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It will be interesting to see if BTD happens for IPIX BOM product which uses a simple 3X per day oral swish and spit.
A question concerning Galera's calculation for SOM duration reduction from 19 days to 1.5 days...relative to the Galera link you posted.
https://globenewswire.com/news-release/2018/02/28/1401167/0/en/Galera-Therapeutics-Receives-FDA-Breakthrough-Therapy-Designation-for-GC4419-for-the-Reduction-of-Severe-Oral-Mucositis.html
Did Galera use the calculation of MEDIAN duration or MEAN(avg) duration to get the SOM duration reduction days? They are not forthcoming in the above PR how they came about with this statistic. AND whether they included the zero day patients not getting SOM? Neither are they forthcoming with this info on their website.
If they are using the MEDIAN duration statistic (midpoint of SOM days) that includes patients with 0 days (NOT getting serious OM) in addition to the duration days for patients with serious OM, then it could be why this number is 1.5 days.
Here is a results link to Galera's Phase 1 of 46 patients for oral mucositis IV therapy including 6-7 weeks of therapy with 90 mg 1x per day and 5 days per week.
https://www.sciencedirect.com/science/article/pii/S0360301617340245
If you look under "Safety" titled paragraph and focus on the bar graph you will see the bottom section shows full Rx of 6-7 weeks for two seperate 90 mg dose protocols and a 30 mg dose protocol. There is an instance of Grade 3 SOM for est. 3 weeks, Grade 3 SOM est. 2 weeks (1 instance), Grade 3 SOM for est. 1 week (2 instances) and 6 instances of Grade 3 of est. 4-5 days.
Looking seperately at the 90 mg and 30 mg for 6-7 weeks of treatment. They are claiming under "Results" titled paragraph, a MEDIAN SOM duration of 2.5 days for 6-7 weeks of treatment. Are they including those patients who never got SOM and contribute 0 days when coming up with their 2.5 days MEDIAN duration calculation??
Hey look, I'm not knocking the product, I want to know what calculation Galera used to come up with SOM duration reduction that was presented to the FDA to get BTD. And why Galera is not indicating in their PR for BTD how they came up with 1.5 days SOM reduction for Phase 2 results (did they include all zero day patients not getting SOM and used the MEDIAN calculation?)
I want to see their Phase 2 results in a bar graph form similar to those in their Phase 1 results link I outlined earlier.
Only caught the following 46 patient results (Phase 1B/2A) on their website (similar to the article above).
http://www.redjournal.org/article/S0360-3016(17)34024-5/fulltext
I have doubts Galera would have as good results with any oral alone attempts (where did you catch this? And their reasoning for doing this - a combo therapy?) Currently, they are infusing 1 hr 5x per week for 7 weeks before the radiation/chemo treatments. Not to belittle what they've currently done.
The goal is to seek an oral Kevetrin Phase 2 and it may well happen.
Quite less expensive than IV, better for the patient, and what a partner would want.
Maybe a preliminary offer on Prurisol 2B was already drawn up with a proposed range of dollar values matched to the different categories of results forthcoming with the Prurisol 2B completion -- and one request in the offer from the interested party was to drop the interim analysis.
How about the wording in the CDA agreement that could say
"At any time, the interested parties may request a delay or postponement of the interim analysis
while intermittent case reports and analysis are shared from the sponsor IPIX."
As for the 2Q interim analysis, remember the trial originally had a completion date of July 2017. It did not finish til end of December 2017. The delays in enrollment may have pushed an intended Q2 interim analysis to Q3. By such time, a majority of patients had completed at least 6 weeks therapy.
You have no idea nor do I whether more stringent disclosure requirements were placed on the Prurisol 2B trial after it got past the Aug 2017 timeframe.
Do you think the CEO and those parties under CDA want it to be told to shareholders, other outside Big Pharmas and the general public why an Interim Analysis is being put on the backburner if there's a possibility that results are near or close tracking Otezla?
Not fair to those parties under CDA...he has an obligation to the CDA parties before us shareholders, especially if it means continued talkative efforts for financing and trial progression.
What statement results from Interim Analysis for Prurisol 2B were you looking for?
It could of just been a statement of statistical significance.
But while going deeper into finishing the trial, maybe those companies under the Confidential Disclosure Agreement did not want a public release of anything even as the basic statement.
Why would parties to a CDA want interim results released to public that can be seen by other pharmaceutical companies?
