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Qualified Infectious Disease Product is just simply a drug (or product) that fights infectious diseases. Numerous drugs including Brilacidin, Daptomycin and others can be used for ABSSSI and are classified for QIPD. Market exclusivity simply means to extend the patent on the drug in this case Brilacidin before it can go to generic it does not mean that Brilacidin has exclusive rights to treat a particular disease.
The feds just held off on interest rates? Leading to CTIX resurgance? =-)
CTIX should start moving up from here and its not some fun TA with charts. Some realities are setting in over at the AVX? temporary base camp. Our boys could be coming home soon.
Good post 58. We have gotten a lot done with little dilution and added significant shareholder value.
Akward PR.
Seems like Prurisol enrollment will go quickly with all the trial sites coupled with fact the condition is fairly common. Looking forward to hearing a recruiting update here.
Blood work is what ended the Kevetrin trial (pk etc) imo. They may have received the data from patient 1 at 750 while they were waiting for safety board to expand the trial beyond 40. They seem to have a good handling of this subject matter.
No way related to SA garbage.
So with no MAD for Kevetrin the MTD being tested now must be 750?
"We believe we have reached the maximum tolerated dose (MTD), but with no dose limiting toxicities in this cohort. Exposure to Kevetrin as measured by plasma concentrations have been achieved which are greater than concentrations shown to
induce apoptosis in nonclinical studies. The final cohort evaluates at least 6 patients, as is typical for a Phase 1 study of this type."
The world global jumped out at me there.
It will be interesting to see the 10k PR this year. For once I will not have to go digging around in the 10k itself the interesting points should be highlighted in the PR..hopefully.
Dolphin, I think we a lot of investors here that are inverse ambulance chasers. The other stock does not have a catalyst lined up until the end of the year and with short-attention-spans they will drive that company back under a buck, which should equate to CTIX going back over 2 soon after.
For Kevetrin phase 2 advanced ovarian cancer it looks the standard care is carboplatin chemotherapy on its own or with another chemotherapy drug called paclitaxel (Taxol). One would have to think this would be one arm of the trial but here is a list of other potentials:
Albumin bound paclitaxel (nab-paclitaxel, Abraxane®)
Altretamine (Hexalen®)
Capecitabine (Xeloda®)
Cyclophosphamide (Cytoxan®)
Etoposide (VP-16)
Gemcitabine (Gemzar®)
Ifosfamide (Ifex®)
Irinotecan (CPT-11, Camptosar®)
Liposomal doxorubicin (Doxil®)
Melphalan
Pemetrexed (Alimta®)
Topotecan
Vinorelbine (Navelbine®)
If I had more time it would interesting to see which are still on-patent and with which companies. Or perhaps an ovarian cancer drug that is still undergoing trials itself used in combination with Kevetrin. Anyways this seems like a situation that might be ripe for a collaboration.
http://www.cancer.org/cancer/ovariancancer/detailedguide/ovarian-cancer-treating-chemotherapy
Any guesses on what drug(s) might be used in combined treatments with Kevetrin for our phase 2 ovaian trials? Any big pharma drugs coming in to the mix?
Guessing Mako co. Is designed to protect personal assets of an individual from lawsuits.
The stock market always goes down in the summer..oh no China or oh no Greece or oh no "x" the brokers want their summers off. The markets heat up when the weather cools and it typically lasts till May or June. If we need $2 for 90 days I don't see the problem. The bears or shorts or whatever just attacked the price will recover just like it did after the short attack in December 2012.
We already know that B ABX is effective what we do not know is that it safe for the masses (people). That is why antibiotic phase 3's are typically large and there is often more than one (phase 3). People exist at different levels of tolerences for different things. Antibiotics are widely used hence the safety exploration in phase 3's.
Phteven, time only. Oncology drugs carry a premium unfortunately antibiotics do not but it is getting better incentivized. IMO, a phase 2 Kevetrin trial in Ovarian cancer with Orphan drug status and signs of efficacy carries equal weight with a QIPD Brilacidin phase 3 in ABX in terms of potential partners, IMO. Also, a Brilacidin ABX going in to a large phase 3 is testing safety not efficacy, perhaps riskier for a partner then Kevetrin going in to a smaller phase 2 testing efficacy. Its all that risk/reward. I believe the company could find a partner for either one right now if need be but the terms wouldn't be maximized and the company has a financing arm (Aspire).
Why would Brilacidin be locked up? The ABX trial is not dependent on the OM trial, please clarify? PS the company ETA on B-OM is December 2016.
Phteven said:
"Equal weight in dollars or timeline?
