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We are now at the stage or pivotal point of imminent trial results for Prurisol Phase 2b, FDA decision on Break Through Designation for B-OM, milestone payments and possible Partnerships or a complete Buyout... that philosophy of making pennies on IPIX is now a fools game.
Well, George is correct AGAIN!!! We broke thru the .60 Cent so called ceiling with ease. Excitement is starting to build for us Longs based on Exciting Novel therapies in BIG Money Disease State Markets!!!
The doomsday's (Unfortunately we all know who they are ... they project their own personal life's misery on IPIX and hope for the worst so they can get some sick pleasure from it... what a way to live life) are going to be left behind.... again! GO IPIX - Enjoy another Summer Weekend everybody!
Great points but you forgot another MAJOR Option or Consideration for Innovation.... A Total portfolio Biotech or Big Pharmaceutical BUYOUT! I'm all for that. Brilicidin, Prurisol and Kevetrin are all novel medications and make a very intreging trio package in desirable disease states.
Facts and Evidence Based Medicine - Earlier Trial below that shows Great Efficacy and Safety of Prurisol in Psoriasis. Easily Found Public Data
• The primary efficacy endpoint of percentage of subjects with ≥ 2-point improvement in IGA was met with the 200 mg Prurisol dose group achieving highest magnitude of effect
• A clear progressive decrease of IGA scores to lower values was seen as early as 2 weeks and further improved out through 12 weeks (200 mg group)
[Note: The p-values from this study were generated for informational purposes only and statistical significance was not a criterion for study success]
• Sufficient clinical improvement was observed to warrant more detailed examination of clinical responses to treatment at 200 mg and higher dosing levels
• Prurisol was generally well tolerated
• As 2/3rd of these subjects (200 mg group) had Baseline IGA=3 (“moderate” psoriasis), their favorable
responses serve as a bridge to investigate Prurisol in a moderate-to-severe psoriasis population
• A Phase 2b trial is planned to begin 2H 2016 evaluating higher dosing regimens (300mg and 400mg) in moderate-to-severe psoriasis, using proportion of subjects achieving PASI75 at Week 12 as the primary endpoint
Dunce Alert: Facts and Evidence Based Medicine - Earlier Trial below that shows Great Efficacy and Safety of Prurisol in Psoriasis. Easily Found Public Data
• The primary efficacy endpoint of percentage of subjects with ≥ 2-point improvement in IGA was met with the 200 mg Prurisol dose group achieving highest magnitude of effect
• A clear progressive decrease of IGA scores to lower values was seen as early as 2 weeks and further improved out through 12 weeks (200 mg group)
[Note: The p-values from this study were generated for informational purposes only and statistical significance was not a criterion for study success]
• Sufficient clinical improvement was observed to warrant more detailed examination of clinical responses to treatment at 200 mg and higher dosing levels
• Prurisol was generally well tolerated
• As 2/3rd of these subjects (200 mg group) had Baseline IGA=3 (“moderate” psoriasis), their favorable
responses serve as a bridge to investigate Prurisol in a moderate-to-severe psoriasis population
• A Phase 2b trial is planned to begin 2H 2016 evaluating higher dosing regimens (300mg and 400mg) in moderate-to-severe psoriasis, using proportion of subjects achieving PASI75 at Week 12 as the primary endpoint
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Great Job LEO, Krishna & Arthur.... Keep communications strong among all your CDA's.
Here's the Reason Why there will be Very High interest in Brilicidin for Severe Oral Mucositis.
Effects of Treatment Induced Mucositis:
* Results in inadequate nutritional intake.
* Leads to poor oral hygiene.
* Predisposes to infections and costly hospital stays.
* Causes chewing and swallowing difficulties.
* Affects quality of life (results in soreness and tenderness of oral mucosa).
* Can be dose limiting and directly impact survival rates!!!!
You are correct Sir!!! Brilicidin as great topline results already in a successful Phase 2 trial... will be great for Patients and Healthcare Providers that know all to well how horrible Severe Oral Mucositis is and how debilitating and extremely painful it is on a Patients body and spirit. Cancer treatments are often delayed as well. It should be a slam dunk for FDA Breakthrough Designation!!! It will also be a very attractive niche drug for an Oncology Franchise (Big Pharma or Biotech) that already has a salesforce calling on Oncology.
