thinking
MineAllMine - You hit the nail on the head. It's my belief Blzzys political leanings and his hatred for JW/former management preclude having an objective discussion on the science behind anatabloc. We don't need to be saved from ourselves, people here can make a decision for themselves. While it may be years off, I do think anatabloc will go the full FDA route and it will be utilized, perhaps as a cocktail with other drugs, in the treatment of alzheimers and probably other conditions. The safety is well established, dizziness as a minor side effect does not negate the benefits and would not stop the product from being pursued. A label warning of the side effect could be used, just like it is used for many other drugs. Use of Oxycodone/Tylenol obviously carries a substantial risk of dizziness (let alone liver issues) but it has not stopped it from being widely used, Highlighting (cherrypicking) this minor adverse effect and saying this is a reason it should not be marketed is nonsense.
Pepsiman2001 - I think your recollection is pretty accurate from what I recall as well. The end of the company followed closely on the heals of the reverse split too. The research I did also revealed the former CEO (Nicholas Landekic) was not well liked in the industry and he might of alienated potential partners. His replacement, Edward F. Smith, inherited a mess he could not recover from in time. Make no mistake about it though, the purchase of the Polymedix assets including Brilicidin and the defensin-mimetics platform was the heist of all times in my opinion. We purchased a unique, first of it's kind antibiotic where bacterial resistance is unlikely to develop. Efficacy was established in the Phase 2a, the 2b is to further refine the optimal dosage (hopefully single dose). So we bought an antibiotic ready for the phase 2b and possible fast tracking that has a potential market in excess of 1 billion for a mear 5-million. Incredible in my mind and that does not include the other drugs in the Polymedix pipeline. Leo found a gem and got it for fire sale money. Gives me great comfort because it reduces the overall risk for Cellceutix as we wait for additional evidence of what Kevetrin is doing, and from all indications it's going stellar there as well.
Thanks "wild4ctix". I am typically a lurker but try to contribute on occasion.
Hi Govorchin,
Thanks for the nice note, so sorry to see the degree cancer has impacted your family/loved ones. It certainly reaffirms the need to stay well read on new developments/research in the oncology arena. I know I try to be well read due to my daughter but fortunately she is as well since she is a nurse. As for our current Kevetrin trial, I am hopeful we get a similar update at this years ASCO as we did last year. Imagine if they can report multiple patients with "tumor regression" by that juncture since additional cohort information will be available. That will open eyes for sure. I also agree the fact that the Univ. of Bologna is moving forward with their study prior to completion of the Phase I at DF speaks volume since it appears they feel they have enough information now so why wait (plus they probably have access to additional info).
One other point I wanted to toss out to the forum here concerns the potential for some of the other assets Cellceutix acquired in the Polymedix fire sale such as the PolyCide Antimicrobial in Surgical Suture Coatings application. The link below shows it had very favorable results in their study. I have been unable to determine what the market might be for this application. Thoughts anyone..... The use of antimicrobial coating technology on other surfaces also is of interest to me since my profession (industrial hygiene/health and safety) takes me in to hospital settings where hospital acquired/nosocomial infections are a big problem. The fruition of this type application/technology may be many years away but imagine developing surfaces that inhibit microbial contamination, the applications, and inmplications are vast.....
http://globenewswire.com/news-release/2012/09/05/488925/10004018/en/Data-Showing-Effectiveness-of-PolyCide-Antimicrobial-in-Surgical-Suture-Coatings-Published-in-American-Chemical-Society-Journal-Langmuir.html
Hi Govorchin,
I enjoy your posts immensely but wanted to provide some comments on the amount of disclosure investors are receiving on the kevetrin trial vs secrecy and the potential for cures in either the current solid tumor trial or subsequent applications like retinoblastoma.
I believe the amount of information released has been fairly good for a phase I. I don’t believe DF is withholding information because of investigators ego’s or so they can maximize the impact/splash of the data. I believe they are being extra cautious because the data has to be statistically analyzed and fully vetted and the trial is not complete. DF rightfully has to approach it from a scientific standpoint so hopes are not falsely raised on incomplete data. We are dealing with very small patient numbers in our study. I for one, have been very happy (ecstatic) with the information disclosed in conference presentations like ASCO and the recent SF conference. As you have summarized Govorchin, we have multiple participants completing multiple cycles (I have tried to research how common it is but have not been successful) and we know we have had stabilization and now a case of tumor regression. I am thankful for having received these tidbits during the trial as opposed to at trial completion.
