Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Ku, I'm mit u. eom
current cancer treatment strategy: prevention 1st. If that fails: earlier detection, and more specific targeted therapy with more sparing of normal tissue.
PPHM Bavituximab,a pilot (1st generation) anti-PS immunotherapy, makes sense because MAB Bavituximab is able to facilitate early detection of cancer (Bavi-imaging project now in clinical trials), and Bavi- has an exclusive and important docking site on the surface of cancer cells and blood vessels that feed cancer cells. It is possible that Bavi will facilitate immunizing cancer victim against recurrence of some like-cancers. Bavituximab and/or anti-PS therapy may also turn out to be a preventative for some cancers. PPHM Bavituximab development strategy does not even remotely imagine using Bavi for second-line failed cases of lung cancer, except perhaps initially. To date the safety profile of Bavi- has apparently been at the least, "satisfactory", and efficacy appears to be duplicable. PPHM appears to be moving steadily toward approval of the specific agent, and expansion of the entire anti-PS platform,of which PPHM has an exclusive.
mojojo, I'm surprised. Usually you're right on.eom
north40k, interesting stuff. impressive. thanks. eom
zare2, sweet dreams...eom
volgoat, agreed. I have no more expectations than I've seen in black and white, yet it seems anti-PS therapy, now in its infancy, has legs.
Send cancer a message via Bavi-Express. Good to see more scientists aboard. Upstream/downstream/mid-stream immune system events in the anti-cancer cascade are fascinating, but let's remember Bavi-Immune is an accidental and relatively recent discovery in the years of Bavi development, due (of course) to immunohistopathology studies in lower animals. Bavi began as a double-armed MAB which was to be one of the most specific targeting agents of its time. Years have passed and Bavi remains the same. Compare it to a vehicle with a special docking site on the space station. "Naked" Bavi-, the Bavituximab now beginning PIII clinical trials was a curiosity, an accidental observation noted when a Bavi missile was put into the body "un-armed". So PPHM has the expertise to carry small molecule anti-cancer agents directly to cancer, docking on cancer endothelial cell "flipped" -PS docking sites. "Naked Bavi was never intended to act alone, but its ability to help confer cancer immunity in second challenge situations, and "upstream" macrophage activation is a welcome adjunct to cancer treatment of all types. Just as "Naked" Bavi- was an accident on the way to the marketplace, it was an unfortunate accident that in dire financial straits, PPHM execs made the decision to pair Bavi- with chemotherapy trials (in India) rather than in conjunction with irradiation therapy. Bavi- + irradiation will almost assuredly work much better than Bavi + chemotherapy. And then there is Bavi- Imaging, another potential blockbuster. And what are about 90% of the posts here about? As mentioned above. It's great to see more scientists contributing here. Good luck to all!
cj,appreciate the posts this am. informative. eom
magicatlast, a breath of fresh air...
nh, my understanding is an oncologist may request "compassionate use" for any oncology indication. It must be "sensible" to the oncologist, obviously, and the heme-onc doc must do the paperwork which is supposed to be easier since Congress passed legislation...
how many pennies to hush the masses? within minutes of an entrenched royalist here yelling "fraud" at the gnomes in Salina Kansas who manage PPHM stock price (from home, of course), the price/share jumps .03 after being negative since Bavi PIII approval was announced. Three pennies turned the tide, and everyone was quiet. No response to the obvious. 8 pennies today cemented a feel-good weekend. of COURSE. I believe in coincidences. and that hardly anyone who counts reads this thread....let's hope they get all this backroom stuff straightened out pretty soon and we can get product to market. still amazed that not one person here has personal or familial or friends in need of something like Bavi, and nobody has tried to get it on a "compassionate use" basis.
this is the most transparent fraud ever perpetrated on the public...and I'm not talking about the science. straddling the zero line at this point in product development in this way is simply a sick joke...and we have no choice but to go along with it or get out. I suppose the partnership discussions will use this valuation as a basis for our recompense. ABsurd.
pps even more unbelievable after PIII announcement than before...and not one mention of PPHM immunotherapy agents in the article RRdog quoted: "Bristol-Myers Squibb's nivolumab and Roche's MPDL3280A are two leading contenders in the field..."
