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Thank you George for the quick and factual response.
Go Leo & IPIX!
Keith,
Yes, we can expect better responses in the Prurisol Phase 2b trial than in the Phase 2a trial because of a dose dependend response was seen in the Phase 2a trial and because the response was also better in subjects with more severe psoriasis at baseline.
Quote:
Innovation has successfully completed a Phase 2 clinical trial of Prurisol in patients with mild-to-moderate Chronic Plaque Psoriasis. Overall analyses showed (pdf) the drug to appear safe, well-tolerated and efficacious in the highest dosing arm across 12 weeks of treatment. Patients with more moderate forms of psoriasis saw the greatest clinical improvements. Pharmacokinetic data further revealed an early and dose-dependent response that improved as treatment duration increased.
Good luck and GOD bless,
George
If this stock gets pushed down any further I will be forced to buy more! Thank you shorties... I am glad IPIX is not on the Nasdaq because I would not have been able to acquire more shares over the past year.
Go Leo & IPIX!
Well said DaubersUP!
I agree with you and Dud in the point that a deal is what is needed. Period.
We have the back-end of financing that will allow us to raise a lot off money. I think currently just over 100 million in financing from Aspire and the shelf. However Aspire at .70 is not a good option for shareholders to tap the remaining 28 million. I agree. I believe that is why the share price does not move mountains on very positive results. Because in the back of every possible investor....when can IPIX make the jump and have the $ and resources to move many trials forward and allow the positive results to make huge MC gains? Bring the valuation to a true value!
That is when we can stop the drip and have institutional support on the stock. There will forever be shorts. We can agree, and that is good. But we need a healthy percentage of the 140 million in real long term investors hands..Baker bros etc...
My gut and to answer your question: I believe Art and Leo have their suitor. I believe they have been working with this pharma for a very long time. I believe that IPIX has made it clear on their goals and valuation proposals and those were no way in hell going to be met prior to receiving Up and OM data. But now the data is in. Now they can move forward and sign the dotted line, IMO.
My real concern is that new interested parties have come into the picture and may derail some of the long term work that IPIX and suitor 1 have accomplished over the past 2-3 years.
But competition is great and makes people move. It can also increase value in biotech...so let’s hope by Leo stating more people are interested in an already ROBUST audience is a good thing
I couldn't agree more. I have not flipped/sold one share since I have owned a piece of IPIX. I will continue to accumulate. It is amazing to me how much manipulation this stock has. NO one should be selling this close to the news we have all been waiting for.
Go Leo & IPIX!
I must say though - that even with the 7 day a week constant Stock Bashing, where is the share price? About $.02 down? MM's and shorts are working OT to try and shake yours shares out. If you do your own DD and believe in the science, what's waiting a little bit longer to give Leo the best opportunity to get us the most bang for our buck? I know I am not selling not one share.
Truly exciting times at IPIX. Listen or read the most current and factual information from IPIX presentation during the January 2018 Biotech Showcase.
http://www.ipharminc.com/new-events-and-presentations/2017/11/20/biotech-showcase-2018
2018 = Nasdaq
Go Leo & IPIX!
Thank you for your factual posting on this board George. I appreciate the daily effort you give.
Go Leo & IPIX!
I estimate that Prurisol at 300 mg per day will achieve a PASI 75 responses of 82.5% at just 84 days
I estimate that Prurisol at 400 mg per day will achieve a PASI 75 responses of 100% at just 84 days
Compares very well against Celgene's Otezla which achieved 33% PASI 75 at 112 days.
Good luck and GOD bless,
George
I agree, Pfizer vs. Novartis although Celgene might be a close third.
Go Leo & IPIX!
Pfizer vs. Novartis
Roche has been added to the short list of companies interested in Prurisol, Brilacidin and Kevetrin
Pfizer
Celgene
Roche
Daiichi Sankyo
Sanofi
GSK
Johnson & Johnson
Novartis
Amgen
Abbvie
Eli Lilly
Good luck and GOD bless,
George
Thank you, I always find these kinds of posts interesting.
Go Leo & IPIX!
Over the past 6 weeks, excluding this partial week, the Accumulation/Distribution chart for IPIX shows that 5 out of 6 weeks have been Distribution weeks. Prior to those 6 weeks, beginning 11/13/17 and ending 12/08/17 all 4 of those weeks were Accumulation weeks. Those 4 weeks of Accumulation may have been in anticipation of Brilacidin results. The weekly chart shows IPIX has closed below the 20 SMA for the past 6 weekly closings, including this week. However, today was an, an Accumulation day with higher volume (338,059) than yesterday (271,273). On the daily the stock price has "hit it's head" below the 20 SMA and the 13 SMA graft lines.
.71 cents? Surprise.
.57 cents?
Thank you for the heads up. I bought more and dropped my average. You are too nice giavinni...
.57 cents?
So many good things coming soon for IPIX! Good news must be coming. Soooooo freaking cheap!
IMO P results will be the next release. Just a guess because as you pointed out DaubersUP there are 7 things that could happen in the upcoming month.
Go Leo & IPIX!
What are we thinking comes next?
