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cloaked one and cheynew, re.PPHM BOD and Admin. What role do you think UTSW has in selection/retention? I enjoy your posts. Thanks for your contributions. I don't understand why anyone would want the price share higher until PPHM has a product nearly ready for sale or a balance sheet commensurate with the share price. Until then the price would be pure speculation and price fluctuations would be even more of a heartache for inexperienced traders or those looking for a solid investment. PPHM has been unusually ethical in avoiding efforts to hype their science which speaks highly for those in control...and makes me think of some very good input from UTSW people.
cj, FAB stuff. HIGHly applicable clinically. Very encouraging. eom
mojo,nice post.agreed.eom
geo, a couple thoughts. I've not so concerned about the skills of the president when the tech is so good, but today, on the day SteveJobs retires, it calls that indifference into question. As he or someone around him said once, you can have all the best tech spinning around out there somewhere in space, but you need someone to tie it all together in a marketable package that everyone needs. Whatta guy. I hope he knows about Bavi and pancreatic CA. The other thought: I've been mostly unperturbed about PPHM financing because I've always believed that BP is present in the shadows at PPHM, and has been so for a very long time. Can you imagine a more economical way of working out the kinks in a potentially great new biomedical technology? And as long as the technology continues to show promise, despite the hue and cry here on this board and in other quarters, PPHM is not going to sink. Our job is to be sure we get our fair share when the BP in the background steps forward to claim its prize. If the technology doesn't pan out we'll all be underwater, and the shadowy BP will simply move on.
geo, that's my sense of it too...
to those who have emailed me here on various subjects I apologize because for some reason I just don't ever think to go there. Today I had to sign in on a remote computer and saw all the emails. I'll try to get to those still timely. AND, I've been guilty of saying this once or twice before, but I think this is the tipping point we've all been patiently awaiting. The scientific foundation for the technology is SO solid; the product apparently safe; and now continued increasing proof of principle. Again I want to congratulate all those employees at PPHM who have worked so diligently (thanklessly?) to bring this about, and for those who have supported the effort with hard-earned life-savings. Let's hope this is the beginning of the end-game, and not a head-feint. Good luck all...especially to patients enrolled in clinical trials.
jake, VERY impressive IMO. VERY hopeful. Actually these numbers are the most impressive I have seen coming from PPHM. The most incredible thing about this news is the ho-hum response. A near doubling of response is difficult to attribute it to any statistical aberration...for whatever reason. Very impressive.
until2000, the short supply of some medications (ie Taxol)would be far down on my list of what is causing the slow filling of PPHM trial patient cohorts. As several posters here have pointed out, it is a very difficult feat to convince anyone to leave their local oncologist and local support network to go to another city, doctor, or hospital to seek an unproven treatment. And frankly, sending a patient off to a clinical trial somewhere else is a money loser for the oncologist involved. Most doctors think they are providing "standard of care" for a given disease state, and that is their responsibility. It would be interesting to see the statistics on how oncologists opt to treat their own cancers. Locally, or with a protocol (clinical trial). I would personally opt for Bavi (and/or Cotara) plus the most successful standard of care therapy.
djohn, enduring another shake-out in margaritaville?
Discovering what lost money in PPHM will buy there?
Agreed, it has been a fascinating ride.
Still to be determined is the final cost and price.
The team appears to be moving the ball forward...
Helping understand and cure viral illness and cancer.
Enough for me. I'm toughing it out in Sonoma Valleyville,
Gorgeous...Perfect weather...A premiere wine region as well.
Lift your glass to a better tomorrow...and cheers!
keep_trying: viral envelopes, or "membranes", which keep the protein contents together inside a virus, are taken from host cell membrane phospholipids and protein. The presence of viruses inside a cell cause the cell's phospholipid bi-layer to flip inside out, thus preventing the virus from using that important component of the host cell membrane for its own, and reducing reproduction. Normally viruses bud from cell surfaces killing or weakening the host cell, or cause it to explode, thus shedding and spreading more virus. I suppose next thing will be prion disease caused by unenveloped viral particles!
djohn.veryintersting.thankyou. Cuppa DRACO?