They want first rights to see results and develop negotiations before any outsiders get the chance. Filter out the competition.
It appears your basing the outcome of the Prurisol 2B trial on lack of Interim Analysis.
There was no Interim Analysis for B-ABSSSI Phase 2B and results were very good.
THE COMPANY is building internal growth with >= 3 shots on goal with their trial progression of drugs.
May we see >= 2 Phase 3 TRIALS RUNNING in 2018... we shall see.
May we see >= 2 Partnerships ACCOMPLISHED in 2018... we shall see.
B-ABSSSI could be tied into a B-UP/BOM deal at a discount to solidify a deal on B. IMO
IMO, if necessary, they could sell Brilacidin ABSSSI.
Remembering the Phase 2B Brilacidin ABSSSI 1 day dose was equivalent to 7 day dose of Daptomycin - Cubicin drug doing approx $1 billion in revs back in 2014.
Cubicin aqcuired by Merck for $9.5 Billion Dollars.
You need to be more concrete.
What would be spectacular results??? for this 12 week Prurisol dosing compared to Otezla's 16 week dosing trial - Otezla probably doing 1.3-1.5 billion in revenue for 2017.
Lay it out there in clear terms.
Your evidence???...back it up.
Where is your 1st hand knowledge?
How would you know?
Dole out some good reasoning.
Your only guessing as you don't work for IPIX at the top level nor know details of the CDAs.
Along with the little tiny cup(s) you get at the dentist office to rinse out. However these will probably be lightweight plastic for reuse over and over and have measuring line(s).
Biodoc, I'm sorry about your home encountering fire.
Hope your family overcomes this unfortunate happening.
Maybe they will look to Brilacidin-OM as a baking sode type
paste with sticky elements. Or coat it with a material similar
to cotton balls to stay in the mouth for extended period.
Any dentists reading this board??
Can it be administered topically with qtips like they do with the
novacaine? And swished out after 15-30 minutes.
Not necessarily. A dosing amount and/or dosing frequency could be the issue or a subpopulation of patients where efficiency was actually met.
And changes could possibly rewrite to favorable outcome.
Hmmm, was it BP that wanted some of the trial at Dartmouth?
A phase 2B Prurisol trial WILL NOT TAKE 6-12 months unblinding and analyzing for 199 patients.
A phase 3 psoriasis trial of 1,200 patients could take 5-6 months
(But IPIX Prurisol psoriasis trial is "Not Phase 3" nor anything close to 1,200 patients).
Here's a grant of 1.5 million for an oral mucositis Phase 3.
https://www.prnewswire.com/news-releases/soligenix-announces-15-million-nidcr-sbir-grant-award-supporting-the-pivotal-phase-3-clinical-trial-of-sgx942-for-the-treatment-of-oral-mucositis-in-head-and-neck-cancer-300520631.html
IPIX trial design for oral mucositis is a lot more stringent on the inclusion/exclusion criteria to solidify proof of prevention for oral mucositis.
IPIX trial design:
https://clinicaltrials.gov/ct2/show/NCT02324335?term=cellceutix&rank=3
IZUN trial design:
https://clinicaltrials.gov/ct2/show/NCT01400620
Dartmouth (The Big Green) says Phase III which is not correct.
clinicaltrials.gov still showing Mary Crowley (Dallas Tx) for Phase 2A.
I think most people would be happy with a repeat or near to it of Phase 2A Prurisol, and not many have gone overboard to project equality to biologics. The focus is nearing or bettering Otezla.
Yes, agree... Brilacidin looks to have wide potential in big revenue areas.
If the trial subject response is true, I'm only pointing out Otezla in their clinical trials could not achieve clear skin PASI 100, and yet Otezla as an oral psoriasis pill probably will achieve $1.5 billion in sales for 2017, in its 3rd year as a marketed product.
Were Otezla trial results impressive or unimpressive to you in light of the 1.5 billion in sales projected this year?
Maybe they told the woman in the San Antonio trial that there was at least a 57% chance it was Prurisol as defined by the 3:3:1 (placebo:Prurisol-300mg:Prurisol-400mg) ratio for 12 weeks of treatment.
We at least know that Celgene's Otezla had only 8% PASI 90 and ZERO % PASI 100 (fully cleared) for their 16 week treatment.
No one has the roadmap as to how and when the different indications of Brilacidin will be licensed/partnered.
It would kind of make sense at this point waiting for BOM results in a short 4-5 weeks.
