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BK, thank you for your very plausible and credible explanation as to possibly why cohort 7 has slowed. One piece of advice, the next time you "don't want to have this conversation", please, for the sake of your "following"---have it. Thanks for the enlightenment.
BK, you have spoken to the potential value of K if sold as a platform drug, but do you have an opinion as to what K's value might be as a "combo" drug? Could K acting as a "wingman" for a multitude of cancer drugs be more lucrative than being sold as a platform?
I agree with you that major pharma will want to do a deal on K as a platform, but it doesn't necessarily follow that Leo and Dr. Menon will see that as the most lucrative approach. On the other hand, cutting a platform deal with big pharma might be less lucrative, but yield more immediate cash.
When the phase 1 data on K is released and evidence of it becoming the "holy grail" is more pronounced, I suspect for major pharma, it will be "game-on." The end of phase 2 trials on K might be the ideal time for deal-making, but given the patent and pipeline problems of major pharma, it's "the early-bird that catches the worm."
BK and anyone else, please feel free to respond.
http://www.investopedia.com/articles/investing/082013/will-immunotherapy-disrupt-oncology-market.asp
BK, since AZN has rejected Pfizer's final offer of $119B and Pfizer has stated that they do not plan an hostile takeover of AZN, what effect, if any, do you think these developments will have on a possible Pfizer buy out of CTIX?
http://money.cnn.com/2014/05/18/investing/pfizer-astrazeneca/index.html
About Cellceutix:
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol "CTIX". Cellceutix is a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology and antibiotic applications. Cellceutix believes it has a world-class portfolio of compounds and is now engaged in advancing its compounds and seeking strategic partnerships.
In looking for an explanation for the news black out on K the Dr Jerry rumor of a potential "Celgene deal announcement" might fit because deal makers usually prefer silence to noise when cutting their deals and the sound around K has been pretty minimal. Obviously, logic does not necessarily dictate truth, but, keep in mind, CTIX is "seeking strategic partnerships" as stated in the: About Cellceutix section of todays PR.
Preparing to enter the multi-billion dollar wound market is indeed great news, however, it has been 6 weeks since CTIX has uttered a syllable about K and I am beginning to think that there might be something to the Dr. Jerry rumor. May 27th is fast approaching, so we'll know, one way or the other, soon.
BK, I was looking at the different payment scenarios you presented in post 59495 and I was wondering how they might change if the circumstances I present below come to pass. I still think, as you, that after phase 2 is the best time to do a deal. You stated that your numbers were based on the fact that the licensee would have to foot the bill for phase 3 trial(s) that could cost roughly $20 million or more, but what if Brilacidin is generating that much or more in revenues before or during phase 3?
In a CTIX PR dated 09/24/13, Leo stated, “…we are investigating commercialization potential of Brilacidin internationally that we believe may be a possibility before even a Phase 3 trial is complete.”
The ADAPT Act of 2013, once enacted, provides a new limited population approval pathway. According to the act, in determining whether to grant such approval for a limited population of patients, FDA “may rely on traditional endpoints, alternative endpoints, or a combination of traditional and alternative endpoints; datasets of limited size; pharmacologic or pathophysiologic data; data from phase 2 clinical studies; and such other confrmitory evidence as the [Agency] deems necessary.”
Also, consider that daptomycin is used in less than 10% of severe bacterial infections, but the drug’s price is so high it generated over $1 billion in 2013
Does not the ADAPT Act, which I believe will be enacted summer/fall 2014, raise the possibility that Brilacidin, with its built in advantage of bacterial resistance, and lets assume 1-day dosing, could garner 10s, if not 100s of millions of dollars as a treatment for bacterial infections that are resistant to all known drugs, even before it enters and/or during phase 3 trials?
Thanks BK for your estimates and thoughts.
Lol...I wish you luck, but, lately I have had a hankering for a Big Mac and fries.
After reading how the SEC defines "quiet period" and looking back on the last CTIX "quiet period" (01/24/13 - 02/25/13) I now conclude that this, more than 3-week, silence on B and K is probably not associated with a "quiet period."