DRACO = the investigators (Rider, et.al) had the idea of combining a dsRNA-binding protein with another protein that !!induces cells to undergo apoptosis!! (programmed cell suicide) —
launched, for example, when a cell determines it is en route to becoming cancerous.
Question: What/when is "launch"?
Surely DRACO must also jump the same DRACOnian FDA high hurdles all other great ideas must, beginning with the sickest sufferers th test toxicity. And toxicity with DRACO...? Another potential horror story.
Fascinating about a dual action...one of the two beingapoptosis induction...when one end of the DRACO binds to dsRNA, it signals the other end of the DRACO to initiate cell suicideor apoptosis. Combining BA
Combining the two elements, dsRNA-binding and apoptosis, is a “great idea” and a very novel approach, says Karla Kirkegaard, professor of microbiology and immunology at Stanford University.
Love that Karla Kirkegaard is all excited about it. Philosophically, who could say no to that name. Thanks again djohn
hey toolong, "All about Bavi". A book title? I like it.
freethemice, good as it gets. independent collaboration of anti-PS concept by French scientists. I mentioned in last post that Bavi is not a cure for cancer, but I do believe that if used early enough it could help the body eliminate cancer cells and help plug that hole in the immune system. The "ace kicker" is that endothelial cells of blood feeder vessels feeding cancers also express -PS, and do not mutate so rapidly as cancer cells. The net widens.
frustrated, nice post. Actually no, I can't "imagine how much better off PPHM would be with some big investment banker" on BOD. So far all involved have avoided catastrophic hype. You said, "I have no problem going down in flames if the science is not good....", and..."we were supposed to know about the science six months ago." We know the science is good. And it seems safe, at least in the short-run. Ready to take Bavituximab every morning with Cheerios? We've seen what it is, and what it does. And cure cancer? Not. Anti-PS sound science is sound. How many concept biologicals actually get FDA permission for testing inside the human body? I view the entire executive at PPHM to exist at the pleasure of the inventor and UTSW, a giant among educational institutions, a veritable veritable southwestern Texas "Mormon Church". And church "elders" call the shots as much as the PPHM BOD. Thank goodness. PPHM stock price is definitely not puffed, which is also a good thing. Recent horrendous losses in PPHM stock and continued skepticism is due as much to the spectre of the shrinking healthcare dollar as to marketability if anti-TNT or anti-PS.
geo..cool. I laffed aloud.
freethemice!fab. terrific find. anyone need translation? this is huge.
drumstick, DNDN is, in fact, the obverse of what vexes many anti-PPHM management and B.O.D. posters on this website. DNDN board and execs are dealing with a lame product that was pushed through the FDA with more emotion that efficacy. The FDA actually got it right with Dendreon the first time when it said "no". The resistance in the marketplace is simple to explain: cost:benefit ratio. It is true that the spectre of DNDN is haunting PPHM and the remainder of the biotech industry as well, and represents one more hurdle to jump over. If a treatment is effective it should be glowingly obvious, and not a contentious subject of whether or not a few days of increased survival (or time to recurrence) is statistically significant. Cancer victims could better spend their end-of-life savings in Paris. They and their heirs would be better off.
cj, good stuff. thanks. eom
The holy grail is reproducibility of results. That's what we're about right now. If it were not for India trials we wouldn't be here right now. That fact makes the plot more stirring.
SwingTrader: here is the reference. As posted previously, it was luck of the worst kind that led us down the chemo- + bavi road, but that was the only avenue open at the time of dire financial stress, when the company grasped the India-Russia straw to stay alive, and opted to try Bavi with chemo rather than a much more promising avenue of Bavi with irradiation therapy...and probably with surgery, or the two combined. Again, as posted before, in the real world of solid cancer treatment chemotherapy is a last resort in most cases. I have no idea what the comparative frequency is of treatment with the two modalities, but I suspect the difference is great. When PPHM announces its first trial with Bavi and irradiation therapy, that will be a bell clapper. Meanwhile we are getting a great idea of Bavi side-effect profile in current trials with chemo.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2917257/Radiat Res. 2010 July; 174(1): 62–71.
