IPIX - Innovation Pharmaceuticals Inc.

Business Description
An early stage developmental biopharmaceutical company...with six pharmaceutical compound candidates that are designed for treatment of diseases which may be either existing or diseases identified in the future. The Company will initially spend most of its efforts and resources on its anti-cancer compound, Kevetrin, for the treatment of head and neck cancers.

 

Stole this from another board for quick reference (sox040713):

CTIX Potential Catalysts and Past Milestones

Q2 2016 Potential Catalysts

- P top-line data (Phase 2)
- B-OM interim data (Phase 2)
- K top-line data (Phase 1)
- Start of B-ABSSSI (Phase 3)
- Start of B-UP (Phase 2, proof of concept)
- Start of K-ovarian (Phase 2)
- Fast track designation for B-ABSSSI
- ASM Microbe presentations (June 19-20)

Past Milestones

- QIDP designation for B-ABSSSI
- Fast track designation for B-OM
- Orphan drug designation for K-ovarian cancer
- Orphan drug designation for K-pancreatic cancer
- Orphan drug designation for K-retinoblastoma
- Rare pediatric disease designation for K-retinoblastoma
- B-ABSSSI positive Phase 2b top-line & bottom line data
- Completion of cohort 11 (750 mg/m2)
- K positive primary outcome (Phase 1)
- P positive primary outcome (Phase 1)
- Stable formulation of B at room temperature
- MTA extension on testing B in implanted devices

Clinical Trials

1. P (Phase 1, completed): https://clinicaltrials.gov/ct2/show/NCT02494479?term=cellceutix&rank=1
2. P (Phase 2, not recruiting): https://clinicaltrials.gov/ct2/show/NCT02101216?term=cellceutix&rank=2
3. B-OM (Phase 2, recruiting): https://clinicaltrials.gov/ct2/show/NCT02324335?term=cellceutix&rank=3
4. B-ABSSSI (Phase 2, completed): https://clinicaltrials.gov/ct2/show/NCT02052388?term=cellceutix&rank=4
5. K (Phase 1, completed): https://clinicaltrials.gov/ct2/show/NCT01664000?term=cellceutix&rank=5

Abbreviations

K – Kevetrin
B – Brilacidin
P – Prurisol
ABSSSI – acute bacterial skin and skin structure infections
OM – oral mucositis
UP – ulcerative proctitis
QIDP – qualified infectious disease product

 

Long term investment, I seldom trade shares in CTIX. The potential in the pipeline is pretty phenomenal when you break it down. The drug candidates and subsequently the investment overall has been significantly de-risked over the past year.

 

Can Cellceutix Emerge From The Shadows Into The Limelight?
Apr. 19, 2016 4:34 PM ET
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14 comments
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About: Cellceutix Corp. (CTIX), Includes: RDY, XNPT


Okam and Nesor Investments
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Summary


Shot for Traders: Prurisol Phase Two top-line results in May 2016 offer traders and speculators an opportunity to pounce on a downtrodden share price with potentially explosive upside.

Boom for Longs: If May’s Phase Two results are good-to-excellent, a fast partnership or outright platform sale awaits, while also allowing for the already robust pipeline to be further nourished.

Psoriasis Trifecta: Effective, Safe, and Convenient Oral Treatment: Prurisol’s safety profile is established; a convenient oral treatment that could better Celgene’s Otezla, providing salvation for patients and riches for investors.

FDA Designated for Passage: Prurisol is 505(b)(2) designated for a fast runway to launch into Phase 3, with highly the noteworthy 5-year market exclusivity—and a proven safety profile.

Extremely Lucrative Market: The psoriasis market is thriving with several recent massive deals. If Cellceutix can post comparable results, then blue sky abounds.



Introduction: Cellceutix on the Cusp

Cellceutix Corporation (OTC: OTCPK:CTIX) has shown itself to be scrappy andingenious, is the type of biotech company that risk-taking investors searching for transformative high-growth stocks crave. One that comes along only so often. Think of an early Regeneron ( REGN) or Celgene ( CELG). Save for a tribe of ardent online forum fans, Cellceutix is a mostly off-the-radar pink operator with the potential to morph overnight into a respected player with the signing of its first Big Pharma partnership-what would be a momentous milestone on the way to the launch of its first blockbuster drug. Cellceutix may be on the cusp to high achievement with its diverse pipeline in bloom. Most immediately, the first significant catalyst comes in the form of its anti-psoriasis drug, Prurisol, whose top line results will be released in May 2016.



