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P's study’s main goal was to provide indications of efficacy, safety and tolerability upon treating patients with mild to moderate plaque psoriasis via oral delivery.
It's not that they were trying to get the right dose. They were testing the oral dosing method for indications of efficacy and safety. They saw a response! Now they know they can increase without safety or side effect concerns.
Ok, guess I can't debate that. Company says they are in talks; you say they are not. Curious, why do you think they are not? Do you work there? The market is there. Results are better than anything on market for B OM.
Also, regarding P, wasn't the purpose of phase 2a to test the oral delivery method?
There were positive results and from the May 24, 2016 announcement. ..
Pharmacokinetics/Pharmacodynamics (PK/PD) further revealed an early (by week 8) dose-related response that improved as treatment duration increased.
I see. IF P fails, then company is going under even if B is a global winner with big markets? I don't see the logic.
Do you charge money for this advice? You must not think the company is in serious talk with big pharma regarding Brilacidin-OM and possibly B UP.
Why I think IPIX will succeed:
B is at a point where taking on debt is less risky, if it increases value of the drug.
A global BP is likely to partner with B OM since it will have global patents and reduces incidence of OM. If data also shows it reduces duration as well, then value increases. Potentially, delivery method could be improved if delivers even better results.
Why I think IPIX could make a meaningful difference in shareholder wealth:
If P shows effectiveness on par with Otezla, but shows earlier effectiveness, then have a marketable drug.
Why I think IPIX could positively and dramatically alter my financial well being:
If K has an impact on Ovarian cancer as some of us think it will, then we could have a drug with tremendous potential.
Money and wealth aside, I hope many benefit from the medical side of the three drugs.
How is mgmt combating the shorts.
Is it safe to say, once you get OM it's difficult to eliminate it regardless of the drug?
Rdunn88, are you saying that the placebo group had "normal" prevention means. Maybe something like a cocktail of drugs that is used currently by physicians? Or is it that placebo group had no drugs.
Only 36.8% incident rate, so 63.2% prevention. It's the fact that B has a noticeable impact to OM prevention is what's important.
B UP too?
Key is reduced chances of incident rate. If it also reduces duration, then even better. Will make it a more attractive drug.
Not to mention a potential better delivery method besides swish and spit.
B OM...
European Patent granted.
FDA Fast Track designation.
40% reduced chance of getting OM.
If get OM, then a chance to shorten the duration by a few days.
Global market game changer for OM.
Anchored the B UC results.
Then, there is the many other indications...skin, etc.
B OM. what would be the possible Phase 3 strategies in terms of dosage?
B OM
Study showed a markedly reduced rate of Severe OM (WHO Grade ≥ 3): Active Arm (Brilacidin): 2 of 9 patients (22.2 percent); Control Arm (Placebo): 7 of 10 patients (70 percent)
Formal collaboration with pharmaceutical companies that have expressed an interest in partnering Brilacidin-OM may well assist further with expediting the drug candidate’s development timetable. Some of these partnering conversations have matured to the point of potentially structuring mutually beneficial licensing agreements, pending the final Phase 2 study results.
The Company believes that a successful Phase 2 trial would be a major breakthrough. Fast Track designation by the Food and Drug Administration (FDA) for Brilacidin-OM has already been awarded. In addition, the Company plans to apply for FDA Breakthrough Therapy Designation should top-line end of study results reflect similar efficacy (and safety) to that observed at interim, in which patients treated with Brilacidin-OM experienced a markedly reduced rate of severe OM compared to those on placebo.
By 2030, the global annual incidence of Head and Neck Cancer is expected to exceed 1 million cases
Prurisol snippets from May PRs after trial results:
Among patients participating in the study with the severest form of psoriasis, those having a baseline IGA score of 3 (“moderate”), the primary endpoint was met in 46.2% of patients who received Prurisol 200mg. This data was derived from analyses of all patients randomized across all 9 participating study sites.
