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They said we could expect start of Staph-aureus trial this half -ph1 trial at Walter Reed for multidrug resistant strains of StaphA, including MRSA - which looks likely since they got the cGMP for their manufacturing facility. Nebulizer bacteriophage treatment (001) for P aeruginosa infections in patients with cystic fibrosis - first human trial expected 2016, don't know which half though. Preclinical for c-dif should finish by end of 2015 - hopefully ph 1 start within a year but have not heard goal date set by company on that yet.
They have dramatically picked up speed in reaching the goals of the new business plan constructed by the clean-up team. Likely to be a fairly common name in biotech within a year and this time next year there will be 2 active human trials going with the 3rd close to starting or active also.
Bucc, the post I wrote just before this one gives my thoughts about your question. Good luck.
Probably a few of us will be joining you!
I know what you mean! Day to day can be so disheartening - but nothing in the company's narrative has changed/become negative so investment thesis intact. Long term outlook good, even excellent. Tough to really visualize that in the face of these serious dips though!
Wish I could answer confidently. Depends on when most recent ALS study will be journal-published. I think they're in study results quiet until that happens and thus can't elucidate on details that would answer investors questions about responders and nonresponders. If no publication near - then the prolonged quiet will bring it down more...
Lots of disappointment re lack of MRI data - which we were never going to get today anyway. People not understanding what a shelf is believe we're soon to have a $200mil dilution. People believe reference to Trimesta cognition study means no ability to partner until that study's resolution. Gods. I could go on and on. Confusion on part of so many longs is spoon feeding content areas to bashers - and they will prey upon this confusion.
On the other hand - sounds like all is well. UCLA dragging their feet - have no idea how Riley deals with that frustration.
004 going well. Very well. Results highly consistent if he is confident they won't need original number of patients planned. 010 ph2 up and running. Expansion with PKU enzyme candidate is smart and frankly brave. This company doesn't plan to stay small and they maintain pipeline cohesion with this new addition. Future looking good imo.
If results are positive at all and show no risk/increased harm to nonresponder pool, this will shoot up dramatically.
$CUR is almost back to my original buy in price. Never thought I'd see that day! Bonus with being long long = active trading around core will lead to riding free shares - even for those of us who aren't skilled traders. Nothing will improve here until questions around ALS study are answered. Possible harm to non-responder cohort much too large a question to attract new $.
it'll shoot right up on news. Path has been made for an excellent spike and higher lows. Getting there...slowly. But pace for next 12-18 months will be much faster than pace so far. Guaranteed fun!
Same here. Happy with any buy under $3!
able to grab a little more on good dip today.
It's going to take prolonged period of no news. I won't hold my breath! But I'll be watching very closely. :)
That's alright. SYN is still early, early. But not for long - as they have 2 agents that will complete ph2 and 3s with unusual speed.
You do make me laugh! My kids often think I am the darkness!
Nice!
Love that post apollo.:)
This will be fun ridin! Another babybio with new team and new business plan who have the skills to take this science forward. We are going to have a blast!
The potential market for the generic Copaxone is reason enough for Pfizers interest. But it is interesting as hell to consider the ramifications of this move and the potential for solid competition for Trimesta. Would certainly be nice to see this move end up being related to SYN. Doesn't need to be for Pfizer to reap huge profits with generic Copaxone though. You're absolutely right - they'd be perfect partner. Or - their buy of US commercial rights might spur Teva to try to hold onto partial label market by acquiring sub-licensee patent rights for combo - which would keep label for this slice of market intact and without generic threat for years. Pfizer might have just upped ante here. Hope so.
There they go - just as they said they would. Company clean-up being well executed! I will buy post r/s, when initial enthusiasm dips and sp dips with it.
Well - can't do a dose comparison between these 2 agents because they're too different. Also - a comparison of efficacy can't be done for the same reasons. There is no commonality between the 2 trials so success or failure of one has absolutely nothing to do with the other. The 3 biologically active estrogens - E1(estrone), E2(estradiol), E3(estriol) - do play many different roles (as well as some shared) in the body and create different metabolites when taken orally.
To make any comparison relevant, a study would need to be constructed with 3rd arm of oral estriol treated women with goals and measurements comparing cognitive effect between the 3 arms. Or - to keep it really clean - 4 arms - both oral and transdermal estriol arms with the oral and td conjugated arms the KEEPS used, all arms receiving active treatment for same number of days, etc...