HOLD your Stock, it's going to to finally Skyrocket in value once the trial results for Prurisol for Psoriasis data is released, there's strong interest from Biotech's and Big Pharmaceuticals like Celgene, Johnson & Johnson, Abbvie and Pfizer and maybe Roche. Kevetrin compound is amazing too, it is the most advanced p53 drug on the planet that has safely shown a positive intra-tumor p53 modulation ... A truly novel agent with Blockbuster potential.
The opportunity is now, IPIX could be the next Pharmacyclics as far as massive wealth creation for large shareholders, I'm all in are you? I owned PCYC when others didn't dare and here I am again.... I feel just as confident.
IPIX is going to pop/skyrocket very soon $$$ I'm very confident and I'm in the industry... I've done my homework and there is a buyout imminent, BP knows B-OM and Brilacidin itself is a Franchise Blockbuster with all the unmet needs it can satisfy across numerous large market disease states.
Prurisol is another Billion dollar a year market, with advantages of being a Non Biologic, in a very large Psoriasis disease state based on the number of newly diagnosed patients every year and large numbers of second line patients that fail the others over time... e.g. (Ortezla). I expect the Prurisol data will be amazingly safe and highly efficacious based on preliminary public data already out there.
"In dermatology, the current focus is on managing Psoriasis with Prurisol. For cancer, the emphasis is on Ovarian Carcinomas, a gateway indication toward Kevetrin treating many other types of hematological malignancies and tumors. In the area of infectious disease, Acute Bacterial Skin and Skin Structure Infection (ABSSSI) is the target indication. As to gastrointestinal conditions, a study is underway evaluating Brilacidin's anti-microbial and anti-inflammatory properties in treating Inflammatory Bowel Disease. Brilacidin is also being tested in Oral Mucositis."
Get a life, troll. Move on if you don't like IPIX!
Karen,
Sorry to hear about the loss of your sister. We are praying for peace, comfort and strength for you and her loved ones.
Sorry to hear about your brother and 4 other friends having to undergo throat cancer and on top of that suffering through oral mucositis!
Most Oncologists and Radiation Oncologists would prescribe Briacidin and most if not all insurance company would approve Brilacidin for OM to reduce suffering and extended hospitalization expenses due to feeding tube administrations and holding therapies because of Severe OM.
Good Work IPIX Team!
Outstanding Results! We're Talking PREVENTION of Severe OM - these results are impressive! 63.2% of patients in the Per Protocol Population (PP) didn't suffer through Severe OM vs. the majority of patients in the placebo arm having to suffer with Severe OM. This is a new era, Oncologists and Radiation Oncologists will now have a proactive therapy to reduce the likelihood and or severity of a terribly painful and debilating condition SEVERE Oral Mucositis that is a very high unmet need by currently available options. It's a great advancement for the treatment of OM. I would expect that these top line results will lead to a partnership and a big surge in stock value due to the untapped Billion dollar market for OM.
Ask yourself, wouldn't you demand Brilacidin therapy for yourself or someone you know as a preventitive easy to administer therapy if you knew the likely hood for OM was high?
"Summary of Topline Results from the Placebo-Controlled Phase 2 Trial"
Brilacidin met primary endpoint of reduced incidence of severe OM experienced by patients during radiation therapy.
Incidence of severe OM in Modified Intent to Treat (mITT) Population: Brilacidin 42.9%, Placebo 60.0%.
Incidence of severe OM in Per Protocol (PP) Population: Brilacidin 36.8%, Placebo 60.0%.
Trial results support continued and expedited development of Brilacidin-OM.
I would go one step further.... B-OM impressive Phase II results are imperative AND a partnership agreement with milestone payments would spike share price and hopefully lead to an uplisting and really open IPIX shares and awareness to the masses.
Leo at el. regarding what we expect to be BOM clinically significant efficacy results... why not go for FDA approval on Phase II Data - It would seem unethical to not get early approval now than to allow people to suffer to what amounts currently to a ineffective treatment options. It's very common today to get Fast Track approvals on Phase II results that show superiority with Phase III confirmatory results for final FDA approval.
"Chicken Littles" - There is NO scientific issues! If to insure the most credible trials results take a little more time... it is in the best interest of stock holders and the duty of the Board of Directors to do their due diligence!!! "Chicken Littles" By the way anyone can type something and say they received it from Leo or anyone else in an e-mail - It's called FAKE NEWs with a verifiable source.
