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As do I.....please keep the lines of communication with Leo open and continue to share.
Are you AKA Izka1?
that is exactly how I interpreted that sox....confidence seems high and he is predicting a "serious" stock price adjustment....I can wait a few more months to see if the previous trial and the current trial confirm what we suspect about B.....all the while K is moving along with no DLTs or MTD....now if the P crossover trial is a success too....lookout!
Question on Kevetrin....if Kevetrin shows only stabilization but not regression throughout the rest of the phase I, but continues to have significantly lower toxicity than other chemos, would we (this board) consider that a huge success?
I agree Incubus....If I were CTIX I would not send out an email to shareholders on a comparison article if what I knew about the trial so far was not promising. I take this as a very good sign about the trial...especially considering no SAEs.
I understand and respect Pete's strategy and wish I had the courage to do the same.....but with this stock for some reason I don't mind holding and waiting for news, especially with all of the upcoming catalysts. I have been burned trying to time these in the past, so I will gladly wait to see if K is the blockbuster we all think it will be. I just realized I may be married to this one....
News! An agreement with a large pharmaceutical for B is in the works....maybe Dr. Jerry was right after all....just not for K. Hang on to your shares with all of your might!!
Whoops....that did help remind me of what we have here and why these trials take however long they take. I also went back and read some information about K in combination with radiation (which I did not know prior) and also with Sunitinib. For the first time I realized how significant the value of K can be when used in combination with other chemo agents. I don't know if I am correct, but it seems that once the MTD is determined in the current Phase I, there will be a flood of trials involving K in some combination with other drugs. I used to think it was more important for K to show efficacy on its own and the discussions about K in combinations bothered me a little. I now see that there is very likely much greater potential if it can enhance other therapies (and perhaps be a single therapy for certain types of cancer as well). Heck, even if it enhances only one current therapy it could be huge. Thanks for the reminder.
I agree BK, especially since the deal for Aztra was shot down this morning and Pfizer will feel pressure to do something quickly to add to its pipeline in the oncology arena. Add in B and P and it seems like a perfect fit. Also, the price tag would be a fraction of what they were talking with Aztra. Could something possibly happen once the Phase I for K is done and the 2B for B is complete?
Great points Pete.....good to see you commenting more frequently on the CTIX IHUB again. I think Leo's most recent PR on the formidable anti-biotic pipeline was his way of telling us things are going exactly as planned and very well with B.
Kelt...I have always enjoyed your posts and look forward to your return to the CTIX board with strong health. Good luck these next several days.
NEWS! 50% enrollment this week and no AERs.....B is working just like they expected.
Added 16K this morning......I think this one is ready to pop. Feels like something significant is coming and if it was negative, management would have been obligated to report it by now. Going with my hunch.
No PRs this week....interesting considering all of the trial activity going on. Does anyone else get the feeling that something significant is going on that we will hear about soon? I could be wrong but it just seems like this is the quiet before the storm. I hope whatever is going on is positive!
Prurisol competition....can anyone tell from the description below (Pfizer) whether this has the potential to impact Prurisol?
Co reports top-line results from two pivotal Phase 3 trials from the Oral treatment Psoriasis Trials Program, OPT Pivotal #1 and OPT Pivotal #2, evaluating the efficacy and safety of tofacitinib, an oral Janus kinase inhibitor, the first in a new class of medicines being investigated for the treatment of moderate-to-severe plaque psoriasis.
The OPT Pivotal #1 and OPT Pivotal #2 studies showed that tofacitinib, as a 5 mg or a 10 mg dose taken as a pill twice-daily, met the primary efficacy endpoints of statistically significant superiority over placebo at Week 16 in the proportion of subjects achieving a Physician's Global Assessment response of "clear" or "almost clear," and the proportion of subjects achieving at least a 75% reduction in Psoriasis Area and Severity Index, two commonly used measures of efficacy in psoriasis.
No new safety signals for tofacitinib were observed in the OPT Pivotal #1 or OPT Pivotal #2 studies. Detailed analyses of these studies, including additional efficacy and safety data, will be submitted for presentation at a future scientific meeting.
Top-line results from the first two studies from the OPT Program, OPT Compare and OPT Retreatment, were previously announced in October 2013, and these four studies, in addition to a long-term extension study, will form the planned psoriasis submission package to regulatory authorities in various markets.
Pfizer currently intends to submit a supplemental New Drug Application to the FDA for the approval of tofacitinib 5 mg and 10 mg twice-daily for the treatment of adults with moderate-to-severe chronic plaque psoriasis by early 2015.
