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I'd be curious of your thoughts on the K "paper" that Leo mentioned many moons ago? Do scientific journal submissions take this long on the norm? Do you think something is released during AACR?
I'm excited for K phase 2 OC. I hope K is a miracle drug :)
Agree. We could see a partner ASAP if this short 10 patient study. P53 is truly the guardian angel of the human genome.
Everything under $1, $2, $3, $4 and beyond are Buying Opportunities here. I'd say anything over $7 would warrant UPLIST and more cash on hand. If we receive a partner or new investments into CTIX then we would have to reconsider based on terms.
The best bio's are the ones that get beaten and sit in the 1-2-3 range for years and one day....poof. They open at 13-14-17 the next day. From there we see year over year gains into the 30-40-80 etc.... Only the bio's with real drugs as you can imagine fall into this category. Bio's with multiple blockbuster candidates that prove to work in human clinical trials however will see much better gains.
I'd say we are in the sweet spot for that teen move this year. Jmo.
Good luck FUDing CTIX and patients that dearly need new treatments.
Best wishes!
Daub
All info came from FDA website.
https://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm
"Brilacidin functions in a robust immunomodulatory capacity, lessening inflammation and promoting healing."
If both interim data sets prove the above this will provide CTIX endless cash. IMO.
Many billions to be made in the Gastro indication. And many many suffering patients will be relieved.
CTIX.
When studying a new drug, it can sometimes take many years to learn whether a drug actually provides a real effect on how a patient survives, feels, or functions. A positive therapeutic effect that is clinically meaningful in the context of a given disease is known as “clinical benefit”. Mindful of the fact that it may take an extended period of time to measure a drug’s intended clinical benefit, in 1992 FDA instituted the Accelerated Approval regulations. These regulations allowed drugs for serious conditions that filled an unmet medical need to be approved based on a surrogate endpoint. Using a surrogate endpoint enabled the FDA to approve these drugs faster.
In 2012, Congress passed the Food and Drug Administration Safety Innovations Act (FDASIA). Section 901 of FDASIA amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow the FDA to base accelerated approval for drugs for serious conditions that fill an unmet medical need on whether the drug has an effect on a surrogate or an intermediate clinical endpoint.
A surrogate endpoint used for accelerated approval is a marker - a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit. Likewise, an intermediate clinical endpoint is a measure of a therapeutic effect that is considered reasonably likely to predict the clinical benefit of a drug, such as an effect on irreversible morbidity and mortality (IMM).
The FDA bases its decision on whether to accept the proposed surrogate or intermediate clinical endpoint on the scientific support for that endpoint. Studies that demonstrate a drug’s effect on a surrogate or intermediate clinical endpoint must be “adequate and well controlled” as required by the FD&C Act.
Using surrogate or intermediate clinical endpoints can save valuable time in the drug approval process. For example, instead of having to wait to learn if a drug actually extends survival for cancer patients, the FDA may approve a drug based on evidence that the drug shrinks tumors, because tumor shrinkage is considered reasonably likely to predict a real clinical benefit. In this example, an approval based upon tumor shrinkage can occur far sooner than waiting to learn whether patients actually lived longer. The drug company will still need to conduct studies to confirm that tumor shrinkage actually predicts that patients will live longer. ********These studies are known as phase 4 confirmatory trials.*********
Where confirmatory trials verify clinical benefit, FDA will generally terminate the requirement. Approval of a drug may be withdrawn or the labeled indication of the drug changedif trials fail to verify clinical benefit or do not demonstrate sufficient clinical benefit to justify the risks associated with the drug (e.g., show a significantly smaller magnitude or duration of benefit than was anticipated based on the observed effect on the surrogate).
Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions.
Determining whether a condition is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the condition, if left untreated, will progress from a less severe condition to a more serious one. AIDS, Alzheimer’s, heart failure and cancer are obvious examples of serious conditions. However, diseases such as epilepsy, depression and diabetes are also considered to be serious conditions.
Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy.
Any drug being developed to treat or prevent a condition with no current therapy obviously is directed at an unmet need. If there are available therapies, a fast track drug must show some advantage over available therapy, such as:
Showing superior effectiveness, effect on serious outcomes or improved effect on serious outcomes
Avoiding serious side effects of an available therapy
Improving the diagnosis of a serious condition where early diagnosis results in an improved outcome
Decreasing a clinical significant toxicity of an available therapy that is common and causes discontinuation of treatment
Ability to address emerging or anticipated public health need
A drug that receives Fast Track designation is eligible for some or all of the following:
More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
**********Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met************
Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA
Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition.
Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
Accelerated approval. Next
Cellceutix 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.