Big deal...waiting since 2014. Do your homework, these things take time. If you weren't realistic or knowledgeable of the biotech industry then that's your problem honestly. I held Pharmacyclics for a long time at single digits and sold at $261 a share... worth it??? I've been holding CTIX/IPIX since 2013.
New Kevetrin Site is Dartmouth-Hichcock Medical Center in Lebanon, NH (An IVY) Great Oncology Reputation!
Please refer to this study by its ClinicalTrials.gov identifier: NCT03042702
Contacts
Contact: Anne Ponugoti 978.921.4125 aponugoti@cellceutix.com
Locations
United States, New Hampshire
Cancer Research Recruiting
Lebanon, New Hampshire, United States, 03766
United States, Texas
Cancer Research Recruiting
Dallas, Texas, United States, 75230
Sponsors and Collaborators
Cellceutix Corporation
Investigators
Study Director: Arthur Bertolino, MD Cellceutix Corporation
Great clinical data on IPIX .... Awesome investment anyway you cut it - Partnerships or outright BUYOUT??? = huge rewards!!!
Dr. Bertolino presents at 3:05-3:25
Dr. Sonis already spoke at 1:15-1:45
In the 20 years that I've been in the oncology industry, Partnerships/buyouts often occur based upon early pre-clinical developments, long before P3 trials
Let's remember Kevetrin's incredible potential:
http://www.ipharminc.com/new-blog/2017/2/27/recent-pre-clinical-research-into-kevetrin-as-a-novel-anti-cancer-drug-candidate
My prediction, very soon the Longs will prevail HUGE $$$ and the Darkness (nickel flipper/emotional rhetoric dumpers) will flee the Light- superior clinical results vs. standard of care therapy always prevails and drives buyouts and high dollar partnerships!
I've seen this before, the market for PCYC for example was stagnant for many years and then went up and down but the HUGE payoff was staying long and the shorts came away big losers... the clinical science then at PCYC and here at IPIX (K,B and P) is amazing - IMO based on the science - Longs will be rewarded!
Today - July 13th, 2017 investors and opportunistic and savvy BP and Biotech partners hear more clinical findings that support Brilacidin as a game changer and great news for patients across many big population disease states.
“For those of us who have been involved in this trial from the start, it’s exciting to see Brilacidin perform as well as we thought it would. The endoscopic evidence we have now gathered on patients is particularly telling,” commented Arthur P. Bertolino, MD, PHD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “Brilacidin’s unique multi-pronged ability to reduce inflammation, fight infection and heal GI tract mucosa has been impressive, based both on subjective and objective scoring measures. It’s no surprise to us why we’ve generated significant excitement regarding Brilacidin among patients, health care professionals and potential industry partners interested in this truly novel IBD drug candidate. We look forward to sharing the Brilacidin UP/UPS data in early July.”
"According to the release, Brilacidin has consistently shown strong signs of efficacy while exhibiting a good safety profile even as dosing increased, supporting its potential as a novel, non-corticosteroid, non-biologic anti-inflammatory drug candidate in treating IBD. Innovation Pharmaceuticals’ formulation development plans for Brilacidin include foam and/or gel for the treatment of UP/UPS, and pills for oral dosing for the treatment of Ulcerative Colitis and Crohn’s Disease."
"The Company believes it has a world-class portfolio of first-in-class lead drug candidates and is now advancing them toward market approval, while actively seeking strategic partnerships. The Company’s Psoriasis drug candidate Prurisol completed a Phase 2 trial and the Company more recently launched a Phase 2b study. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. The Company’s anti-cancer drug Kevetrin successfully concluded a Phase 1 clinical trial at Harvard Cancer Centers’ Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, and the Company has commenced a Phase 2 study in Ovarian Cancer. In the laboratory, Kevetrin has been shown to induce activation of p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations. Brilacidin, a defensin mimetic compound, has shown in an animal model to reduce the occurrence of severe ulcerative Oral Mucositis (OM) by more than 94% compared to placebo."
“The Company is in a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention of OM in patients with head and neck cancer; interim results have shown a marked reduction in the incidence of severe OM (WHO Grade ≥ 3). The Company’s lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infection, or ABSSSI. Top-line data have shown a single dose of Brilacidin to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy for certain multi-drug resistant bacteria (“superbugs”). In an ongoing Phase 2 open label Proof-of-Concept trial, favorable interim results have been observed in the first two cohorts of patients treated with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of Inflammatory Bowel Disease (IBD)."