The Importance of May

Cellceutix has always downplayed Prurisol's potential for success compared to their star oncology drug, Kevetrin, and their novel antibiotic, Brilacidin. It's their longshot-but sometimes longshots go in. Prurisol was evaluated in aPhase 2 FDA trial for mild-to-moderate chronic plaque psoriasis as an oral treatment. The possibility for remarkable results in the lucrative psoriasis field would constitute a seismic jolt that would immediately send cash-rich, deal-hungry suitors their way. For the Cellceutix investor, strong Prurisol results would catapult the company into unfamiliar unshackled blue sky territories, including the likely acceptance of its pending Nasdaq up listing application, which could further ignite a Prurisol run by introducing the company to a new flight of institutional and private investors.

Towards a Partnership

In the dermatological space joint venture deals readily occur after the conclusion of Phase 2 trials, and Cellceutix CEO Leo Ehrlich has stated that interested parties are awaiting the trial's topline data in May. The CEO haspreviously inferred that the company would fast forge a deal if results deliver."Should the trial be a success, our plan is to seek a partnership through discussions with parties that have previously shown interest in Prurisol." An expedient and lucrative deal would provide a significant jumpstart out of the developmental doldrums, while positioning Prurisol as a potential blockbuster candidate that could outduel the likes of Celgene's ( CELG) multi-billion dollar oral psoriasis drug, Otezla (Apremilast). Such a scenario would be a windfall; permitting heavy investment in R&D and expansion of Cellceutix's maturing drug candidates.



A Stealthy Compound Emerges

If flying under the radar is the Cellceutix storyline to date, then Prurisol has utterly avoided radar detection. Within the psoriasis community, scant information exists referencing Prurisol, save for The National Psoriasis Foundation which recently added Prurisol to the top of their website's list oforal drugs in development. Prurisol is unique: a small molecule chemical entity that acts through immune modulation and PRINS reduction. It's an ester of abacavir, an already approved HIV drug, Ziagen, whose profile is well-known, and has helped Prurisol to a critically important FDA 505(b)(2) designation allowing for an endorsement of its safety profile and a five-year post market exclusivity pathway. With strong patent protection, and established manufacturing by Dr. Reddys Laboratories, Ltd. (NYSE: RDY), a robust framework is built for expedient upward scaling should results deliver in May. An excerpt from the 2014 FDA IND application from Cellceutix's Dr. Krishna Menon:

"Not only is there no cure for psoriasis, but the biologics that are so commonly used today have been shown to frequently become ineffective in a relatively short period of time, leaving a tremendous market opportunity for a new drug. Being that Prurisol is a small molecule, it is less likely that the body will develop antidrug antibodies, as it does with biologics to stifle their efficacy. The preclinical data showing that Prurisol essentially eliminated all traces of psoriasis without signs of recurrence leaves us extremely optimistic about the potential of the compound as it enters human trials."

 

A Booming Psoriasis Market

With approximately 7.5 million psoriasis patients alone in the United States, and nearly 80-90 percent of those suffering from plaque psoriasis, the psoriasis market is arguably the most lucrative within the bio-pharma dermatological space-and the growth trend is substantial. The psoriasis market was pegged at $6.6 billion in 2014, and is projected to crest $13.3 billion by 2024, according to the consulting and research firm GobalData. The cost of biologics is also soaring, with a per patient average cost per annum of around $40,000. Without a clearly defined market leader, and seemingly every large pharmaceutical company angling for a piece of the lucrative pie, the appetite for deal making is voracious and is only expected to become more so as competition intensifies.