Fast Track - next post
B-OM phase 2 started over a year and a half ago - approaching 2 years early this summer. CTIX was very hopeful this trial would show certain properties during the trial that would lead to CTIX starting the B UP trial. Leo hinted many times that this UP trial would only commence if certain feedback from the OM trial was received. Shareholders were pleased to learn the UP trial would commence. Shareholders were then given the first cohort/lowest dose update on B-UP and the results were fascinating according to the staff and comments from the patients were forth telling. The hospital staff even believed the next two cohorts would fill quickly based on word of mouth of this drugs potential. It will be great to hear if cohort 2 follows suite.
I would not be surprised if this cohort 2 has better response and then in a couple weeks OM results prove to be the same. (Same properties are being explored). This could potentially be the first partnership drug. We know B has been followed for years by big Pharm and we know they have agreements where big pharm placed a SECOND large order of B to test the same properties on devices.
Can The OM trial be cut short and could the FDA move it straight to market based on the safety profile and ease of use as a rinse and spit? Does the designation for OM allow that?
Exactly what I took from Leo's email. They won't stop and hold tight shareholders.
The best about Leo and Menon: they don't stop. That is a fact; I sincerely hope they keep going after every Mako and the entire community helping to smear their good names.
Maybe not this year or next...but they won't stop
Thanks KarinCA. Great write up. Everyone has their own preference. And for people actually following people's advice on an Internet chat board is not a good idea. Everyone do your own DD.
The greatest DD here: CTIX has not failed one trial in its history.
That is exactly what I have been saying. The clue is they are not making a push to deploy pump tactics. They know exactly what they own and simply need time. So they slow roll a million or 2 shares to aspire over each quarter while trial after trial moves forward. And finally we lay in the sweet spot of late stage trial data. Come get it BP.
If CTIX did not have confidence in a suitor I would guess we would see more hype and more investor friendly rah-rah to pump the SP. but IMO it is not needed. We have enough cash to bring home 4 strong data sets of phase 2 trials. These data sets will transform the company overnight as Dr B said.
Sit back relax. If we hit .65 buy more. We know it's not dilution. Imo. Just more shares in strong hands.
The SP doesn't matter in times "exactly" like this. CTIX is hardly diluting with aspire as you can see in the last Q. Like 1 million shares in 3 months. It would be a completely different story if CTIX was planning on fronting 30 million for a phase 3 trial right now. But all of us should get the hint...SP does not matter now or IMO for the next 3 months. A deal is done IMO. The final numbers of the deal will be inked based on phAse 2 data.
This is my gut based on how mgmt is moving forward currently.
I don't think Leo, Menon or Dr B have one ounce of worry because several BP are in the hunt. If great data is released CTIX will be sought after and prices go up when multiple people are bidding for a single item.
Just like the market- SUPPLY AND DEMAND. New oral Psoriasis drugs are highly in demand and very low on supply.
We are in a perfect spot. IMO.
The good news is they really do have very valuable products and we can gauge value by current market statistics for those indications and gather DD on current medications.
Next stop is understanding just how effective the drugs are. We already know they are safe. Very exciting times here at CTIX.
Recap - In the past 1.5 years, CTIX has Completed:
1) Phase 1 Kevetrin trial at Dana Farber - SUCCESSFUL
2) Phase 2a Prurisol for Mild-Moderate psoriasis - SUCCESSFUL
CTIX began these trials:
1) Phase 2 trial for Brilacidin-OM (Summer 2015) (Interim Data - 5-7 weeks away)
2) Phase 2 Kevetrin for Ovarian Cancer (Winter 2017) (Data this year)
3) Phase 2b Prurisol for Moderate-Severe psoriasis (Fall 2017) (Data this summer)
4) Phase 2 PoC Brilacidin for UP/UC (Summer 2016) (Data on cohort B next week)
Management Additions:
President/CMO - Arthur P. Bertolino
VP, Clinical Sciences and Portfolio Management - Jane Harness
VP Regulatory Affairs - Lavonne Lang
Noteworthy:
*Development of Kevetrin into an Oral drug - so far so good! Bridge study under way.
*In December 2016 management reviewed Cellceutix’s development of Prurisol (KM133) and determined that no royalties on its sales would be due to outside parties.
*Brilacidin Phase 3 for Absssi - "Our strategy for now is to achieve success with other trials and attract partnering opportunities with significant down payments and milestone payments which can fund these trials."
___________________________
I am probably missing some items but again, within this past 1.5 years and all of the above progress, CTIX has only diluted 8 million shares and have decreased it's cash by 4 million dollars. And the share price in the time has gone from mid $3.00's to just under a $1.
Essentially the science has proved to be everything MGMT has been touting for years. They added very reputable senior management, and have done so by being extremely frugal...
Not to mention they have about 20 million left with Aspire if needed and a 75million shelf-reg.
CTIX will catch up and be back north of $5 soon IMO. We just need to ride the right wave.