A. Prurisol phase 2b topline data?
B. Kevetrin Oral formulation Update?
C. Brilacidin for IBD update on next step?
D. Brilacidin B-OM final study report? More data?
E. Brilacidin OM Breakthrough Designation submission to the FDA?
F. Deal or License?
G. Kevetrin - addition data for the phase 2 Ovarian Cancer? RECIST data
Any guessers?
I hope you are right George so we can get this show started...
Go Leo & IPIX!
I estimate that Prurisol at 300 mg per day will achieve a PASI 75 responses of 82.5% at just 84 days
I estimate that Prurisol at 400 mg per day will achieve a PASI 75 responses of 100% at just 84 days
Compares very well against Celgene's Otezla which achieved 33% PASI 75 at 112 days.
Good luck and GOD bless,
George
The OTC is not for the weak and is high volatility vs higher reward. Do your research and you will see there is nothing to be afraid of. IPIX has been making steady progress under great leadership. That is all an investor can ask. The share price will follow.
http://www.ipharminc.com/
Go Leo & IPIX!
What is with this stock! Manipulation or is something not as good as it seems! Getting old
Big smile! Thank you George.
Go Leo & IPIX!
Expanded Access for Innovation Pharmaceuticals Drug Candidates
\
http://www.ipharminc.com/expanded-access-and-compassionate-use/
Good luck and GOD bless,
George
It depends what progress/news starts to drive the share price. If it meanders to $5.00 I would consider taking some of my initial investment off the table and let the rest ride. If it is blockbuster news I am all in and riding the wave until the adjustment period. $57.00 per share has always been on my mind since my initial purchase and would get me all out.
Go Leo & IPIX!
Question for the true LONGS who have been invested and stayed invested since the $5.00 days: What would you consider a fair value per share price that you would think about cashing in?
You're absolutely right petemantx. Leo has done an incredible job positioning this company for a very interesting 2018.
Can't wait to see what the next few months brings us. I hope the Nasdaq.
Go Leo & IPIX!
I think any shareholder with complaints at this stage of the game should have their heads examined. What is there not to like about IPIX?
I know I will get some snarky share price jabs but that is not Leo's job, his has been to get our drugs advanced down the line at the lowest possible price and to keep IPIX afloat financially. I'd say he has done a remarkable job.
RELEASE: http://www.ipharminc.com/press-release/2018/1/16/innovation-pharmaceuticals-presents-at-2018-biotech-conference-oral-mucositis-drug-candidate-garners-exceptional-interest-after-successful-phase-2-trial
January 16, 2018
Innovation Pharmaceuticals Presents at 2018 Biotech Conference; Oral Mucositis Drug Candidate Garners Exceptional Interest After Successful Phase 2 Trial
Brilacidin
BEVERLY, MA – January 16, 2018 (GLOBE NEWSWIRE) Innovation Pharmaceuticals, (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to inform shareholders of a productive appearance by Innovation last week at leading health care meetings held in San Francisco, with an audio file of the Biotech Showcase presentation now available on the Company website.
Interest in the Brilacidin Franchise—based on the breadth of its treatment potential—was notable. Strong momentum gained as a result of Brilacidin’s recent positive topline findings seen in both Inflammatory Bowel Disease (IBD) and Oral Mucositis (OM), coupled with previously successful results achieved in Acute Bacterial Skin and Skin Structure Infection (ABSSSI), has delivered a complementary cross-indication scientific anchoring for each Brilacidin indication in the Company’s pipeline.
In particular, Brilacidin-OM received an exceptional degree of attention at the San Francisco shows, further adding to an already robust partnering matrix. Innovation is developing Brilacidin-OM under a FDA Fast Track designation as a novel therapeutic and recently met the primary endpoint in a Phase 2 trial for preventing severe OM as well as a key secondary endpoint by delaying the onset of severe OM. Brilacidin has effectively earned a leadership position as an easily-delivered oral rinse drug candidate in OM—what many analysts predict will become a $1 billion market opportunity within the next few years.
“What must be stressed is that Brilacidin is a mature, later-stage drug candidate with platform potential. It took the recent completion of two Phase 2 trials, in IBD and OM, to further validate the exceptional results achieved from our Phase 2b study in ABSSSI. 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.”
Biotech Showcase Event Recording
An audio file of the Corporate Overview given at 2018 Biotech Showcase, on January 8, in San Francisco, is now available and accessible on the Events and Presentations section of the Company’s website.
Brilacidin-OM (Phase 2 Trial Completed)
As announced earlier, the Company has completed a Phase 2 randomized, double-blind, placebo-controlled trial (see NCT02324335) evaluating Brilacidin’s ability, administered as an oral rinse, to prevent and attenuate OM in patients with Head and Neck Cancer (HNC) receiving chemoradiation with at least 55 Gy across 7 weeks. The study’s primary endpoint was met, with Brilacidin, as a preventative treatment, showing a clear reduction in the incidence of severe OM (SOM) (WHO Grade ≥ 3) compared to placebo. A key secondary endpoint in the trial, delaying the onset of SOM, also was met. The Company has begun exploring patient-friendly improvements to drug delivery (the use of sachets) and will be meeting with the FDA to determine next steps in the clinical development of Brilacidin-OM. Patents for Brilacidin-OM have also been granted globally, most recently in Europe. Worldwide, the potential market for OM, largely untapped, is estimated to be in excess of $1 billion, with the Company considered a top contender in this space.
sox, thank you for the great reminder of the possible Psoriasis deals before IPIX. There are a handful of you that post on this board that make me feel so much better when you are actively posting. Negative nannies don't stand a chance.