The Race for a First-in-Class Oral Psoriasis Treatment

An easy-to-take oral treatment for psoriasis that is both safe and effective, with better efficacy than existing biologics, is the holy grail for psoriasis sufferers. Approximately 80 percent of psoriasis cases are for mild-to-moderate cases and overwhelming first line of treatments are injectables, creams, or light therapy. Eliminating the need for messy topicals and burdensome injectables (which carry countless serious adverse side effects; (Taltz of Eli Lily (LLY) and Enbrel of Amgen (AMGN) with their own) is the desired evolution in the race for a cure. An estimated 75 percent of mild-to-moderate psoriasis sufferers discontinue treatment due to the difficulties of injectables, while less than 60 percent of psoriasis sufferers seek treatment on account of a dismal outlook of options. Furthermore, approximately 80 percentof the approximately 320 million psoriasis suffers discontinue treatment at therisk of job loss and psychological and social pitfalls associated with their conditions, as the treatments are too burdensome to consistently administer.



Can Prurisol Outduel Otezla?

Celgene's expected multi-billion dollar blockbuster, Otezla, the first oral treatment for mild-to-moderate psoriasis approved in over 20 years in 2014, continues to shine despite its failure to better certain injectables, and generally lackluster comparatives, even to Celgene's own acknowledgement. ISI's Mark Schoenebaum commented on Celegene's presentation, "Early physician feedback on efficacy matches our view, and even the presenter remarked the efficacy was 'modest' during the official presentation." WhenOtezla compared to biologics in therapeutic efficacy, Otezla's PASI 75 response is 30 percent against many injectable biologics with greater than 60 percent responses. Otezla also struggled mightily in the UK and Germany, due to lingering questions over comparable efficacy and pricing to better existing treatments. Re-enter Prurisol as a possible groundbreaking oral treatment. While there are currently 15 oral treatments in clinical trials, the oral psoriasis landscape is replete with ineffective and side effect rich drugs, Otezla included. Struggling, Vitae (VTAE), is another, whose stock confoundedly nearly doubledin March 2016 on Phase 2a proof of concept trial results that reported severe diarrhea and high trial discontinuation in nearly 30 percent of participants-demonstrating how forgiving the market is to mediocre oral treatments that champion patient convenience.



Recent Lucrative Psoriasis Deals (Amidst Muddy Results)

The last twelve months has shown a flurry of activity in the psoriasis space. Lucrative partnerships and platform buyouts have ensued, several of which were predicated on unexceptional efficacy and safety profiles, reinforcing the potential for Prurisol to command a premium should results deliver in May. Drawing on recent deals for drugs with questionable safety and efficacy profiles, there's a strong argument that if Prurisol results are fair-to-good, that Cellceutix can still tap the highly lucrative market with a joint venture partner wanting to build upon the oral platform in a Phase III trial. Now, should Prurisol achieve exceptional results, then Cellceutix will likely far exceed the following recent psoriasis deals:

Recent Psoriasis Deals

$575 Million: AbbVie (ABBV) strikes a deal with Boehringer.

$490 Million: Dr. Reddys (NYSE:RDY) strikes a deal with XenoPort (NASDAQ:XNPT)

$445 Million: Valeant (VRX) strikes a deal with AstraZeneca (AZN)

Complications Abound

" Under pressure, XenoPort sells U.S. rights of failed psoriasis pill to Dr. Reddy's "

AstraZeneca auctions off troubled psoriasis drug to Valeant in $445 million deal"



For the Brave: Cellceutix's Inherent Risks

Poor Prurisol results may send the stock towards a sharp correction testing the sub $1.25 range, while placing added weight on its flagship oncology and antibiotic drugs to deliver. The inability to strike a deal within three months may further create added pressure for the company to tap it's already announced shelf registration, or raise funds at an un-desirable valuation. While the company has said that it is well-funded through 2016, it is increasingly clear that with approximately $5 million in the bank, a $15 million open equity line with Aspire Capital, and an open $40 million shelf registration, the importance of a non-dilutive partnership to advance its pipeline exists. A Prurisol partnership comparable to those of Boehringer, ZenoPort, orAstraZeneca would instantly transform Cellceutix into a legitimate player, and quell all discussions of financial pressure for years to come.

Safe Harbor in Pipeline Diversity

Should the Prurisol trial reveal unflattering results, investor protection comes in the form of a strong pipeline that continues to progress with pace, strength, and diversity. To date, the company has adeptly navigated the challenging FDA regulatory environment; has yet to fail an FDA trial, as it advances in numerous ongoing clinical trials in the United States with impressive results. Cellceutix has notched an envious FDA fruit salad of specialty designations, including Fast Track, QIDP, Breakthrough Designation, Rare Pediatric Disease,Orphan Designation, and 505(2) pathways, which stand starkly in the face of skeptical small cap biotech OTC investors. Cellceutix's pipeline remains, Still Flying Under the Radar, as one Seeking Alpha contributor recently penned in an in-depth analysis of the company's science and pipeline.



