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nh, thanks.last post meant for you.eom
geo, love it. retraction! Can't believe I didn't know that UTSW and MDAnderson are both part of UT system, and I worked at Texas Medical Center (Baylor/Methodist side) for a few years. So the level of competition between the two (UTSW and MDA) cannot be in the same ballpark as I suggested if they are both Univ. Texas institutions. I am sure primacy is important to both, but I feel certain that useful coollaboration is also possible. Thanks!
geo, somehow I cannot imagine MD Anderson and UT Southwest collaborating on anything, moonshot or not...unless it originated at MD Anderson or was so good as to be a no-brainer. Maybe I am wrong. The former is one competitive and narcissistic entity, and that is not to detract from its well-deserved reputation. I would go to MD Anderson for treatment over almost any other center.
geo, that's about right, especially if liver and melanoma pans out
stoneroad, thanks. Big pharma and everyone else knows cancer is a genetic event, and it will be gene therapy which turns it around. Meanwhile, with the reality of dying people requiring some sort of treatment, it is a question of what works best now...and immunotherapy ain't it. We went down theimmunology path almost 50 years ago with BCG and melanoma. Granted, results are (incrementally) better, and we have a hugely greater understanding of the immune system, but solid cancers big enough to be seen and felt, if surgically accessible, need to be removed. Bavi has a GREAT future if it can be used diagnostically to light up early tumors, and therapeutically to help slow growth of metastases and prevent recurrence. That last 1/2 sentence is enormous. Therefore I am more optimistic than ever about Bavi. The Brekken papers were huge. I don't need to repeat that if I were throwing resources at one or the other-- a trial of Yervoy + Bavi, or irradiation + Bavi--it would be the latter in a heartbeat.
unemon, you are right, but betcha things change when they cobble together a Bavi + irradiation trial. Who can deny that such must be an absolute top priority at this stage. The upside potential is vast compared with the melanoma trial which, I agree, will probably show some incremental improvement is months of survival. We're talking not incremental improvement, months to progression, but total cures now.
geo, would you choose death or exile? Your choice. The company dies or it goes to India for human trials. Did we get to choose which cancer, which stage, which modality to combine with? Emphatically not. That was it. Enough money for one spin of the wheel. Before all that Bavi was supposed to be a double armed missile delivery system, but when preclinical (animal) trials showed indisputable immune-histological evidence of immunological activity, with massive movement of macrophages (garbage clean-up white blood cells) into Bavi-cancer interaction sites, we went that direction, with "naked" (unarmed) Bavi touted as an immunological stimulant, which it is. That puts us in a unique situation of indisputable safety and some moderate tumorcidal activity for upstream/macrophage/yada reasons bantered about ad nauseum here. Why do we still use chimeric (mouse-derived) parts to synthesize Bavi? Because it is more immunogenic... Bavi stimulates/alerts the immune system more than the fully humanized form of Bavi (now being made) which was a construct designed (by P Thorpe, UTSW) to carry a cytotoxic load directly to tumor...and that' where the guys that know are heading. Not toward a hopeless situation like Yervoy for melanoma. Note: we (treatment community) are heading toward more and more targeted therapy. Anti-PS has a definite role there.
hypi, I have said for more than a decade that PPHM trades like a public utility, and I fear that is what it might end up...and of course that is not all bad in all cases.
Couch, PPHM story incredible by any standard. You missed the decade of preclinical naysayers. And also the last gasp desperate grasp at straws to take clinical trials to India for human trials of Bavi + Chemo when PPHM finances were days from doom. It was a last gasp effort to get Bavi into humans at a bargain basement cost to the company in nearly-deads, and the results showed definite signs of anticancer activity...which has carried through with consistency through today. We knew THEN that Bavi + irradiation showed the greatest promise, but had no choice in what trials were open to it. Now we continue down that dead-end line of Bavi + irradiation for incurable disease...pancreas, melanoma, liver, etc. Hopefully PPHM can soon jump to another track after showing this staying power, and be used in less advanced disease to help prevent metastases and help clean up the dead cells and residual tumor after irradiation and surgery. Chemotherapy is going to soon be limited to targeted therapies taking small molecule cytotoxins specifically to tumor, and Bavi has that capability too. Remember, Bavi was first designed as a "double-fisted" monoclonal antibody capable of binding to cell wall phosphatidyserine (-PS) with one fist, and lobbing its payload carried on the other arm into tumor substance. We'll get there.
