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My note on Kevetrin this also a note on how slow Harvard might be but when you look at the secondary objectives of this trial: change in tumor size, decrease serum tumor marker and changes in p21 biomarker expression etc the level of testing in these secondaries is not very far along...apparently.
From the last PR "biomarker p21 increased in 6 of 14 patients at relatively low doses of Kevetrin and we expect a higher percentage of p21 expression when the data is evaluated from higher doses"
With 14 patients be tested that would take us all the way back to cohort 4 which I believe dosed at 75 mg/m2. If this is as far as we are with all of the secondaries we are not even up to the level yet considered to be efficacious at 100-200 mg/m2.
So if you consider the success so far with ovarian and pancreatic cancers this information might only be updated to cohort 4! If all secondaries are equally progressed. A patient may have had 7 cycles but the secondaries measure may be not be up to date.
Food for thought hopefully for those that think Kevetrin has lost some of its excitement. I personally don't think the "miracle" will happen till phase 2 when the dosing is figured out and becomes routine.
I think we can all agree that Harvard is slow, but right here now that might be a good thing.
Eat your Broccoli!
I don't think one SAE in a trial with 200 patients is of much concern. If its even a SAE and not Dapto. I have been on a lot of prescription drugs that came with warnings, liver failure seems to be a popular one my personal favorites is death and they suggest you contact your doctor if it occurs etc.
My general feel for the poly assets is that the drugs were wonderfully powerful and PolyM tended OD (over dose) them in their limited human trials. Having said that if it is a SAE related to Brilacidin I would guess it came in the 3 day arm of the study where the OD scenario may have played out again. It looks like all 3 arms of B were successful and I was cheering for one of the one day doses anyways. The 3 day dose total would be 1.2 mg/kg total and the low single 0.6 mg/kg so we have a half dose from the high to work with. It would be interesting to see a plasma drug levels peak and trough against time for B for residual effects.
I am not ruling out that a SAE occurred in the Dapto arm. There is a known hypersensitivity/allergic reaction to Daptomycin with its own SAE's.
That was just the 10k rally waiting for the ABSSSI rally.
IMO
BK, are those US rights only, worldwide etc
Thanks
That east coast lunch time is very clear on the pps.
Biodoc, we are truly sitting pretty here!
Biodoc, Leo addressed this issue. Participants in the 2A study were not returning for all their visits and were considered failures at the time. They would miss one appointment then make the next etc. B was working too well.
There was a article someone wrote recently that criticized the B 2B study because it was invitation only. Obviously the author didn't realize the issues in the 2A trial. The company were trying to find participants that would return for all their visits. The 2a trial was conducted in Ukraine and Canada.
Excellent Sox, and we are spotted 10% non-inferior and Dapto cannot be over 100% its a lock. If any of the arms failed all of the short-comings would have to be in one arm lets say the low-dose one-day. Its impossible that both one day arms failed. We got a one-day treatment for ABSSSI huge win for society! And this is not one of those low-grade/retread antibiotics we are compared top of the line Dapto.
Someone brought up a military application here. Love the thought of our soldiers carrying a one-day B-shot in their backpack.
Only 3-4 million for a phase 3 B ABSSSI? Makes me double think about partnering. I thought it would be much higher than that but will 3-4 million get you to the FDA?
TD, I agree and its slightly worse with the double-blind.
"Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Brilacidin Oral Rinse Administered Daily for 7 Weeks in Attenuating Oral Mucositis in Patients with Head and Neck Cancer Receiving Concurrent Chemotherapy and Radiotherapy”.
And here is how the B-OM trial will go.
Holy comprehensive update= 10k
I sent a email to Leo inquiring about the 10%, will post it if he responds. There maybe natural fluctuations p21 levels and the 10% maybe a statistical barrier to insure its the drug causing the change. Overall 10% sounds pretty high to me.
In my rudimentary mind I see B-OM trial as being the B-ABSSSI of the mouth. There is a wound and your trying to heal it. With 60-120 patients I think the trial will go quickly. I have never heard the company use the words "preventive care" so I assume its treatment of an existing condition with no placebo or comparator.
IMO you don't file the IND if you not ready to go. B-OM should be going before we get final data on B ABSSSI. As far as design look at Sox post earlier this week.
30 days if FDA has no comments its a go
P21 increased in 6 out of 14 patients this must go all the back to around cohort 4 which I believe was around 75 mg/m2 so relatively low doses still the last time they tested.
My hope for coming out of this phase 1 trial is to get 2-3 strong leads on specific tumor types to follow up on in advanced trials hopefully DF tumor mapping abilities kick in here. The beauty of K might not be seen till we get out of the dose escalation phase and in to dose optimization and regulars patient treatments in advanced trials.
The only slight downside from todays presentation for me was all the planned trials/IND's for so many different trials and drugs my head started spinning. Where is all the money going to come from ?.?..but I suppose a top of line 1-day dose antibiotic should catch a fair price from any partners.
Good times
Thanks for the summary Yooper!
I am liking the theory that K is not expected to DLT at 350 since this is well beyond estimated therapeutic range they are just looking at declaring a high safe dose and move on. But, would this last cohort then be a expanded cohort even without the DLT?