An Orthotopic Lung Tumor Model for Image-Guided Microirradiation in Rats
Debabrata Saha,a Linda Watkins,b Yi Yin,b Philip Thorpe,et.a. Tumor Response to Image-Guided Irradiation
PS is absent from the surface of blood vessels in normal tissues but becomes exposed on tumor blood vessels in response to oxidative stresses in the tumor microenvironment (26). He et al. demonstrated that vascular targeting of human lung tumors by the monoclonal antibody BAVITUXIMAB was enhanced by ionizing radiation (23). In this study we used the monoclonal antibody bavituximab to identify PS in A549-luc tumors in lungs before and after irradiating the tumors. Figure 4B, panel (ii), shows the increased localization of bavituximab in tumor vessels, indicating that PS becomes exposed (>90%) on tumor endothelium in response to 10 Gy radiation (green). In contrast, about 20% PS exposure and bavituximab localization was observed on the unirradiated tumor tissue [Fig. 4C, panel (ii)]. No bavituximab localization was noted in normal rat lung exposed to 10 Gy radiation [Fig. 4A, panel (ii)]. To confirm tumor vasculature labeling by bavituximab, vascular endothelium was stained with a mouse anti-rat CD31 antibody [Fig. 4A–C, panel (i)]. Nuclei were stained with DAPI [blue, Fig. 4A–C, panel (iii)]. Figure 4B, panel (iv), shows that the merged image of the tumor vessel is yellow. No convergent staining was visible in either the irradiated normal lung tissue [Fig. 4A, panel (iv)] or unirradiated tumor tissue [Fig. 4C, panel (iv)]. Thus radiation exposure induces PS strongly and selectively on the tumor vessel. In an additional experiment....
Other new types of radiation therapy include:
•Intensity-modulated radiation therapy (IMRT): an advanced mode of high-precision radiotherapy that utilizes computer-controlled x-ray accelerators to deliver precise radiation doses to a malignant tumor or specific areas within the tumor. The radiation dose is designed to conform to the three-dimensional (3-D) shape of the tumor by modulating—or controlling—the intensity of the radiation beam to focus a higher radiation dose to the tumor while minimizing radiation exposure to healthy cells. See the IMRT page (www.RadiologyInfo.org/en/info.cfm?pg=imrt) for more information.
•Stereotactic radiosurgery is a highly precise form of radiation therapy that directs narrow beams of radiation to the tumor from different angles. For this procedure, the patient may wear a rigid head frame. Computed tomography (CT) or magnetic resonance imaging (MRI) help the doctor identify the tumor's exact location and a computer helps the doctor regulate the dose of radiation. Stereotactic radiotherapy is similar physically to radiosurgery but involves fractionation (multiple treatments). This modality would be recommended for tumors within or close to critical structures in the brain that can not tolerate a large single dose of radiation or for larger tumors. See the Stereotactic radiosurgery page (www,RadiologyInfo.org/en/info.cfm?pg=stereotactic).
•Three-dimensional conformal radiation therapy (3D-CRT): a conventional form of radiation treatment delivery that uses a specific arrangement of x-ray beams designed to conform to the shape of the tumor to maximize tumor dose and minimize normal surrounding tissue dose. This form of treatment is tailored to the patient's specific anatomy and tumor location. CT and/or MRI scan is often required for treatment planning.
•Brachytherapy: the temporary placement of radioactive materials within the body, usually employed to give an extra dose—or boost—of radiation to the area of the excision site. See the Brachytherapy page (www.RadiologyInfo.org/en/info.cfm?PG=brachy) for more information.
kt, I posted some time ago a reference in the peer-reviewed literature about bone marrow suppression with Cotara-like drugs used systemically. Not sure how that will play out. In that same post I mentioned that since it does not pass the blood-brain barrier because of its size, Cotara is a natural for catheter delivery to brain tumors. A cause for concern is that so much time has passed since it has been approved in China for lung cancer, and there is no solid data out of there yet..that I know of. Having said that, if I had the disease (lung cancer) I would opt for Cotara and Bavi out of all the chemo- agents I can think of to select from.
jr, good on ya.
heavy duty geo and geocap, It's the agora, the marketplace, traditional lurking place of every variety of man and beast.
