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George,
I believe one of the past PRs indicated that one of the secondary endpoints for Prurisol 2B trial would be eczema.
Karin,
The last row in the Upcoming Milestones Table appears to be showing Brilacidin ABSSSI starting in 2017. Management must seem confident of a license/partnership deal for Prurisol after its Phase 2B (end of 2nd quarter 2017) and the deal value within a range well enough to cover an ABSSSI trial in 2017. IMO
Thanks for the table of events.
Agreed Karin. I wonder if at the end of the Kevetrin 2A POC, they extend it for additional patients using the Kevetrin oral formulation, if its ready by then. Do remember them extending Kevetrin Phase 1. Waiting for the trial design to find out.
I'm thinking we'll get an update between mid Nov and early December on cohort 1 finish. Perhaps and hope your right about mid Jan cohort 2 PR at finish of patient #3 instead of patient #4 as applied dosage of Brilacidin will have doubled by then.
Yes, I thought the next PR on B-UP would be after cohort 2 or at earliest midway thru cohort 2. The news seems fairly good on
cohort 1 in light of this being the weakest dosage. Seems they are quite encouraged so far with the results after 4 out of 6 patients,
so we got the PR. It may be going forward, we get news at the end of each cohort and also when 4 out of 6 patients are done in each cohort.
Super display of information. Thanks Sox.
Hi George,
Thanks for sharing this...looking forward to the rest of the trial.
Anyone here feel the Kevetrin Ovarian Phase 2A will involve 70% of patients on IV and 30% on oral formulation (is it supposed to be ready?? ...maybe so if its part of the mice testing they recently are doing)
Dr B said early 4th quarter on Prurisol Phase 2B.
- Guessing by Oct 31 (33% into the 4th quarter)
Kevetrin 2A
- Guessing by Nov 30
Brilacidin Ulcerative Proctitis 2A
- Guessing by Dec 30
(want to ensure 2 of the 3 B-UP cohorts have been completed)
My guess would be update on additional trial sites for BOM Phase 2 trial by Nov 15
Are you implying Dr Bertolino and Dr Golumbeski have a strong connection from their days at Novartis and this may lead to something?
I see Golumbeski was a Novartis VP for Biz development and licensing (2002-2008)....but Bertolino didn't start at Novartis until 2008. Maybe Golumbeski interviewed Bertolino (doubtful as Dr B was a dermatology specialist) and they became a long term connection since 2008.
"From 2002 to 2008, Dr. Golumbeski was Vice President, Business Development, Licensing and Strategy at Novartis-Oncology, a business unit within Novartis, where he was a member of the Executive Committee, which was responsible for the overall results of the business unit franchise."
Did Celgene run a trial for mild to moderate psoriasis using Otezla??
If so, did their mild outcome outperform Prurisol's mild results?
I know they ran a phase 3 for moderate to severe psoriasis.
Would/could Celgene use Otezla and Prurisol in some combination as a psoriasis therapy?
I think maybe we're better off siding with Pfizer to eliminate the oral psoriasis drug combination as an outsider
and not within a part of Celgene - they may be manipulative with Prurisol sales.
If they want to buy the rights for minimum $500 million to Prurisol for only the indication of psoriasis, okay after Phase 2b and
on condition they partner with Brilacidin on very favorable CTIX financial terms.
We'll see how this all plays out.
Just my humble thoughts...don't know what to expect.
I believe there is an interim analysis for the Prurisol 2B trial.
If there is a settlement coming, then Sullivan should seek the optimum reward, so that lawyers like Rosen who file frivolous lawsuits with no DUE DILIGENCE, especially within 2 hours of a concerted short attack article of 40+ pages typed BS DON"T EVER DO THIS AGAIN.
I would like to see 5-7 million in damages and this case published in that law newsletter someone posted previously.
This case went on for over a year...what could CTIX have raised thru Aspire during that time??
Let say maybe 3 million shares raised between 1.80 to 2.30
Sullivan needs to come up with something favorable for lost opportunity of raising capital to grow the business, hence the delays of clinical trials progress.
Please Sullivan, don't let these folks off easy.
