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According to my calculations, B-OM 4 weeks follow up ends next week. WOW, did I just say NEXT WEEK??!!
I don't think this post is factual regarding IPIX. Why is it stickied?
I think you made the right decision to go hide in the bushes while things play out this morning. A lot of people were caught flat-footed this morning. When you and team have revised your strategy, come back and play some more.
You should read post 198526. Apparently you were caught flat-footed and not aware of what an incredible drug Prurisol could be....
I think a lot of players were caught flat-footed this weekend. Surprise positive news story for those who search the stickies on the top of the list.
WOW! Thanks for sharing... prurisol is worth at least 10 billion dollars!!!
The best part is the OM results are a lock. IPIX will still be batting 100%. Counting down the days!
Agreed! Thanks.
Patient enrollment announcement was aug 7th. Today completes the 7th week from that announcement (unless you want to venture someone is finishing up over the weekend). 11 weeks (7+4) will be through Oct 20th.
Press Release: Innovation Pharmaceuticals Completes Patient Enrollment in Phase 2 Study of Brilacidin for the Prevention of Severe Oral Mucositis
BEVERLY, Mass., August 7, 2017 (GLOBE NEWSWIRE) – Innovation Pharmaceuticals Inc., (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today announces that it has completed patient enrollment for its ongoing Phase 2 clinical study of Brilacidin for the prevention of Severe Oral Mucositis (OM). A total of 61 patients have been enrolled, with topline results anticipated in 4Q2017.
7 weeks of treatment through today...now we wait for the 4 weeks of post-treatment follow up. If you come up with a different date, please let me know!
Congratulations! B-OM dosing is complete... let's count down the weeks till this trial is finished.
back online.
Looks that way to me.
Slide 5 - "Near-Term Catalysts by Year-End—trial completion, results reporting;
collaboration/partnership opportunities"
Pete,
I have a hunch this is more to do with getting the Prurisol trial completed by year end...
If you count out the 16 weeks from Sept 1, you get Dec. 22nd.
Then, if you take Leo's email to cabel at face value, the slow enrollment pushed the completion date back. So, Leo probably had the choice to request the interim data, but at the risk of increased trial investigator bias. The remedy to get the risk back within range would be to increase enrollment further. But if he did, then he would have the much bigger issue to deal with, which is ultimately having to change the trial completion date to 2018. So he chose to forgo the interim data to keep us on schedule for the whole trial.
Nice article. Thanks!
I'm so glad that even if you do just a little bit of DD, you can see how IPIX has designed the P 2b trial to show statistical significance, rendering doubt unwarranted.
Fake news!
Don't believe me?...maybe you should read the disclaimer on the bottom of the page...
"all information and blog posts found on this site is to be viewed for entertainment purposes only and is to be considered fake news even if it is actually happening or happens!"
Nice! Thanks for posting
By George, I think you might be right!
You bet, bud. Anytime.
It wasn't a bid deal then, it's not a big deal now...
BEVERLY, MA--(Marketwired - January 25, 2016) - Cellceutix Corporation (OTC: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that approximately 75 percent of the subjects enrolled in the Company's Phase 2 clinical trial of Prurisol for the treatment of chronic plaque psoriasis have completed dosing, defined as 84 days of daily treatments of Prurisol or placebo. The subjects will now be followed for an additional 4 weeks, without taking any further study medication.
The four-arm multi-center Phase 2 trial, three arms with different dosing regimens of Prurisol and one arm placebo, is designed to assess the efficacy and safety of Prurisol given orally compared to placebo in a randomized, double-blind setting in patients with mild to moderate chronic plaque psoriasis. The trial was expected to enroll 100 subjects and actually enrolled 115 subjects. The primary efficacy endpoint will be the percentage of subjects with greater than or equal to a 2-point improvement in Investigator's Global Assessment (IGA) rating as defined by visual inspections of patient lesions. The final study visit for the last subject is expected early in April 2016, with top-line data anticipated approximately four weeks later.
cabel, in the phase P 2a trial, they over-enrolled, too... (in the OM trial, they over-enrolled 61 vs 60).
Anyone making a big deal about this or even suggesting that this is for the 400mg group is just speculating...
I think that kind of speculating is counterproductive.
I think you are confusing B-OM with B-UP. UP was open label, OM is double blinded, placebo controlled. So to Cabal's point, we got interim results for OM, which seems to go against your logic.
