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Bio-similars Anyone?
"Infringement rights" -- Don't know sounds more what a patent attorney or co. lawyer would worry about. Reviewers are free to bring up anything and I've gotten some doozies to deal with but they should address to the quality and originality of the work. I publish in physics, math and EE journals and most everything is so far from commercialization that such considerations never arise. My more immediately practical work is classified and never is published. Most of the papers I review lately are from China. I think they write in Chinese. pop the manuscript in Google translator and send it off. UGH!!! Thank heavens I don't have to publish or lecture in Chinese (yet).
A report regarding immunotheropy in bladder cancer and PD-1 PD-L1 should be of interest here...
http://www.nature.com/news/immune-system-offers-clues-to-cancer-treatment-1.16395?WT.ec_id=NEWS-20141202
And please stop blaming PPHM for the timing of IST publications. They have no control over when things are published. The principal author only has limited control choosing when he or she submits the manuscript. Then there is all the haggling with the reviewers. The publication comes out when the publication comes out at the discretion of the journal. Published over a hundred scientific articles in refereed journals myself. It can be a pain, both as an author and as a referee.
Yes. It was called the sequester.
"...a significant chance that M_APP pharmaceuticals, manufacturer of "Z_M-APP" is a front for an agency that need not be named" Yes just the names M_APP and Z_M-APP gives it away in my mind. Couldn't they be more creative?
So if DTRA should show up and requisition 100K files of bavi for shipment to W.Africa, what would be the implication for Sunrise? Then again should the epidemic really get out of control what would that do to the stock market and (gulp) our lives?
http://necsi.edu/news/2014/ebola-update.html
Have you ever submitted an article to a peer reviewed academic journal? We are still finalizing an article after two years. It didn't pass the reviewers at Nature and now is destined for another to be determined journal. And its good work. Some journals are very picky and some reviewers can be unreasonable. (Unless I'm the reviewer. I'm never ever unreasonable. ;->)
So current ebola prospective drugs are in very short supply and are considered risky. Bavi has shown some (modest) efficacy in animal models and is known to be safe when administered to humans.
What if the WHO or some such body (with Gates backing) would request Bavi for the epidemic?
Would there be sufficient Bavi to send to W. Africa and continue the lung trial much less any new breast or liver trials? Should the present trial be slowed down, treating those only already enrolled until supplies could be mustered for ebola? How much bavi is in the fridge? How long would it take to whip up a monster batch?
Interesting ethical questions here.
Anyone on the board with medical ethics credentials?
Microbe_man thanks for your observations. If you had been able to be present at Hutchins' presentation and were able to ask one question what would that have been?
Just wondering?
Fred
The Duke paper was eventually published just not in Nature. It can be a struggle getting things published especially in prestigious journals.
Then again it could have been that 3rd reviewer:
Sunstar
Thanks for the comment. I realize the difference between the Bavi trial and the one reported in the article. My point was that if I were a patient, novice to mabs, and in serious trouble with metastatic melanoma, I would rush to get the treatment described in this very positive article. This would tend to direct patients away for enrolling in our trial delaying the results that we all anticipate here.
I do not follow the board that closely so I hope this hasn't been reported previously:
Yesterday's MedPageToday has a very positive write up about the ASCO presentation of the pembrolizumab + ipilimumab Phase I trial. Looks like this combination may eclipse the Bavi + Yarvi IST. If I had advanced metastatic melanoma I would demand this combination. It may be hard to find patients for the Bavi trial.
http://www.medpagetoday.com/MeetingCoverage/ASCO/46159
Hummm.... I purchased a small amount of INCY years ago along with a number of other small bio-techs and forgot about them being distracted by the circus here on the PPHM board. They are all way up even after the recent bio-tech sell off. I'm green PPHM but not by much at the moment. Come on PPHM catch up and surpass!!!
dia
Thanks for that post. I'm printing it out and keeping it as a reminder of what we're about here in science.
Fred
Fargo...
I agree entdoc. I always feared that RB, SK & Co were too quick to jump on the downstream bandwagon.
