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.7302-----lol
It was interesting to read some of the old quotes from previous PR's and Articles where MGMT was interviewed over this past weekend! Thank you for all that reminded me of so many quotes of the company mentioning meetings with BP and details on strategy. It somewhat put things into a strange perspective for me though - one that you can kind of now look back and see things that you once did not and it somewhat paints a pretty picture moving forward.
I personally would not like to be in MGMT's shoes right now. There are just too many ways they can move forward and I am hoping they make the correct choice for the long run. I do have full confidence they will, but I can only imagine how difficult this could be. The scenarios could be endless because Brilacidin is such a unique drug with just too many possible indications in it's back pocket. We could have an enormous market lighting deal in the upcoming days with some huge milestones if a single BP wants to take the reigns of B all together and does not want to share indications with others.
If B-OM proves to be anywhere around 60%-80% preventative over a 30% placebo we will see a nice deal IMO. If they mark the 80% we could see a huge deal since we would run the show and every HN patient would take B-OM for prevention.
What then for B-UP/UC? It's the same properties and will further show proof of B's magical efficacy. Will the BP want to allow some other BP to step in on BD indications (btw we could see Crohns etc...) $$$$$
What about the B-Absssi that is already just chilling and waiting for a phase 3 as discussed all weekend? That is low hanging fruit.
Move to the derma options with B - eczema, HS, acne!!! $$$$
It is just so overwhelming to think about and what does MGMT want to do? Ride in to the sunset and let BP take the reigns on many items or do they want to license out each indication and have multiple partners on B?
It will be interesting to see, but after reading all weekend the past comments on partners and putting together on when the hired Dr. B is making me smile ear to ear right now........bc I think we are very very close to the turning point where this stock will reach 20's, 30's, 40's 50's easily and keep going over the years to come. JMO
Good luck all!
Yes. It will take more time. More patients and more sites to close . I'd be extremely happy with your estimated timelines.
Let's just put all our focus behind OM right now. This trial could take IPIX to the big board. I was praying for interim result numbers but what if they are better...fingers crossed.
Thanks. I agree about P and B being the near term drugs and the potential is endless....there is basically no ceiling.
However, I bought into IPIX for K and believe in it and pray it does what Dr M believes. I'm hoping the tight kid is because of BP and great results. I'm hoping for a big surprise in regards to K
What is your thoughts on Kevetrin.? We know a very small progressive cohort trial began in Feb. we know it was a 5 and 5 patient cohort. We know it began and dosed the first patient in Texas at Mary C's and you could find the trial on their website. We know IPIX dropped a PR over the summer stating they opened a second location up in the east coast and we all found K on their trial site. We noticed that the Texas site no longer had the K trial on their site.
So....almost 9 months into a 10 patient trial, we are blind. IPIX said we should get some kind of data by end of year...not topline but data? (I'd have to go back and find the verbiage),
IMO - I would have expected a pr stating cohort 1 is complete and safe...moving to 2. Do you think we are still in the first cohort?
.72 will look like a dream in a couple weeks IMO. I'm thankful I found this company and pray it's drugs make it to market.
We should be there now. The disconnect on SP and pipeline value will be reassessed soon imo.
I'm just excited to see how B plays out with BP. So many indications and so many future indication.
Let's make BP buy 25million dollars worth of open market shares just as a placeholder for possible future licenses. ;)
Remember. B-OM needs to clear about a 55% prevention rate to CRUSH all competition. However the primary outcome is prevention for IPIX.
I think we see 70%+ for B-OM
Can't wait.
This CEO took a company that was going under. Lent the company millions and is making good money on his return. He took a company going bankrupt with basically two drugs (p and K) with zero clinical trials to a company that added the B franchise which could prove to be more valuable than humira....and now in 8 human trials. 5 completed and successful and 3 about to drop results.
All while adding about 50 mil shares. Over 5 years. Not bad at all
Great CEO. The share price will catch up and prob gap 10-20 dollars on first partnership
Great post. IPIX seems to stand up to tough trial conditions. I think P phase 2a using IGA plus mild to moderate with an expected 2 pt jump and the change to prevention in b-OM are examples of the confidence IPIX has and shows they don't mind going nose to nose with tough conditions.
Maybe even the B- UP photos could be put in that envelope too. Many trials do not include that.