How to Play the Prurisol Game?

Everyone loves a scrappy underdog story that can upstage an established giant, in this case: Cellceutix bettering Celgene's Otezla in an oral plaque psoriasis duel. Imaginations can run wild with what a bidding war would resemble if Prurisol's results are exceptional-and perhaps with raging bull interest from Celgene ('Celgene Open to Big Deals') for obvious reasons. With Cellceutix's share price seemingly safely trading in the $1.58-1.78 range as of middle April, an ideal entry point is subjective and relative based on how substantially the stock could run if Prurisol results are stellar-or even just 'pretty good'. Consider, Cellceutix's former 52-week high of $4.80 per share in 2014, which was driven by the advancement of their lead oncology drug,Kevetrin. Should Prurisol results surpass Otezla's efficacy and safety profile, then an immediate rise to the $15-$20 range is within reason towards a fast and lucrative big pharma partnership or platform buyout, especially given its 505(2) pathway. Now, should results be on par with the aforementioned recent psoriasis deals orchestrated by ABBV, VRX, RDY, then the $8-10 range could be fast achieved with a comparable partnership valuation and upfront cash in the $400 million range. Also, lurking is the open Nasdaq application, a catalyst that could further fan the flames of a strong Prurisol result, bringing added legitimacy and a battalion of new investors-and naturally, further pipeline advancement with its novel compounds, Kevetrin and Brilacidin.



Whether a gambler, believer, or second-chance barefoot pilgrim-buckle up,sometime in May 2016 top line results for Cellceutix's dark horse Prurisol for chronic plaque psoriasis will be released. If they exit anywhere from good-to-stellar, scrappy Cellceutix may make a biotech run for the roses with the grand debut of its first blockbuster; from the shadows into the limelight.

 

Cellceutix Institutes "Database Soft-Lock" on it's Phase 2 Psoriasis Clinical Results, Top Line Results Expected in May; Additional Comany Updates

BEVERLY, MA–(Marketwired – April 19, 2016) - Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to inform shareholders that the clinical database for Prurisol’s Phase 2 FDA trial for mild-to-moderate chronic plaque psoriasis has instituted a “Database Soft Lock.”

Also referred to as a “database freeze,” this step in the regulatory process means all case information has been compiled and put into the database and all known queries have been resolved. Next, the Quality Assurance staff will review all the data points to ensure statistical accuracy in preparation of the dataset’s final analysis and confirm that all data points, including PK data, are in-line with the Statistical Analysis Plan.

Additionally, the Company would like to provide the following updates:

FDA Feedback Received for Phase 3 Trial of Brilacidin-ABSSSI

Cellceutix has received a response from the U.S. Food and Drug Administration (“FDA”) regarding the Company’s Special Protocol Assessment (“SPA”) for its Phase 3 Trial of single-dose Brilacidin for the treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI). The FDA reviewed the Company’s SPA submission and has requested certain changes be made to the protocol, as is typical procedure (see ‘About SPA Agreements‘ below). Cellceutix will be scheduling a meeting with the FDA to discuss the proposed protocol changes toward finalizing the agreement. Meanwhile, the Company is moving ahead in matters of clinical supply procurement and study sites selection.

About SPA Agreements

Obtaining Special Protocol Assessment (SPA) designation from the FDA is an important step as it reinforces the potential of a promising drug in clinical development. The SPA agreement delineates key statistical and clinical endpoint requirements, streamlining the process toward a product gaining FDA approval should the agreed upon criteria and outcomes be met. The SPA process itself can be iterative in nature. In fact,according to industry data, 78 percent of SPAs require multiple review cycles and an average of three months to finalize the SPA. For more information about the FDA’s SPA program, please visit:http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080571.pdf.