I can't say I really know but my scenario would be that a BP may have been doing some research of its own on PS and wanted to get the rights to the patents. They may have approached PPHM and SK/ES said no. To gain the patent rights on the cheap they needed to force PPHM into bankruptcy. Assuming that Bavi may provide, say, a 10% improvement over SOC alone they could discredit PPHM by randomizing the scans or labels on the scans submitted to the independent reviewers in phase I lung cancer and just interchange the A and B arms in the Phase II. Thinking that the low dose 1 ml/kg Bavi result would be within the bounds of the possible for the placebo arm. (Actually PPHM had expected the low dose arm to saturate the available PS sites and work as well as the3 ml/kg arm -- as it did with some reduction in dosage due to the switching.) Seeing the literally incredible results of phase I the nefarious entity realized that their phase II scheme would not fly since Bavi was performing much better than expected. They then had the A and B arm labeling switched back shortly after the phase II trial started. They could still discredit PPHM by encouraging PPHM to assay the vials for Bavi content and discover the "error". PPHM then had to announce that an "error" had occurred in the trial vitiating the results or be destroyed by having a third party find this out.
Anybody in the know could have made out like a bandit by shorting at $5 but it is unlikely that our entity would be a party to this because it would raise immediate investigations and an unwanted paper trail. They were after big money.
This is just in my opinion only, of course.
In some fields the examiners are overwhelmed by the volume of applications. A couple of my patents took 4 or 5 years to be approved and there were no appeals. I had forgotten about them and had moved on to other studies myself and was completely surprised by the notifications.
Left the study, progressed or died. (My take on the wording).
Hey, could someone give me a link to this poster. I don't have time to sort through all these posts.
Thanks
"aikifredicist, which of the two US test sites were you referring to? "
Well as I said my memory may be faulty but at the time reports on this board intimated that clinical investigators and PPHM management were expecting stellar results for the first line open label phase II test. Of course the tenor of the remarks here may have been compromised by my our endemic hopeium.
(Snowed in again in DC -- Ugh.)
No, I don't think SK is sandbagging. They are just being prudent in controlling information flow at this partially delicate time.
(And by the way I meant "knight" not "knife" in my earlier pose. I was auto-corrected -- Ugh.)
Gene your opinion seems to be all over the map. Shall we say its evolving? ]
Everything was in the bag, papers signed, et. al. and now we need a white knife.
Possible white knife coming to rescue SK...
My memory may be faulty but at the time the front line phase II results appeared to be very good from the perspective of the doctors at the test sites. (Open label.) The final judgement was rendered by an independent group reviewing the scans who came back with equal performance in both bavi and placebo arms. It appeared to me at the time that perhaps the paperwork relating the scans sent for review and the patient identities were somehow randomized. Some actor was responsible for labeling these scans. Hummm.... I wish SK were more forthcoming with the details of the procedures in force in this test.
In most oncology trials the improvement in the trial arm is modest and a randomizing to the data with the placebo arm would not be detected. In this trial the reported placebo results were way beyond expectations. Sounds like a red flag to me.
CJ I am very sorry to hear of your loss.
We are all very appreciative of your efforts in collecting archiving all that is known about PPHM.
Our prayers are with you.
Actually 2 million miles is damn close !
Im not saying anything about Gene's predictions.
(Ok, I'm trying to read between the lines on his amusing prognostications.
Sort of like buying exactly one lotto ticket giving a guy leave to fantasize about the new Bentley and million dollar condo to go with it.)
Take two Bavi and get a good nights sleep:
http://news.uchicago.edu/article/2014/01/27/fragmented-sleep-accelerates-cancer-growth?msource=MAG10
A bit more light on the immune function in cancer.
That may be true for helping at a conference site, however much work needs to be done at the conference organizers site. I don't know if this is in the LA area or not. Also contributing staff for the conference itself may be a good move in that it would enhance the visibility of Peregrine. (See the conference webpage.)
Fellow condensed matter physicists in the DC area are called on every year to help the American Physical Society prepare for their March meeting. The APS is located in College Park, Md and thus close by. The conference this year is in Denver. The Denver registration desk will probably be manned my U Denver/U Colorado/NIST Bolder people.
Additional support:
My first guess would be that the company had people help the organizers with the prep for the meeting and maybe will contribute support personnel at the site to man the registration desk, etc.