Go Leo & IPIX!
Recent Psoriasis Deals
1. Allergan in $640M Vitae buyout deal as it further expands dermatology pipeline
"Allergan buys into the Fort Washington, PA-based biotech’s dermatology pipeline that includes VTP-43742, a midstage, first-in-class, orally active ROR?t (retinoic acid receptor-related orphan receptor gamma) inhibitor for the potential treatment of psoriasis, as well as other autoimmune disorders."
http://www.fiercebiotech.com/biotech/allergan-640m-vitae-buyout-deal-as-it-further-expands-dermatology-pipeline
"The compound recently completed a Phase 2 proof-of-concept multiple ascending dose trial in patients with moderate to severe psoriasis."
https://www.allergan.com/news/news/thomson-reuters/allergan-to-acquire-vitae-pharmaceuticals-adding-i
2. Fumarate makes weight as Xenoport, Dr. Reddy's ink potential $490M deal
"The terms call for $47.5 million up front and another $2.5 million related to the transfer of certain clinical trial materials to Dr. Reddy's. Xenoport will be eligible for as much as $190 million if regulatory milestones are met, which could happen over a period of several years, the companies said. Up to $250 million more may come if commercial goals are hit, and royalties as high as the midteens are included for U.S. sales."
http://www.bioworld.com/content/fumarate-makes-weight-xenoport-dr-reddys-ink-potential-490m-deal-0
"Shares of Santa Clara, CA-based XenoPort were down 25 percent by midmorning Tuesday after the company announced positive preliminary results from a Phase 2 clinical trial of its oral psoriasis drug.
Although the biotech said it expects to begin Phase 3 trials of its drug, XP23829, in 2016, a high rate of gastrointestinal side effects may impede its efforts. XenoPort’s shares had initially been up 19 percent earlier Tuesday morning."
https://www.dddmag.com/news/2015/09/xenoport-shares-dive-after-psoriasis-drug-study-results
3. Purdue Strikes $790 Million Exicure Deal to Diversify
"Purdue Pharma LP has struck a deal with Exicure Inc. to buy the rights to an experimental psoriasis treatment for as much as $790 million, the latest in a string of moves to diversify away from opioid pain drugs, the backbone of the company’s business."
https://www.bloomberg.com/news/articles/2016-12-12/purdue-strikes-790-million-exicure-deal-to-diversify-from-pain
4. AbbVie hands over $595M upfront to partner with Boehringer on PhIII psoriasis drug
"AbbVie ($ABBV) is handing over $595 million in an upfront payment to partner with Boehringer Ingelheim on its late-stage psoriasis drug, the anti-IL-23 BI 655066."
http://www.fiercebiotech.com/partnering/abbvie-hands-over-595m-upfront-to-partner-boehringer-on-phiii-psoriasis-drug
sox, thank you for the great reminder of the possible IBD deals before IPIX.
Recent IBD Deals
1. Johnson & Johnson commits $990M to land Protagonist’s oral Crohn’s drug (preclinical)
"Johnson & Johnson has landed rights to Protagonist Therapeutics’ preclinical Crohn’s disease asset PTG-200. The deal gives J&J a stake in an oral interleukin-23 (IL-23) receptor antagonist in return for $50 million upfront and up to $940 million in milestones."
"The asset is due to enter the clinic this year. Protagonist will run and fund the trial with J&J taking over—and covering 80% of the costs—once it advances to phase 2. Beyond this, a series of major paydays await Protagonist. J&J will pay Protagonist $125 million if it moves the drug into phase 2b and a further $200 million if it sticks with the asset after getting a look at data from the trial. The rest of the cash is tied to regulatory and sales milestones."
http://www.fiercebiotech.com/biotech/j-j-commits-990m-to-land-protagonist-s-oral-crohn-s-drug
2. Celgene Completes Acquisition of Receptos, Advancing Leadership in Immune-Inflammatory Diseases
"Celgene Corporation (CELG) today announced it has closed its acquisition of Receptos, Inc. Receptos stockholders received $232.00 per share in cash, for a total of approximately $7.2 billion, net of cash acquired."
http://www.fiercepharma.com/pharma/celgene-completes-acquisition-of-receptos-advancing-leadership-immune-inflammatory-diseases
3. Celgene enters deal potentially worth over $2.5 billion for Nogra Pharma's Crohn's disease drug
"Celgene announced a global licensing deal Thursday potentially valued at more than $2.5 billion to develop and market Nogra Pharma's experimental drug GED-0301 for moderate-to-severe Crohn's disease and other indications."
https://www.firstwordpharma.com/node/1205296?tsid=1
4. Gilead swoops down on Galapagos JAK1 candidate filgotinib in $2.075B deal
"Gilead Sciences Inc., is stepping in where Abbvie Inc. stepped out, laying down a whopping $725 million, with up to $1.35 billion more to come in milestones, for rights to Galapagos NV's Janus kinase 1 (JAK1)-selective inhibitor filgotinib (GLPG0634)."
http://www.bioworld.com/content/gilead-swoops-down-galapagos-jak1-candidate-filgotinib-2075b-deal
5. Salix Expands in GI Drugs and Beyond with $2.6B Santarus Acquisition
"Salix Pharmaceuticals said it will acquire Santarus for about $2.6 billion, in an all-cash deal that expands the buyer’s gastrointestinal (GI) drug portfolio and extends its product offerings into primary care and diabetes."
http://www.genengnews.com/gen-news-highlights/salix-expands-in-gi-drugs-and-beyond-with-2-6b-santarus-acquisition/81249089
This is now a none issue for me. Thank you for shedding light on this subject cabel.