Anyway - my point is just that KEEPS has nothing to do with Trimesta trials and no inferences made between the 2 are valid.
http://www.ampliphibio.com/news.html
July 30th 2015
AmpliPhi to Present Research on Efficacy of a Novel Bacteriophage Cocktail in S. aureus Lung Infection Model at ICAAC/ICC 2015
Category: Latest News
AmpliPhi to Present Research on Efficacy of a Novel Bacteriophage Cocktail in S. aureus Lung Infection Model at ICAAC/ICC 2015
San Diego and Richmond, VA, USA, Ljubljana, Slovenia, and Sydney, Australia, July 30, 2015 – AmpliPhi BioSciences Corporation (OTCQB: APHB), a global leader in the development of bacteriophage-based antibacterial therapies to treat drug resistant infections, today announced that data comparing the efficacy of its bacteriophage cocktail to vancomycin in a Staphylococcus aureus lung infection mouse model will be presented at the joint Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) and International Congress of Chemotherapy and Infection (ICC) 2015 meeting, September 17-21 in San Diego.
Karen Joy Shaw, Ph.D., AmpliPhi’s Senior Microbiology Consultant, will present the data in a poster entitled ‘Efficacy of a Bacteriophage Cocktail in a Staphylococcus aureus Mouse Pneumonia Model is Comparable to Vancomycin’ (F-274) as part of the poster session ‘New Agents and Approaches Addressing Gram-Positive Pathogens, including Mycobacteria’ on Friday September 18 at 12pm in Exhibition Hall F.
tp - that was not investigative journalism. It was hack. The writer gave no evidence that he is aware of the significant change events that have occurred in the past year. He refers to promises made by a long gone CEO 3 years ago. Gotta ignore the bash - especially when it's so poorly done. Company has potential for a great future now. I'll be watching closely for the next year to see how they do with the cleanup - esp the financial cleanup. And when this team provides that evidence of follow thru and excellence of management - I'm in. They have some radical therapies here. Gamechangers. And another company is one step ahead in formulation of phage tech with different biomass targets. In this emerging phage field - second is a good place to be. With any brand new tech - work with FDA during trials and refining to lower risk profile is really challenging. Opinion only - but in such a scenario, I prefer someone else to clear the path, making my process more efficient, less expensive. Also - if someone else clears the way with a successful product - usage and efficacy is already in the minds of many clinicians. A readiness exists that isn't present for the company that reaches finish line first. They get stuck introducing the entire new technology field to the medical world. It's a huge undertaking - as hospitalists and pcp's have little time to learn the new and prefer, for safety reasons, to work with the familiar. When APHB is ready to market - the entire concept will have much more familiarity in the mind of the average clinician (though it will still be quite new). Huge advantage.
It really is an excellent technology. I take nibbles at it too - now that new team in, should be slow, steady grower. A lower risk investment than most of this sector - but also won't provide any kind of dramatic overnight spike. Which is fine with me. A bit boring...but fine.
What a great read!!! Thanks for posting that story.
Hi Citrati,
I didn't see your response before posting mine. But you did confirm my post as I said 'everyone who knows me here knows SYN is my favorite!'. And IDRA next in line. :)
Thanks for the kind words Citrati!
You've done great with Pieris already!Nice!
Everyone who knows me here knows that SYN is my favorite little bio. Management and pipeline excellent. Like the long term potential of IDRA. In CYNAF for relatively quick buyout potential. Long in CUR - but stem cell risky, risky and I'm riding free shares there. Would never rec for buy-in now - need too much detail on recent ALS trial first.Long MRIC. Got in after management change - like SYN. Will be slow grower. Its my device holding. Waiting impatiently for new management team of APHB to complete reverse split then I will take position there as long.
Good luck!
Thanks Citrati!
And I am still deeply in your debt. Your charts and explanations have helped me immensely! And they continue to do so. I am grateful to you.
The impression many of us have received is that it was Zacks, more so than Jason, who called CUR undesirable after trial results came out. And his 3.50 is in the ball park. That's his worth estimate for today - with modest success for 566 and 189. Obviously - significant success would elevate this estimate and failure would decimate it. Given the unknowns that will persist related to 566 trial until it is published - his estimate holds appropriate caution.