People from my lab are often called upon to support academic conferences by sorting abstracts, manning registration desks, etc.
Personally I prefer the spongebob squarepants with thunderbolts power points. The animation was impressive but it kind of creeps me out.
Thorpe's work was funded by a combination of government and philanthropic funding. His discoveries would not have been possible without 40 or 50 years of basic research largely funded by the NIH. There is roughly a twenty year horizon between basic science and application. By defunding basic research we are short changing the future.
I often review papers for publication coming from China. Most of them are poorly researched. Their present system is not a threat. However we have trained Chinese nationals in our finest research universities. Most wish to stay in the US because of our political system and the quality of our research establishment. China is actively trying to lure its nationals back home. If the basic research environment in the US continues to to decline due to the effects of sequester we can expect that the PRC may start to succeed and substantially augment its research capabilities at our expense. This would vastly accelerated with a change in the political climate in China.
(Check out Thorpe's coauthors.)
I saw that report too. It was a very cursory look at the changing cancer treatment scene. Its too bad that PPHM was not mentioned but considering the minimal time allotted and the vast effort in immunological approaches to cancer treatment currently being pursued it is not at all surprising. He did alert the audience that the immune response is being insisted and that the old poisons are being supplanted.
His point about government funding for basic research is certainly valid. Thorpe did not cook up Bavi in his garage in his spare time. The development was funded by NIH and private philanthropy. The development would not have occurred without many years of basic research in many laboratories largely funded by the US taxpayer. (Thanks!) The sequester has seriously damaged all areas of science in the US. It is very short sighted.The fruits of that research has driven the technological revolution in this country and the world. We are loosing our lead to Europe, China and Japan.
In the near term small tech & biotech companies like PPHM can pour our investor funds into commercializing fruits of this taxpayer funded work.
Boy I wish I could sneak in to the meeting and see the poster and talk with the authors. Its just five minutes away from my lab. But those meetings are policed and non badge wearers are quickly ejected. (And I'm dressed as a physicist -- running shoes, jeans, corduroy shirt, not as MD -- coat and tie.)
3000 characters is typical for an abstract for a contributed talk/poster at a scientific conference. I've submitted many. Such presentations are generally incremental in scope not broad many years surveys of a particular area of science.
But who's willing to get to the convention hall at 7 AM already?
Will there be anyone other than the presenters there?
Thanks Bungler for your informed response.
Physics is simple, immunology is very complex. I always keep in mind that we may be blindsided by any departure from what is now known or assumed to be known at the moment.
I really dislike the processes where hopeful conjecture turns into established truth only to be crushed by further developments. This board is bipolar. we need to be patient and let things play out as they will. We are not in control of the science here on investors hub.
Hey Goat.
I truly pray that betabodies will be all that you expect but I'm a scientist and I know that Ma Nature can be a bitch. She'll lull you, beguile you, excite you and cruelly deceive you and occasionally reward you handsomely. She's the two faced goddess Fortuna of Roman myth.
Just maybe it is a good thing that unattached Bavi I exits the blood stream in a day or two. Maybe if BB's stick around our stelar record of no serious side effects will no longer hold. Maybe the immune activation will no longer work so well. We need test results and pre-clinical will not be enough.
Hey biopham I respectively believe you have flipped out over cellular magnetic fields. If you actually believe that I'd stay away from MRI machines. Regarding the sun 11 year cycle I would worry about the solar maximum sunspot activity and the prevalence of solar flares. They can fry our satellites and also fry our pathetically vulnerable power grid. Also you could worry about the fact that the earth's magnetic field is decaying and will reverse. I'm pretty sure I won't be around when that happens though. When our earth's field vanishes we will be buffeted by the solar wind and immensely vulnerable to solar flares.
Of cource as a Fed I can no loner attend much less present at any scientific conference. I had a paper accepted for presentation at the Society for Industrial and Applied Mathematics last March but that was nixed due to the sequester and now even urgent program review travel is out. Some guys were trying to go and present on their own time at their own expense but even that is not permitted. Also if you expect prompt response from the FDA you are out of luck. THeir funds are frozen and most employees are furloughed. Friends at NIH are also furloughed. THis is completely ridiculous.