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I appreciate the input from those in the area. I guess we need to hope for the best, but be prepared for the possibility of a month or two delay. Just because some robust individuals have weathered the storm, does not translate into those with illnesses being as resilient to overcome the hurdles of Mother Nature. Receiving cancer treatment is not as simple or easy as driving to your local take-out and picking up fast food. There are many pieces to the puzzle and strict protocols and time lines where if there is potential for delay and possibility of not being able to collect samples at appropriate intervals, it may get postponed. I personally work at a busy trauma hospital in The New York area where we have seen many procedures and surgeries get postponed due to the weather - it is simply the nature of he beast. As I said previously, I am confident that kevetrin will have its time to shine in the sun.
Anyone from Boston want to comment on the recent weather winter storms and its impact on the roads and travel in the region?
I raise the issue because I would speculate that this may cause an unanticipated delay for cohort 10 as it relies on brave cancer patients having the energy to fight the storm.
You can't fight Mother Nature, and kevetrin will have its time in the sun in the near future:)
Sounds like the IND B-OM made a nice impression:)
I can confirm that there are many in the medical and scientific community very excited about B-OM, besides for the ABSSI trial results, news of the phase 2b for B-OM trial patient enrollment can carry us above and beyond $3.00.
As I mentioned in previous posts, I am both a physician and researcher in a large trauma center in the northeast.
Similar to the IND for prurisol, where if there was no FDA concerns, we were able to start trial after 30 days, same may be true for Brilacidin-OM, and we may be seeing that trial potentially start after 30 days as well.
Similar to the IND for prurisol, where if there was no FDA concerns, we were able to start the clinical trial within 30 days the IND for pry the side in OOM
Just a thought...
Now that patent dispute has been resolved over kevetrin, I am hopeful that updated kevetrin information will be more forthcoming to the public.
In contrast to the speculation on this message board of late that it was Dana Farber forcing a lid on information.
Above is my own speculation, I welcome any additional thoughts and discussion...
Excellent post Tails, I very much agree, this patent dispute has seemingly been resolved relatively quietly without it
Your point is well received, and I would agree that daptomycin is not often used in the Perioperative period, as it's use is often reserved for the sickest of patients with pathogens that are resistant to multiple antibiotics. Vancomycin, is more typically used when indicated in the Perioperative period.
Orthopedic surgery as you mentioned, and I would add cardiac surgery with prosthetic valves, implantable pacemakers or any similarly implantable devices may certainly benefit from a superior antibiotic offering prophylactic antibiotic coverage.
However, cefazolin (as you correctly mentioned a first generation cephalosporin) and others noted requires redosing at 4 hour intervals, perhaps one day be better replaced by a drug such as Brilacidin if it truly is able to be instituted as a single dose offering better compliance, less drug resistance, wider antibiotic coverage (gram positive as well as gram negative microbes), and safe side effect profile.
Yes, prior to virtually every surgery, prophylactic antibiotics are given, with the most common one being cefazolin (2nd generation of cephalosporin class).
If Brilacidin can prove itself to be drug resistant, minimal side effect profile, single dose effectiveness for wide array of microbes; it may at some point be considered very useful for prophylactic use prior to surgery.
Obviously, that would translate into billions of dollars in revenue for that indication alone.
September 9th.....
R&R conference and apple iPhone 6 unveiling, both basically just one week away.
Both events will be monumental and a day to be remembered...
R&R just 2 weeks away....
Dear fellow CTIX followers, today is certainly an exciting day and milestone for cellceutix and it's shareholders.
We have now really solidified prurisol, our third drug in clinical trials, as a potential blockbuster.
Moreover, with the news of orbactiv receiving expedited FDA approval, I am even more excited about the future of Brilacidin.
With brilacidin vs. orbactiv, we simply have a better mouse trap, and in due time I am confident that the market and scientific community will understand and respect that.