Otherwise, business dealings are premature w/o full effect.
Even if PASI 75 was 20% including all arms at 6 weeks with 70%-80% complete, it's possible no assumptions can be made in comparison to Otezla until all 12 week data is known. At that 70-80% 6 week point, probably only 55%-65% are done with their 12 week treatment.
Some may view 20% PASI 75 halfway thru as not good, without consideration of waiting for the complete 12 weeks of treatment to finish.
Your thoughts are pre-emptive.
Why not wait on P and B-OM results and possible contractual engagments on these 2 drugs before saying game over or game played the wrong way.
Prove it! Prove it!
That you know everything of communcations and negotiations going on inside the company.
Instead of writing little sentences of non-facts, I want to see you spill the truth of WHAT is EXACTLY going on inside the company.
Summarize in a couple of paragraphs, your proof. Your post has no supporting facts as to why there is ZERO interest in their 3 drugs.
We don't really know what the content of the Interim Analysis was to be:
A phrase of "statistical significance" and "safety" without any concrete results and no indication of patient numbers??
Those BP under CDA may have objected after June 8 to an Interim, gave their reasons to IPIX and trial investigator and IPIX was overruled by one or both parties.
The priority here for decisions on trial continuation, safety, and how intermediate/final results given:
DMC(data and safety monitoring board)
Investigator
IPIX with consideration from BPs under CD and the 2 above
The May 6 2013 was a statistical significance look at a 16 week primary endpoint.
It's an interim analysis of an extension trial up to 52 weeks.
The interim look at week 16 was probably necessary to determine if the extension was worthwhile in doing. Is it an early data release, probably not as it only revealed looking at a primary endpoint. More a sequence event to evaluate worthiness of an extension.
The other point is they only declared statistical significance, at least I don't see any unblinded results or percentage yielding results.
http://ir.celgene.com/releasedetail.cfm?releaseid=795052
I found Interim Analysis for psoriasis and it seems they are in the multiyear of 3-5 year studies (again extension studies).
IPIX Prurisol is not an extension study and its primary endpoint for
PASI 75 is only 12 weeks as opposed to 16 weeks. Would 4 more weeks be
more favorable to IPIX, who knows.
I will get back to you Friday.
It may have been necessary for early BOM interim due to the placebo being just water and if BOM had a start as looking like water, it would have been a waste of money to let the trial continue if BOM was not noticeably better. With such an unmet need for those with Severe Oral Mucositis, an earlier look would see if BOM was promising compared to other treatments that hardly work, and justify continuing where many others have failed.
Until a SHAREHOLDER'S GROUP email or PR is sent as 100% verified by the CEO, I will keep on as if no news yet.
The Brilacidin-ABSSSI Phase 2B results of a 215 patient trial were outstanding (comparable to Daptomycin - 1 billion in sales).
And there was NO INTERIM ANALYSIS, even to leak out results at 70% trial completion.
ONLY a safety report was given halfway thru the trial.
Strange you mention long before August, but don't give any meaning to what long is.
If the Prurisol 6 week interim includes 85-90% of patients, there is no way it could have been completed in April/May (this is 2nd quarter).
I don't know nor do you what the final % targeting majority was for 6 week Prurisol interim and when this would happen. The % could have been a moving target to aid in providing more certainty about the results to those Big Pharma under CDA and zone in on a more accurate negotiation amount.
An 85-90% completion should be good enough to make a probable trend prediction on the last 10-15%.
Can you or anyone else provide example(s) within the recent past 3-5 years where an Interim Analysis for a psoriasis trial was released by any Biotech/Big Pharma company at the 50%-70% completion mark because results were blowing the lid off the roof??
70% of patients completed at 6 weeks would only amount to an estimated 55% patients completing 12 weeks.
If the Prurisol interim analysis were to include 12 week PASI 75 for patients, then a 70% patient completion at 12 weeks
is more sure than a "silent-majority" 55% completion at 12 weeks, especially since the arm distributions for the Phase 2B trial
are 3:3:1 (300 mg Prurisol:Placebo:400 mg Prurisol).
An 85% 6 week patient completion probably translates to an estimated 70% of patients with a 12 week completion. Maybe they want certainty before they release the Interim Analysis.
There were problems with Kepivance (Palifermin) that restricted its use for oral mucositis.
Read on:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=75669686
Karin, good catch on the mean remission rate of 42% for mesalamine.