However, the mystery (at least in my view) still remain. Why the 3-week and counting news-blackout on B and K. Could it be that Leo is doing a deal and has initiated a self-imposed quiet period? While it is nice to speculate about what could be, in the end we'll just have to wait and see.
DrBones, I think it is very possible CTIX is still in a "quiet period." Here's why:
1. Even if this study is successful, and I think it will be, it only sets the stage to proceed to another study (phase 2/3). This doesn't seem material to me.
2. Mentioning that enrollment is going "smoothly" for the Prurisol study and no mention of how enrollment is going for the Brilacidin study.
3. CTIX's first PR since 4/14 (3 weeks) and no mention of B or K. Now that strikes me as strange.
All of this, to me, says "quiet period." Hope we're right.
Frontline Documentary: Hunting The Nightmare Bacteria Runtime 54:11.
http://www.pbs.org/wgbh/pages/frontline/hunting-the-nightmare-bacteria/
The ADAPT Act of 2013 and Brilacidin.
The Antibiotic Development to Advance Patient Treatment (ADAPT) Act of 2013, successive legislation to the GAIN Act of 2012, was introduced December 12, 2013 with the purpose of advancing drug development to counter the growing threat of Superbugs worldwide.
, the ADAPT Act advances drug development in three ways:
1.) Develops a new, accelerated pathway for antibiotics and antifungals
This pathway provides for FDA-approval of drugs in order to treat emerging threats in limited and specific patient populations.
2.) Strengthen resistance monitoring by the CDC
The CDC will also monitor use of antibiotics to treat serious and life-threatening infections and make this data publically available to providers, hospitals, and academics.
3.) Update Susceptibility Test Interpretive Criteria for Microbial
Specifically, the ADAPT Act would amend the FDC Act to add Section 505(x), allowing the sponsor of an antibacterial or antifungal drug intended to treat a serious or life-threatening disease or condition (or a biological products intended to treat a bacterial or fungal infection associated with a serious or life-threatening disease) to request that FDA approve the drug “to treat a limited population of patients for which there is an unmet medical need.” In determining whether to grant such approval for a limited population of patients, FDA “may rely on traditional endpoints, alternative endpoints, or a combination of traditional and alternative endpoints; datasets of limited size; pharmacologic or pathophysiologic data; data from phase 2 clinical studies; and such other confirmatory evidence as the [Agency] deems necessary.” The labeling of products approved under the limited population pathway must include the statement: “This drug is indicated for use in a limited and specific population of patients.”
The FDA has, thus far, compiled a list of 18 “qualifying pathogens” for which developers would receive incentives, under the GAIN and ADAPT Acts, for developing products for a “qualified infectious disease.” Staphylococcus aureus (brilacidin’s main target) is listed as one of the qualifying pathogens. The list of pathogens is due to be finalized in June 2014.
I might be wrong, but I think the ADAPT Act, after it’s enacted (hopefully this summer), will allow CTIX to seek an accelerated pathway for brilacidin using Phase 2 data. CTIX already has Phase 2A data and they will have Phase 2B data in the fall. I believe these 2 Acts will enhance the value of brilacidin in the eyes of suitors. These Acts are also good news for CTIX as they begin to target specific gram-negative pathogens, most of which are on the list of qualifying pathogens.
Here's a link for the ADAPT Act:
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2013/12/adapt-act-would-create-a-new-limited-population-approval-pathway-for-antibiotics-and-antifungals.html
I'm also curious about BK's thoughts on this matter. In the meantime here are a couple of Leo's comments on the matter. The first comment is excerpted from CTIX PR dated 09/09/13:
"We intend to quickly advance Brilacidin into a Phase 2b clinical trial, a drug that we believe could one day compete with drugs like Pfizer's Zyvox, which generated $1.35 billion in sales in 2012."
