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If Prurisol efficacy is equal to Otezla with much faster time to achieve that efficacy (faster, effective uptake) and safety is better, it appears Prurisol should be the "take this first" oral drug for psoriasis (frontline treatment). In this way, it is already superior.
As far as approaching biologics territory, doesn't necessarily have to hit the middle range for biologics. A 45-55% PASI 75 would be a homerun...again given it's an oral without severe side effects of biologics and the effectiveness of biologics can wear off over time.
IMO, Prurisol achieved IGA 0/1 (equivalent to PASI 90/100) of 43% in Phase 2A 200mg for moderate patients due to strong patient effect early-on in the first 2-4 weeks. If I remember right, Otezla achieved only 8% PASI 90 in Phase 3 and nothing for PASI 100.
Thanks Karin for the outstanding new article updating your admired IPIX collection of writings.
Hope you were able to hit the beach after finishing that well-written contribution.
Hi Pete,
I'm sorry about the loss of your mother. Praying and hoping you have the emotional and spiritual support and love to live the future in a way your mother would be proud and similar to when she was around.
Know the difficulties, lost my mother to Creutzfeldt-Jakob disease about 15 years ago.
Take care.
Pipeline A
1) Brilacidin ABSSSI Phase 2B
Pipeline B
There is now completed:
1) Brilacidin ABSSSI Phase 2B
2) Brilacidin UP Midstage (TOPLINE data Thursday)
To be completed 2017:
1) Brilacidin OM Phase 2 (Additional data Thursday)
2) Prurisol Phase 2B
(Interim analysis - any day now- targeting majority of patients with 6 weeks treatment May 10 PR around 70% enrolled, it's now 8 weeks later...is targeting majority of 6 weeks patients about 70-85% enrollment??)
Possible completion 2017:
1) Kevetrin Midstage Ovarian Cancer
Is the repetitive talk about no partner for Pipeline A infer no partnership from some or all drug indications in pipeline B??
Would you like them to cut a deal right now for just Brilacidin-ABSSSI??
You tell us.
Do some research.
The conference is in Boston.
Probably folks from Novartis, Pfizer, Merck, JNJ are in the New England, New Jersey area.
It's an easy flight to the return base, perhaps even an ok drive.
It's the quality of data delivered and not the time delivered.
It could very well be last because it gives all BPs the chance for private conferences with Innovation Pharmaceuticals(IPIX) to view the endoscopy - video, images and final trial results of Brilacidin UP and interim analysis of Brilacidin OM along with discussing negotiation valuations before it hits the public news.
Combination put together questions of when to make a deal for these Innovation Pharmaceuticals (IPIX) 2017 upcoming mid-stage trial results.
Pick out which combinations of all three drugs (Brilacidin, Prurisol, Kevetrin) along with their different timelines of data results would you like to see when a deal or deals are done.
Feel free to use the numbers below (1-11) along with B for Brilacidin, P for Prurisol and K for Kevetrin.
1) Do you think a deal should be carved out before Prurisol Interim results?
2) Do you think a deal should be carved out after Prurisol Interim results?
3) Do you think a deal should be carved out after Prurisol Final results?
4) Do you think a deal should be carved out before Brilacidin-OM Interim July 13 results?
5) Do you think a deal should be carved out after Brilacidin-OM Interim July 13 results?
6) Do you think a deal should be carved out after Brilacidin-OM Final results?
7) Do you think a deal should be carved out before Brilacidin-UP final July 13 results?
8) Do you think a deal should be carved out after Brilacidin-UP final July 13 results?
9) Do you think a deal should be carved out before Kevetrin-Ovarian cancer Interim results?
10) Do you think a deal should be carved out after Kevetrin-Ovarian cancer Interim results?
11) Do you think a deal should be carved out after Kevetrin-Ovarian cancer Final results?
Your timeline for a deal or deals sounds like yesterday, today, or tomorrow.
Just don't know how many were screened on that May 10 PR and where in the process. The PR did say over 70% with screening, I'll wild guess 65-68% were enrolled at that time.
Is majority 65-68% also??
Maybe next week (1st week of July) we hear more.