Go Leo & IPIX!
I just read the details of the product and it hase been available on the market for years.
I sent it to Leo before looking into it and Leo commented back (Our CEO is pretty bright):
Obviously, if this was "effective" in treating OM it would be unethical for the hospital or FDA to allow placebo in an SOM trial. I don't think I need to say any more than that.
Quote:
The ProThelialTM is the only FDA-cleared prescription medical device containing polymerized crosslinked
sucralfate. As a full management oncology support product, ProThelialTM has been associated
with both the rapid reversal/elimination and complete prevention of oral mucositis. It was cleared by
the FDA in August 2013, and has produced results heretofore unassociated with any mucositis
intervention.
On November 8th 2014, an agreement was signed with Walgreens, wherein it will function as one of four
Specialty Pharmacies to provide healthcare professionals and mucositis patients, immediate access to
ProThelialTM. The main goal of this partnership is to increase visibility and thereby accessibility of
ProThelialTM to oncologists in the US, and to ensure that every mucositis patient has access to
ProThelialTM.
Thank you cabel, "believe pharmas view us as the leaders in the race for a drug to prevent SOM" That's great. I can't wait to see how this plays out.
Go Leo & IPIX!
Funny you should ask,...
Just got this back from Leo after I sent him a link to the article PP posted.
They did a much larger trial. Their patients were dosed by infusion multiple times a week for a number of hours. Obviously a huge disadvantage to our brilacidin rinse. We are not concerned. You can't disregard their placebo arm SOM percentage which was slightly lower than ours. In addition they reported "in the overall incidence of SOM through 60 Gy of radiation" We reported "cumulative radiation dose criteria of at least 55 Gy—the minimum treatment threshold for inclusion in the efficacy population." So we made it more challenging for ourselves by using the lower number of 55GY.
We had multiple meetings in San Francisco and believe pharmas view us as the leaders in the race for a drug to prevent SOM.
Thank you, I learned a lot.
Go Leo & IPIX!
Great weekend re-read:
c.ymcdn.com/sites/www.bioflorida.com/resource/resmgr/imported/ShareVault%20whitepaper%20-%20Getting%20Ready%20for%20BioPharma%20Partnering%20v2.pdf
Remember Leo confirmed they have had a great virtual room with cable!
Our time is near friends. IMO.
Novartis would be an awesome partner for IPIX. Thanks for keeping us updated.
Go Leo & IPIX!
Bump: Update on below. CDA with Ipix prevent from disclosing further deatils on (bevorstehende Zusammenarbeit) "imminent collaboration". Found in Austrian medical paper.
Possible B inroads in Europe. I came across an interesting few sentences in an editorial of a medical periodical this weekend. It was in an Austrian paper written in German with a reference to a French physician that specializes in neck and throat cancer who seemingly has followed Ipix trials. Unfortunately after a little research I wasn't able to find the reference, but will keep trying when time permits. What I found so interesting is that Novartis was mentioned in the article as an interested party to the progress of an American company (Ipix not mentioned) in clinical trials of OM. FYI: Novartis is the second largest Global Pharma in the world and its headquarters is in Basel, Switzerland. The new European patent is either very timely or quite coincidental or is it? I just thought I would share this tidbit. I will keep perusing other periodicals. Even though I am fluent in French and German technical medical jargon and terminology is problematic at times for me to interpret. Finally IMHO, B-OM will be a Godsend even in the worst case scenario. If it only is efficacious for 35% of the population and assuming there are 10 million sufferers/year of this affliction. 3.5 million will be cured/helped. What Pharma wouldn't want to have that drug? P will also be a huge benefit to those suffers with significant remuneration with whomever partners with Ipix. Lastly, K is why I invested in CTIX/IPIX 6 years ago. MAKO albeit a reprehensible company has afforded me the ability to make lemonade from lemons as they plummeted the SP. Sorry for the trite metaphor. My DD and medical background tells me that K will be a winner, too. That being said K will probably take more time to reach fruition. I pray mostly that millions of people will be alleviated from the horrible suffering and pain. Additionally, K could very well save millions of lives. To that end I pray that God hears the words from my lips and that it reaches his ears. Making money with Ipix is just a bonus for me. My mother had throat cancer and I watched her suffer unbelievably for 10 years before she passed away. All the best to everyone. Merry Christmas, happy holidays and safe and healthy New Year.
All the best Billy10us
So many uses for Brilacidin. Thanks George,
Go Leo & IPIX!
Brilacidin oral tablets in formuation for the treatment of UC and Crohn's.
Quote:
BRILACIDIN
Brilacidin is Innovation's lead drug candidate in its defensin-mimetic franchise.
