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23 weeks since Leo stated the following:
These recent data, taken in aggregate, are what various actively engaged pharmaceutical companies have desired from us for some time—and they are what triggered a newfound flurry of inbound partnership discussions at the San Francisco conferences,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “Datasets now in hand, reflecting three successfully completed Phase 2 studies across which multiple endpoints were met, have brought the Company to an important inflection point regarding Brilacidin. In coming weeks, we look forward to advancing these discussions with attractive partnership / licensing scenarios, towards determining the best path forward for the Company and its loyal shareholders.”
Seriously?
Still waiting...
Definitely is nice to see some green numbers next to IPIX for a change, even if it's only the Daily Gains column for now.
I need a bigger rally than this. I'm still down 60%.
IPIX reported results in early January, so data had to be unlocked at that time (this thread is regarding OM results, in case you missed what I was replying to).
Why do you think it took 3 months to report this? I don't understand why all data couldn't have been analyzed in one 40 hour work week. I've done plenty of data analysis (not in healthcare though), and it never takes long at all. Seems weird to me, but maybe that's normal in healthcare?
My issue with waiting for P data to sell the company is that IPIX would likely have to turn down potential partnerships for B alone in hopes that P is good to sell the company. Or he tells the potential partners "I might do a B deal with you, but you have to wait x months before I decide". That gives the potential partner x months to change their mind, or get frustrated and walk away.
IF there are potential B deals on the table, I think the best decision would be to pick the best deal and sign it asap. But I don't work in the medical field or have a management position in any company, so what do I know...heck, I don't even know if there are any B deals on the table.
11 weeks and counting! IMO, B-OM had the worst trial results of the three B indications, and yet additional potential partners were added to the list.
"Brilacidin-OM received an exceptional degree of attention at the San Francisco shows, further adding to an already robust partnering matrix."
Sign a deal and get some trials moving this year!
I didn't overassume. I gave my interpretation and provided an example as to why I expected a partnership within a couple of weeks.
He's not a smart boss, in my opinion of course :)
Very true, but I think it's important to hold IPIX accountable for what is PR'd.
And those results would be expected in 2 or 3 weeks. Not 10+ weeks.
I work in manufacturing. If I have been talking about cost saving ideas with my boss for a while, then I said to him "in the coming weeks, I look forward to advancing these discussions with attractive cost savings scenarios", what do you think he would expect? He would expect cost savings results! Not more discussions.
According to a press release on January 16, IPIX was weeks away from an attractive partnership.
How do large sellers line up at the ask for IPIX when the market isn't open?
Hopefully the protocol was followed by all sites. I'd hate to a large gap between ITT and PP again. It would be nice to see a statistically significant difference in groups in both ITT and PP populations.
I believe Otezla's trials had a very small dropout rate and a small difference between ITT and PP, but that's going based on my memory.
It's been 10 weeks since IPIX stated they would be advancing discussions with attractive partnerships 'in the coming weeks'.
Let's imagine another small bio company out there owned K and we had a competitive drug. I would be willing to bet many longs on this board would be stating how slow they are moving with K, how the Ph2a wasn't successful, how it will be many many more years before it's in a real trial, etc.
Their trial description stated it was a dose-escalating trial. There was no dose escalation and no explanation given to why dose wasn't increased. I don't believe the trial was necessarily a failure, but IPIX really hasn't said too much about the trial, which is concerning.
Hate to side with the bashers, but K has been a disappointment. Just sort IPIX's PRs by K and look at all the references to moving the drug along, yet look at where we stand.
Two great examples:
3/2013: Given the limited treatment options, devastating effects, and small patient population, Cellceutix believes that retinoblastoma would make an excellent candidate for a phase 2/3 trial once our present phase 1 trial is completed.
6/2015 ASCO: "Several companies and institutions wanted to discuss the possibility of Kevetrin in combination with their drugs or therapies to potentially increase efficacy and reduce or avoid side effects in a variety of cancers, including some rare, hard-to-treat and pediatric cancers"
1/8/18 - Flurry of partnership discussions took place. B-OM received a lot of attention.
1/16/18 - In the "coming weeks", IPIX was supposed to advance these discussions with licensing scenarios and/or attractive partnerships. This was 9 weeks ago.
1/29/18 - More discussions had taken place about producing topical B. This time, "negotiations" are taking place, not just discussions. This was 7 weeks ago.
Any day now.....
