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Judging from the PR Bavi probably is a placebo here. However, to grasp at straws, it is possible that there is only so much PS exposed and that 0.3 mg/kg takes care of it and no improvement occurs at 3.0 mg/kg (saturation). The difference between dosage results then is a function of the slow (weak) response of PS capping on HCV elimination and statistics.
(Though I wouldn't bet on it. -- Hmmm, I'm still invested so I guess I am inadvrtently betting on it.)
Unhappily I have to agree with DD on this. Though I would not be as definitive. Why did the 0.3 mg/kg do better than the 3.0 mg/kg? The effect does not scale with the dosage. Why no numbers on the patients achieving EVR? Could exactly one 0.3 mg/kg Bavi patient have achieved EVR at 12 weeks? Is this a statistical fluke? And, of course. saline is safer than interferon too.
(Disclosure: I still have 26k shares riding on this.)
(I would encourage pharmas to report trial failures at conferences as well as successes. The FDA should require it.)
Sorry guys, it closed today on my 134 out of 2000 share partial order at $0.88.
(total 32+160+1400+134 = 1729 out of a 2000 share order)
Nature article on early non-small cell lung cancer treatment with crizotinib:
http://www.nature.com/news/targeted-treatment-tested-as-potential-cancer-cure-1.9372
And don't forget to bring along your torches and pitchforks.
If the asm isn't webcast, can someone attend and live blog the proceedings?
Today's New York Times article on a new cancer treatment.
http://www.nytimes.com/2011/09/13/health/13gene.html?pagewanted=1&_r=1&src=se
It was a two year enrollment. Then, supposing that the Indian surgeon can teach all the participating surgeons how to properly place the cathetors, how much longer for MOS? 24 + 80 some months?
A rather odd new treatment for brain cancer:
http://news.yahoo.com/s/ap/20110415/ap_on_bi_ge/us_brain_cancer_medical_device
New competition in pancreatic cancer:
http://www.medpagetoday.com/HematologyOncology/OtherCancers/25872?utm_source=breaking-news&utm_medium=email&utm_campaign=breaking-news
Then again there is Celldex's CDX-110 which is in phase IIb for treatment of glioblastoma multiforme and showing very promising results.
BP woes from today's NYTimes
http://www.nytimes.com/2011/03/07/business/07drug.html?pagewanted=2&nl=todaysheadlines&emc=tha25
Glofho's analysis estimates the probability that one drug gets through the approval process given that that drug is at phase III. However PPHM has cotera, bavi for cancer & bavi for viral/bacterial infections.
The probability that at least one of these drugs is successful is a bit higher. Assuming the probability of success of cotera and bavi for cancer are both .66 and bavi for infections is .14 then
(1-(1-.66)^2*(1-.14))*0.35*0.8*0.55 = 0.15, i.e. (1-the probability that they all fail) times the business success factors. This is assuming that all of the cancer trials with bavi are essentially one independent trial-- the the drug acts in the same way for all solid cancers. It also assumes the bavi for infections is back at pre phase I. Both are conservative assumptions. A 50% improvement over the previous estimate.
OT: The importance of new companies for drug discovery: origins of a decade of new drugs
Interesting article regarding drug discovery and the contributions of small biotech's:
http://www.nature.com/nrd/journal/v9/n11/full/nrd3251.html
HIV immunity is all in the amino acids
Worldwide study implicates structural changes in a protein binding site
Though not directly related to PPHM, this may be of interest -- from todays Nature News:
http://www.nature.com/news/2010/101104/full/news.2010.582.html?WT.ec_id=NEWS-20101109
Phase II study of metronomic chemotherapy with bevacizumab for recurrent glioblastoma after progression on bevacizumab therapy.
Alternative treatment strategies remain critically needed for this indication.
http://www.ncbi.nlm.nih.gov/pubmed/20853132
I wouldn't assume a prompt response from TMTI. It may happen. However in my experience these things take time to run through all the hoops.
I live on DoD contracts and occasionally have an in or two with funding agencies though not with TMTI.
From all the DoD technical review committees that I have chaired and sat on I would think that Peregrine submits their report to the sponson, then the sponsor assembles a tech ref committee and they review the report and make a recommendation. This could take a while reconciling schedules especially in the summer when people are on vacation. Though I'm not sure of the procedure at TMTI.
Looks like this works in a manner similar to Bavi in a viral infection.
http://www.newscientist.com/article/mg20627614.600-remove-hivs-invisibility-cloak-to-defeat-it.html?DCMP=OTC-rss&nsref=online-news
Experimental Cancer Drug...
http://www.nature.com/news/2010/100512/full/news.2010.236.html
An other radically different approach to halting cancer cell proliferation.
From today's Nature -- "Time to adapt"
Regarding new guidelines for cancer trials...
http://www.nature.com/nature/journal/v464/n7293/full/4641245b.html
A new generation of clinical trials could yield breakthroughs, but must be handled with care.