Maybe dual partnerships. US and Europe with different partners. Just a thought
Great point that may be overlooked in a real world situation. The OM trial took off and the final 40 patients completed in half of the time the first 30 did...or it seemed that way. I give credit to the interim announcement. The clinical trial circle is strong and I think if this phase 2 shows the 70-80% prevention...the phase 3 will have patients and institutions lining up to participate. IMO.
Could be an expedited trial as well with breakthrough and rolling review.
Excellent summary post! BP is very interested. Fact
Standing SLOW CLAP! Excellent post. It's time Pete......to all move forward!
What is your price estimate on this scenario;
BOM partner based on 70% prevention rates. Maybe 25mm upfront 200mm milestone to market, 30-40% royalties
Kevetrin proves exactly what BP wanted to see in the phase 2 OC trial. Great results and major tumor shrinkage
P shows 50% PASI 75 and 10% PASI 100 in the phase 2b
Don't even think about UC Eczema crohns absssi etc.....
I mean....I'd have to expect well over 20 dollars a share and on the Nasdaq. IMO.
Enough day dreaming. Onto the weekend.
This stock is unrecognized. The third party verification will put IPIX on many more media channels. This is an otc biotech....there are too many to count and most are one trick ponys that dilute and dilute and RS and dilute etc.... it's hard for real investors to filter thru so many.
Just look at our friendly little board...the same show----day in and day out. We need a name like Pfizer on the next PR and then my friend......and only then will we see huge gains and a new class of investors. IMO.
We should all feel lucky to have stumbled on this company. IMO. I've never in my many years seen such a pipeline at a price like this.
Fact: IPIX has never failed a human trial. The safety and efficacy in every trial has shown enough to get the thumbs up from the FDA.
For all new investors please see Soxs sticky on trial progression. Starting in 2012
Great info on Oral Mucositis here: http://monopartherapeutics.com/oral_mucositis
This is the company that licensed Validive from Onxeo in September. (See the deal here: (https://www.onxeo.com/onxeo-grants-exclusive-worldwide-license-validive-developed-treatment-oral-severe-mucositis-monopar-therapeutics/)
But look at the projections and the explanation of the HPV virus and how HEAD and NECK cancer is expected to increase. HPV is a scary thing and we will be in the danger zone for the next 15-20 years due to the HPV vaccines only several years old.
B-OM could be much much much more valuable than we all think IMO.
I like BK's projections and this alone could take this stock price to a place we never even considered.
Everyone, get some rest over the next week and enjoy your family and friends. Be thankful and show thanks IMO! We have a long ride ahead of us and at some point I feel we may leave orbit.
Let's just hope for a 70-30 spread on data. That will be game changing for us bro. And if we see 80's and maybe high 80% rates of PREVENTION!
We will all be celebrating. That would pull in a huge deal or ATLEAST make several BPs jump quick. IMO.
Days away from knowing.
This company is top notch. ;). One of the biggest milestones in company history is on the horizon my friend. It will absolutely transform the conpany
This specifically cannot be overlooked. Dr B is a very intelligent and respectable man.
"We’ve set for ourselves a high bar, to be sure, but feel confident that if we deliver strong top-line results, Brilacidin-OM will stand apart from any future competition—a potential first-to-market and best-in-class OM treatment.”
I've done the research on current OM drugs being tested to compare....and this statement is 100% accurate.
Huge potential for IPIX and shareholders.
“What’s important to understand about Brilacidin-OM, at this stage of its development, is that it truly represents a potential breakthrough treatment in OM,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “A majority of OM treatments currently being evaluated in clinical trials still target reduction in duration of OM symptoms, rather than going after OM prevention—what we’ve established as our primary efficacy outcome in the completed Phase 2 trial. We’ve set for ourselves a high bar, to be sure, but feel confident that if we deliver strong top-line results, Brilacidin-OM will stand apart from any future competition—a potential first-to-market and best-in-class OM treatment.”
By the way! This deal will transform IPIX and blow the lid. Mark it. Never looking back. Imo
The entire PR is full of those words. A CEO has to put all those words in there or if something happens and data is bad and there are no partnerships....big lawsuit awaits.
Great PR.
I can summarize: there are many Interested BPs and IPIX has had many conversations. They even reach a point where term sheets have been delivered and the final piece that is needed....raw phase 2 data!!! If the data is good...a deal is done man!
That's what Leo said and in a very protective manner. I get it though.
IPIX - long
Agree. Validive was just licensed for 1 million upfront - 108 million in milestones to approval...not sure if phase 3 costs were included but also double digit royalties that can rise as sales increase.