Competition for Prurisol?
Galapagos and partner GlaxoSmithKline say their anti-inflammation candidate hit its mark in a mid-stage trial on psoriasis, a stroke of good news for a drug beset by developmental slipups.
The treatment, 2586184, met its primary endpoint of improving psoriasis severity at 12 weeks in a 66-patient Phase IIa study, the partners said, and the two reported no serious adverse events. Glaxo is running the placebo-controlled study on its own, and, under a 2012 deal between the duo, Galapagos is in line for up to $47 million in milestones and a cut of sales if the drug makes its way to market.
That seemed like a shaky proposition after Galapagos revealed in February that its Big Pharma partner had halted a Phase II study of 2586184 in lupus due to lack of effect and put on hold a Phase I/II trial testing the drug in ulcerative colitis. GSK's moves pinned any hopes for the JAK1 inhibitor on the then-pending psoriasis study, and now, in light of the drug's latest success, the U.K. giant said it plans to review the data before deciding whether to press on into Phase III.
I cannot recall for certain, but didn't we start the new dosing protocol that CTIX requested in cohort 7 as well....meaning we have no side effects so far with the increased dosing?
NEWS! No SAEs so far in K cohort 7 and 30% enrollment in Phase 2b for Brilacidin with no SAEs........plus efficacy shown in preclinical on new drug...subtle comments on B, K and P that are very significant.
I agree Sox.....every day that passes without news on the MTD is a significant positive in my mind. If K is simply as effective as some of the current chemo treatments without the side effects, it would be huge. If it is more effective without the side effects, it will be a game changer. All indications are it will be the latter....very exciting!
As each day passes and we do not hear about adverse side effects with K, I believe it is another reason to think that the results from K will be worthwhile. I can deal with the sideways share price over the long term to see what K ultimately becomes because I am not selling a single share until I know what the outcome for K is. Even if it is simply as or slightly less effective as other treatments (i.e., extends OS by several months) without the terrible side effects, it will be significant to those with this terrible disease. Add in the fact that U of B wants to start early for some reason and I think the second half of 2014 could be an interesting ride.
Interesting to look at where Idera was less than six months ago....less than a $2.00 stock and now in the $4.00 range. If the results from the CTIX ongoing trials are even just decent, this will skyrocket....Karin is right, we will have four trials ongoing and only need one to be a moderate success to make a significant impact.
Novartis may be watching CTIX closely in terms of P based upon the PIII results for psoriasis they published yesterday.....self injection required and "significant skin clearance" but not 95-100% from what I can see. Below is the announcement. I like the other article Tails posted that talks about $5B "bolt on" acquisitions.
New phase III psoriasis data show rapid, significant skin clearance and convenient administration with Novartis' secukinumab (AIN457
It is great that P is likely to start the Phase I crossover trial soon. I believe that is a 45 day trial (May/June) and then if successful, the Phase 2/3 under 505(b) can begin, which should be relatively short in duration as well. Sure would be nice if we had results by the end of 2014. Am I too optimistic on the timing?
That is a great post.....
Couldn't agree more Mac....
I'm with you CanesNH....I have some of the same holdings that you and Pete have that have done well....but I cannot give up my CTIX shares at this point...I have been impatient in the past and it has cost me....not this time.
M & A Activity article that could be of interest to CTIX
"As The Wall Street Journal reports, Roche churned out about $18.6 billion in free cash flow last year, and analysts expect it to completely pay down the $47 billion Genentech deal by 2015. That gives the company a chance to expand its reach through M&A, Humer told the newspaper, and the company is looking for deals large and small. But being the world's biggest drugmaker by market cap means Roche can afford to be picky, and the Swiss giant won't pull the trigger unless a deal makes scientific, strategic and financial sense, Humer said. "We don't need to spend that cash," he added.
Roche is already well entrenched in oncology, but the company has plenty of room to grow in rare diseases, antibiotics and neuroscience, high-value areas in which it has either suffered setbacks or struggled to piece together a promising pipeline. Roche's pRED R&D operation is already rolling on the collaboration front, striking deals in R*A therapies and anti-invectives and looking to spend "up to a few billion" in the next year or so, partnering chief Sophie Kornowski-Bonnet told F******B** in January."
Alex I believe you are correct....see below. I think orphan drug designation and fast track are different due to certain funding issues being more available under orphan status...not sure though. I am not sure what year the article below is from either.