Nice Sunday read about research cost for developing a new drug.
http://www.forbes.com/sites/matthewherper/2012/02/10/the-truly-staggering-cost-of-inventing-new-drugs/#2ffec42b4477
ctix continues to progress well with clinical trials which in turn could be of potential, significant interest to a Big Pharma partnership.
Thanks BigKahuna.
Maybe "repeated dosing" means repeated every week (the cumulative of 3 doses per week)
I emailed Mr Ehrlich about this, guess your right won't know til final protocol established.
Yes an oral is quick access and easier maintenance. Hope it stands out well in the near future.
Hi BigKahuna,
Followup question:
Does anyone have it down pat what repeated dosing (3 times per week) means?
Is it dosing three days in a row; once per day?
Is it dosing at hour 0 and hour 23 on day 1;
at hour 0 and hour 23 on day 3;
at hour 0 and hour 23 on day 5
of each week?
or something else...?
From the PR about Kevetrin Phase 2a:
Ideally, a dosage regimen is established for each drug to provide the correct plasma level without excessive fluctuation and drug accumulation outside the therapeutic window. Kevetrin has less than a two-hour half-life. PK results indicate that with the current dose regimen Kevetrin is almost completely out of plasma within 24 hr. Therefore, little drug remains for any substantial period of time afterwards.
Based on these findings, we believe the impact of Kevetrin when administered to patients with repeated dosing (3 times per week), as planned in the upcoming ovarian cancer trial, will achieve fairly steady levels of Kevetrin above the MEC. The sustained activation/modulation of p53 will modulate multiple signaling pathways and should substantially increase its therapeutic efficacy.
I thought Phase 1 was maximum tolerated dose with a view on safety.
I think 7 of 11 ovarian patients had stable disease over 3-6 months with these patients coming in with the disease already spread to major organs.
Now we get into the dosing frequency of 3X/week
A possible non-toxic drug as the first punch of a 1-2 punch cancer treatment is worth investigating further even if it shrinks tumors at most 30-40%, it will have done a partial substitution of the chemotherapy's job.
Hopefully this is the least of what they are aiming for with Kevetrin.
One would think its an indication that efficacy is good enough to continue the trial on an expedited basis.
At what point did Sucampo drop their failed OM trial and was it based on interim analysis or failure before that point?
One would think CTIX has a fair idea now how things are going.
ALL IMHO
Need a partner and NASDAQ. Retail investors can't keep it above 4 for an extended period of time. Need excellent results from P2 Prurisol and P2 BOM to get in 3-4ish territory. Then a partner with cash infusion to get uplisted and institutions can keep her steady.
I looked at your mentioned Eleven Biotherapeutics - they have 73.6% institutions and 12.73% insiders and the price moved from .31 to 4.37 per share. Hopefully, the President Bertilino will eventually hire someone excellent to road shows the potential of the company to the Wall Street funds and institutions as we get closer to NASDAQ uplisting.
Not starting the P3 B-ABSSSI temporarily hurt the stock price IMHO.
We were led to believe for quite a while that this trial was going to start.
You can't let a company with this potential sit on this current exchange forever.
Anyone know Dr Bertolino's email address? Thanks in advance.
I forgot to send this out back in the day about CMO transition talk.
The company in the article was bought out for 21 billion March 2015.
They had 4 CMO's in 5 years.
https://cleanupcall.blogspot.com/2014/09/management-turnovers-at-pharmacyclics.html
BigKahuna,
The Kevetrin Ovarian 1B is 3 doses per week. Based on what's seen after 1B, they could do even 4 or 5...etc doses per week to start Phase 2...correct?
Possible for them to run a POC Ovarian Phase 2 using the oral formulation while they are in Ovarian Phase 2 using the IV delivery?
Thanks
Wonderful post!!
I'm hoping at the very least we get a detailed report after each
dosing cohort (50mg, 100mg, 200mg) - even better, a report at the halfway point of each cohort.
The POC concept has me wondering about what the 1B Kevetrin will be like. Similar to the POC BUP where we
get news as it comes without waiting for the formal once/twice per yr presentations.