That was for an OM drug that had weak data.
If b-OM sticks 80% prevention. Game-over. We will take the entire market share imo.
HPV induced H&N cancers are on the rise 6 fold. And expected to rise over the next 10-15 years.
Big big money in this market
It's a PR to help raise cash. That's all but also gives us longs a hint that we will be rewarded BIG TIME....just don't sit and watch the water boil. Go out and make the world a better place....each and every day.
They terms he uses represent multiples as well. Maybe there will be multiple licenses and partners. Europe, US? Etc.... we will find out on enough.
LOL - You could be correct! Interesting language/tone:
___________________________
After unblinding...the Company will initiate an aggressive development plan going forward, including: applying to the Food and Drug Administration (FDA) for Breakthrough Therapy Designation and possibly applying for a similar expedited path in Europe; enhancing oral rinse administration with patient-friendly formulation and packaging; and, dedicating internal resources to Phase 3 trial design planning and execution.
Formal collaboration with pharmaceutical companies that have expressed an interest in partnering Brilacidin-OM may well assist further with expediting the drug candidate’s development timetable. Some of these partnering conversations have matured to the point of potentially structuring mutually beneficial licensing agreements, pending the final Phase 2 study results.
______________________________
IMO - It appears IPIX will use our people and resources to move OM to phase 3? However below they mention licensing agreements and they do mention Europe, so maybe in my unicorn and rainbow world, we will do the Doctor/Admin stuff in preparing for the trial and BP will throw it's money around to make this all go much quicker?
I like the PR though - first time IPIX really puts a line in the sand and really addresses BP and the type of agreements they are discussing.
GO IPIX
They have a partner ready and data in the upcoming days will set the price. Today's PR imo is Leo telling the BPs -----Hey!!!!! Any last minute bidders!?!? Raise up the price.
Good luck getting back in - or nibbling NR. This won't hit the moon until the dotted line is signed. We have some time. Maybe
Thank you. In response to the original comment by TIAB which.....never-mind.
505(b) was granted by the FDA. There is no smoke and mirrors. The 505(b) could potentially extend Prurisol exclusivity by up to 5 years I think. Do people understand what that means? I believe; In the final year on the market, let's say year 10 while making 2 billion a year will extend 5 years. While the % increase is a 10% year over year....it would be like $10.6 billion additional dollars made. I think that's a big deal.
Also not to mention the phase 3 trial is often less stringent so it will most likely cost less...less phase 3's less patient population equals cheaper and quicker to market.....that is very valuable in the real world.
Again. The FDA decided and granted.
and in a rare occurrence they can have astronomical impacts on share price - even phase 1 or preclinical.
If news was released that kevetrin patients had their cancer tumors shrink completely and were in full remission, you better believe this would tale off into the billions for market value. P53 effects how many cancer types? Answer:ALOT
I can agree but the market is unpredictable. Some news over the past year was rehashed news and the SP responded Xs the original news. Maybe shorts covering or who knows.
Leo and Dr B have proven a new strategy over the past year plus. Let the science do the talking and try and hold down the fort during the storm. There has been zero flash, zero media exposure and pumping like all traditional OTC stocks...which is the norm down here because of the lack of institutional support to negate the manipulation. I think iPIX is one of the most respectable companies that trade on the otc but that does not put the triscuits in our tummy's now does it.
I just wonder how close iPIX is to a deal. Are we no where near or has term sheets been distributed and final data is the last piece?
You brought up Kevetrin. Why NO communication on this? If one follows Leo's path, no communication is rare. I mean I guess we have 2 MAJOR QUESTIONMARKS coming up and will be answered:
1). Why no update or detail on P phase 2 interim results being released. (Minus the email to you)
2). Why no update on Kevetrin
I am sincerely hoping that Leo has really really good data or news on both and decided the two elements of surprise can catapult this share price when the explanation is available!
I.e. - Prurisol data is exactly as you stated 40-50% Pasi 75 and 10% Pasi 90-100. Then he explains why he could not release interim after he drops the results.
Or i.e. Kevetrin is actually curing cancer in several subjects and they are working with BP on a huge deal and what to say to the world when the results are ready.
That would be amazing and a total blind side on all flippers - haters and shorters. Because we are all conditioned to be ready for each step by Leo through his PR style which is great because its transparent. But a surprise IMO would be welcomed!!!