Also, we are not SPECULATING if we should interim results for P, WE WERE TOLD BY MANAGEMENT ON AT LEAST 2 OCCASIONS AND IT'S ON THE COMPANY TIMELINE.
Be safe, bud!
Biohedge...posts like these are good to keep everyone grounded and thanks for the topic.
All this talk of partnership started early in the year...imo, 2 changes to timelines occurred. 1) P trial enrollment went at a slower pace than anticipated. It was my belief that IPIX would partner this first. 2) B-OM enrollment accelerated must faster than anticipated.
I think the combination of these two events will change the order for partnering. I'm sure Leo and Co. are focused on landing a deal for year end, but now I'm starting to think that partnership will be for B, but only because the OM trial will have top line data first.
To me the single most important corporate objective is having sufficient funds for all the indications of B. In my opinion, a small UP deal gets us there, a medium P deal or a medium OM deal will be more than enough.
Approximately 189 study participants will be enrolled. Subjects will be randomly assigned to one of three treatment groups in a 3:3:1 randomization ratio, respectively.
Group A (n=81): Prurisol 150 mg bid
Group B (n=81): Placebo
Group C (n=27): Prurisol 200 mg bid
https://clinicaltrials.gov/ct2/show/NCT02949388?term=cellceutix&rank=4
PS. "bid" means twice/day
I just re-read that yesterday and it gives me confidence in my safety expectations for the P trial.
I registered for the NewsMakers conference. If you go through the registration process, they have several different "types" of registrants. Though none of them really fit me a an individual investor, some of have a $600 charge for attending, while others are $0. So I registered as a $0 type.
Because it is a Friday, in the end I might not be able to make it, but wanted to at least make an attempt. I haven't gotten a confirmation email yet, so I'm not sure if they vet your application first. I'm interested if anyone else has gone through the registration process yet and/or plans on attending.
Just want to provide some logic:
According to Clinical Trials for Prurisol:
"A subject studied under this clinical protocol will commence with a screening period of up to 4 weeks, a treatment period of 12 weeks, and a follow-up period of 4 weeks ending with an End of Study evaluation."
4+12+4= 20 weeks
From the PR today: "We will also highlight the major events upcoming for us in the fourth quarter, namely anticipated completion of our Phase 2 trials of Brilacidin-OM for oral mucositis and Prurisol for psoriasis"
When I start with 12/31/17 and count back 20 weeks, I get August 13th. To me, this means that ALL 189 participants are at least going through screening.
And since that PR, they have added 6 new recruitment sites.
Great post flash! Always keeping things real
Q: Are you having an issue for Dr Vamvakides to sign the patent assignment document? What are the implications of this, if any?
CM - All patent applications are owned by Anavex, independently of who filed them (Dr Vamvakidis or Anavex). Dr Vamvakides is required according to license agreement to comply with signing IP related paperwork. Sometimes this process can be delayed, but has no implications. If a signatory cannot be provided, e.g. if a signer cannot be reached, the patent application continues - just an additional form is required. Hence, it does not change the course of the filing. Anavex is confident of its intellectual property rights in the cited patent applications.
https://seekingalpha.com/article/3354415-interview-with-dr-christopher-missling-ceo-of-anavex
I agree Sox, any day now...
P interim results
Tic toc, Matagordaville. Our time has arrived! Can't wait for the next shareholder meeting.
I think Leo is is busy with Menon working on a pill for bipolar disorder...
If you would have read the first sentence in your link, you would have realized you are wrong again.
** Warning ** This post is speculative in nature.
We all have to guess when we are getting P interim data. The only bit of info we learned was it will be on the majority of patients (which means we don't have to wait for 100 % enrollment), but never-the-less, we don't know what the % is...or do we...
The only enrollment update we received by Leo was 70% enrollment on May 10th. Why didn't Leo update us at 50% or any other...? Was that 70% number our magic number?
If you do the math and count 4 weeks for screening from that date, then add 6 weeks of treatment, I get a date of July 19th. As with all other data reveals, there will need to be some time to get the data processed and reviewed. But to me, the clock starts ticking for interim P results after July 19th.
And Jeez, that's not far away at all...
Can't wait till the next in-person shareholder meeting!! By then we'll have our first deal and be uplisted on the NASDAQ. Everyone will be speculating about which drug will be partnered next!
He is very humble and likes to talk about the science.