More Facts not hype that support investments in IPIX: Kevetrin, Brilacidin AND Prurisol are all currently being evaluated in Phase 2 Trials in multiple high unmet need disease states. Each with Blockbuster potential!
Let's look at just the Prurisol Psoriasis market potential!!!
The Prurisol Phase 2b trial has a planned completion with clinical updates in 2H 2017.
About psoriasis:
Psoriasis is a common, non-contagious, auto-immune disease that affects more than 125 million people worldwide!!! Plaque psoriasis is the most common form of the disease and appears as raised, red patches covered with a silvery white buildup of dead skin cells. Scalp psoriasis is a form of psoriasis that is reported to affect approximately half of all patients with psoriasis5. The disease has a significant impact on patients' quality of life, which is an aspect of the disease underestimated by most physicians3.
Psoriasis is not simply a cosmetic problem, but a persistent, chronic (long-lasting), and sometimes distressing disease, which can affect even the smallest aspects of people’s lives on a daily basis. Up to 30% of patients with psoriasis have, or will develop, PsA8. PsA is a condition in which the joints are also affected, causing debilitating symptoms including pain, stiffness and irreversible joint damage8,9. Psoriasis is also associated with other serious health conditions, such as diabetes, heart disease and depression8.
I
Thank you! Great points you made, huge potential. I'm in the Bio-Oncolgy business and been in the pharma for 20 years. I invested big in PCYC and it was a great ride. I'm equally excited to put my money where my mouth is on IPIX. Love the first in class molecules, targeted therapies and science here
Happy 4th of July, family and friends is what's important!
July 13th should also be exciting for IPIX!!!
Investors - The IPIX Opportunity, do you believe in the Science and shrug off emotional chatter - Big Pharma does. The opportunity window to "stock up" under $1.00/share will close and shortly thereafter it will take off suddenly due to a high level of interest and opportunity from Big Pharma and others Biotechs.
Here's the opportunity:
Invest in IPIX and your supporting and believing in not 1 but 3 Novel Molecules with First in Class Mechanisms of Actions in High Unmet Need populations where patients are suffering and physicians are looking for better answers. I personally own six figures shares. The first in class opportunity in high dollar markets is reminding me of another opportunity I believed in - a BTK inhibitor that was bought out for $261 a share only a few years ago. IPIX is WAY under valued too.
Example: High Unmet Need and Big Market Potential for Prurisol: Theres a commerical running non-stop for a psoriasis biologic medication that brings in $2 Billion a year and read the label, causes many to have depression and suicidal thoughts and many other nasty Adverse Effects and patients relapse.
IPIX OVERVIEW from the IPIX website
Innovation has developed three lead drug candidates—each with first-in-class potential across multiple clinical indications attributable to novel mechanisms of action—with dermatology, oncology, anti-inflammatory and antibiotic applications.
Prurisol—an orally-delivered medicine for treating psoriasis
Kevetrin—a non-genotoxic cancer drug that modulates p53
Brilacidin—an immunomodulatory agent with anti-inflammatory/antibiotic properties
Based on sound science, and covered by strong intellectual property and patent protections, these drug candidates are in mid-to-late stage clinical trials.
Advancing under a number of special FDA designations to help expedite development, improve likelihood of drug approval and gain market exclusivity, they address large areas of unmet medical need and represent sizable commercial opportunities.
Investors will be rewarded, do your homework and quit with all the EMOTIONAL Reactions!!!
Fact: We've never been closer to top line results:
B-OM $$$HUGE Market, thousands of patients suffering everyday in the US alone, HIGH UNMET NEED for many undergoing Chemo/Radiation treatments!!! Interim Analysis ph2 trial presentation in Boston, COMPLETED ph2b by the end of THIS year. BP Potential is awesome.
B- UP/IBD top line data/results - completed last cohort, Proof of Concept July 13th @ Drug Discovery & Therapy World Congress in Boston, presentation from 3:05-3:25pm EST AGAIN Huge BP potential this year!
Short trading week next week and then the real fireworks the following week July 10 - 13th in Boston, where it all began! Done this before, made big on following the science - never been disappointed with any of these IPIX trials yet in high unmet need diseases and conditions. Stay Strong!!!