Modeled after Host Defense Proteins (HDPs), the “front-line” of defense in the body's innate immune system, it is a synthetic, non-peptidic small molecule that kills pathogens swiftly, significantly reducing the likelihood of drug resistance developing. Just as importantly, Brilacidin functions in a robust immunomodulatory capacity, lessening inflammation and promoting healing.
Innovation is evaluating Brilacidin, under Fast Track designation, in a Phase 2 clinical trial as an oral rinse to attenuate Oral Mucositis in patients with Head and Neck Cancer who have received chemoradiation. Topline study results indicate Brilacidin has a high potential for preventative treatment, as evidenced by a clear reduction of severe OM (SOM) among patients on Brilacidin as compared to those on placebo. Additional secondary endpoint analysis, showing Brilacidin delayed the onset of SOM, further supports the drug candidate's therapeutic effect.
Innovation also is testing Brilacidin, administered with water in an enema, in patients with Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS) — a type of Ulcerative Colitis (UC), and, like Crohn's Disease, an Inflammatory Bowel Disease (IBD) — in a proof-of-concept Phase 2 clinical trial. Topline findings support Brilacidin as a novel, non-corticosteriod, non-biologic IBD treatment, with a majority of patients treated achieving induction of clinical remission. Formulation development plans include foam and/or gel for the treatment of UP/UPS and oral tablets for the treatment of UC and Crohn's.
As a mimic of HDPs, which play a key regulatory role in the etiology of skin diseases, and due to its limited systemic absorption when topically applied (a favorable pharmacokinetic profile), Brilacidin may have other applications in treating dermatological disorders. Additional trials of Brilacidin are planned in Acne, Hidradenitis Suppurativa and Atopic Dermatitis (Eczema).
A key aspect of Brilacidin's mechanism of action, inhibiting Phosphodiesterase 4 (PDE4), may further support its use in treating Asthma, Psoriasis, Psoriatic Arthritis and Chronic Obstructive Pulmonary Disease (COPD), alongside other chronic autoimmune conditions.
As an antibiotic, representing the first in a new class of anti-infectives, Brilacidin is being advanced in the clinic under Qualified Infectious Disease Product (QIDP) designation — qualifying the drug candidate for Fast Track and Priority Review, as well as an extra 5 years of market exclusivity upon drug approval. A Phase 2b trial was completed evaluating Brilacidin as an intravenously-administered medication in treating Acute Bacterial Skin and Skin Structure Infection (ABSSSI). Trial data showed a single dose of Brilacidin to be comparable in safety and efficacy to a 7-day dosing regimen of FDA-approved Daptomycin.
“BRILACIDIN [...] HAS A HIGH LIKELIHOOD OF REACHING COMMERCIALIZATION.”
— Dr. Michael Zasloff
Pre-clinical work has been conducted, as well, on the gram-negative, anti-fungal, biofilm and material applications of HDP-mimetic compounds.
Brilacidin and related compounds are protected under various composition and use patents. A patent was filed and is pending for the use of HDP-mimetics in the prophylaxis and/or treatment of inflammatory diseases of the gastrointestinal tract. Another patent for compounds for use in treatment of mucositis has been awarded numerous global protections.
http://www.ipharminc.com/brilacidin-1/
Good luck and GOD bless,
George
Thank you and great comparison chart!
Go Leo & IPIX!
Hot D., I can upload images.
If this works it will ruin me. Anyway, I noticed that people are starting to anticipate prurisol topline results. Maybe this image helps in the ensuing interpretational melee:
[img][/img]
Old methotrexate is the king of nastiness (contested, thou. Sometimes it is not number of items in the boxed warning but Da' size!). Xeljanz is the undisputed king of cost and efficacy plus the crown prince of nastiness. Otezlas claim to fame is that is mild in every way.
As far as it is possible to say prurisol tracks Otezla favorably. I put pricing info in as a constraint on those with tendencies of seeing multiple billions.
Good luck.
I would assume it would be more beneficial for Leo to get the trial results out soon as they are available so that BP can adjust accordingly before emptying their budget. That is if there isn't negotiations already occurring.
Regarding OM OR IBD OR ABSSSI - I personally know at least 10 people who have GI issues and have never met anyone with OM - not that means anything. My Mother-In-Law is slowly loosing her battle with brain cancer and was lucky enough to not get OM. That being said, in my personal experience and in my area there appears to be a greater need for a treatment for UC/UP/UPS. It is seriously amazing to me that BRILACIDIN is this diverse. Could this be the drug that changes the game.
Then there is PRURISOL that looks like it is going to beat out the leading market drug Otezla. An oral drug that provides serious efficacy treating psoriasis.
KEVETRIN may change the world and oncology. Unbelievably awesome!
I have been with IPIX for 6 plus years now and the time is almost here and we are going to see where Leo intends to take IPIX.
The numbers are stocked in IPIX's favor and 2018 is going to be one to remember. Too many good things are happening at IPIX. Hello Nasdaq.
Thanks again Pete for your contributions to this board!
Go Leo & IPIX!
Our expectations seem to be that most are on the same page as to the Prurisol 2B trial proving to be a success, but quite a wide divergence on just when the results will be known. Appears to be everything from just a few days to possibly two months or so. I tend to side with the longer time frame but could be pleasantly surprised as the B-OM secondary endpoint PR was put out way earlier than I was expecting.