THE BRILACIDIN-ORAL MUCOSITIS (PHASE 2) TRIAL IS QUITE ADEQUATE at 60 PATIENTS SPREAD AMONG TWO ARMS...
30 PATIENTS FROM BRILACIDIN-OM ARM and 30 PATIENTS FROM PLACEBO ARM.
BRILACIDIN-ORAL MUCOSITIS IS SUPPOSED TO --PREVENT-- SEVERE ORAL MUCOSITIS (GRADE 3 or 4)
LOOK AT THE PHASE 2 FOR SOLIGENIX 942 TRIAL DRUG FOR ORAL MUCOSITIS.
THE SOLIGENIX COMPANY HAD 78 PATIENTS IN ALL; AND SPREAD AMONG THOSE 78 PATIENTS WERE 4 ARMS:
A PLACEBO ARM
1.5mg/kg ARM of SOLIGENIX 942
3.0mg/kg ARM of SOLIGENIX 942
6.0mg/kg ARM of SOLIGENIX 942
SOLIGENIX 942 --DOES NOT PREVENT-- SEVERE ORAL MUCOSITIS (GRADE 3 or 4); IT'S MORE DESIGNED TO REDUCE THE TREATMENT DAYS FOR SEVERE ORAL MUCOSITIS.
SOLIGENIX EVENTUALLY HAD TO DO 111 PATIENTS(UP FROM 78) CAUSE THE 1.5mg/kg ARM WAS THE ONLY ONE WITH POTENTIAL.
WITH 111 PATIENTS,SOLIGENIX 942 PHASE 2 COMES OUT TO 28 PATIENTS PER ARM, LESS THAN THE 30 PATIENTS PER ARM FOR BRILACIDIN ORAL MUCOSITIS PHASE 2 RUN BY IPIX (INNOVATIVE PHARMACEUTICALS).
Cabel or Anyone Else,
We know 46% of moderate patients in 200mg Prurisol arm had >= 2 point IGA improvement.
Do we know what % of moderate patients had a 3 point IGA improvement in 200mg Prurisol arm?
Thanks.
I'm just hoping after the Kevetrin Ovarian phase 2 trial finishes end of 2017, the Italian research group initiates a POC phase 2 for Kevetrin AML.
Thanks runninggirl hopefully 1 day you'll have another find for an Italian hospital that might start Kevetrin for Acute Myelogenous Lukemia.
Runninggirl,
Thanks for the update, 2 new sites for BOM, 2 new sites for Prurisol.
I'm wondering if interim Prurisol is maybe 80% patients completed at 6 weeks. We do know some analysis in Q3 2017... like soon.
Your talking in the past, I'm waiting on data results of 4 Ph2 trials within 1-6 month timeframe.
Mako is pure sleaze.
Hey, the Mako article may have been rushed over to Seeking Alpha due to the name and CUSIP id change and it didn't get there as fast as the criminals wanted it to.
I do believe they will get caught eventually as there are alot more eyes on them and for very bad reasons, the articles are way out of line - misinformation, lies, and gross exaggerations with a willful purpose to feed the financial flow into underground criminal networks with the continued same writing style. My parents, high school and college teachers would have trashed my works for sure if it were Mako replicas. My Jesuit college English professors would have ripped those things up right in front of my face during live classroom audiences.
Is Mako running their own Psoriasis Phase 2B that could equal or better Otezla, in other words are they a similar biotech product to product competitor to IPIX...? Mako labs...huh?
Maybe you like to overextend yourself on this reply of yours.
So allow me some fairness to extend or overextend my thoughts.
Maybe the CEO is no, no, and no to a reverse split because he is aligning what he sees in the current data results of Brilacidn-OM Phase 2, Brilacidin-UP Phase 2, and Prurisol 2B to the language of the CDAs they have in place with Big Pharma and is confident in coverage of a future deal.
Why didn't you relay that message to JAZ* Pharmaceuticals or Pharmacyclic* in their lining up the phase 2's back in their midstage trial work or did you?