Hi Biodoc. My thoughts exactly. I am a bull here but honestly can't make out why the hush hush over a full year. In my huge head I'm thinking:
1) everything is taking much longer than anticipated on recruitment and we still are in cohort 1
2). The ties to BP on this are EXTREMELY tight. They did change the landscape of this trial in the first place, so a partnership is imminent and the company was told per an agreement that they the BP are the only ones to see or hear about interim data sets.
3). Data is extremely promising and IPIX has decided to throw the market a curve ball for once and keep it tight to the vest until the trial is complete.
This drug imo is so valuable I do believe that it could be our first collaboration agreement. However the speed of the trials has lulled the market to sleep and they forgot about it. I remember speaking to Dr B about his thoughts on K as I knew he was a derma guy...he said he is in awe by the possibilities and truly without a doubt thinks K is a "possible" blockbuster. He has to throw possible in there but the tone was like that word did not exist.
Not comparing. It's down on the thoughts from the market they gave up too much. It's a tight rope for decisions made by bio's that's for sure. People scream: "PARTNER PARTNER!!!! Take a deal" and then many others.... NOOOOOO that is way tooo low and cheap- I'm suing the company for not exhausting all options for a better deal". Etc....
I posted that because the tidbits of hungry BP for cancer drugs! One
And two how it took a year since the first discussions to partner. I fully expect a partner after one of these phase 2 trials.
Kevetrin - Hoping it will come back into the SPOT light!
A good deal for a younger BIO - mid phase on fierce bio:
https://www.fiercebiotech.com/biotech/bayer-pays-400m-upfront-to-buy-into-loxo-cancer-drugs
I liked these snippets:
With filings for approval in the U.S. and Europe already in the works, Loxo has been emboldened to predict the deal will generate $1 billion over the next few years.
That figure reflects the industry’s appetite for cancer drugs and strength of the data generated by larotrectinib.
All told, Loxo could receive $1.55 billion, almost half of which is due to land in its bank account by the end of next year. The numbers proved compelling enough for Loxo to drop its go-solo plans.
Loxo was approached by large biopharma companies after posting data on larotrectinib earlier this year, CEO Joshua Bilenker, M.D., said on a call with investors. This led Loxo to evaluate the various deal models proposed by potential partners against its existing go it alone plans, before homing in Bayer’s offer as the best fit.
Why the good Dr. left Revance. People were curious why and some thought something could be wrong at revance at the time. IMO. Dr B received a chance in a lifetime.
Have a great day! Cool board!
Dr. B took a job with IPIX. He is about to take the company from sub 100 million mc...to potentially billions. If you see IPIX's pipeline, you'd understand. I was doing a little DD on Dr Bs past and connections. I like what I see and IPIX is prime for a partner. 3 phase 2's are about to drop topline over next 2 months. Psoriasis, oncology, and Oral Mucositis.
March 27, 2017
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
Brilacidin
Study showed a markedly reduced rate of Severe OM (WHO Grade ≥ 3): Active Arm (Brilacidin): 2 of 9 patients (22.2 percent); Control Arm (Placebo): 7 of 10 patients (70 percent)
BEVERLY, MA – March 27, 2017 (GLOBE NEWSWIRE) Cellceutix Corporation, (OTCQB:CTIX) (“the Company”), today presented positive results from the Company's ongoing randomized, double-blind Phase 2 study of Brilacidin in the prevention and control of Oral Mucositis (OM) in patients receiving chemoradiation for treatment of Head and Neck Cancer. In a preliminary Interim Analysis, a marked reduction in incidence of Severe OM (WHO Grade ≥ 3) was observed in patients treated with Brilacidin who received at least 55 Gy cumulative units of radiation. Study results, complementing favorable data released last week in the treatment of Ulcerative Proctitis/Proctosigmoiditis with Brilacidin, further establish Brilacidin as a novel anti-inflammatory drug candidate with potentially broad applications.
Presented below is information on Cellceutix’s clinical trial of Brilacidin for OM, including preliminary Interim Analysis of 19 patients (9 administered Brilacidin; 10 administered placebo) who have reached or passed the planned visit at the end of 5 weeks on study, and received a cumulative radiation dose of at least 55 Gy.