Here's the link for this PR;
http://finance.yahoo.com/news/cellceutix-acquires-polymedix-assets-bankruptcy-103000188.html
In a 01/21/14 PR Leo made the following comments:
"Following a week of meeting with other biotechnology companies, investment bankers and analysts, the Company realized that it was significantly undervaluing its estimation of the potential value of Brilacidin for ABSSSI. Several factors influenced the determination, including the dire need for new antibiotics that have not yet developed resistance and are less likely to develop resistance, recent changes in reimbursement policies and an ongoing shift to encourage cost-effective therapies, which is supportive of single-dose treatments, such as two of the dosing regimens in the upcoming Phase 2b trial of Brilacidin. The Company sees reduced reimbursement for the other competing drugs for ABSSSI that have already developed resistance and a higher reimbursement for a drug like Brilacidin, which is needed for patients who have resistance to existing antibiotics. Further, reimbursement is expected to be higher for drugs that prevent serious illness or death and for those where there is no alternative treatment."
Here's the link for this PR:
http://finance.yahoo.com/news/cellceutix-sees-increased-valuation-potential-120000077.html
Looks like the pricing scheme for Brilacidin (presuming it's superior to Dapto) could vary depending on the circumstance of utilization. Like, yourself , I, too, would like to see what BK's educated thoughts are on this subject.
I think you will find this helpful as well:
http://en.wikipedia.org/wiki/Beta_defensin
A very true and insightful post.
In corroboration of your point I'd like to offer a quote from Warren Buffett:
"Games are won by players who focus on the playing field--not by those whose eyes are glued to the scoreboard."
If true, great news, great intel. Thank you!
First, I'd like to say welcome to the board. Like yourself, I, too, am a newcomer to this board, however, unlike yourself I do not possess a strong background in science in general and no background in microbiology in particular.
That said, I'd like to point out that an antibiotic does not have to be a "panacea" in order to make you rich (which I believe to be the goal of most, if not all on this board). Admittedly, skin and soft tissue infections, which brilacidin addresses, are easy infections for most antibiotics, but this is still a $17 billion market. Additionally, the drug to which brilacidin is being compared, daptomycin, generated over $1 billion in sales in 2013 and the leader in the skin infection market, Zyvox, generated $1.4 billion in sales in 2013 and both are susceptible to bacterial resistance.
As a local political candidate recently stated, "Don't compare me to the 'Almighty' compare me to the alternative." I think this applies to brilacidin as well.
Your posts have prompted me to increase my understanding of defensins and for that I thank you.
Is B getting closer to the "holy grail"? The following comment by Dr. KSS seem to suggest just that.
"...single doses of brilacidin often being quite sufficient to cure an infection,..." (emphasis added)
This comment hints at success on some level with B's "one and done" dosing. The antibiotic resistant bacteria and ABSSSI is a $17B a year market, and if B ultimately achieves "one and done" dosing, it's one Cellceutix will have a firm lock on.
More News On CTIX Antibiotic Pipeline
[https://ca.finance.yahoo.com/news/cellceutix-corp-reports-favorable-results-trial-antibiotic-130500942.html/b]
Great Find Doug, my 3 favorite CTIX lines
1. "Brilacidin is deep in phase IIb clinical trials and performing admirably,"
2. "...to date no bacteria have displayed an ability to resist it."
3. "...the quite compelling circumstance of single doses of brilacidin often being quite sufficient to cure an infection."
Great article and a nice professional opinion.
Thanks Grizz,
I have tall respect for the intellectual capital on this board and it gives me great pleasure to think that I am contributing in some small way. I may have a point of view, but I rely on you guys to do the heavy lifting. I learn a lot from you guys. Thank you for your kind words.
Yes 58, I agree and the leverage would be maximized if Brilacidin achieves 1-time dosing with comparable or superior efficacy. Keep in mind that Brilacidin also has the advantage of a unique method of action or as Patrick Cox (post 52272) explains, "Defensins lock onto bacteria and other microorganisms and effectively perforate their outer membranes. The resultant 'leaks' disrupt the microrganisms vital functions. Cox further added, "To escape the defensins, bacteria would have to evolve entirely new outer membranes characteristics, which is nearly inconceivable for these simple organisms." This is one of the reasons bacteria will not become resistant to Brilacidin.