Bunny,
Please break the costs down for us of what it may cost to finish
the following mid-stage trials:
Part I for Bunny
1. The final 20% enrollment for Prurisol Phase 2B
2. The possibly 50% remaining enrollment for Brilacidin-OM Phase 2
3. The completion of the currently active final 17th patient for Brilacidn-UP?
4. The completion of Kevetrin-Ovarian cancer 10 patient trial?
Part II for Bunny
Can 3 out of 4 mid-stage trials be completed within 6 months?
We know Brilacidin-UP will be completed early July.
Your comments may seem to indicate the Market knows all the answers as it has ears and eyes to the meetings and multiple CDA documents being exchanged between Big Pharma and Innovation Pharmaceuticals referred to in the Conference Call last week. Some Big Pharmas interested in one of the drugs, others interested in a combination of drugs (via the Conference Call)
Can you offer any enlightenment to the above content of questions in regards to company IPIX with currently running 4 mid stage trials and an antibiotic with a completed phase 2B that was equivalent to the former Cubist Pharmaceutical's Daptomycin that had 1 billion or so in sales (probably accounted for >= 80% of Cubist Pharmaceutical sales) before it was bought out by Merk for 9.5 billion?????
https://seekingalpha.com/news/1503931-cubist-q4-revenues-plus-22-percent-cubicin-annual-sales-top-1b [show]
Of course this is all voluntary on your part!!!
Thanks in advance.
Bunny,
Please break the costs down for us of what it may cost to finish
the following mid-stage trials:
Part I for Bunny
1. The final 20% enrollment for Prurisol Phase 2B
2. The possibly 50% remaining enrollment for Brilacidin-OM Phase 2
3. The completion of the currently active final 17th patient for Brilacidn-UP?
4. The completion of Kevetrin-Ovarian cancer 10 patient trial?
Part II for Bunny
Can 3 out of 4 mid-stage trials be completed within 6 months?
We know Brilacidin-UP will be completed early July.
Your comments may seem to indicate the Market knows all the answers as it has ears and eyes to the meetings and multiple CDA documents being exchanged between Big Pharma and Innovation Pharmaceuticals referred to in the Conference Call last week. Some Big Pharmas interested in one of the drugs, others interested in a combination of drugs (via the Conference Call)
Can you offer any enlightenment to the above content of questions in regards to company IPIX with currently running 4 mid stage trials and an antibiotic with a completed phase 2B that was equivalent to the former Cubist Pharmaceutical's Daptomycin that had 1 billion or so in sales (probably accounted for >= 80% of Cubist Pharmaceutical sales) before it was bought out by Merk for 9.5 billion?????
https://seekingalpha.com/news/1503931-cubist-q4-revenues-plus-22-percent-cubicin-annual-sales-top-1b
Of course this is all voluntary on your part!!!
Thanks in advance.
Are you inferring with your comments that Dr Bertolino (Prez and Chief Medical Officer) who came aboard June 2016 and is in agreement with pushing Prurisol Phase 2B ahead, along with mid stage trials of Brilacidin-OM, Brilacidin-UP and Kevetrin-Ovarian Cancer is also in this category you describe about Leo the CEO?????
The Mako stuff started in Aug 2015, we are coming up on 2 years.
IMO it wouldn't take more than 2-3 years from here to prosecute if
it comes to a good case.
MMs in the past have been prosecuted by the SEC in collusion with hedge funds under illegal stock manipulation in this type environment.
Mich IMO, these are coordinated efforts where shorts are in collusion with longs of the same ilk to push the price down and then move it back up again with longs and shorts in these same group sets working in unison.
Careful there it takes time...hope your fingers fell asleep typing and you meant crappie (type of fish)
Why would/must additional data be given from a very good report dated March 27th... what data are you looking for???
What more are you looking for from a report of over 2 and one-half months ago?
We were told ONLY 22% got severe oral mucositis using Brilacidin-OM while 70% in the placebo got severe oral mucositis.
http://www.cellceutix.com/press-release/2017/4/3/cellceutix-reports-very-encouraging-interim-analysis-of-phase-2-drug-candidate-brilacidin-for-severe-oral-mucositis-om-in-head-and-neck-cancer-patients-high-potential-for-preventative-treatment
There was one on this board who on more than one occasion indicated $200 million.