“We are extremely proud of Brilacidin as it represents the first potential new class of antibiotics to treat serious skin infections in some twenty plus years and very much look forward to the start of the Phase 3 ABSSSI trial as soon as our SPA discussions with the FDA conclude,” stated Leo Ehrlich, Chief Executive Officer of Cellceutix. ”There is a huge unmet medical need, worldwide, for newer and better antibiotics, with the market likely to gravitate toward single-dose drugs like Brilacidin. Commonly praised by clinicians once introduced to it, Brilacidin is positioned to help fill this void, and in the process, further unlock shareholder value. In addition, we see the ABSSSI clinical trials as a gateway for Brilacidin’s use in bacterial biofilm infections and its use in the treatment of diabetic foot infections.”

Clinical Advisory Board Addition

Dr. Frances A. Farraye MD, MSc, has joined the Cellceutix Clinical Advisory Board. Dr. Farraye is Clinical Director in the Section of Gastroenterology and Co-Director of the Center for Digestive Disorders at Boston Medical Center. He is also Professor of Medicine at the Boston University School of Medicine. Prior to accepting the position, Dr. Farraye consulted with Cellceutix to help design the protocol for its planned Phase 2 ulcerative proctitis clinical trial. Commented CEO Leo Ehrlich, “We are thrilled to have Dr. Farraye formally join the Celleutix team. His expertise and leadership has been clearly demonstrated throughout his stellar career. Dr. Farraye’s experience and knowledge will help us explore Brilacidin’s potential in treating other gastroenterological conditions. Brilacidin continues to impress us as we explore its application in numerous clinical areas.”

About Dr. Francis A. Farraye, M.D., MSc.

Francis A. Farraye, M.D., MSc, Professor of Medicine, Clinical Director, Section of Gastroenterology and Co-Director, Center for Digestive Disorders, Boston University School of Medicine

Dr. Farraye is a Fellow of the American College of Physicians, American Society of Gastrointestinal Endoscopy, American Gastroenterological Association and the American College of Gastroenterology. He has published over 350 original manuscripts, abstracts and book chapters. He has served on numerous national and international committees including as a member of the ACG Board of Trustees. The New England CCFA named Dr. Farraye Humanitarian of the Year in 2003. In 2009, the ACG awarded Dr. Farraye the William Carey Award for service to the college. Dr. Farraye has been recognized as “Top Doctor” in Gastroenterology by Boston Magazine and U.S. News and World Report since 2010. His newest books for clinicians are Gastrointestinal Emergencies and Curbside Consultations in Inflammatory Bowel Disease and for patients Questions and Answers about Ulcerative Colitis, Questions and Answers about Crohn’s Disease and Ulcerative Colitis for Dummies.

- See more at: http://cellceutix.com/cellceutix-in...itional-company-updates/#sthash.x9HzZG53.dpuf

 

Looking strong going into probable Phase 2 Trial results release within the next couple week for Prurisol, the long forgotten (or just under the RADAR) drug candidate of CTIX.

 

Results were reported to be unblinded last week, results probable for this week. This is a binary event that will either send the stock back to 1$ or up to $5+ and an uplisting (which remains open). Probably with positive results, a partnership withing a couple months.

 

BEVERLY, MA–(Marketwired – May 24, 2016) - Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, antibiotic, and anti-inflammatory applications, is pleased to inform shareholders that topline data from the Company’s Phase 2 FDA trial of orally-administered Prurisol in the treatment of mild to moderate chronic plaque psoriasis have been compiled and reviewed. The trial successfully achieved its primary endpoint, further validating Prurisol’s potential as a novel oral treatment for psoriasis.

• - Clinical efficacy demonstrated in the highest dose (200mg) comparator arm
• - Compound shown to be safe and well-tolerated with a dose-related response
• - Oral delivery often preferred among patients, increasing adherence to treatment
• - Additional studies planned in moderate to severe psoriasis and eczema

Study Background

Enrolling 115 patients, the placebo-controlled, randomized, double-blind trial tested the efficacy and safety of three separate, twice-daily, dosing regimens of Prurisol—50 milligram (mg) (50mg QD), 100mg (50mg BD), and 200mg (100mg BD). All patients were assessed via the 5-point Investigator’s Global Assessment (IGA) scale, ranging from a score of 0 (“clear”) to a score of 4 (“severe”). The IGA scale is preferred by the U.S. Food and Drug Administration (FDA) and is comparable to the older and more commonly used Psoriasis Area and Severity Index (PASI) in evaluating psoriasis severity of patients, with many dermatologists preferring it in the clinical trial setting. Generally, an IGA score of 0/1 demonstrates a strong association with a PASI 90 score.