For those that appreciate a bit of logic: daptomycin is an improvement over vancomycin, Orbactiv is an improvement over vancomycin, and finally brilacidin is an improvement over daptomycin. Thus, daptomycin is an improvement over orbactiv, hence my comments of a better mouse trap.
As a clinician that works at a large trauma hospital in the northeast taking care of patients in a critical care setting, as well as my scientific background in neuro-immunology, I can attest that it so rare to see such promise from a small biotechnology company.
I have been following CTIX consistently over the past 3 years and with its past accomplishments in place, I have no doubt that the next 3 years will be even more exciting and revolutionary.
Gram staining (histology) is used as a very general classification for Bacteria.
Based on the characteristics of a bacterial cell wall, the staining is either considered positive or negative.
Ebola is a Virus.
Nice CTIX news today:
I guess that partially explains why there was limited progression over past few months to move forward on brilacidin for eye, ear, and foot indications.
Honestly, I did not fully realize that
Brilacidin was not stable at room temperature and that was a temporary limiting factor moving the platform forward.
Although, today's news is unlikely to significantly move share price in the very short term, but nevertheless, it's good to know further overall progress and continued advancement of pipeline remains a very strong priority.
In response to big kahuna who apparently was not able to read between the lines of my previous post, I am forced to elaborate.
I was not at all trying to say that psoriasis was a side effect of abacavir treatment.
On the contrary, abacavir (or better yet prurisol - which is pharmacologically similar to abacavir) may possibly be a cure.
This may be hinted by a possibly lower prevalence of psoriasis in patients taking abacavir to treat HIV (0.2%) in comparison to the general population (2-3%). See my previous post as to site reference and limitations on speculation.
I am optimistic and hopeful regarding the future of Prurisol as a top of the line treatment for psoriasis - both as a physician/ scientist as well as a cellceutix shareholder.
Disclaimer: I am long CTIX and have been a follower for over 5 years
In anticipation of the completion of the current prurisol trial, which hopefully will be announced in the near future, I decided to google "abacavir+psoriasis."
Interestingly, one of the top hits (ehealthme.com) has a recent report regarding side effects that have been reported by patients treated with abacavir (typically HIV patients). Of note, only 0.2% of patients on abacavir reported psoriasis. However, the prevalence of psoriasis in the general population is significantly higher at 2-3%.
In regard to the above mentioned, I do not have access to how the data was collected and whether more patients taking abacavir have psoriasis but did not list it as a side effect - so caution is very much advised regarding speculation.
Nevertheless, this may be a hint that abacavir, or better yet, cellceutix's prurisol is efficacious in the treatment of psoriasis.
Thus, I am very much looking forward to a future proof of concept and/or phase 2/3 clinical trial prospectively looking at efficacy.
I would like to comment regarding an issue of contention on this board over the past few months regarding who is paying for phase 1 kevetrin trial.
Although, I do not know any details of the arrangement between cellceutix and Dana Farber, based on my general knowledge and experience as a clinical physician/ scientist, I offer an opinion.
I think both sides of this argument are partially correct. Cellceutix is definitely paying for this trial, but the cost of this trial (being performed at one of the best cancer institutions in the world) is actually very inexpensive relative to a trial being done more privately at a study site designed specifically for clinical trials.
Private Clinical trial sites are a business where compensation is expected for their work. Thus, you may have more personal control/ direction in comparison to a study at an academic center. In contrast, academic centers are seeking to answer scientific questions to better humanity.
There are numerous advantages and disadvantages to doing trials via either route - many of which have been discussed at length over past year - so I will not elaborate on that at the moment.
In the early stages of cellceutix, prior to aspire, when clinical trial funding was a bigger issue than today, we were actually very fortunate and privileged to have the kevetrin study accepted at an institution such as Dana Farber - let's not forget that.
Excellent point sox.
NIH awards are extremely competitive and are given out only to prestigious organizations with cutting edge and superior technologies.
This is certainly validation and will likely pave the way to further successes via collaboration and ultimately drug approvals with positive trial data.