cheynew, correct, but even traders want to know which direction the momentum, if any, and PPHM is clearly heading north after the Brekken breakthrough. Wait for the Bavi + irradiation trials announcement. Bavi's role in boosting phagocytosis is what I am looking at for surgery and irradiation, and THEN the immunostimulatory effects of preventing recurrence and metastases. I am certain that is current op strat, or should be.
north40k,interesting post re Yervoy and Bavi. I hope they scrub the trial. It makes no sense when neither agent has a prayer against melanoma (advanced melanoma at that). The strategy must be to get Bavi to patients it can most benefit in the shortest possible time, and there is no question at this point that it is Bavi in combination with irradiation therapy, and then Bavi as a delivery system for small molecule cytotoxins. Yervoy and Bavi is a waste of time and resources.
BCSPaladin, nice post. Right on. I DO think big pharma has a huge amount more information now after Brekken's report on Bavi + irradiation. I DO believe this brings us much closer to a deal, or, if not, it boosts my confidence enormously in Bavi's future. Up to now I have been mostly focused on safety, and intrigued by the incidental finding of Bavi's immunostimulatory properties, but not impressed with Bavi + chemo, although I believe it will probably end up being combined with chemo. Maybe I should put it another way: I've never been impressed with chemo for most solid tumors, and have always felt we are throwing oncologists a bone to even let them on the treatment stage with irradiation and surgery. It's like, what else do we have to offer. But now with more precise irradiation (e.g. gamma knife)plus Bavi for immunostimulation, macrophage activation for cleaning up the irradiation kill, and increased resistance to recurrence, we have a imminently marketable product which will be the first of many. (PS I think Bavi will eventually be used pre-op AND post-op for the above reasons).
Brekken presentation today: strategic importance: what remains unsaid: I have not seen transcript details, and only have a vague recollection of the summary here of what was said, and that was more than one hundred posts ago, news of Brekken's talk, but I think what Brekken did today was signal that we have settled on an application for a killer app for the Bavi platform: that is, Bavi + irradiation. Not namby-pamby "iffy" results with chemo. The results of Bavi + irradiation are overwhelming. It is killer, and not maybe. The odds of success are impressive. Bavi safety has been established. Bavi immunological boost is a reality. The mechanism of action (MOA) is defined. Folks, this is not a red light, or an amber. This is a glaring green light for the anti-PS program. Where is the celebration? Who is squeezing the last ounce of oil out of the olive? The shorts. How long before they have to cover?I think it is obvious that the liver data is not going to be a gob smack. Prices don't head south like this when great clinical results are pending. That's not to say liver survival won't be improved, but the safety factor again, plus some improved survival is all I expect. Bavi plus anything against melanoma is a pipe dream. But anti-PS remains a dynamite technology in search (for five years) of its best application, and Bavi + irradiation for lung, breast, prostate....etc. is IT...for now. Later there will be fully armed and humanized Bavi of the future. Lets not give away the farm to the shorts and doomsayers. Brekken has just provided a huge assurance to any prospective partner. PS> I am as frustrated as everyone else here.
north 40k, nice! eom
Internet forum, I'm with you. Holding on. buying only occasionally. The psychology is just all wrong for me.
The price goes up, and I hold because I am sure this is
"it". Price goes down, and I can't stand to take my losses.
Sound familiar? I DO agree with the masshysteria post. PPHM is not dogfood, that's for certain. Neither does it appear to be
a (serial) heavy-duty killer of advanced solid tumors. I am content with the very good likelihood that it is going to be a significant adjunct to irradiation therapy, and chemotherapy for early-diagnosed tumors.
masshysteria: FAB! thanks. this is not your first rodeo, I can tell.
ok eyebuy, how do we bump price .05 again tomorrow?
eyebuy, good for you. this nonsense continues just as long as stockholders allow it.
re CP and FTM: supra-human efforts. Burn-out?! Mission accomplished? Temporary breather. More peer-specific dialog elsewhere? Personal/other professional demands...a hundred other reasons possible. Meanwhile the antiphospholipid therapeutic platform remains strong, and new applications continue to look promising. A decade ago I said PPHM trades like a public utility 99% of the time, and things haven't changed much in the interval.