Dapto has a 7-day dosing regimen and this raises the possibility of patient noncompliance, which occurs when a patient fails to finish a regimen of antibiotic therapy. According to Cox, "...noncompliance can quickly create highly resistant and lethal strains." This might be the reason Daptomycin, "...is used only rarely, in less than 10 percent of severe bacterial infections,..."
What we know at this point is that in a 2A study Brilacidin's 5-day dosing regimen achieved comparable efficacy with Daptomycin's 7-day dosing regimen. We also know that Brilacidin has a new method of action that effectively addresses bacterial resistance and Daptomycin does not. I think Brilacidin has already shown superiority to "Dapto" and I also think there is a lot more good news to come, like reduced AEs,1-day dosing and increased efficacy.
The way Big Pharma is scurrying to get their antibiotic "houses" in order, when the 2B data is unblinded in the fall, Leo might as well get a bullhorn and announce "Let The Bidding Begin".
Tails,
I like your ballpark. Thanks!
Gov, I was referencing the 2A study, which had a 5-day regimen. The 2B study is as you mentioned, 2 1-day and 1 3-day.
Clinically, Brilacidin's comparator is Daptomycin, competitively it's Zyvox. According to Patrick Cox (post 52272),"Dapto, as it's often called, is a blockbuster drug used as a last line of defense for serious bacterial infections, especially those caused by drug-resistant bacteria. It is used only rarely, in less than 10 percent of severe bacterial infections, but the drug's premium is high, and so it accounts for over 80 percent of [Cubist's] antibiotic revenues. Seeking Alpha (04/25/14) reported that Cubicin (Dapto) topped $1 Billion in sales in 2013. Daptomycin has 7-day dosing regimen. Patent expires in 2017.
Brilacidin is in a Phase 2B trial to study lower doses and shorter courses of therapy. In this study, Daptomycin is what Brilacidin is being compared to, but the ultimate goal is to gain FDA approval for Brilacidin to be used in the area of ABSSSI (at least initially) and the 800 lb gorilla in this area, according to Seeking Alpha, is Pfizer's drug Zyvox, which had $1.4 Billion in sales in 2013 (40% more than "Dapto"). Zyvox has a dosing regimen of twice daily for at least 10 days. Patent expires in 2015.
Even if Brilacidin doesn't hit the "holy grail" of antibiotics (1 time dosing), but I believe it will, its Phase 2 success in achieving comparability to Daptomycin with a 5-day dosing regimen, along with its unique method of action that effectively addresses the problem of bacterial resistance, strongly suggest to me that Brilacidin is headed for "blockbuster" status. As Seeking Alpha pointed out, "For comparably priced antibiotics to treat MRSA and severe skin structure infections, about 60% of pharmacy directors support keeping formularies stocked with shorter-course therapies because it promotes earlier patient discharge." And, lest we forget, annually in the U.S., 14.2 million people are treated for skin and skin structure infections and 7 million for MRSA infections.
Cellceutix doesn't own drugs it owns platforms from which drug pipelines are made. In a best case scenario, can anyone tell me what the value of a company would be if it owned the "holy grail" of cancer, the "holy grail" of antibiotics and a cure for psoriasis? It's too mind-boggling for me to ponder. (A ballpark figure will do.)
New MRSA Superbug resistant to Vancomycin in Brazi.
http://news.yahoo.com/mrsa-superbug-emerges-brazilian-patient-181548942.html
I thought this was an interesting article and I am posting it for the Board to read and comment.
http://www.bloomberg.com/news/2014-04-11/cancer-miracle-patients-studied-anew-for-disease-clues.html?cmpid=yhoo
I think I found the Kevetrin study on govorchin's link. On the page that appears go down to Leukemia and click on the words "research site" right above the line that reads "A clinical research study of R05429083..." It is my guess that this number is the identifier for Kevetrin. Everything else seems to fit.
Now, about me. I have been a CTIX shareholder for about a year and I follow this board religiously. I have respect for all the posters here and I have learned a lot over the past year. This is my first post and I hope it proves to be a helpful one.
Thank you all for sharing your intellect on the Biotech arena. Your audience is probably a lot bigger than you think.