Today's PR was actually very informative and exciting - especially for those with a medical and scientific background. We have access to the scientists that created brilacidin, who truly understand its vast potential, while being funded by prestigious NIH grants.
Fox Chase Chemical Diversity Center, Inc. Pennsylvania Biotechnology Center
Dr. Richard W. Scott, Vice President, Research
Dr. Scott has spent over 28 years in the pharmaceutical industry and has extensive experience in multiple disciplines including microbiology, anti-infectives, acute coronary care, neurobiology and animal model development. He began his career as a Principal Investigator in Central Research Development at E.I. Dupont deNemours and then moved to Cephalon, Inc. in 1991 where he held positions of increasing responsibility prior to becoming Vice President of Neurobiology. He led groups involved in recombinant expression of target gene products, establishment of transgenic and gene-targeted animal models of neurodegenerative disease processes, and drug discovery in signal transduction pathways.
In 2002, he co-founded PolyMedix, a company focused on the development non-peptidic mimics of the host defense proteins for infectious disease and cardiovascular disorders. He led the research team responsible for the identification and selection of the clinical lead compound, brilacidin, that successfully completed a Phase 2 clinical study for treatment of acute bacterial skin and skin structure infections (ABSSSI) and identified a potent antagonist of heparin and low molecular weight heparins (delparantag) that also reached Phase 2 clinical study. Additional programs in the research group that were supported by grants from the NIH, NSF and Departments of Defense included the development of antimicrobial mimetics for treatment of Gram-negative infections, oral and disseminated Candidiasis, malaria and food-borne infections. Dr. Scott is an author on over 67 peer-reviewed journal articles and book chapters, and is an inventor on 8 US patents.
Phase 1 is usually done on healthy patients!! Usually small group of patients just to show safety.
This prurisol study if had been done on psoriasis patients, would likely not be enough patients to show statistically significant efficacy!!
These are often not easy decisions and only hindsight is 20/20.
Regardless, going forward with prurisol for phase 1 in healthy patients - I think is the correct choice, for quick and easy study allowing quickest path for eventual drug approval!!
Contact your broker, I believe shares can theoretically be purchased on the open market, however, there needs to be a seller for you to be a buyer, liquidity may be an issue for next several months.
I forgot to mention in my previous post that Ancef (Cefazolin) has a 10-20% incidence of allergic reactions in those patients that are allergic to penicillins, and is therefore usually not given to those patients.
The alternative is usually Clindamycin, however, there is a known risk for possible C. difficile-related pseudomembranous enterocolitis.
Once again, it would be nice having a safer alternative that has long lasting and effective coverage with only one dose, such as with Brilacidin.
If the only side effect may be some arm tingling - I am sure the patients would not even notice, specially if given some anesthesia concurrent with their surgical procedures.
The above is merely based on my own speculation and experience. I am a clinician with dual degrees in both medicine as well as immunology and work in a busy trauma hospital in the Northeast.
I think Brilacidin based on its PK/PD and extensive coverage against skin flora may have the potential to be a superior drug to Ancef.
Brilacidin may perhaps be the drug of choice given prophylactically prior to every single surgical procedure worldwide!!
Currently, an antibiotic called Cefazolin (Ancef, Kefzol), is prophylactically given prior to the start of almost every single surgical procedure to prevent surgical site infections (SSIs).
[Cefazolin is a first-generation cephalosporin that arrests bacterial cell wall synthesis and thus inhibits bacterial growth. This antibiotic is routinely used as the prophylactic drug of choice becasue it is primarily active against skin flora, including Staphylococcus aureus, and therefore a logical choice to prevent SSIs. Typical dosing is every 4 to 6 hours due to the pharmacodynamics and pharmacokinetics of the drug.]
I raise the above points because as a clinician treating patients in the peri-operative, I am always hopeful that a better "Ancef" is coming our way.
With the current trial of Brilacidin already underway, I am extremely excited and optimistic that this new drug may have potential and uses that far exceed many of our wildest imaginations. The market potential can be truly astronomical!!