Cheers!
thanks KT and wook. Anti-PS (PPHM's Bavituximab) has always been a fascinating idea and brand-new platform looking for a definite application, and we all know it is not going to be a cure for
bulky/advanced solid cancers with or without chemo. However, the evidence is now convincing/compelling that Bavi will be able to significantly improve cure (total) of these same tumors when used in combination with radiotherapy. As mentioned, the current evidence is strong enough for that application to reassure any prospective investor who understands the issues. Cheers! and IMO only.
wook and keep-trying, methinks if your hypotheses are true about big pharma suitor(s) seeing liver cancer data, and about the data being good, I would suspect the price would be heading the opposite direction, although I expect it will turn upward at this point.
EyeBuy, nice post. You said, "something is up...and it ain't pre-clinical data". Agreed, but it is difficult to assume "no linkage" between price spike and the preclinical lung cancer data of 100% cure with Bavi+Irradiation. That information would turn anyone's head. We are parsing wee numbers and survival times in days or months in trials of Bavi+chemo. The masses are interested in CURING their solid cancers. It seems the immunotherapy and chemotherapy will be used to prevent metastases and in very early disease. Immunotherapy is a dream that will come true for future generations when there is no longer bulky cancer disease that is a suitable target for "the beam". Cheers!
It is difficult to OVERvalue the recent PPHM preclinical finding of total (100%) cure of lung cancer with Bavi+irradiation vs 17% with Bavi alone. We have become fixated here on Bavi+chemo when, in the real world of cancer treatment, chemotherapy is looked on with the greatest of disdain. There is a disconnect when one wants to eliminate a form of treatment which is currently a necessary evil, and then add something to it (Bavi) to make it more effective. True, we would like to eliminate irradiation therapy too (AND all cancers), but we have a shot at more kill zone specificity and less collateral damage with irradiation...and it appears that Bavi enormously helps clean up the mess with irradiation and probably increase sensitivity. The Bavi+irradiation study results of last week are enormous. Talking immunotherapy for prevention of primaries, prevention of recurrence, treatment of very small, or inhibition of metastases makes some sense. We're trying to get to a place where we can use focused irradiation and surgery (in whatever order) for primary and then salvage therapy, as needed. Chemotherapy at some point if you must. I know all oncologists do not agree with the above. That's how they make their living.
terrific five minute (well-illustrated) review of MABs,cytokines, checkpoint inhibitors, and immunotherapy vaccines for the nonscientists here. http://www.fightcancerwithimmunotherapy.com/ImmunotherapyAndCancer/TypesOfCancerImmunotherapy.aspx?creative=33306686320&utm_source=google&utm_medium=cpc&utm_term=cancer%2Btreatment&utm_campaign=Cancer%2BTreatment
Other guy: perfect word, "comical". do you suppose that like politics and las vegas, this is all theatre? absurd. eom
y'all: good work, grumble and ye shall get 5.5 cents.eom.
I can actually live with that gain every day. cheers.
notbob, agreed, nice post, eom.
bungler, correct, or another generation of Cotara, TNT that carries I131 to tumor core. NOW you are talking success against solid cancers. The rest is p...ssing in the wind.
