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You're right. Events update as opposed to pr. So update not sent to investors - just listed on their site. http://www.syntheticbiologics.com/index.php?s=19&item=88
It's not a platform for release of any new news. I've been curious since they put out the pr. Have put much thought into it. Why 'latebreaking' preclinical? This isn't new. Before they released the slides I compared authors names to the preclin work in SYN site and could see it matched those of last preclin poster presentation....So why bother?
Stirring the pot. They're stirring the pot. Throwing out teasers, trying to capture interest of investors before pr'ing trial results. Once again - the only reason I can come up with for this is a psychological one. Good marketing. Creating desirability to heighten sp rise on trial news.
But...fwiw...I think many newbies have received the impression that Sunday is a scheduled results release session and its possible we'll see an sp dip on Monday morning with some disappointment selling.
I've actually put some thought into that in regards to APHB. I've wondered if - when this company releases a preclinical pr - investors are reminded of how very early in its development this company and its pipeline are - causing emotional dip of disappointment/impatience. My theory may have no basis in reality whatsoever - but its all I could come up with to explain such perplexing behavior.
Here's another step forward Someconcerns:
http://www.ampliphibio.com/news.html
September 18th 2015
AmpliPhi Announces Data Demonstrating Efficacy of a Novel Bacteriophage Cocktail is Comparable to Vancomycin in S. aureus Lung Infection Model
Category: Latest News
Results presented at the Joint Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) and International Congress of Chemotherapy and Infection (ICC) 2015 meeting
San Diego and Richmond, VA, USA, Ljubljana, Slovenia, and Sydney, Australia, September 18, 2015 – AmpliPhi Biosciences Corporation (NYSEMKT: APHB), a global leader in the development of bacteriophage-based antibacterial therapies to treat drug-resistant infections, today announced experimental results highlighting that its prototype bacteriophage cocktail demonstrated comparable efficacy to vancomycin in reduction of Staphylococcus aureus (S. aureus) in a murine lung infection model. Data from this study, performed in collaboration with the Hearts Consulting Group and the University of North Texas (UNT) Health Science Center, were presented at the joint Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) and International Congress of Chemotherapy and Infection (ICC) 2015 meeting, taking place in San Diego from
September 17-21.
“We are encouraged by these positive results, which demonstrate comparable efficacy between our investigational bacteriophage therapy and a standard of care therapy like vancomycin for S. aureus infections,” said M. Scott Salka, Chief Executive Officer of AmpliPhi. “These data provide valuable insight as we continue to evaluate and optimize an effective phage-based therapeutic cocktail for combating S. aureus, a potentially lethal bacteria that has demonstrated widespread resistance to
traditional antibiotics.”
To assess the in vivo efficacy of bacteriophages to treat lung infections, neutropenic immunocompromised (ICR) mice were inoculated intranasally with S. aureus. At two hours post infection, scaled dosing of the bacteriophage cocktail was administered intranasally to three dosage groups (50 µl; n=5 for each group), with a second identical dose administered at six hours post infection. Vancomycin was administered subcutaneously at two and six hours post infection to a fourth, positive control group. Two control groups were infected, but untreated. The groups treated with the bacteriophage cocktail at the two highest doses (1 x 109 and 1 x 108 PFU per phage per dose) showed a 3-log reduction in bacterial cell counts relative to untreated controls at the same time point, which was comparable to the efficacy seen in the positive control group treated with vancomycin.
“These results further validate bacteriophage therapy as a potential solution for treating bacterial infections and represent an instrumental step in determining optimal dosage levels,” added Salka. “S. aureus is a common, hospital-acquired opportunistic pathogen that can cause serious, and sometimes antibiotic-resistant, infections. Combatting this unmet medical need will improve patient outcomes and alleviate an enormous burden on the global healthcare system. The need for alternative treatments for drug-resistant infections has never been more evident. It is critical that we continue to investigate novel antibacterials and accelerate their development
and commercialization.”