Right!!!! Increased OS only by 8 million shares...only decreased cash by 4 million and DOMINATED all trials and started several others. And the share price went from mid 3's to 95 cents.... Hahaaaaaaa.
Seriously. Think about that. It does not add up. This could be the most undervalued bio stock in the market.
Not one failed trial to date. Not one negative item reported to date for any drug. All drugs are in the billions for possible revs
Puma has been active now since this major decline. Hound, can you compare your numbers from Aruda per year sales to Pumas yearly volume? It would be interesting.
It will make us extremely wealthy while helping to save lives. Win win in my book. Karma is a great gift
Awesome. CTIX is going to make us so flipping rich. I love the progress
Leo did say this indication could be the cash cow for CTIX. Extremely lucrative. More than P and K
Excellent News. Keep moving along.
Monmol. What is so bad about CTIX? Please share. I will listen...
Is it the 4 current phase 2 trials that have exciting data thus far? Or is it the phase 3 ready new class of antibiotic just chilling waiting for a partner? Hmmmm... Or are you simply referring to a share price!?!?
Longs - Please keep this in mind. A little reality check :)
Just after the MAKO piece and all the other BS:
July 17th 2015 - $3.36 - SHARE PRICE
August 2015 OS - 118,170,536
Cash - $8.4 Million
Sept 30th 2015 - Still had 28.2 Million from Aspire
Proprietary Program
Indication
Clinical Status
1.
Kevetrin
Inhibitor for Solid Tumors (ONGOING)
Phase 1
2.
Prurisol
Psoriasis
Phase 2A (ONGOING)
3.
Brilacidin
ABSSSI
Phase 2 Completed
4.
Brilacidin - OM
Oral Mucositis
Phase 2 (ONGOING - Just started)
FAST FORWARD ------------------->
February 2017 - Share Price - .93 CENTS
January 2017 OS - 126,408,756
CASH - 3.9 Million
Dec 31st 2016 - Still had 19 million from Aspire
Proprietary Program
Indication
Clinical Status
1.
Kevetrin
Ovarian Phase 2A Trial Recruiting - 10 Patients 2 Cohorts (5 in each)
3X's a week dosing starting at 250mg/m2 compared to Phase 1 which started at 10mg/m2 once a week. THIS COULD BE HUGE!!!
2.
Prurisol
Psoriasis
Phase 2B - Recruiting - 189 Patients; Double the dose from the successful 200mg Phase 2A
Powered Study - Using same scale as most competitors (PASI) and dosing Moderate to Severe - Much more likely to succeed. THIS COULD BE HUGE!!!
3.
Brilacidin
ABSSSI
Phase 3 - SPA on hold until share price rebounds (Partner at anytime)
4.
Brilacidin - OM
Oral Mucositis
Phase 2 - Ongoing - Interim Data due out in 5-7 weeks. THIS COULD BE HUGE!!!
5.
Brilacidin - UP/UC
Currently in 2nd Cohort of 3 Cohorts. Data expected on 2nd Cohort in 1 week. So far excellent Data. THIS COULD BE HUGE!!! If again successful this could show that B-OM is on track to be a winner!
SUMMARY ------>
Down about 4.5 Million in cash - Diluted about 8 Million in OS, but ALL trials are on track to succeed and we have actually moved forward on all fronts. We added huge names to the companies MGMT team and have added several CDA's with BP.
I don't see how anyone in their right mind could justify the market value of CTIX compared to where it was and prior. We are days/weeks/months away from our first major partnership. Hold tight my friends and add willingly.
Go CTIX!
Excellent. 3 weeks of 3xs dosing. Please K!!! Help humankind.
"...a primary focus for the 2017 calendar year is completing work necessary to forge partnerships with larger pharmaceutical companies presently engaged with Cellceutix, some under Confidential Disclosure Agreements (CDAs). "
"Forge Partnerships". Plural
"with larger pharmaceutical companies" Plural
"companies presently engaged with Cellceutix," Plural
"some under Confidential Disclosure Agreements (CDAs). " plural
So we see: CTIX wants to forge more than one partnership with multiple BP's which more than one are currently under a CDA and other BPs that are interested/engaged do not have a CDA.
That equals. A lot f interest. If the numbers prove to be good...I'm betting we see one this year. At least one!
If you can post that...I can post....who would not want to deal with Dr B. 3 bps are probably bidding on P as we speak and that is why there is not one once of worry at CTIX... This can go to .40 for all they care. Only 2 months away from 2 B trials and another month or sooner for B. They have all the time and cash needed for that range. If over 35% Pasi 75 we see nice deal. Over 50% we see a great deal. Over that we see a historic deal.
Big Pharm needs cash cows. There is no time to let CTIX polyitself. BP won't risk possible loss to other Bp
You can only live so long in a hole.
Thanks for all the messages.
Hoping K can really kick some arse!