Sure would be interesting to know what is the focus of Dr M at the current time. Just thinking about B, do they go after the IBD side or the dermatology side? Hope we get a large, top line partner to be able to address concurrently. For K, I hope the line is already forming by current top line treatments to conduct combo research with their products. If that is the case, does IPIX need a K partner at the current time or would we be able to ride the combo trials and partner with each successful indication for that particular treatment? Don't know if I am making myself clear, but IPIX provides the K and researcher provides the funding for the combo trial with their product. Like the U of Bologna trial from years past.
Obvious from the above musings that I consider chances very high that all three drugs will receive very positive P2 results and that all will be examined for further indications.
Quick query - K has advanced steadily in the area of greatest activity by cancer research -- p53. How come we have seen nothing in the way of funding by the Cancer Society when they bring in billions upon billions yearly? Hate to say it, but I am highly dubious of ALL charities, except for those like St. Judes, Shriners, etc where nearly 100% of acquired funds go to the hospital and patients themselves.
The results should be rolling any day and the rally about 1 minute after. Before his death my father had very moderate psoriasis and had an awful time managing it. IMO P could be very big.
Go Leo & IPIX!
Moreover, the Company learned that some patients were previously unsuccessfully treated with other therapies, including biologics and apremilast (Otezla®).
Just incredible! I had totally forgotten about that comment. The odds of success in the Prurisol 2B trial are well above 50/50!
The bar is set so much lower than the 2A trial using PASI and moderate to severe.
When is the P rally to the countdown of top line results going to begin?
Awesome post George, next week might be our week. Thank you for posting that information. Nasdaq here we come...
Go Leo & IPIX!
Why Prurisol is worth at least $10 Billion!!!
At 300 mg per day and 400 mg per day Prurisol as an inexpensive and convenient oral drug will capture more of the market share now held by more expensive biologic treatments that currently are estimated to be over $8 billion per year.
Prurisol is worth at least twice what Otezla is worth!!!
Look up net present value which considers the years of revenues of say $6 billion each and every year for over a decade.
Also, Prurisol will be effective for other inflammatory diseases and conditions including arthritis including psoriatic arthritis, rheumatoid arthritis, osteoarthritis, multiple myeloma, asthma, etc.
Comments from the principle investigators from the previously completed Prurisol Phase 2a trial:
Quote:
Investigator Comments
Cellceutix would also like to share some observations and comments from Principle Investigators (PIs) overseeing different participating clinical sites in the trial. 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®).
Included below is a sampling of responses that were authorized to be published:
"Well designed study, patients were pleased, minimal to no side effects."
"Good tolerability was shown with very few AEs reported. Good compliance and good patient satisfaction."
"Overall impression of the study is very positive, as well as the patients' satisfaction."
When asked, "Why would you choose Prurisol (should it be approved) over another oral compound for psoriasis?" and "Why would you choose Prurisol over an injectable biologic?" responses included:
"Because [Prurisol] does not cause any severe side effects. Patients dislike needles and injections because they cause pain and discomfort."
"Patients overall prefer oral medications over injectable medication. Our experience with injectable studies for other indications has been that many subjects do not like taking them and those studies tend to be difficult compared to oral medications to recruit subjects."
"Because of [Prurisol's] low side effect profile."
"Patients prefer oral treatments."
Love the last two sentences of your post which I find very interesting. Another great read and thank you for posting on this board.
"With Otezla psoriasis goes and tuberculosis comes."
"With prurisol psoriasis goes and so does influenza."
Go Leo & IPIX!
Absolutely! That's the reason why I try to do some 'sensitivity' tests.
I calculate, if possible, at least
1. Some statistical test (Fisher's exact, Log-Rank etc.) to check for type 1 error (even if values are given, I try to double check). In this case, 6/18 or 6/19 vs 4/23, Fisher's two-sided exact test gives p = 0.289 or p = 0.468. Now I know that statistically speaking there is about 30 to 50 % chance that the prurisol phase 2a results are a lucky coincidence and 50 to 70 % chance that there is at least the difference of 31.6 to 33.3% vs 17.4 % in 2+ point IGA drops.
2. Check historical values for like drugs i.e. oral psoriasis drugs. The only ones that I found with near comparable results available are Otezla Esteem plus Liberate trials. I repeat results with a worst case correction I did NOT DO BEFORE (my bad).
Otezla vs placebo, sPGA/IGA response: Final IGA = 0 or 1 and 2+ point drop in IGA at week 16.
Esteem 1: 21.7 to 30.4 % vs 3.7 to 5.4 %
Esteem 2: 20.4 to 28.1 % vs 4.4 to 6.9 %
Liberate: 21.7 to 27.3 % vs 3.6 to 5.0 %
About that worst case correction and some other things. Otezla numbers include IGA 4 subjects, prurisols do not. Worst case assumption: Only IGA 3 subjects in Otezla trials satisfied sPGA/IGA response. That gives you the upper limits you see above. Note that All results are for week 16, prurisol results are for week 12. Eyeballing from available graphs Otzela scores improved slightly between weeks 12 and 16. Hence what you see are slight overestimates for Otezla when compared to prurisol.