The poster presented by AmpliPhi will be available on the Company’s website at www.ampliphibio.com.
You too C!
Wow! That happened? That is great!
Thanks C!!!!! Hope you enjoy this idra run!
Nice. My thanks to both you and Biohunter.
To say biotech looks like bipolar is probably mild. At its worst, it looks absolutely schizophrenic. :)
Oh well! This last quarter should lift the mood of SYN investors. It will be news active.
growing pains. spurts of serious activity followed by long, quiet sleep. follows the diurnal pattern of most adolescents. looks bipolar even though it's in healthy norm. early stage biotech - not for the faint of heart!
No wish to jinx PIRS but I was thinking its hitting 2.50 again quite soon! Right before I read your post, I was seeing what I could shift around in my biotechspec acct to take advantage of that! Not enough mobility there right now as I bought some noncore IDRA yest to sell on the next anticipated run-up....hopefully those trading around the core profits will help me build up here - but the 2.50s may be over by then. sigh.
boy! Wouldn't I love that! Well - wouldn't we all love that!
http://www.ampliphibio.com/news.html
AmpliPhi Biosciences Announces Appointment of Alexander Gaidamaka as Vice President of Chemistry, Manufacturing and Control
San Diego and Richmond, VA, USA, Ljubljana, Slovenia, and Sydney, Australia, September 2, 2015 – AmpliPhi Biosciences Corporation (NYSE: APHB), a global leader in developing bacteriophage-based antibacterial therapies to treat drug resistant infections, today announced that Alexander Gaidamaka, Ph.D., D.V.M, has been appointed as the new Vice President of Chemistry, Manufacturing and Control.
Dr. Gaidamaka brings extensive experience to the Company, with over 25 years in the life sciences sector. Prior to his role at AmpliPhi, Alexander served as CEO and CSO of Personalized OncoTherapeutics Inc. He has held executive R&D, product development and quality control roles at Pharma Green LLD, Merial, Sanofi Pasteur, Bioniche Life Sciences Inc. and Biopharm JSC. Dr. Gaidamaka was also previously head of the Department of Immunopharmacology & Allergology at the All-Union Research Institute of Drug Chemistry and Technology, Ukraine. He received a Ph.D. in immunology and microbiology and D.V.M from the Kharkov State Veterinary Academy, Ukraine.
M. Scott Salka, CEO of AmpliPhi Biosciences commented on the appointment: “As we drive our bacteriophage-based pipeline towards clinical development, we are expanding our senior team to add certain critical skills. Alexander brings decades of experience and leadership to his role of overseeing the compliant manufacture and quality assurance of our phage-based therapeutics. We are delighted to welcome Alexander to the team.”
In June, AmpliPhi announced that its dedicated bacteriophage manufacturing facility in Ljubljana, was cleared by JAZMP, the Agency of the Republic of Slovenia for Medicinal Products and Medical Devices, to manufacture bacteriophages under current Good Manufacturing Practices (cGMP) standards. AmpliPhi will produce Staphylococcus aureus and Pseudomonas aeruginosa bacteriophages to be used in planned human clinical trials.
AmpliPhi is currently advancing three pre-clinical programs as therapies to treat methicillin-resistant Staphylococcus aureus (MRSA), Pseudomonas aeruginosa infections in cystic fibrosis and Clostridium difficile.
You are in accumulation mode here and elsewhere it seems. A strong and positive message to other potential buyers.
What Boo said. :)
Reading 8k in question, it looks like a solid and long term collaboration. SYN gets exclusive international patent and ip access for this technology and the tech listed is genetically modified viral construct &/or genetically modified bacteria. SYN in charge of development, commercialization, manufacturing...I think the PKU target is a good one, but the tech itself will be the gold of the investment. Years and years from maturity and I have absolutely zero idea what could be in the confidential treatment order beyond info provided in 8k. I don't imagine its anything earthshaking.