RRdog, there is little question that anti-phospholipid technology will be used therapeutically. the questions vexing us all is "when and how," and if PPHM be the company to do it?
The peer-reviewed medical literature on monoclonal antibody use as immunological adjunct is expanding, so the concept is about as water-tight at this point for anti-PS as is possible given proven favorable side-effect profile experience in human trials, and histological positive effects on monocyte and dendritic cell behavior. meanwhile we continue inching toward the tipping point.
are we forgetting Bavi PLUS irradiation therapy? the key.
lots of tumors are simply chemotherapy resistant, and this whole chermotherapy + Bavi scenario is an unfortunate kick-off to Bavi clinical trials. However, we have to live with the exigencies of those times, and that was to grab onto India and Russia trials and "go for it...anything...something...to get someone's attention. In the real world of cancer therapy chemo is, in many types of cancers, by far the "weak sister" among options: surgery, chemo, or irradiation. I feel as sorry for chemotherapists as their patients. Chemo is often given when there is little to no hope of a cure with the other two modalities. Sometimes all three are used. Pinpoint targeted microscopic irradiation therapy is increasingly the treatment of choice for many tumors, and Bavi should show some tremendous improvements in the surgery-irradiation numbers because of macrophage activation, etc., and we haven't even started down that path.
Also, Bavi was revolutionary because it was double-armed, and could latch onto -PS sites with one arm and carry a cytotoxic agent in the other. Somewhere along the line (unpublicized) it was discovered that armed Bavi loses its specificity for PS and tends to wander. That little problem can and will be remedied. Do you people on the board realize the significance of an anti-cancer agent actually making it to this point? Where human beings are taking it in a serious assault on the disease? It's all pretty exciting, but all of you here can probably remember 2-3 years ago during those heady days of revolution that I said it would be an FDA squeaker.
geo, that sounds about right too. thanks
senrex methinks you have it about right
cheynew, totally interesting and germaine. thank you..for this, and all.
tarifa...too funny...if it weren't sad. Stick around. You're too valuable to lose...I meant "too loose"...have a good weekend y'all. This has been VERY difficult. Imagine what's going on behind closed doors at PPHM.
chey, thank you. terrific [!!] paper.
djohn, what's your best guess about the abstract content?
XXSP, a very good question. eom
mojo, interesting post, thanks!
check "brain cancer" instead of glioblastoma multiforme?
wxcbs:ER if it worsens.
thurly, don't hold your breath on this one.
jakeman,thanks.Good perspective on MAB market potential. Avid is a huge plus for PPHM.
rrdoggyguy...YES!
stoneroad, thank you for the well thought-out post, and actually I agree with almost all of it. the problem is that the 1% you leave out is the meat of the nut, and the rest is thick shell.
An anecdote for you. Most of you know I was early into ImCl the day after WhackoSamWaksal appeared on CNBC. Hooked up at about 16 and rode it to about 120 on the basis of hype and hope while during that run-up not ONE practicing oncologist I asked had ever heard of Erbitux. IN hindsight of course that is for good reason. I don't want to beat you over the head with "the science," which you don't bash, and don't celebrate either, but one must hitch their wagon to sumpin', and in my case, and PPHM's, it isn't Waxsal-type-hype or a cast of glam front office actors. TNT and anti-PS is simply a matter of common sense to me...reasonable and logical...here to stay, and grow. You mentioned lottery. I've never played one. But I continue to bet on PPHM...while agreeing with you about 99%. Go figure!
thanks cj, i knew that i had gotten that information on duramycin anti-PE from some reliable source...you. hey freethemice! what's your daytime job. your "handle" points toward a bench scientist?