So, I learned something, again.
A. Otezlas result are very consistent.
B. With worst case correction prurisol percentage is barely above Otezlas upper limits, but it is above.
C. The percentages for placebo in prurisol trial is well above that seen in Otezla trials. Maybe my assumption that all 2+ IGA drops in placebo happened in IGA 3 group is too harsh. That has consequences in Fisher's exact test. 6/18 to 3/23 gives p = 0.147 or p = 0.257. In this case there is about 15 to 25 % probability that the result is just a coincidence and 75 to 85 % change that the difference is at least 31.6 to 33 % vs 13 %.
The difference between Infinity and me is not that we do not agree about the above results. I think we do. The difference is that we see them differently. For Infinity the above is still too high risk, to me it is a risk worth taking. Currently we are in quantum situation: neither of us is wrong, yet. That gets resolved with P3 trial or just possibly earlier.
About a month or so ago, when I was still mulling over whether to write an article about IPIX I came across this trial. Otezla Unveil trial. It happens have ONLY moderate subjects, IGA = 3. So here is UNVEIL:
Otezla (n = 148) vs placebo (n = 78), percentage of subjects having PGA/IGA score 0 or 1 at week 16
30.4 % vs 9.6 %
The numbers for 2+ point IGA drop are also the worst case scenario for prurisol trial considering IGA 0 or 1 score. So let's repeat:
prurisol (n = 18 or 19) vs placebo (n = 23), percentage of subjects having PGA/IGA score 0 or 1 at week 12
31.6 to 33.3 % vs 13.0 to 17.4 %
So far, prurisol is, at least, tracking Otezla. And if the situation stays the same it is more than enough because prurisol has one major trump card. Otezla is immunosuppressant, prurisol is not. Prurisol is based on abacavir which is an antiviral. A slight exaggeration:
With Otezla psoriasis goes and tuberculosis comes.
With prurisol psoriasis goes and so does influenza.
Very, very, very, very GRAND although it would have to be vague release so not to allow the shorties to figure out a rebuttal strategy.
He is probably just waiting patiently to drop the hammer...
Go Leo & IPIX release for Monday!
How GRAND it would be if Leo released an announcement on Monday morning stating he was partnering one of the indications with one of the Big Boys!!!! The Shorties would be stepping all over themselves scrambling not being able to do anything about it until Tuesday since Monday is a Holiday....
Here Today! well said and I agree. I also think we will see the NASDAQ sooner than later which will open up the playing field. Go Longs...
Go Leo & IPIX!
What's truly amazing is that for the last 3 months (probably longer) all we have heard from the "Shorties" is about all the Dilution and how Leo has been hitting the Aspire funds. But if the figure of 40k+ in new outstanding shares is Factual, then I must commend Leo for his fiscal responsibility and looking after our investment. I do not care what anyone says, he has been doing a great job to minimize our debt which is imperative for a small Bio company. Our pipeline is stacked in my honest opinion and am excited for what's to come this year.
BAM! Great response...
Go Leo & IPIX!
Infinity I beg to differ little bit.
Yes, prurisol is the least favorite of mine in IPIX pipeline. But if it ever gets approved it has its own unique charms, besides being an oral drug.
1. Not immunosuppressant
2. Presumably low manufacturing cost
One month of abacavir 600 mg daily has gone below 500 USD, Otezla is around 3000 to 4000 USD montly.
As to big pharma investing based P2a data. Some even prefer to do it then - because of the risk discounted price they can get. Novartis went public not so long time ago saying they see prices for late stage developmental drugs as too high and therefore prefer to go after riskier but cheaper earlier stage drugs.
It seems that my percentages, delightfully, do annoy you. Well, in that case, I can't resist but put few more here. These are from Otezla Esteem 1 and 2 (you know, those pivotal trials) and may help explain why I am optimistic even with prurisol.
Esteem 1, percentages for 2+ point drop in sPGA/IGA
Otezla 30 mg ITT = 526; 21.7 %
placebo ITT = 282, 3.7 %
Esteem 2, percentages for 2+ point drop in sPGA/IGA
Otezla 30 mg ITT = 274; 20.4 %
placebo ITT = 137, 4.4 %
Is it only stupid me, or does it look like prurisol percentages from that little trial can go down a lot in P3 trial and prurisol still eats Otezlas lunch?
This cannot be argued and thank you George for providing us with FACTUAL information about Aruda.
Go Leo & IPIX!
The truth about the number of shares of IPIX that the Arudas cuurent have now 7,316,824 shares of Common Stock Class A. compared to the 8,000,000 shares of IPIX that they started with in August 2014.
https://www.sec.gov/Archives/edgar/data/1355250/000117152018000018/eps7690.htm
https://www.sec.gov/Archives/edgar/data/1355250/000117152015000117/eps6076.htm
Good luck and GOD bless,
George
Pa-Pow! another great post and I couldn't agree with you more! I like this one so much I might forward it a couple of times today.
Go UNCLE Leo & IPIX!
Leo Probably made the GREATEST deal in the HISTORY of the Pharmaceutical Industry.
He paid $5m for a drug that will in all likelihood produce 10 BILLION+ in yearly revenues when all is said and done.