We should be hearing news on lead compound prs-080 (iron def anemia in patients with chronic kidney disease) ph1 data soon - second half 15. It'll be a nice pipeline validation. They should announce start of ph1b/2a trial for same agent soon.
Final IND studies for their inhalation agent (prs-060) likely to be announced this quarter but possibly not til next. That's never a big driver of sp for most companies. For Pieris - it's really important because with 060 they're going to validate the first inhaled anticalin poc and they already have preclinical grant with U Melbourne...060 could have huge market. So, important milestone for us but won't reflect on sp yet.
Some PRS-343 preclinical results due out this half also. That's their agent that shows promise in HER+2 tumors, with possibility of mediating a much larger percentage of HER2+ expressing tumors than any therapy avail now - as this agent may target low expression tumors as well as those higher expressing ones that currently respond better to treatment. Normally - preclinical results are fairly meaningless for any company's pipeline. For good reason - right? Failure rate in human trials is excessive even for agents that looked amazing in preclinical. But positive preclin results here might actually cause a stir - because such results will prove the ability of the agent to target both low and higher expressing HER2+ tumors - an incredible advancement.
All of this is so early - even though positive results would be important - the early development stage of each of these agents may mean sp still doesn't receive much support....
I don't think I answered your question...Jury is out as to whether or not fundamentals can hold sp if market settles more.
Thank you Boo! Here is excerpt from the Griffin's Securites update you linked:
IMPORTANT CLINICAL MILESTONES
Q1,’15 Initiated Phase 2a study of SYN-004 in ileostomy patients to assess GI distribution
Q2,’15 Initiated Phase 2 study of SYN-010 to evaluate two dosage strengths on breath methane levels
Q2,’15 Initiated Phase 2a study of SYN-004 in individuals receiving ceftriaxone and a proton pump
inhibitor
Q3,’15 Topline results from Phase 2a study of SYN-004 in subjects with ileostomy
H2,’15 Topline results from Phase 2a study of SYN-004 in the presence of a proton pump inhibitor
Q3,’15 Initiation of global Phase 2b study of SYN-004 in patients entering hospital with pneumonia
Q3,’15 Commence discussions with potential licensees of SYN-010
Q4,’15 Top-line data from Phase 2 trial of SYN-010 in constipation-predominant irritable bowel
syndrome (IBS-C)
Q4,’15 Results from non-human primate study of pertussis toxin antibody for prophylactic use
Q4,’15 Interim results from global Phase 2b study of SYN-004 in patients entering the hospital with
pneumonia
2015 Initiate development of a probiotic therapy for phenylketonuria (PKU)
2015 Preclinical development of a carbapenemase based prophylactic drug
2016 Initiate Phase 3 trial of SYN-004
2016 Initiate Phase 3 study of SYN-010 for IBS-C
Sal - Finding your posts helpful as usual. Good clarifying for me re 8k details. Appreciate it.
Thanks C! I'll watch closely!
Just a little preclinical so far. Loooong time away from humans.
A little time and a little quiet and one or two offerings and I hope to be buying in around 5.(sounds way too optimistic, I know, but I am patient). All potential based right now - have a few ph1s to get off the ground in next year - will need to issue shares to raise more funds. My hopeful plan is to continue to sit and wait and buy in with dips occurring with negative emotional investors response to offerings necessary for pipeline production. Small number outstanding shares right now will increase and sp will lower and I'll be waiting. I want a good sized position in this company. Its plenty early (imo) and I expect to have good opportunities at accumulation.
So far in the future that its not even a valid consideration in assessing company potential at this time.
Can't compare gary. Two completely different technologies. Both high risk - but imo stem cell investing is the highest risk area in an already risky biotech sector. AVXL still very early - will have cool downs in the future. CUR could skyrocket if investors like what they read when full publication of recent ALS study done - or - CUR could absolutely crash if they don't like the published info. Good luck with whatever you choose.
only a few tweets since her last blog Buc.
I've been full for a long time now.