BK, do you believe its possible that the new protocol for injection site redness is what allowed for this dose increase? We know Harvard is slow and safety board is tight. Are we shooting for Kevetrin at 500 now!!! Might explain infusion rate protocol change?
Looking from the outside and if this wasn't being done in humans this 350 dose appears to be seeking some DLTs. Feels like they are trying to wrap things up OR we have a ways to go still perhaps their is more beyond that original estimated therapeutic range?
Baffling!
Uplisting to NYSE using standard 3? https://usequities.nyx.com/listings/list-with-nyse/nyse-mkt-listing-standards
Chem Yep! B phase 2a low and medium dose where in 90%'s and this trial surpassed that rate. The only way I can see not all arms working is if Dapto has a cure rate over 100%...it cannot! (of course)
The trial was a smashing success we now wait for the official data!
There were so many developments there I will have listen to this archive 3 more times just to get all the notes down!
Any nay-sayers for B-ABSSSI 1-day not working now please show your math. Remember you cannot go over 100% cure rate for Dapto and B is spotting 10%. And B 2a low and medium dose where in the 90% range.
WOW, B 1-day works and they are getting serious about K!
Look at Sox stickie at the top
Etrade I am completely lost at what your trying to say? Of course the company can do whatever it wants.
Partner K, B ABSSSI, and P sure I hope so but put a check in the other box and your sitting pretty! You didn't give up the big 3 yet and you can still partner K, B ABSSSI, and P. Just going by the wording in Leo's PR and wild speculation.
Funny thing about that PR is that it actually announced that Leo is the one presenting! We usually have to ask. If big news is coming its coming from Leo.
Leo has stated he was looking to partner B in other indications because they would be expensive to do so on their own. Toss in a meeting with big pharma, 30 kg B manufactured, resolution of a long-term grievance, and the upcoming significant corporate development. Perhaps we partnered B minus ABSSSI but the other indications for B and other parts of the old poly pipeline: oral mucositis, and antibacterial and antifungal infections.
With funds from this partner perhaps they take B ABSSSI to phase 3 on their own or its just another partnership in the making.
Feels like something is different here now..Exciting times!
Beautiful post BK! Born to be a stickie!
"Work for Hire" Dr. Menon please remember it in the future! I am strapped with this at my work. My creative juices have authored several patents unfortunately known of them are in my name!
An analogy here: I was on my way to the beauty contest but decided to stop along the way for a hair cut just tighten up the edges. Well as always I win the beauty contest and its 10K prize but now Super Cuts wants half the purse! Stating they were instrumental in me winning while we all know its because of my because gorgeous blue eyes and chiseled chin.
This is also like someone's rich grandpa dying and all the estrange distant cousins showing with lawyers to the reading of the will.
Dr. Menons mistake and he paid.. I say commendable. My view is this does nothing to hurt shareholders in fact resolving this issue might let Kevetrin go free i.e. they may have felt forced to resolve this issue so that K partnerships could be struck...but dam what a price Dr. Menon had to pay!
Excellent point Sox! "CTIX can simply issues 16 million shares to settle the dispute. The fact that they did not do so shows that they truly care about their shareholders."
Well then Mr. NR I look forward to your next posting with link, cut and paste is fine too, with great anticipation! Please!
Rmz, this is exactly why so many investors get excited about RR. It appears to be Leo's method of saying shhhh don't tell anyone, but here is what is going on with Kevetrin at DF. Just look at last years presentation on Kevetrin. Those results were never PR'd only the Polymed deal and Prurisol information made it outside the original presentation and they weren't the highlight of the presentation. I won't even do a IMO for the last sentence.
Its well understood that Leo can't say much about the Kevetrin trial and this predates last years RR presentation but look at all the wonderful information he gave us!
If you haven't seen it go to Events and presentations section and click on Rodman & Renshaw power point from Sept. 9th 2013 on the companies website.
My expectations for RR 2014 are:
Updated K information with the same content as last year that would include p21 as well.
I don't think there will be too much preliminary data on B p2b because I am not sure the study will be unblinded till the last patient had their 28 day follow-up. Does anyone know otherwise?
On all other subjects P, B-OM etc the most interesting thing that might be reported is the timing of events. When they plan on filing etc.
I feel like Leo was swinging for the fences last year at RR so perhaps their will be a surprise this year as well. I suspect we will get a PR on Monday announcing the presentation this coming Monday hopefully with news of the completion of cohort 8 too!
Nice find Gov! It looks like that study done at the University of Washington got published in the American Society for Microbiology. I don't recall where it was published when we first saw it.
Just imagine a updated Kevetrin RR 2014 is days away!
Bologna is waiting on the MTD from Kevetrin P1
Is Kevetrin a miracle? I am not sure that can be proven-out in a phase 1 dose escalation study with a primary mission of safety. We would have to get a lot of patients in multiple cycles in therapeutic range. Its puts a unfair burden on K that may not get a chance to show what its really capable of till later trials when the dosing regime is confirmed and tumor types identified.
But then if you correlate increasing p21 with stability and tumor shrinkage! And there has been a lot of patients taking repeated cycles!
My own personal miracle would be to stop contradicting myself!
"which provides benefits for both patients and society" Society is my favorite part. Sixty-six pounds of Brilacidin you don't manufacturer that much if it isn't working!