It is interesting to do a side-by-side comparison between the two based on publicly available literature, and it could be argued that Prurisol performs on par with, if not better than, Otezla® at the identical stage of development
Cellceutix Phase 2 Trial of Prurisol for Mild to Moderate Psoriasis Meets Primary Endpoint
- Clinical efficacy demonstrated in the highest dose (200mg) comparator arm
- Compound shown to be safe and well-tolerated with a dose-related response
- Oral delivery often preferred among patients, increasing adherence to treatment
Overall analyses showed Prurisol, which is being developed under the FDA’s 505(b)(2) program, to be superior to placebo in the 200mg arm. Pharmacokinetics/Pharmacodynamics (PK/PD) further revealed an early (by week 8) dose-related response that improved as treatment duration increased.
For purposes of direct comparison, the Prurisol trial outperformed a similarly designed Phase 2b trial in the treatment of mild to moderate psoriasis conducted in 2011 by Anacor Pharmaceuticals in which a topical anti-inflammatory compound was assessed.
Numerous PIs noted patients expressed a desire to have access to Prurisol following the study’s conclusion. Moreover, the Company learned that some patients were previously unsuccessfully treated with other therapies, including biologics and apremilast (Otezla®).
Leo Ehrlich, Chief Executive Officer of Cellceutix, commented: “We had always wanted to explore Prurisol’s clinical merit, as it had excellent results in laboratory studies. We put it to the test under some of the most demanding conditions, with respect to the IGA versus PASI scoring systems; short treatment duration; low dosing levels; enrollment that included patients who were previously treated with biologics; and evaluation in mild to moderate psoriasis patients, where it can be more difficult to achieve a meaningful therapeutic effect. To see such a strong response among patients, achieving clear to almost clear skin without serious side effects—the downside of biologics—in such a short period of time, is exceptional.
Based on PR comments in May, no reason why P will not better Otezla.
Price seemed to change with the Cox article. News should come out before end of December, which should improve price further. Partnership will be the true catalyst when it comes.
Prurisol. I took some snippets from the announcements back in May. Shows why such high confidence in Phase 2b.
Among patients participating in the study with the severest form of psoriasis, those having a baseline IGA score of 3 (“moderate”), the primary endpoint was met in 46.2% of patients who received Prurisol 200mg. This data was derived from analyses of all patients randomized across all 9 participating study sites.
It is interesting to do a side-by-side comparison between the two based on publicly available literature, and it could be argued that Prurisol performs on par with, if not better than, Otezla® at the identical stage of development
May 24, 2016
Cellceutix Phase 2 Trial of Prurisol for Mild to Moderate Psoriasis Meets Primary Endpoint
- Clinical efficacy demonstrated in the highest dose (200mg) comparator arm
- Compound shown to be safe and well-tolerated with a dose-related response
- Oral delivery often preferred among patients, increasing adherence to treatment
Pharmacokinetics/Pharmacodynamics (PK/PD) further revealed an early (by week 8) dose-related response that improved as treatment duration increased.
May 24, 2016
Cellceutix Phase 2 Trial of Prurisol for Mild to Moderate Psoriasis Meets Primary Endpoint
Prurisol
- Clinical efficacy demonstrated in the highest dose (200mg) comparator arm
- Compound shown to be safe and well-tolerated with a dose-related response
- Oral delivery often preferred among patients, increasing adherence to treatment
- Additional studies planned in moderate-to-severe psoriasis and eczema
BEVERLY, MA–(Marketwired – May 24, 2016) - Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, antibiotic, and anti-inflammatory applications, is pleased to inform shareholders that topline data from the Company’s Phase 2 FDA trial of orally-administered Prurisol in the treatment of mild to moderate chronic plaque psoriasis have been compiled and reviewed. The trial successfully achieved its primary endpoint, further validating Prurisol’s potential as a novel oral treatment for psoriasis.