As always, I am LONG CTIX!!!
Looks like trials are possibly being run in California and Las Vegas, based on google search of the listed names of the clinical investigators on clinicaltrials.gov
Glad to see trials are being done in USA by board certified emergency medicine physicians.
Once again, management has shown they are committed to their products and are doing quality clinical trials!!!
Excellent trading day, a close above $2.00 with average trading volume of ~200,000 shares!!
Why are we wasting time talking about BOD?!?
If we had a BOD, that may have prevented us from acquiring B and the rest of poly assets.
Our strength is the ability to act swiftly without the typical corporate slowness.
We eventually will need a BOD, but in due time, current management may realize it's not in our best interest at this stage - they have been steering us very well - let's keep the faith!!
Right now it's all about the trials!!!
I am LONG and ALL in CTIX!!!!
Can anyone please comment whether it would be easier for cellceutix to develop a partnership before uplisting, i.e. less paperwork/ red-tape / regulatory approvals!! Perhaps, we are close to a partnership!?!
I have attended many scientific/medical conferences in the past and have always found it a good forum to find out cutting edge information.
Even if we don't get all the information we are hoping to hear, rest assured that new investors as well as big pharma will be on the prowl and are experts at understanding future potential.
Further, even if we don't get immediate bump in share price, investors will be keeping CTIX on their watch list ready to buy, pounce, and grab your shares when the timing is right.
We are lucky to have gotten in early at a very much discounted price - the risk and faith we have all taken will be very much rewarded down the line.
Today will be a historic day for CTIX even if we don't appreciate all the news and events at the moment, hindsight is always 20/20, stay the course!!!!
I am LONG on CTIX and have been a follower for over 3 years and appreciate the efforts of all those on this board!!
Over the past few years, I have been increasingly comfortable increasing my position as CTIX expands their pipeline, making my investment less risky with the chances of successful product(s) exponentially more likely.
Although, I am not expecting a full out buyout of CTIX in the very short term, which may be very enticing for many of the desperate large pharmas out there that have been unsuccessful with their own R&D, would a $2 Billion price tag be unrealistic for a company with so many potential drugs in clinical trials with such large potential profitable markets?!? Moreover, a $2 Billion price tag would translate to approximately a $20 per share price.
Perhaps, it is time we all get together for a group deal on some good tax/estate lawyers!!!!
Good luck to us all in 2014!!!
Dr. Jerry, I am also Long on CTIX, have been a follower for over 3 years, have accumulated a very substantial position.
Over the past few years, I have been increasingly comfortable increasing my position as CTIX expands their pipeline, making my investment less risky with the chances of successful product(s) exponentially more likely.
Although, I am not expecting a full out buyout of CTIX in the very short term, which may be very enticing for many of the desperate large pharmas out there that have been unsuccessful with their own R&D, would a $2 Billion price tag be unrealistic for a company with so many potential drugs in clinical trials with such large potential profitable markets?!? Moreover, a $2 Billion price tag would translate to approximately a $20 per share price.
Perhaps, it is time we all get together for a group deal on some good tax/estate lawyers!!!!
In patients experiencing severe systemic bacterial infections - sepsis - it often leads to septic shock - where patients may experience - severe HYPOtension requiring powerful medications to artificially raise the blood pressure (pressors). I wonder if "B" was so efficacious that it resolved their septic shock by eradicating bacterial infection before the physicians had a chance to stop
the infusion of pressors!! Regardless, as a clinician that has dealt with patients experiencing sepsis - I am always much more concerned with hypotension (decrease perfusion and oxygenation to vital organs - brain, kidneys, extremities) than hypertension, which may actually be a beneficial side effect!!!! I was LONG before the acquisition and now I am LONG and EXCITED!!! Keep the good news coming!!!!
I am trying to get a feeling of how the insiders themselves are feeling regarding this stock, but cannot seem to find the info on yahoo finance or this ihub regarding insider transactions - anyone want to shed light?