"With a number of upcoming anticipated clinical milestones (see below), management is hopeful that partnerships can be struck in 2017 to help advance the Company's pipeline of First-in-Class drug candidates—Prurisol, Kevetrin and Brilacidin—toward market approval."
http://www.ipharminc.com/new-blog/2017/1/6/bloomberg-biotech-deals-expected-to-bounce-in-2017
Even the company is hoping.
Agreed. We are now entering "coming months" instead of "coming weeks".
What does "Der" Leo mean?
I went on the IPIX website, clicked over to their PR's, then sorted the PR's by drug and clicked on the most recent P-related PR. I then ctrl-F "results" in the PR and had the answer to the question in under 1 minute. Also, I'm sure the timing of results has been discussed multiple times today, as it is pretty much everyday. Frustrating...
Read the PRs
"In coming weeks, we look forward to advancing these discussions with attractive partnership / licensing scenarios, towards determining the best path forward for the Company and its loyal shareholders."
I interpret "in coming weeks" as 2-4 weeks; otherwise, people would use 'months' instead of 'weeks'. It will be 7 weeks this Tuesday. I know I know, these things take time........
I've read one or more people say that Leo stated he wouldn't partner until all Phase 2 results were in. Can someone please provide a link to this, if it's true? Thanks.
No problem. I submitted it a few times, but I guess my wording on other posts wasn't up to the message board standards. Hopefully it sheds some insight into gauging trustworthiness as well, but as someone else stated, it is still a public message board.
Post # 141391
I haven't read that PR since the trial ended, so thanks for sharing it. I also agree they found what they were looking for, and didn't see the point in continuing a very slow-recruiting trial.
IPIX is typically very open in their PR's, so I find it interesting that they never mentioned the number of patients recruited (as if they knew 2 of 10 wasn't good, so they didn't mention it). I guess we'll just have to wait and see...as usual.
Clinical Trials site shows Study Completion Date of 11/10/2017, yet it was PR'd to end until 2/8/2018. My guess is that IPIX waited those three months with no additional patients enrolled, so they ended the trial (ultimately knowing they need pill form due to half life). Definitely not the outcome I was hoping for with this trial, but likely a good decision by IPIX instead of letting it drag on any longer.
That's what I was thinking as well. I was just hoping to get some other opinions from people who likely have a better background in the medical field than me.
Clinicaltrials.gov site has the "actual enrollment" at 2 participants.
In your opinion, do you feel 2 patients is a large enough sample size to gain the information they wanted from this trial? Do you think they may have stopped the trial early due to slow enrollment?
Thanks for your input. Can P53 activation occur by chance? My concern is that the study only enrolled a handful of people, so any data collected doesn't hold very significant value to me (unless of course the P53 activation could have only occurred from introducing K to the body). As I stated before, some of this science stuff is over my head.
From what I remember, Leo never publicly stated interim results were not going to be released. We just waited for results and they never came. He supposedly emailed one person to explain why, but that is not verifiable information.
I could be wrong with this since I'm going based on memory, so feel free to link a PR where he states provides this information.
Just to preface my comments below, I have no experience in the medical field and still don't even understand the Western Blots graph, but I am frustrated with K like others.
The first sentence describing the study on clinicaltrials.gov:
"This is an open label, dose-escalation trial to study the safety, biomarker changes (including modulation of p53), objective tumor response changes, and pharmacokinetics following administration of two different treatment regimens of Kevetrin over a 3-week period to subjects with platinum-resistant/refractory ovarian cancer."
I would consider it successful if IPIX provided data that supports everything above. Even if some secondary endpoints weren't met, it could still be successful if they provided evidence as to why they weren't met (i.e. short half life).
How many patients completed the trial? Was there any tumor response? Any safety issues? Any differences in biomarker changes between patients? Did the higher and more frequent dosing provide any patient benefit over the Ph1 dosing?
Why was the trial discontinued? Was it because modulation of p53 was met in the first patients (if so, why wasn't the trial discontinued on 12/27)? Was it because there was no tumor response? If so, why did we see some tumor response at less frequent dosing in Ph1?
What is the status on the oral formulation? How long until it's ready?
Maybe they will be providing additional info in the coming weeks, but they don't state that in the PR.
I think your numbers are off for PP population, but maybe I'm screwing something up. Here's what I'm getting:
Per Protocol actually started with 20 patients, not 27.
6 patients ended with IGA3
3 patients ended with IGA2
Started with 20 in Mod/Mild and ended with 9. Reduction of 11 people. Still has the same overall reduction percentage as your numbers though.
The ITT is a little strange. It seems like they used 27 people in the chart, but then used 28 people in the graph (that's the only way I can get the numbers to work).