“I think it is pretty easy to see why we are thrilled at our prospects with four different mid-stage trials ongoing,” said Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Cellceutix. “Each study has a valuable component in demonstrating the robustness and potential of our pipeline and I greatly look forward to what I suspect will be a 2017 with a steady flow of information across all four trials.”
“Success in any one of our mid-phase trials could instantly transform the Company overnight,” commented Cellceutix Chief Executive Officer Leo Ehrlich. “Having already engaged in productive discussions with large pharmaceutical companies, Cellceutix remains partnership-focused in 2017. Potentially life-saving drugs and tremendous value creation await patients and shareholders alike as we strive to deliver compelling trial results.”
This is a great company trying to do great things. No BS by Management. Keep your salaries and keep on going! Thank you.
"Over the next month to two months, Cellceutix expects to have interim data from both Brilacidin trials. This is particularly important for the development of Brilacidin and pursuit of partnerships as the data can provide clinical evidence of the immunomodulatory and anti-inflammatory properties of Brilacidin for indications that represent areas of unmet medical needs."
This is not made up stuff Max. This is real science and several here are making a strong effort to scare. Sad day when my young 40 year old friend died of Ovarian Cancer this week and people post on this board to scare and lower the share price for a financial gain while hurting the company to move forward. So sad.
Hats off and a moment of silence. RIP
Yeah. I'm a numbers guy. But I also realize the valuation I expect can take 5 or more years. I'm fine with that.
Our first partnership should take all short term investors to the point they are happy. I'm here until Leo sells.
If the science continues on this path...100 dollars is the low end. The markets for all these drugs are extraordinary. It all depends on safety profile and efficacy levels.
Ie. If P continues the already proven path that is documented at 200 mg - we can expect a billion per year in revenue in year 2 of approval, bare minimum based off Otezlas path.
B-UP is huge especially when we move into Crohns. Etc....
B-Absssi could beat Dapto? 1 billion per year.
Kevetrin...just wait and see after this trial. Especially if we can move to Oral. It could be multiple billions per year.
Etc. it's not fairyland projections. As of today the science is on par to meet the numbers
Excellent update. Next 2 weeks into 8 weeks we have some exciting news. Partnership worthy data to be digested. BP has one toe in and hopefully the data makes them jump in.
Great update.
Thanks Hound! Not toxic at all.
One of the best things I like about CTIX is they are simple and work hard. No fluff or smoke and mirrors...just straight science and very professional. Keep it up CTIX!
Hopefully that pays for the bridge studies which will create great value to shareholders. It's the name of the game
F1ash- I read this differently:
"...would support value of the drug candidate at that stage of development in excess of $1 billion."
If P shows what it did in Phase 2a at 200 mg and completes the phase 2b with exact same results; we are looking at a value of ATLEAST 1 billion dollars per their conversations thus far with BP.
IMO. Ever since Dr B has jumped on board and they now have been in more high level meetings with more BPs than ever in the history of CTIX....they know exactly what the value would be. HOWEVER! If the higher doses lights up the scoreboard trumping phase 2a...well then! Now we have a much higher and new value in BPs eyes.
That my friend is what we are waiting for. Phase 2b results at higher dosing levels.
Just my 2 cents
Let's see the results in this trial for P first. We can make it to that without major dilution imo. And if we see something special you can bet your shares we will have a partnership. And a very lucrative one at that. IMO
The first partnership will be epic to share price increase.
Good luck
I missed this: "Elsewhere, when we mentioned the bioavailability achieved in oral Kevetrin to scientists at our previous Phase 1 clinical site, they commented that it could represent a significant improvement to lengthy or frequent intravenous infusions and urged us to select them as a site for future Kevetrin trials. That is very encouraging, as they are some of the most respected and experienced investigators in the world,”
Very promising that Dana Farber wants K back in house.
Pfizer partner soon. IMO.
Business 101. Generate interest from multiple parties. Those parties at some "point" will start to try and jump/crawl over each other to get "in" first.
(Disclaimer: the product must show enough promise and value for the above to happen. Obviously)
As a CTIX long, I wonder what/when is that point?
Hoping for bOM interim next week
That is great! I think P is the only drug that CTIX would not have to share Royalties? Don't quote me, but I think K is part Aruda, and B is the University of Pennsylvania or Pitt?
This company is on a roll with science. Great 8-K and even better info in the Q. The cash was a little higher than I expected. I will say this to all of us true investors of CTIX. There is a plan A, B, C, D and E. This management team IMO is on the ball. I would not stress the cash at this point. And I'd say even if one trial does not pan out to expectations I'd still have full confidence. My own personal opinion ...a deal is done just waiting on adding additional zeros at the end once results are out. Big Pharm knows. Snooze you lose.
B-OM
B-UP
P
Now K
Good evening.