HKWTHHI
Hope they don't sell out until a grape cluster bunch of those indications for the Brilacidin platform have been tested in trials and moved far along into almost completed Phase 3's.
I wonder if Dr Menon, being originally from India got the new name change from this company:
Innovative Pharmaceuticals
http://innovativepharma.in/
Maybe Leo can change it again one last time to Innovative Pharmaceuticals if the current name and CUSIP change has any decent effect on the naked shorts.
Manipulation - pure and simple. I've read enough untrue crap on IHUB, seen the trading manipulation and read about the SEC prosecution of people using IHUB for purposes like this. Hopefully, Sullivan-Ashcroft law firm along with the SEC is looking into all of this.
Suppose 6/7/8 out of 10 show stable disease > 6 months as a monotherapy and P53 is induced (biomarkers present).
BP would have no interest for a kevetrin (oral pill and/or IV) combined with chemo trial for Ovarian cancer??
The K and BUP trials are within the stage 2 boundaries and are thus part of a phase 2 trial to consider dosing ranges, safety at those ranges and efficacy. Anything done at that point is setting the stage for a Phase 3 trial design. Hence, phase 2 is mid-stage, comes after phase 1 and before a final phase 3.
Prurisol is now in a late stage of a phase 2B where probably >= 75% enrollment done. (Interim analysis on all patients coming within 2 to 2.5 months where at that point the company knows the 12 week outcomes of probably 80% of patients thru case reports - and maybe they will be sharing these results with any big pharma attached to the CDA).
Results could be equal or superior to Otezla efficacy at the 300mg and 400 mg doses with better safety for the 2B. Phase 2A 200 mg dose of Prurisol showed 46.2 % of moderate patients had IGA score of >=2 (Represents PASI 90 and PASI 100 collectively).
Otezla expected to do 1.5 - 1.7 billion in sales this year, the third year of Otezla being on the market. Still have plenty of room to penetrate the European market.
This current trial is for moderate to severe psoriasis and a success as described above will move CTIX closer to Otezla like sales figures.
Patiently, eagerly waiting while enjoying the upcoming summer.
So there is the possibility that a Phase 3 Prurisol would have 1 trial only, instead of the normal 2 trials, based on the long, historical safety record of Ziagen. And the trial itself could be completed in 8 months with a possible FDA approval based on a 16 week primary endpoint, with a continuation(extension) of the trial for >= 1 yr. to test further healing/stabilization of psoriasis with Prurisol.
??? open to reader editing of my thoughts ???
Once the 6 week interim of all Prurisol patients is released, the CEO should have 12 week case reports for 75% or more Prurisol patients. Analysis from there should be pretty clear about the trend.
Hopefully, we get a total count of patient results for PASI 50, PASI 75, PASI 90 and PASI 100 for the 6 week interim of all patients.
Any final negotiation of numbers for an agreement could start if/when they can match up case ids from the 6 week report with those case ids already finished dosing at 12 weeks and share it with those BPs that may be part of the CDA.
Maybe she bought 100-200k shares of ctix from
her own account and wanted to return back to Michigan??
The P2B has 25 exclusion criteria, the P2A had 12 exclusion criteria.
The P2A enrolled 115 patients (15 above the original 100 intended)
The P2B intends to enroll 189 patients, who knows if it goes into 200+ ???
You won't know until clinicaltrials.gov is updated with the actual final
patient count.
PROVE TO THE IHUB VIEWING COMMUNITY THAT WHAT YOU STATE CLEARLY FOR ALL TO SEE THAT YOUR STATEMENT IS TRUE ABOUT THE PORTFOLIO = ZERO
REFERENCING GIOVANNI POST #179682
IF YOU HAVE TIME TO THROW OUT YOUR QUOTED PORTFOLIO STATEMENT BELOW, MAYBE YOU CAN GIVE US THE INSIGHT BY WALKING US THRU THE ALL THE 3 DRUGS IN 5 DIFFERENT INDICATIONS (4 IN PHASE 2, 1 PRE PHASE 3, NO FAILURES YET) OF HOW YOU CAME UP WITH A PORTFOLIO VAULE OF ZERO.