Study Background
Enrolling 115 patients, the placebo-controlled, randomized, double-blind trial tested the efficacy and safety of three separate, twice-daily, dosing regimens of Prurisol—50 milligram (mg) (50mg QD), 100mg (50mg BD), and 200mg (100mg BD). All patients were assessed via the 5-point Investigator’s Global Assessment (IGA) scale, ranging from a score of 0 (“clear”) to a score of 4 (“severe”). The IGA scale is preferred by the U.S. Food and Drug Administration (FDA) and is comparable to the older and more commonly used Psoriasis Area and Severity Index (PASI) in evaluating psoriasis severity of patients, with many dermatologists preferring it in the clinical trial setting. Generally, an IGA score of 0/1 demonstrates a strong association with a PASI 90 score.
For more information comparing the IGA and the PASI psoriasis scoring systems, please see the link immediately below. Two additional links have been provided summarizing recent dermatological studies by Regeneron and Anacor that used the IGA scale.
http://www.ncbi.nlm.nih.gov/pubmed/24354461
http://newsroom.regeneron.com/releasedetail.cfm?ReleaseID=963078
http://investor.anacor.com/releasedetail.cfm?releaseid=921668
Entry criteria for the study required: a total Body Surface Area (BSA) affected by plaque psoriasis of 10 percent to 20 percent; a baseline IGA score of 2 (“mild”) or 3 (“moderate”); and the identification of a target psoriatic lesion with a score greater than or equal to 3 based on a different (than the IGA) lesion-specific 5-point scoring scale. Clinical signs that psoriasis is clearing typically are more noticeable in patients with a greater severity of symptoms. This translated into a rigorous and aggressive study design for the Prurisol trial.
The primary endpoint assessed was the percentage of patients achieving at least a 2-point improvement from baseline on the IGA 5-point scale as measured by visual inspection of patient lesions at the end of the 84-day (12-week) treatment period. In effect, given the entry criteria, participants had to at least obtain an IGA score of “clear” or “almost clear” skin, dropping to 0 or 1 after starting from a baseline of 2 or 3. Secondary endpoints included additional improvement measures tied to degree of patient response at various time intervals.
Results Summary
The Phase 2 Prurisol trial, while not powered to demonstrate statistical significance, was conducted to inform any future fully-powered Phase 3 trial(s) that might be merited. As a result, the study’s main goal was to provide indications of efficacy, safety and tolerability upon treating patients with mild to moderate plaque psoriasis via oral delivery.
Overall analyses showed Prurisol, which is being developed under the FDA’s 505(b)(2) program, to be superior to placebo in the 200mg arm. Pharmacokinetics/Pharmacodynamics (PK/PD) further revealed an early (by week 8) dose-related response that improved as treatment duration increased.
Evaluating the primary endpoint at 84-days (week 12) in the 200mg arm, 35.0% of the patients receiving that dose of Prurisol demonstrated clinically significant improvements compared with 16.7% of patients on placebo only. This percentage includes patient data from one site where investigator non-compliance may have occurred. Were that site to have been excluded from overall data analysis, as is done in some clinical studies (refer to the journal article linked to below, published findings from another psoriasis study), 43.7% of patients in the 200mg Prurisol arm would have met the primary endpoint. Patient responses in the 50mg and 100mg arms were statistically comparable to the placebo arm.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4229025/
For purposes of direct comparison, the Prurisol trial outperformed a similarly designed Phase 2b trial in the treatment of mild to moderate psoriasis conducted in 2011 by Anacor Pharmaceuticals in which a topical anti-inflammatory compound was assessed. See the link below.
http://investor.anacor.com/releasedetail.cfm?releaseid=587511
Sub-population analyses further showed greater efficacy demonstrated in patients who had a baseline IGA score of 3 (“moderate”) as compared to those with a baseline score of 2 (“mild”). Some of these patients even experienced a 3-point reduction in their IGA score, going from “moderate” to “clear.” This suggests Prurisol may be more effective in treating moderate to severe psoriasis patients to a greater degree than those patients who exhibit less severe symptoms. In moderate to severe psoriasis studies, the placebo response also tends to be lower.