Nothing yet to hold SYN up except ideas. C-dif and C-IBS trials too early - and proposed mechanism of action and goals for both probably a little out of the box for main street investing - who will want more maturity before getting excited. Trimesta - not going to do anything for us until a partnership is announced. Not going to be the miracle agent so many want it to be. But will offer continuous support for SYN once they show someone else paying for its development. So - while we wait for the pipeline to age a little, a Trimesta partnership should hold us above lows like this - if and when it happens.
With you on the impatience thing Citrati...
Its more likely the fda recognizes that very high number of people are on PPI's and prophylactic use in hospitalized patients still a common practice. 004 will regularly meet with ppi and cephalosporin abt combo prescribed to patients. Ppi's also increase risk of CDI, in some studies up to 65%. FDA started issuing warnings in 2013. Ppi's decrease gastric bactericidal activity by up to 50% and basically neutralize gastric juices that kill c-dif. Combine increased risk of ppi use with increased risk of cephalosporin abts and its easy to see why fda want this info. Syn-004 wont be much good to anyone if it cant function in concert with ppi's.
Increased gastric ph from ppi use likely not a concern. Much preclin done on 004 with human chyme. Wide Ph range tested, up to 6.8. Even that high, it degraded, maintained activity and stability for 6 hours. This was same for entire range. Given reliability of this type of chyme study, where they replicate exposure to hcl then to gastric secretions of varied duodenal environs (and much more), it would be highly unlikely if human trial results differed. The company studied human chyme/004 at ph much higher than ppi would cause.
Its in the duodenum that IV cefrtriaxone and other ceph abt's are released,coming in thru bile duct. This is important part of why SYN is so focused on 004 degredation in this area. It matters if it degrades in stomach. We want it to start breaking down in duod, activating as the abt is reaching duod thru ducts, both being pushed together via peristaltic waves to jejunum on. Intraintestinal longevity is really important. Those 6 hours are needed, and a breakdown in the high acid environ of the stomach would harm outcome. We'd basically have the old version, that couldn't stay active long enough to be viable.
Also, if you look at inclusion and exclusion of 004 studies so far, it looks very unlikely that a patient suffering from gastroparesis would be accepted.
I've been counting on it!
To Investor Relations,
It would be very helpful to investors researching your company if anticipated trial initiation windows were included in pipeline descriptions on your website. Broad windows are acceptable to the average investor, ie, 'first half 2016' as evidenced by the information typically provided by many biotech companies on their pipeline page. There is no comprehensive description in pr's, corporate updates or on pipeline page about estimated timing of initiation of human trials. Instead, disparate references are made here and there throughout the years communications.
Organization in accessible area of prospective pipeline timeline goals, at least for phase one studies, would be much appreciated.
Thank you,
It looks like they fixed that. Now separate columns for development, preclin, ph1&2, ph3.
So - IR may have followed thru on your email. A good sign.
That is my concern. Although, in general they have given very little info on human trial commlencment timeframes so maybe I shouldnt be surprised. The little I know was put together from various pr's and financial updates from the rest of 2015. No comprehensive summary statement regarding pipeline activity and timing. Ill try to remember to drop IR an email tomorrow requesting that. Would be helpful to have it right in their site on pipeline page.
They've communicated about it with FDA. Know 004 candidate. As far as I know - application planned after results of ph2's. But that's from recall and not fact checking. (too damn tired to do that right now.)So if anyone has evidence to contrary - it is most welcome.
yes - me too! Thanks for your always generous teaching C!
Love that! You must be a fellow bioGeek! And may the BioForce be with you too!
Thanks for that update C! I'll be buying over next few market days. Slow grower/steady burner. Good quiet biotech investment here.
And not a word about timeline for ph1's - whether they're still on track or delayed... They could have fit that in there...
Citrati. I can't think of any response to your support except thank you.
Thank you!
Boy - do I ever agree. They make stuff up and then believe it - even in the face of contrary evidence. Its painful.
You hadn't missed it Bucc. I posted it about 30 seconds before I alerted you to it.