C - they dropped the marketing ball after approval. They have a big product - covers entire suite of this MRI add-on tech. Computer programs/biopsy guides with frames, drapes, and the surgical equip specially fitted for the system, etc..So - its a big investment for any hospital and requires much staff training. Train surgeon to procedure, MRI tech to software program, OR tech to set-up. Advantage of increased safety and accuracy in multiple procedures indisputable - but obviously sales need real investment in marketing and that's where they totally failed. Once a hospital buys, the company has recurring customer as procedural tech (which is diverse) is done with multiple single use items - assisting in infection control and requiring ongoing resupplying by hospitals.
So - last year they cleaned house. Replaced CEO in Oct. New VP marketing early Dec and 10mil private placement 2 weeks later! New CFO this March. Closed their TN offices - as they needed to - they were paying admin salaries and getting nothing in return. Now that money goes to marketing including a push to get slots in multiple medical conferences - which was not priority with old management. These guys are not kidding around. They have made marketing a priority - finally - and we can expect things to pick up from here on out. It's a big undertaking. Once this tech is adopted by a hosp - this is what they use. Too expensive to change out in a few years.
This will continue to be a slow grower, but it should experience steady growth now that a good team is leading. Its cutting edge and updatable tech that works with the current MRI systems hospitals have already invested in - so MRIC designed a huge technology improvement assist for a machine that most hospitals in our country have. Slow and steady until it becomes preferred standard of care is best outcome and I believe that is quite possible. But not for a few years of consistent marketing push.
Just answered. Now going to N Conway to chill out on one of their beautiful lakes. Have a great weekend!
ya. This management team are an amazing group. Sharp as...anything we'd want them to be sharp as. I think they're the best team out there right now - in the baby biotech world.
Reading that makes me smile and want to laugh maniacally!!!!!
Thanks C!
Hi C. I'm a buyer, slowly. Good pipeline. Good preclinical data. Early still - but already improvement on the field. I'm all about next gen protein tech right now. Early tech in the field produced limited, overly specific agents with significantly higher risk of provoking undesired immune responses but enough time has passed and the newer tech touches diverse targets/diverse diseases with minimal to no unwanted intrusion, decreased to negligible undesired immunogenicity. Cheaper to produce. Safer. Expanding treatable disease targets. I like the company. Good management. They execute. Good financial management. Part of their pipeline development was comparison based against other therapeutic protein technology and against monoclonal antibody tech. They id'd very detailed weakness of both and created preclinical and clinical goals which included measuring performance of their tech against the others, getting very specific in outperforming in the identified trouble areas. Smart use of the weaknesses of technologies that are bringing in a ton of money right now. They want to prove from the opening gate that theirs is refined, new, safer. They'll need to do this in order to loosen the hold monoclonal antibodies have on the market.
I'm buying in the 2.50s for as long as I can. Do think we'll have a couple of dips there over next few weeks.
Also - buying AVXL for same reason. Protein tech. Corrects protein misfolding errors which are associated with countless dread diseases. Spike today on good news but it'll float back down. Watching for Treventis to go public. Protein folding correction tech targeting many brain based diseases but also has developed a system that id's and constructs models of misfolded protein structures in order to screen new protein drug candidates for perfect structure based design. Everyone will want this, including Pieris.
That's it for now C!
Take care!
It's about time!
I still scoop it up on dips C. Eventually - IDRA will be quite a success story.
You mostly ignore it until ALS trial publication comes out. :)
So, they were direct with you re those goals of not going to market, maybe only wanting to go thru ph2 and have someone else pick up ph3. Interesting!
And you're right - as usual - lets get to $5 first!
A few months ago, I noticed specific wording in their 10-Q that really intrigued me. I'm all 8-Kd out right now so just can't bring myself to find the exact paragraph (it is in one of my old posts here though - probably around same date of 5/11 10-Q release). Anyway - I interpreted the wording to indicate a plan to sell SYN before pipeline goes to market. They have 2 leads that have a huge market waiting for them. If they went thru dvlpmnt and marketed well - I think 70 reasonable. (I never count trimesta in these pipeline projections). But if they sell after 004 and 010 are more mature but not yet on market, I think we'll get less.
Very nice. Thank you.