At the American Association for Cancer Research annual meeting in Washington DC last week, a recurrent theme was complexity. The deeper scientists have delved into the fundamental nature of cancer, the more they have come to recognize its vast genetic diversity, which can make even tumours of the same cancer type seem unrelated.
It is encouraging to see researchers embracing new methods to deal with that complexity. One especially promising technique highlighted in several talks was the 'adaptive' clinical trial, which allows researchers to avoid being locked into a single, static protocol for the duration of the trial. Instead, investigators can evaluate data as they come in, and use that information to change a trial's structure (see page 1258).
...
New drug test protocol: breast cancer
"Major changes to the way cancer drugs are tested in people could lead to better and cheaper therapies coming to the market more quickly."
http://www.newscientist.com/article/dn18670-personalised-cancer-trial-promises-better-drugs-faster.html?DCMP=OTC-rss&nsref=online-news
HIV in progenitor cells...
Hayward lakes in BC too.
But to change the subject: an interesting article in NatureNews regarding HIV and progenitor cells:
http://www.nature.com/news/2010/100307/full/news.2010.109.html
HIV infection can persist despite treatment because the virus stays dormant inside cells, ready to multiply again after therapy stops. Now, researchers have discovered that progenitor cells that develop into immune cells are an important reservoir for the virus....
If anyone on this board can reasonably be considered a professional colleague of Haynes, please profess an interest and ping him on the status of his paper.
And get back to us.
(At least such an inquiry is not uncommon among physicists.)
Has anyone downloaded and commented on this article in the latest Nature Medicine?
"Attacking the flu: Neutralizing antibodies may lead to 'universal' vaccine pp1251 - 1252, Grace L Chen and Kanta Subbarao"
My lab does not subscribe to Nature Medicine.
If one were to assume that PPHM is in the end stages of negotiations for BP partnering of Cotera then PPHM should insist it would be willing to exercise a reverse split to keep NASDAQ compliance so that BP will not use the RS deadline to extract more favorable terms (to BP). Should this be the case I would rather PPHM do the reverse split and get a better deal some weeks later for themselves (and us) if it comes to that. Of course upon RS the day traders would immediately short the stock and I would pick up more shares, hopefully, at their ultimate expense.
Question for the physicians / bio-chemists on the board.
Should Duke researchers manage to create a vaccine that elicit antibodies that attach to ps in a similar fashion and effect to bavituximab would that make bavituximab in its non-loaded state redundant? Will they have created a vaccine that cures HIV, all enveloped viruses, and cancer to boot ? And where would that leave PPHM?
Ok, its not likely to happen any time soon, but what if?
As an government lab professional myself and a longtime reviewer of physics and engineering technical articles, I never show papers under review to others, however I may from time to time ask a colleague who specializes in a particular area if something makes sense to him. Of course I have never have been in a position to profit from my reviewing efforts. They are more of a professional nuisance than anything. I do note that often, if some group is about to publish an important article. a competitor will get wind of it and with the possible connivance of the editor rush a paper to appear in the same issue. So some leakage is certainly possible and, when substantial financial gain is to be had, it may be inevitable.
Ok, I'll also often grouse to a colleague about the deluge of Chinese submissions where all the meat is buried in obscure references to unobtainable Chinese journals and the language is Chinglish.
Just to stir the pot a little:
I noticed that no one picked up on the implication of my previous post. The submission of the Duke paper to Nature Medicine implies that, since the journal is peer reviewed, two or three researchers from independent probably academic groups have the paper in their possession along with an editor. Though the reviewers are required to keep the paper confidential they probably will mention something about it to their colleagues especially if the results are outstanding or if they have a problem interpreting part of the paper. One could fantasize that the current run-up is in part fueled by such a leak of this info prior to acceptance and publication.
Now that I've be sufficiently wicked for today, I'll head out on my bike to enjoy the rest of the afternoon here in DC.
Hey, I hope the publications make it without delay. I've been invested in PPHM for about 4 years and have 35K stocks and am about even at the moment.
I also have reviewed a half dozen journal articles so far this year and have two papers waiting for reviewers to get back on my submissions. The magic words are "accepted for publication" not "submitted for publication".
Im a physicist and both submit and review submitted articles for publication in physics and engineering journals. They did not say that the paper has been accepted for publication. Getting a paper accepted can take a while and I've been known to reject papers for publication. I doubt if this paper would be rejected outright but there may still be some give and take with reviewers before it appears in print especially in a prestigious journal like Nature. Don't hold your breath.
Though I presently support management, the NYTimes has a relevant article this morning on corporate boards and stockholders.
http://www.nytimes.com/2009/06/07/magazine/07wwln-lede-t.html?_r=1&partner=rss&emc=rss