Anyone have guesses where the Kevetrin Ovarian Phase 1b/2 will occur?
Is it possible to do a quick 25 patient 1b at Mayo Clinic and then Phase 2 spread out at community hospitals. I remember a few here saying Dana Faber is too slow...
Great interview Karin - thanks.
My guess (IMHO)
Interested parties gave CTIX their figures as to what a deal right now would be worth.
Ctix now knows which parties are most interested by the value they placed on Prurisol recently after May P2 results. Ctix's Bertolino has decided to focus on maximizing the value of a deal (considerably upping the dosages) in the Phase 2B.
CTIX must feel they have enough interested parties, that after 2B results, there will be a bidding competition for Prurisol, either as a partner or sale.
Shapiro led the K study. He was there to answer questions about K on the poster and external of it. I take it you weren't there by your comments.
Maybe he was given 440K and named both President and CMO because a partnership deal is likely.
PCY? Imbruvica ran a 1b/2 and 50/50 deal with JnJ was commenced after INTERIM data of 2 Phase 2s.
You really think we are looking at 3 years for a deal if results are very good??
Be fair here, K was only given 1x/wk. Moving now to 3x/wk, the results on ovarian at just 1x/wk were very good on Stage 4 patients with exhausted options.
If K ends up being a combination addon that improves the efficacy of popular cancer drugs, then we win despite the extra time.
Safe wording, "explore partnerships", meaning to look at something in a careful way to learn more about it...
as if negotiations from several BP have started and are being analyzed
"search" might sound like looking for something not already there yet.
Yes let's hope their halfway there on negotiations...some general upfront agreements written up and now being fine tuned on the back end.
In your experiences of dealmaking:
Is there evidence of a preliminary baseline for a deal when hiring picks up out of the blue after employment count has been steady for a while (maybe to accomodate a potential upfront cash infusion)?
IMHO sounds like their attempting to bring new talent in place before a license/partnership is finalized.
What loose ends would need tying up if this is possibly the baseline workings of a deal?
If Celgene were to become interested in Prurisol, maybe they would license/partner Prurisol to lessen the threat of an oral pill being equal or equivalent to their Otezla (for psoriasis) with less side effects.
Would Celgene be interested in Prurisol license/partnership?
Would Celgene be interested too in a trial with minimal Otezla combined with Prurisol?
Interesting to think about...
Yes, screen shots would have been great. Now it would be the server logs and possibly database of old archived records as snapshots.
I'm in for joining a lawsuit.
Maybe ctix will sue.
Law profession should not be cut and paste and send over the internet to millions of people within two hours. No verification done of outrageous claims against ctix and slander of company operations and their employees.
http://www.bizjournals.com/boston/blog/bioflash/2016/06/judge-dismisses-shareholder-lawsuit-against.html
Yes, we need to find some cash and support from a big pharma partnership, especially wise to have a strong cash position upon first arrival to Nasdaq. We are batting 1000 for phase 1 ovarian cancer and (for 2 phase 2s with 2 potential blockbusters). However, I will not be a happy camper if by Dec 2016 we are still 0 for 2 in the license/partnership department and tapping Aspire all along. And the company will know about it directly from me via letter and in person. Pleased with the P results,let's get some cash infusion for something here so we can get out of the retail investor kingdom (pinks) and bring institutions on board and get closer to real value.
Yes, quite possible. Wondering now if they are waiting on BOM interim analysis and thereafter B platform might then be bundled with Prurisol in a partnership with one big pharma company.
One might think IMO that Mr Ehrlich may request the results delivered to him M-THUR if good to excellent and on Friday if bad (any possible license/partnership for Brilacidin-ABSSSI could be finalized over the weekend and mitigate bad P news PRed on Friday). ALL IMO (who knows what shakes out),...it just seems they are placing their hopes on good Prurisol results for financing B-ABSSSI phase 3 without having to cut a deal yet on the Brilacidin platform. If Prurisol is a no go, then maybe they'll cut a license deal for B-ABSSSI earlier than they would like.
Karin,
great post keeps things organized and saves research time
großen Beitrag, hält die Dinge organisiert und speichert Forschungszeit