For more information comparing the IGA and the PASI psoriasis scoring systems, please see the link immediately below. Two additional links have been provided summarizing recent dermatological studies by Regeneron and Anacor that used the IGA scale.

• http://www.ncbi.nlm.nih.gov/pubmed/24354461
• http://newsroom.regeneron.com/releasedetail.cfm?ReleaseID=963078
• http://investor.anacor.com/releasedetail.cfm?releaseid=921668

Entry criteria for the study required: a total Body Surface Area (BSA) affected by plaque psoriasis of 10 percent to 20 percent; a baseline IGA score of 2 (“mild”) or 3 (“moderate”); and the identification of a target psoriatic lesion with a score greater than or equal to 3 based on a different (than the IGA) lesion-specific 5-point scoring scale. Clinical signs that psoriasis is clearing typically are more noticeable in patients with a greater severity of symptoms. This translated into a rigorous and aggressive study design for the Prurisol trial.

The primary endpoint assessed was the percentage of patients achieving at least a 2-point improvement from baseline on the IGA 5-point scale as measured by visual inspection of patient lesions at the end of the 84-day (12-week) treatment period. In effect, given the entry criteria, participants had to at least obtain an IGA score of “clear” or “almost clear” skin, dropping to 0 or 1 after starting from a baseline of 2 or 3. Secondary endpoints included additional improvement measures tied to degree of patient response at various time intervals.

Results Summary

The Phase 2 Prurisol trial, while not powered to demonstrate statistical significance, was conducted to inform any future fully-powered Phase 3 trial(s) that might be merited. As a result, the study’s main goal was to provide indications of efficacy, safety and tolerability upon treating patients with mild to moderate plaque psoriasis via oral delivery.

Overall analyses showed Prurisol, which is being developed under the FDA’s 505(b)(2) program, to be superior to placebo in the 200mg arm. Pharmacokinetics/Pharmacodynamics (PK/PD) further revealed an early (by week 8) dose-related response that improved as treatment duration increased.

Evaluating the primary endpoint at 84-days (week 12) in the 200mg arm, 35.0% of the patients receiving that dose of Prurisol demonstrated clinically significant improvements compared with 16.7% of patients on placebo only. This percentage includes patient data from one site where investigator non-compliance may have occurred. Were that site to have been excluded from overall data analysis, as is done in some clinical studies (refer to the journal article linked to below, published findings from another psoriasis study), 43.7% of patients in the 200mg Prurisol arm would have met the primary endpoint. Patient responses in the 50mg and 100mg arms were statistically comparable to the placebo arm.

• http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4229025/

For purposes of direct comparison, the Prurisol trial outperformed a similarly designed Phase 2b trial in the treatment of mild to moderate psoriasis conducted in 2011 by Anacor Pharmaceuticals in which a topical anti-inflammatory compound was assessed. See the link below.

• http://investor.anacor.com/releasedetail.cfm?releaseid=587511

Sub-population analyses further showed greater efficacy demonstrated in patients who had a baseline IGA score of 3 (“moderate”) as compared to those with a baseline score of 2 (“mild”). Some of these patients even experienced a 3-point reduction in their IGA score, going from “moderate” to “clear.” This suggests Prurisol may be more effective in treating moderate to severe psoriasis patients to a greater degree than those patients who exhibit less severe symptoms. In moderate to severe psoriasis studies, the placebo response also tends to be lower.

Regarding Prurisol’s safety profile, only a single Serious Adverse Event (SAE) was reported in the study, that being in the 50mg arm, with the type and the rate of occurrence of additional Adverse Events (AEs) similar and evenly distributed across all the three dosing arms and the placebo arm.

Additional detailed data review and analysis is underway and an end-of-Phase 2 meeting with the FDA will be requested to help determine the dose(s) and design for future studies, which may include higher dosing regimens to determine Prurisol’s maximum therapeutic effect. The Company plans to release other summary findings from this trial in the coming months, with full results anticipated to be submitted for journal publication and presentation at a future medical congress.

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.”