He out maneuvered EVERY BIOTECH company BIG and small in the world to secure the deal of a LIFETIME! They sat there with their thumbs up their butts and will now PAY Leo BIG TIME for doing so.
Scottsmith you are very fortunate to have an UNCLE like LEO!
DaubersUP,
Soooo well said. You and I have similar views on IPIX. I generally don't read anything from the shorters on this board because they repeat them selves day, after day, after day after day.
Time is ticking and soon we will see who read this one right.
Thanks for your valuable input.
Go Leo & IPIX!
This entire conversation today is completely outlandish. IMO
The idea that IPIX is only worth 100-200% on a buyout is absurd.
Here is a little hint on how things move:
1) Acquire or Develop a compound
2) Raise funds to further develop the compound
3) Raise funds for pre-clinical testing
4) Based on results - Raise funds to take the drug into the clinic
5) Raise more funds to pay your company and third parties to continue to test and develop said drug.
6) Keep raising funds if you see more and more positive results, because the company has to move forward and to the next phase and present at the next showcase etc...
7) Keep raising funds
At some point there is validation and a ton of cash that is thrown at the company if the drug proves out. When this happens.
THE SHARE PRICE RISES! It's not hard to understand. There is no more reason for the company to raise funds through stock, so what happens? The share price rises!
We are waiting for that point.
The X factor between IPIX and many other bio's is that IPIX has 3 potential blockbuster drugs and we know currently that 2 of those compounds have multiple blockbuster indications.
There is no way that IPIX is sold any time soon. The validation must come first to increase our share price, and then every move that is made and every result that is documented the share price rises even more and more and more and more and more because IPIX is off the OTCBB and has INSTITUTIONAL SUPPORT by being on the NASDAQ and IPIX has an injection of cash from partners and support from partners to help expedite everything. At that point and when they get to phase 3 in many of the indications, a full buyout could potentially happen IMO - and by that time we are looking at 6-80-100 dollars a share price ---- so the buyout YES could be 100-200% the share price. Maybe 160, 180 200? That is when a buyout occurs.
There will be no buyout at this point for $5 or whatever is being thrown out around here.
Go look back at the major success stories starting out in the OTCBB - .55 to 1.60 to 3.00 to .80 to 4.60 to 14.80 to 33.80 to 68.00 to 101 to 211 buyout.
That happens over a 9 year span and the major take off occurs over the final 2-3 years...
WE ARE SO CLOSE IMO -------- the first domino will fall sooon!!!! IMO
Thanks but I don't believe in luck.
IMO, Luck is sometimes mistaken for hard work, attention to detail, passion and persistence. I believe these are all qualities Leo and his team possess which is why I am invested this stock.
Go Leo & IPIX!
good luck to you
DaubersUP,
I agree and hopefully IPIX will get on the NASDAQ soon.
Go Leo & IPIX!
I attempted to buy at .73 this afternoon. 7K and it would not let me. However many trades occurred below at .7139. So freakin weird. Can we please leave the otc? I’m ready.
George,
Thanks for your post.
IMO, I believe PRURISOL will be huge. I hope we get the results soon.
Go Leo & IPIX!
TradingPro,
Dr. Bertolino expertise is dermatology and he worked for Pfizer.
Pfizer Assembling New Commercial Team For Move Into Dermatology
Quote:
The big pharma is moving into a new therapy area – dermatology – as part of a three-pronged strategy in Inflammation & Immunology that also includes rheumatology and gastroenterology. Pfizer’s first product for dermatology, crisaborole for atopic dermatitis, could launch next year.
https://scrip.pharmaintelligence.informa.com/SC097506/Pfizer-Assembling-New-Commercial-Team-For-Move-Into-Dermatology
FDA turns down Pfizer's Xeljanz in psoriasis
USregulator dampens the firm's hope of expanding arthritis drug's uses
http://www.pmlive.com/pharma_news/fda_turns_down_pfizers_xeljanz_in_psoriasis_842286
Good luck and GOD bless,
George
TradingPro,
Leo has paved the way for this to happen. He has been hitting the mark and making steady progress. The time is nearing and we are going to see what this puppy is really worth!
Thanks you for your post.
Go Leo & IPIX!
I owned Trius and Durata they got bought out and each had contingent value rights associated with the deal. Durata for example got bought out around $25, and had in addition $20 in future CVS, $4 per CV. Each CV was for future milestones like approvals, and the last one was for a total amount of revenue generated after 3 years. They can be for about any risk the acquirer wants to mitigate, even trial phase II & III starts. So I could definitely see IPIX having a deal with associated CVs. Durata had a lot of naysayers and shooters boasting about how it was going down big. Then the BO announced, it was comical. Shorts were shell shocked for many days on the message boards. At first in denial, it was very entertaining.
gianni,
IMO You're right, the share price is $.71. If you were paying attention you would realize that I don't "argue", I provide facts and remain optimistic. I am glad you and others on this board have kept the price down so that I could acquire 135,000 shares at an average of $.74 bringing my total average way down. I appreciate all your work. It doesn't matter what the price is now, what REALLY matters most is what I sell it at. I would not have bought the shares if the price was $5 like it was before the attack.
Please keep reminding me what a deal I have been getting over the past year.
I appropriate you taking a special interest in me personally!
Go Leo & IPIX!