I also think it’s prudent to keep in perspective any talk about “cures” at this juncture. For solid tumors it’s typically 5 years cancer free after a complete response, so we cannot accurately claim anyone will be cured, even if they have a complete response, at the end of the Kevetrin phase I. Hopefully down the road those folks will fall in to that category. To provide some perspective, our Kevetrin trial is utilizing CT scans as a measurement of response. Even if there was a complete response and no evidence of a primary or metastatic tumor via CT scan after treatment, this is not a guarantee of cure. The link below illustrates this.
http://jco.ascopubs.org/content/24/24/3939.short
Review of the study, “Complete Response of Colorectal Liver Metastases After Chemotherapy: Does It Mean Cure?” reveals:
“Overall, 66 LMs (liver metastases) disappeared after chemotherapy as seen on CT scan. Persistent macroscopic disease was observed at surgery at the site of 20 of 66 LMs, despite CT scan showing a complete response. The sites of 15 initial LMs that were not visible at surgery were resected. Pathologic examination of these sites of LMs, considered in complete response, showed viable cancer cells present in 12 of 15 cases. The sites of 31 initial LMs that were not visible at surgery were left in place during surgery; after 1 year of follow-up, 23 of 31 LMs considered in complete response had recurred in situ. Overall, persistent macroscopic or microscopic residual disease or early recurrence in situ were observed in 55 (83%) of 66 LMs having a complete response on imaging.”
I want to emphasize, I am not trying to be a wet blanket here, I am just trying to keep things in perspective. The results we have had thus far for kevetrin are great, but it’s still early in the process. The only way to critique the potential efficacy is to let the trial run its course and then review the data. There are many examples where promising preliminary data on new drugs/treatments ultimately proved to be no better, or in some cases worse, than the standard treatment that was in use for a given use at the time. In closing I’ll use the following example. Back in the early 90’s, early data on the efficacy for the use bone marrow transplantation (specifically autologous peripheral stem cell transplants) looked very promising as compared to other standard care methods. After several years of use and study, I believe it was determined that the approach did not offer superior long term benefit in terms of survival. My first wife rightfully tried this treatment based on available data at that time. Unfortunately, despite the extremely aggressive treatment where upon completion she was in complete remission, she subsequently succumbed to the aggressive breast cancer just 6 months after the treatment following relapse at the age of 34. While I own a ton of Cellceutix stock and want to see this succeed for financial reasons, it’s even more important from a from a personal perspective since I have a daughter and I know of several others where Kevetrins success is ultimately much more personal implications.
Govorchin so you know I respect your tenacity to keep pushing for information, keep doing it! I just wanted to express my thoughts. I’ll try to post again later today/tonight on another brillicidin topic that has not been spoken of that excites me.
Best to all, especially to those fighting cancer!
'Orion Nebula" and earlier "BK" - thanks so much for taking the time to clarify why "curing cancer" is not a realistic outcome for Kevetrin, even if it is successful beyond our wildest dreams. Way too much talk about curing what obviously is a host/multitude of disease states broadly classified as "cancer. Will select patients be cured of cancer, I believe so, how many and what type remains to be seen. By the way, most solid tumor cancers are not considered "cured" until a they are five years disease free after treatment, even then some relapse but the odds are in your favor at that milestone, thus it is used as a measurement milestone. So even now, if a patient in our Kevetrin trial had a complete response and had no observable disease, they are not "cured". We need to be mindful of how we use that term. Not trying to be a wet blanket, we just need to keep it real. That said, the progress we have made is fantastic. The fact that multiple patients with refractory disease have completed multiple courses is very noteworthy. The fact that we already know there is documented tumor reduction at what the experts believe is sub optimal doses is also fantastic. I just don't understand the folks who are upset with the progress here. This is not a get rich tomorrow stock, biotechs and PI/II or III trials always take longer than expected. The fact we will have multiple trials this year is great news. They would not be considering starting the other Kevetrin trials if the evidence of its utility was not there. Wish there was a post recommendation feature here. Orion, BK & Biohedge your posts are very worthy, as are many others here - not trying to leave others out. Good luck to all!
Hi Apparition, perhaps you are right but it was a fun academic exercise to flush out the details Hope we all hit the lottery with CTIX, I know I have my tickets.
Hi Thales622, not certain if I follow you. The cruxes of one of the class action law suits I believe was that Star miss-represented the relationship between Star & JH in that they led others to believe JH was intimately involved in the study. As we know, Paul Ladenson, the JH endocrinologist involved in the study, is a paid consultant by Star. That said, I just find it surprising that on JH own web page they list the thyroid study under "Johns Hopkins Research". Well Star did not write that, JH did, how can Star be litigated for misleading folks about the relationship when JH themselves lists the research as JH Research? I would be presenting that information front and center if the meritless class action lawsuit gains any traction.
Thanks Blzzy, and same to you. I found it very interesting that the Johns Hopkins web page listed in the referenced study is under "Johns Hopkins Research" Kind of negates the claim in the litigation that Star was promoting the link between Star and JH. It's plainly on JH web page - Star are you observant of this........
Fair enough, I agree I want to see additional studies, but marginal to me means not good results - the thyroid stuff is definitely not marginal, that's why the authors felt additional/continued assessment was warranted. I think the other anecdotal results reported by users are indicative of a growing tangential body of evidence information that is what has the FDA's knickers in a knot. If I a thyroid problem I would definitely be using it. In the internet age word gets around quickly and people draw their own conclusions, that's why the FDA is uncomfortable since the study referenced was a double blind study typical of one done by a pharmaceutical company. Good investing..