We're talking a nearly complete QDIP antibiotic entering phase 3 against experimental oncology drug wrapping up phase 1. I think we require a completed P2 on Kevetrin to get an idea of what it's worth. If it works it's likely 20-100 Billion. No pharma will pay anywhere near that without a completed Phase 2. It will take a few years to get there.
Brilacidin is locked up until B-OM P2 is completed in June 2016. Chance of partnership before 2017 but most likely in 2017 sometime."
RS is impossible at this point. The company has repeatedly stated they are not going to do it if they did it anyways it would be biotech suicide. A long like myself would sell if they did at this point after they repeatedly said they would not. Not going to happen.
I also don't see the reason why they need a RS? They have financing and in regards to uplisting they only need a $2 share price.
It doesn't matter to me if its 450 or 750. Orphan drug status came with 450 or less as did disappearing lesions. Wait till they start dosing for efficacy in phase 2. I don't agree with your time line for Kevetrin partnership. The details coming out of this phase 1 will start to trickle out of Harvard this year. I give equal weight to partnerships for Kevetrin solid tumors and Brilacidin ABX.
I believe only 1patient was treated at 750 before they had to go back to the safety commitee to expand beyond 40 patients. Time-wise I don't see how they could have fitted in cohort 12 and then drop back to 750 testing MTD.
Reason #2 that it might be 450.
Thanks BK, my thoghts as well. Time-wise it makes since to me that the expanded cohort is at 450. Though they could have had some "quick" DLT's at cohort 12 and expAnded 750.
Before applying they already applied
I remember this time as well. Plz do not call clinical sites.
Yes, this is preventive care trial.
Gov. I agree B-OM seems like a lock given the data from the phase 2b ABX trial and it is going up against placebo. But I say its impossible at this time for their to be an "leaky" information from a preventive care study that just started and is double-blind.
We wouldn't know that till the end of trial. We would be lucky if they have enrolled 5 patients so far. I doubt any trial subject has even had time to develop OM yet.
Impossible to know with B-OM. Its a double blind PREVENTIVE care trial. No info till the end some patient may never get OM and be on placebo yada yada
UPComing Catalysts: KEVETRIN, KEVETRIN, KEVETRIN. Uplisting: no comment. Brilacidin 3 ABX some more Kevetrin and then maybe something about Prurisol.
According to my predictions for CTIX stock price over the years. None of us are really here because the company was bought out two years ago for 10 billion dollars.
My new prediction is that once this Kevetrin data starts rolling out we will bought out for 10 billion dollars by the end of this year!
Its good to be stubborn =-)
Cabel, I am uncertain why the B-OM gets so much of the posts about partnering etc. I believe the trial will take a long time mainly due to difficulties in recruiting. The inclusion/exclusion listed on the trial site for this trial are very detailed. I believe the reason that MD Anderson was dropped as one of the trial sites is because there is already a trial running there for the last few years for OM with another drug. Someone please correct me if they heard different? IMO CTIX has a lot of catalysts coming up but B-OM is not likely in the picture for awhile. I am not even sure if there would be a interim safety review where would could gleam over some data early???
Below are some of the inclusions/exclusions listed that jumped out at me. I not sure what most of them mean but they are detailed requiring a patient to follow a particular path of treatment for the cancer. No previous treatments for OM etc and every head and neck cancer patient would have to fall through a few hoops to qualify for the trial. Also, as I stated earlier some cancer types that are "generally" considered head/neck cancers are also excluded.
Inclusions:
Have recently-diagnosed (within previous 3 months), pathologically-confirmed, non-metastatic squamous cell carcinoma of the oral cavity and/or oropharynx, that will be treated with CRT therapy as first line treatment; scans (CAT, PET, and/or MRI) obtained within 45 days prior to consenting (screening) can be used to determine the patient's eligibility
Have a plan to receive a continuous course of conventional external beam irradiation delivered by intensity-modulated radiotherapy (IMRT) as single daily fractions of 2.0 Gy to 2.2 Gy with a cumulative radiation dose =55 Gy and =72 Gy. Planned radiation treatment fields must include at least two oral sites (buccal mucosa, floor of mouth, ventral/lateral tongue, soft palate) with each site receiving = 55 Gy [Note: the independent RTQA consultant must confirm that the planned radiation treatment meets the protocol criteria]
Have a plan to receive a standard cisplatin chemotherapy regimen administered weekly (30-40 mg/m2) or approximately every 21 days (80-100 mg/m2)
Exclusions
Has tumor(s) of the lips, sinuses, salivary glands, nasopharynx, larynx, hypopharynx or unknown primary tumor
Has metastatic disease (M1) Stage IV C
Has had prior radiation to the head and neck
Plan to be treated with induction chemotherapy before initiation of RT
https://clinicaltrials.gov/ct2/show/NCT02324335?term=cellceutix&rank=3
Nice geographical distribution of trial site for Brilacidin-OM which is probably necessary to capture some of the head and neck cancer patients given their is only about 65k diagnosed every year coupled with the exclusion criteria of the study which appears to exclude mouth tumors etc which are generally considered to be head and neck cancers so that is 65K minus a few. I expect enrollment to be slow in this trial. I would think this study would require more trial sites than Prurisol.