Finn, Jr.,
CPA, the Assignee for the Benefit of Creditors of ActivBiotics, announced
today that the Office of Orphan Products Development of the Food and Drug
Administration (FDA) has granted Orphan Drug Designation for M40403 for the
prevention of radiation -- or chemotherapy -- induced oral mucositis (OM)
in cancer patients.
The development of oral mucositis is a major, debilitating side-effect
in the radiation and chemotherapy of cancer. Oral mucositis is one of the
main reasons for poor compliance with and early discontinuation of therapy
by patients being treated for their condition. Nearly half a million
patients develop oral mucositis each year across all cancer indications,
and of these 90% are associated with solid tumors. Although the estimated
potential of the total oral mucositis market is $1- 2 billion, this
therapeutic area is one of high unmet medical need, with few successful
treatment options available.
Meant to include the following in my last post:
January 23, 2014 I BioAlliance Pharma SA (Euronext Paris – BIO), an innovative Company dedicated to the development of orphan oncology, announced today that Validive® (clonidine Lauriad®) received a Fast Track designation from the U.S. Food and Drug Administration (FDA) for the prevention and treatment of oral mucositis induced by radiotherapy and/or chemotherapy in cancer patients.
Cabel....Not sure about your question, but saw this earlier. I think Fast Track is quite different and there can be more than one drug with Orphan designation or Fast Track designation. It would be interesting to understand why CTIX elected Orphan drug path as opposed to Fast Track. I do think Orphan drug designation might include some funding options. Anyone?
Thanks for that BK....You articulated what I could not. Well said.
It seems if the establishment is in place to prevent a "cure" so to speak, there are a lot of large pharma companies spending significant dollars getting to phase III for cancer therapies without a lot to show for it. Could it be that due to technology advances we are finally getting to the point where a therapy like K can be understood and developed? I have to believe that if K gets through Phase I and there are signs of tumor stabilization and regression at the current higher doses, large pharma and high level institutions like DF and MD will be lined up to get more involved. At that point the share price will have likely jumped and the risk of supression will have lessened substantially. IMO of course.
Thanks Sox....I see one of the companies failed the Phase II study and the other sold all of its assets quite a while ago. I was not able to find another company with Orphan Drug designation for Oral Mucositis. There is one with Fast Track designation that is still in Phase II that I identified, but not orphan drug. I agree, it bodes well for CTIX.
Is the tumor "regression" reference different than what was in the slides at R&R? If so, that is a significant development IMO and the increase in dosage for cohort 7 at 165 mg/m2 has got to be making the CTIX staff very excited.
Does anyone else think that the Orphan Drug application for oral mucositis if approved for B could be significant? I don't know how long the FDA review takes (I think it is around 2.5 months), but I have this feeling that B for that indication could be a sleeper for CTIX. JMO.
Looking forward to Wednesday and further updates from NR!
I agree it is frustrating to wait for something concrete to move the share price, but I am still very committed to staying long and seeing what happens with this incredible company. With the passing of one of the Ihub CTIX friends, it becomes even more clear to me that the enjoyment derived from the journey is the most important thing to pay attention to. That being said, I will plan to pay close attention to the many changes that will no doubt come about in 2014 for CTIX and will simply enjoy the ride. If the PPS ends up shooting to the moon (which I think has significant potential to happen), it will be a bonus.
Merry Christmas Everyone....it has been an enjoyable 2013 following CTIX and the posts on this board even when not much has changed stock price wise....imagine how much fun it will be when the good news starts to flow and the incredible science starts to show itself. Looking forward to spending a wonderful New Year as part of the CTIX shareholders! Kelt and Teed we are all pulling for you.
Thanks W4N.....the responses sound like everything we all were hoping for. I cannot wait for the JPM conference...from the upbeat nature of the response, I am thinking we may get some very interesting and exciting information at that time!
GO CTIX!
I bought into CTIX in early 2013 knowing that it would be a long term investment that would probably go through ups and downs. With all of the positive news this past 6 months (K cohort progression, B acquisition) I feel even more confident that one of the three pipeline drugs will be a major success. I have sold too early in the past on a few stocks when share price declined (and then recovered), but none of those had anywhere close to the potential that CTIX has, so I am grateful that I learned my "patience" lesson with those stocks instead of this one. Nothing has changed in terms of news with CTIX, so I plan to hold each and every share with a tight fist. I can live with quiet times and fluctuations well into 2014.
I was able to buy additional shares at $1.55......thrilled that the trade went through! Accumulate on the dip! The next few months are going to be very interesting and active.