STUDY DESIGN
CTIX-BRI-205 is a Phase 2 randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of Brilacidin as an oral rinse in preventing and controlling OM in patients receiving chemoradiation therapy for Head and Neck Cancer. The study is anticipated to enroll approximately 60 patients in the United States, 30 each to Brilacidin treatment or to placebo (water). Brilacidin (45 mg/15 ml oral rinse—“swish and spit”) is administered 3 times daily across 7 weeks (49 days). Pharmacokinetics of Brilacidin are to be evaluated if there is measurable systemic exposure (from drug concentrations in plasma).
The Brilacidin OM trial uses a World Health Organization (WHO) OM Grading Scale, a common measurement tool in assessing the presence and severity of OM, as defined below.
WHO Scale for OM
• Grade 0 = None
• Grade 1 = Erythema and Mouth Pain Soreness; no Ulceration/Pseudomembrane formation
• Grade 2 = Ulceration/Pseudomembrane formation; solid diet
• Grade 3 = Ulceration/Pseudomembrane formation; liquid diet
• Grade 4 = Ulceration/Pseudomembrane formation; not able to tolerate a solid or liquid diet (except enough liquid for medication)
Primary Endpoints of the Brilacidin OM trial are:
• Incidence of Severe OM (WHO Grade ≥ 3) experienced during radiation therapy (across 7 weeks) by patients with Head and Neck Cancer receiving a cumulative radiation dose of at least 55 Gy in the course of their chemoradiation treatment
• Safety and Tolerability of Brilacidin
A Secondary Endpoint included in the Interim Analysis is:
• Duration of Severe OM (WHO Grade ≥ 3)
Pharmacokinetics of Brilacidin is determined from:
• Brilacidin concentrations in plasma
INTERIM ANALYSIS
Preliminary efficacy and safety data from 19 patients who met the criteria for evaluation were reviewed. To be included, patients needed to have reached or passed the planned visit at the end of 5 weeks on study, and have received a cumulative radiation dose of at least 55 Gy. Patients receiving Brilacidin, as compared to patients on placebo, showed a markedly reduced rate of Severe OM (WHO Grade ≥ 3). Additionally, Brilacidin was generally safe and well-tolerated.
Primary Efficacy Results Incidence of Severe OM (WHO Grade ≥ 3)
• Active Arm (Brilacidin): 2 of 9 patients (22.2 percent)
PREVENTION RATE OF 77.8% - BOOM
• Control Arm (Placebo): 7 of 10 patients (70 percent)
Secondary Efficacy Results Duration of Severe OM (WHO Grade ≥ 3)
• Active Arm (Brilacidin): Mean 10.5 days (Range 3 to 18 days; 2 patients)
• Control Arm (Placebo): Mean 14 days (Range 3 to 39 days; 7 patients)
Safety and Tolerability Profile
• Brilacidin administered as an oral rinse was generally well-tolerated by patients
• Safety findings were typical for patients with Head and Neck Cancer being treated with chemoradiation; no treatment group differences were apparent on vital signs and clinical laboratory safety tests
• Six patients (2 in Active Arm, 4 in Control Arm) experienced at least one adverse event categorized as serious. Nine Serious Adverse Events (SAEs) were reported for these 6 patients, and all were classified by the Investigator as Not Related to study drug
• Incidence of Treatment-Emergent Adverse Events (TEAEs)
o Majority of the TEAEs reported (Active Arm, 164 TEAEs; Control Arm, 143 TEAEs) were related to chemoradiation or the underlying study indication
o No TEAEs were classified as Likely Related or Definitely Related to study treatment
Pharmacokinetics
• Plasma samples from 6 patients treated with Brilacidin were analyzed and all concentrations of Brilacidin were below the lower limit of quantification (i.e., < 10 ng/mL)
“These interim results suggest the potential for an even greater effective therapeutic response as formulation and dosing is further optimized,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Cellceutix. "There currently is no existing preventative treatment available for OM patients in this population, with only limited therapies focusing on symptom relief. Already under Fast Track designation, should Brilacidin earn FDA approval for the treatment of Oral Mucositis, countless patients may no longer have to suffer from this horribly debilitating condition as a side effect of cancer treatment. The use of Brilacidin to prevent the onset of OM could even lead to an entirely new standard of care in this area as we strive to bring this drug to market.”
Cellceutix, over the past months, has added additional clinical sites to this study. Completion of the clinical trial is expected before year-end.
http://www.ipharminc.com/press-release/2017/3/27/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
I think I am going to buy 10K more tomorrow. I convinced the ole lady it was going to pop in the next 3 months :)
Looks like someone had a vacation day today :). Also looks like someone filled and turned positive...
as the world turns I guess.......