Hypi, the balloon in shares traded, and price jump last week followed closely on news that preclinical studies (in mice) showed a difference of 17% v. 100% survival in lung cancer with irradiation therapy alone, and irradiation plus Bavi. Those who treat solid tumors like lung, breast, and liver KNOW that no amount of chemo plus any immunologic adjunct, no matter how powerful and in what combination, is going to cure or significantly dent those solid cancers. No way is Bavi giong to make a big dent. These tumors are like new bodies growing, new bodies that have to be killed. It doesn't happen with chemo plus anything. Not the case with irradiation. Irradiation fries tumors. Hiroshima-like. But it fries other tissues too. In the case of irradiation it is not a matter of frying the entire tumor, but of cleaning up the devastation from kill and "overspray". That's where Bavi helps: promoting/facilitating the scavengers (macrophages), white cells, that clean up the mess. 17% cure vs. 100%. This means that an incremental improvement in liver cancer survival is irrelevant. The big thing that matters in the liver trial is that adding Bavi does not increase side effects or morbidity. Any improvement in survival is lagniappe. No more, no less. So if there is no significant improvement in liver cancer survival, and the pps dives, is that the end? not at all. Bavi makes a lot of sense with irradiation AND surgery. Also, with chemotherapy, but the last is a last resort in any cancer therapy playbook. PS. Bavi is far from PPHM's only pipeline bullet.
amazing what 5.5 cents does for one's mood.eom
pphmTOOlong, I really like that post. thanks. eom
Has adaptive immunity in any form been seen/published in humans with Bavi...or strongly suspected?
biopharm, yes adaptive immunity conferred by Bavi is an enormous item. A good summary of the subject is at the UCSF site: http://missinglink.ucsf.edu/lm/immunology_module/prologue/objectives/obj02.html
biopharm, good reminder re. veterinarian use. Denise was referring to preclinical work not being exciting...I think.
hypi, another good post. welcome aboard! I am equally amazed by the people in very high places in the biotech world who do not know about PPHM. I was in on ImCL from an early date, and was equally surprised at how few people knew about Erbitux until Martha Stewart and Sam Waxsal went to jail...even after Karl Icahn "came to the rescue". Suppose we need another Martha, Sam, and Karl dog and pony show here? I don't think so. PPHM has incalculably more assets than ImCL ever had...which was mostly hype.
biopharm, interesting stuff on Doctor Hellman and Doctor Susan Desmond-Hellmann. Can you connect the dots for me (provide "a bit more color" as the current jargon goes re. their possible connection with PPHM other than HIV space.
hypi, well-written, agree whole-heartedly, but the suppression has been going on for over a decade. The Wednesday-Thursday volume and price spike was definitely positive, people don't throw $40 million at a stock which is generally perceived to be on a downward trajectory rather than having upward momentum. If PPHM is valued now at about the value of Avid, say, and if there is actually a big pharma in the shadows, it is easy to see how the buyer is going to get in on the game at a fraction of what it should. This action could be something as far-fetched as one country/kingdom throwing in $25 million one day in buys, and harvesting stopped-out stocks, and turning around and selling that much the next day. This still does not representa whole lot of money to some individuals in India, Russia, Saudi Arabia...or relatively scarce US billionaires. That is only one possibility which does not even relate to a big pharma.
jbain, VERY interesting P values. Mojojo's heads-up on melanoma is impressive. The recent unveiling of anti-PS (Bavi) favorable effects on irradiation treatment of lung cancer (in mice), and backup information on PE effects on irradiation, all lend credence to the enormous value and future of PPHM patent portfolio and clinical/preclinical experience with a phospholipid platform.
The previously cited new article on colorectal cancer refractory to/or resistant to, irradiation therapy is killed completely in a high percentage (of bald mice) by adding an anti-PE-like activating compound to the irradiation protocol. So "fossfatwiddleEthanolamean"..."-PE" is another important membrane compound in cancers...in ADDITION to "-PS" hosphatidylserine,the membrane compound Bavituximab homes in on. This means another phospholipid is a huge player intesting a cancer...colon cancer. Preclinical tests of a compound which blocks -PE "clogging" makes tumors enormously mores responsive...makes them dead tumors. So, manipulate membrane PE exposure as well as PS, with Bavi. If you saw this science article and wanted to know what drug company has patents on -PE treatment applications, you would probably find the PPHM patent library large in that space. Interesting stuff.
an example of the vast applicability of phospholipid biochemistry in the treatment of cancer is this new paper. This time,instead of PS (phosphatidylserine), or PC, this article talks about PE(phosphatidylethanolamine, colon cancer, and reducing its resistnace to irradiation therapy by manipulating PE receptors. We used to love saying foss-fa-tiddle-ethan-o'-la-meen in med school biochem class http://www.ncbi.nlm.nih.gov/pubmed/24594691