Sponsor Comments

Cellceutix believes that the results from the Prurisol Phase 2 trial are extremely encouraging, especially for the 80 percent of psoriasis sufferers exhibiting milder symptoms of the condition. These people are more likely to switch between therapies or be off treatment altogether. Planning is underway to explore Prurisol’s potential in the treatment of moderate to severe psoriasis and eczema, a skin condition experienced by up to 30 percent of children and 10 percent of adults. The Company is hopeful Prurisol may one day become a leading treatment for psoriasis regardless of disease severity.

Leo Ehrlich, Chief Executive Officer of Cellceutix, commented: “We had always wanted to explore Prurisol’s clinical merit, as it had excellent results in laboratory studies. We put it to the test under some of the most demanding conditions, with respect to the IGA versus PASI scoring systems; short treatment duration; low dosing levels; enrollment that included patients who were previously treated with biologics; and evaluation in mild to moderate psoriasis patients, where it can be more difficult to achieve a meaningful therapeutic effect. To see such a strong response among patients, achieving clear to almost clear skin without serious side effects—the downside of biologics—in such a short period of time, is exceptional. We would like to thank patients and investigators who participated in the study. Prurisol has taken a key step towards potentially becoming only the second oral treatment approved by the FDA for psoriasis in decades.”

Leo Ehrlich continued: “More broadly, these outstanding results are the first of what we hope are more to come as the Cellceutix pipeline continues to progress. With our three lead drugs, Prurisol, Brilacidin, and Kevetrin, now in later-stage FDA trials, each a possible first-in-class treatment, we are thrilled with what the future holds.”

About Psoriasis

Affecting an estimated 125 million people worldwide, psoriasis is a chronic immune-mediated skin disorder presenting with varying symptoms and levels of severity. The condition is characterized by raised and inflamed patches of skin, often on the elbows, knees, scalp, hands and feet, and causes itching, irritation, stinging and pain. Often feeling socially stigmatized, over 80 percent of people with psoriasis report it negatively impacts the quality of their everyday life. Mild cases are defined as affecting less than 3 percent of the body’s surface area, with a majority of cases limited to less than 2 percent of the skin. Moderate psoriasis covers 3 to 10 percent of the skin. If it covers 10 percent of the body, the disease is considered severe. Up to 40 percent of psoriasis patients will develop psoriatic arthritis (PsA) within 7 to 12 years. Psoriasis also is associated with numerous comorbidities, ranging from cardiovascular disease, autoimmune disease, and cancer to psychological disorders. Despite recent advances, there remains a need for orally-delivered psoriasis drugs, and other treatment alternatives to biologics, which are known to have serious side effects and contraindications, and generally lose their effectiveness over time. Additional information can be found by reading the World Health Organization’s (WHO) 2016 Global Report on Psoriasis: http://apps.who.int/iris/bitstream/10665/204417/1/9789241565189_eng.pdf

About Prurisol

Prurisol is a small molecule that acts through immune modulation and PRINS reduction and has completed a Phase 2 FDA trial under the U.S. Food and Drug Administration’s 505(b)(2) pathway. In laboratory studies, Prurisol was found to be effective against psoriasis in animal models, both in induced psoriasis and in a xenograft model using human psoriatic tissue. Prurisol eliminated virtually all signs of psoriasis with no reoccurrence of the lesions. Prurisol is synthesized through a five-step process using commercially available starting materials.

About 505(b)(2) Designation

Under the FDA’s 505(b)(2) regulatory pathway, a drug’s road to market approval can be significantly shortened and at much reduced costs. Often only one pivotal Phase 3 study, enrolling a smaller number of patients than is typical, may be required. As well, the drug is eligible for up to five years of market exclusivity post-approval. For more information about the FDA’s 505(b)(2) program, please visit: http://www.fda.gov/downloads/Drugs/…/Guidances/ucm079345.pdf

Cellceutix clinical trials on Clinicaltrials.gov:

https://clinicaltrials.gov/ct2/results?term=cellceutix&Search=Search

- See more at: http://cellceutix.com/cellceutix-ph...-meets-primary-endpoint/#sthash.T9bQvbq6.dpuf

 

Results were positive, no price action. Don't know what it will take to finally drag this out of the gutter. Trial results clearly aren't doing it. Uplisting or partnership will likely do it, but... who knows! Company is outperforming, SP is underperforming!