In contrast IMO, Prurisol recruitment should be relatively easy and they have so many sites! I would think the Florida sites would have been enough for quick recruitment. I guess Leo wasn't kidding about playing some catch-up with Prurisol.
Both studies run the course of about 11-12 weeks. Prurisol with 100 patients with results expected in April 2016. Brilacidin-OM with 60 patients with results expected in December 2016.
Taking a second look at the inclusion and exclusion criteria for B-OM... it is tight. I suppose its because there is overlapping battle-fields here with infection and cancer. I got the 65k number from Johns Hopkins link below.
http://www.hopkinsmedicine.org/kimmel_cancer_center/centers/head_neck/
NR, they just had the end of phase 2 meeting and they have not gotten to the phase 3 meeting yet with the FDA. Clinical trials take time for numerous reasons for all biotechs. Should we expect a small biotech to move at break-neck speeds when even the big boys with seemingly endless resources cannot?
Farm, why wouldn't CTIX sell the voucher? All of their current drugs in trial are already incentivized. Prurisol 505b, Brilacidin ABX GAIN act, Kevetrin orphan drug. If B-OM works at all it will be fast-tracked. I don't envision them bringing a drug to market by themselves and they shouldn't have to kick in the voucher for any partnership. A small biotech under constant dilution receiving 350 million would be a game changer in my book.
Farm, did you know the voucher might be worth 350 million? I didn't glad Leo told me.
The company is applying to the FDA for 350 million dollars essentially with the Pediatric Disease Priority Review Voucher (PPRV) incentive program. We are starting to see some of those ripe apples on the Kevetrin apple tree. The voucher is received upon approval of application.
About the Rare Pediatric Disease Priority Review Voucher Program
The program is intended to encourage development of new drug and biological products for prevention and treatment of certain rare pediatric diseases. A PPRV may be issued to the sponsor of a rare pediatric disease product application and would entitle the holder to priority review of a single New Drug Application or Biologics License Application, which reduces the target review time and could lead to an expedited approval. The sponsor receives the PPRV upon approval of the rare pediatric disease product application and it can be sold without limitation.
- See more at: http://cellceutix.com/cellceutix-requesting-meeting-with-fda-on-kevetrin-for-pediatric-retinoblastoma/#sthash.rF0vBMrr.dpuf
The time consuming 3+3 trial design was not needed in the final cohort
???
In cancers that had no other treatment options with end of life scenarios and Kevetrin is not even optimally dosed yet! With an elimination half-life of ~2 hours Kevetrin should make for some interesting advanced trials.
I see our thymoma patient started in cohort 8 with dosing starting at 350 mg/m^2. Dosing started ~June 16th 2014 for this 48 year old male. The 5 year survival rate for stage 4 thymoma is ~45% but we don't know how long he has been at this stage before entering the trial.
With a high response rate p21-wise in the two prostrate cancer patients that started out in cohort 2 and 4 with initial doses starting at 30 and 75 mg/m^2. One wonders how well this group will be explored in this phase perhaps they entered a few new prostrate cancer patients in the final expanded cohort.
I said a few years ago that if they could come out of the phase 1 with 2 or 3 strong leads I would be very happy! Looks like we will get that and it will be interesting to see what comes of Harvard's renowned tumor mapping abilities.
Its been clear for years, based on comments from the company, that Kevetrin's dosing frequency needs to be increased making more advanced trials very interesting. Kevetrin has not lost any of its massive potential during this 3 year phase 1.
As a long-term holder I am very happy just to have this darn phase 1 end!!! And apparently quite successfully!!! I suspect ovarian cancer will not be the only indication for Orphan drug status.
p.s. Leo emphasized reviewing this year's ASCO poster in today's PR so I did and theses are my thoughts.
http://cellceutix.com/cellceutix-clinical-trial-of-anti-cancer-drug-kevetrin-entering-eighth-cohort/#sthash.paHiTiku.dpbs
http://cellceutix.com/wp-content/uploads/2014/06/A-phase-1-dose-escalation-safety-pharmacokinetic-pharmacodynamic-study-of-thioureidobutyronitrile-a-novel-p53-targeted-therapy-in-patients-with-advanced-solid-tumors..pdf
http://www.cancer.org/cancer/thymuscancer/detailedguide/thymus-cancer-survival-rates