Numerous PIs noted patients expressed a desire to have access to Prurisol following the study’s conclusion. Moreover, the Company learned that some patients were previously unsuccessfully treated with other therapies, including biologics and apremilast (Otezla®).
Leo Ehrlich, Chief Executive Officer of Cellceutix, commented: “We had always wanted to explore Prurisol’s clinical merit, as it had excellent results in laboratory studies. We put it to the test under some of the most demanding conditions, with respect to the IGA versus PASI scoring systems; short treatment duration; low dosing levels; enrollment that included patients who were previously treated with biologics; and evaluation in mild to moderate psoriasis patients, where it can be more difficult to achieve a meaningful therapeutic effect. To see such a strong response among patients, achieving clear to almost clear skin without serious side effects—the downside of biologics—in such a short period of time, is exceptional.
I don't get the P concerns or doubts. It's not a biologic. We know lab results. We know it's dose dependant. We know it's safe. We know P2a was a more difficult scale and P2B is easier. We know improvement is better with severe or moderate and P2B focuses here. We know the comments by some patients about moist skin. We know it works faster than other Psoriasis medicine. We know Dr. B has the background.
To me it's not a matter of if; it's a matter of how much. Are we comparable to biologics or not? Soon we will know.
Read the MP Advisors report again. Can someone help interpret figures 11 & 12 for me in the Prurisol section? Many thanks!
Tuesday, Nov 28 2017.
Just don't like the idea of dedicating resources. Unless he meant hiring. I would rather continue advancing the other products.
If P is moderately successful yet safe possible to have another small study to increase dose? Or do they stop development and try to sell at best price?
If outstanding results then I anticipate phase 3 with or without partner.
Not worried about a partnership. Quite frankly a total purchase of the company is more likely, IMO...if K is positive along with P. So, speeding up trial results and delaying agreements builds more value. However, I do hope for partnership instead of buyout.
Our best hope is to delay deal as long as possible without too much dilution. And science keeps progressing. Too me, this is our best hope, which would maximize value the quickest.
Why would P fail? I just don't see that happening. My guess is that it will be better than Otzela with fewer side effects and show positive effects earlier.
December
Fully agree
IMO, if K OC study provides hoped for results, then it will be full speed ahead for K.
Maybe todays PR was meant for people who want to buy more shares...giving a signal of more concrete timing with BOM. Maybe Leo does have somewhat an idea of general P results but does not want to look at interim as it could reduce the end results. Hesitation because he knows in general the results are sufficiently good. Who knows.
I think some criticism of Leo/IPIX is deserved and healthy. Allows us to debate good and bad points so that we can all make our own decisions. If only good items are posted and discussed then doesnt keep mgt accountable for timing, actions, comments. I don't like the nonvalue and illogical FUD by some as it insults some of us. However, I do like the back and forth about some of the decisions made and timing of next steps. This is what makes leaders stronger and companies better. We are likely all putting our money to work and Leo does get a good salary, so he can handle it. And as shareholders we deserve pushing, hard work, and smart decisions by mgt.
Ok, thanks. In your opinion, why is the short half life considered a good aspect of the drug? I remember many comments made on this front.
Can you define what is meant by not effective in IV? Do you mean not practical? Or do you mean no results?
Possible that the recent finance deal and shelf is mostly meant for Kevetrin? If K OC trial reveals what is hoped for, then the company has essentially said they will push forward strongly.
Thank you Frrol.
Is the impression that K activates P53 or does it activate something downstream?
Let's just say Leo failed some things whether failed up listing , too high salary, other...how valuable will the company be or even how strong if positive P results coming up, positive OM, and postitive K results upcoming. Will it be Leo's success?
Thanks both! Good stuff. Looking forward to KOC results. Interesting about Dana Farber.
Aileon seems to attmpt to inhibit protiens MDMX and MDM2. How does this differ from K? I believe K is attempting to activate wild type p53 and degrade mutant p53. Maybe someone else can better explains the difference.