From Wikipedia: Nivolumab (nye vol' ue mab) is a fully human IgG4 monoclonal antibody designed for the treatment of cancer. Nivolumab was developed by Bristol-Myers Squibb and is also known as BMS-936558 and MDX1106.[1] Nivolumab acts as an immunomodulator by blocking ligand activation of the Programmed cell death 1 receptor. A Phase 1 clinical trial [2] tested nivolumab at doses ranging from 0.1 to 10.0 mg per kilogram of body weight, every 2 weeks. Response was assessed after each 8-week treatment cycle, and were evaluable for 236 of 296 patients. Study authors concluded that:"Anti-PD-1 antibody produced objective responses in approximately one in four to one in five patients with non–small-cell lung cancer, melanoma, or renal-cell cancer; the adverse-event profile does not appear to preclude its use."[3] Phase III clinical trials of nivolumab are recruiting in the US and EU.[4]
Roche's MPDL3280A ASCO abstract: "An ORR of 21% (25/122) was observed in nonselected solid tumors, including several pts who demonstrated tumor shrinkage within days of initiating treatment. Additional pts had delayed responses after apparent radiographic progression (not included in the ORR). Some responders demonstrated prolonged SD prior to RECIST responses. The 24-week PFS was 44%. Pts with PD-L1–positive tumors (from archival samples) showed an ORR of 39% (13/33) and a PD rate of 12% (4/33). In contrast, patients with PD-L1–negative tumors showed an ORR of 13% (8/61) and a PD rate of 59% (36/61).
Nitwit, welcome back! eom
I think Garnick DOES have it right about the hardest part of the R&D being behind us now. Managing time to market, and marketplace devices will determine the stock price. It looks like we've beaten the biotech odds and have a winner. Events of today make PPHM look like the perfect speculative investment. I've started to buy again after almost a year of holding. What is amazing is how shoppers looking at PPHM now can have no small clue what we've all been through supporting this effort. Keep in mind that Bavi has not even BEGUN to show its best clinical application...in less severe disease and coupled with irradiation therapy rather than chemo. There'll be bear raids and short sellers and naysayers and boat rockers, but I think we can all breathe a whole lot easier now. Cheers!
mazelman: "ECOG criteria are used by doctors and researchers to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis
0 Fully active, able to carry on all pre-disease performance without restriction
1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
2 Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours
3 Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours
4 Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair
5 Dead "
Except for ECOG 5 (!!) it is possible to improve the ECOG score, but that "entry score" would not change during the trial period.
when all $$$ interests are properly aligned.... PPHM pps soars
stoneroad, I just reread the breast cancer abstract, this time aloud to my wife. The awesome promise put forth in that study is eloquent testimony to the future of Bavi. What out there comes close in that instance? This is not a shot in the dark. It's the summation of an enormous output of bench science, lower animal work, and finally human studies in nearly-deads...with head-turning results. I would prescribe Bavi, and my wife would take Bavi...for sure...in the applications reported on here. Except pancreatic. We simply need more information in that application.
BCS, I'm not so sure Bavi has the capacity to "ruin 20 BPs". To the contrary, Bavi has not to date proven to be an advanced solid cancer "hammer", but it is an obvious adjunct therapy to improve on every anti-cancer modality out there. For instance, we have impressive evidence of Bavi's even greater synergy with irradiation therapy than with chemotherapy. If everyone here understood the historical imperatives dictating the Bavi investigative pathway PPHM has taken to the treatment table, they would understand that these trials are only the first of what promises to by myriad more. How about Bavi in early disease? The FDA is well wired in to all these nuances...and will allow Bavi to move forward.
eyebuy and ImaPseu, yoose are correct. Retraction! We don't really know the actual comparative ECOGs but if ImaPseu is correct, no ECOGs > 2.
exwanna, to me the ECOG numbers speak volumes here after we accept that 11.7 months is not going up. The difference between ECOG 2 for placebo, and Ecog 3 for Bavi patients is a huge factor when clinically savvy people look at that 11.7 mo. figure, and the safety profile. I repeat, amazing.
biopharm,great post!
ftm, I am a clinician who also combs the peer-reviewed literature on a daily basis, the poster presentations abstracted at ASCO are excellent: packed with choice information which arrests one's interest and, like you, leaves all in tune here wanting more. I say, "Excellent work PPHM!" This entire ASCO should be dedicated to Phil Thorpe, PhD, PPHM's visionary and now parted pharmacological genius. As just mentioned, the NSCLC ECOG figures are mind-boggling. To get an idea of the enormous difference between Ecog 2 and Ecog 3 patients, one need only review this website. Amazing. "abstractinghttp://ecog.dfci.harvard.edu/general/perf_stat.html.
The best thing about BAVI is it is so far from being a dead-end treatment soon to be supplanted by the next generation of anti-cancer agents. Bavi's stimulation of the immune system in cancer is only scratching the surface of its vast potential...in imaging (Bavi uptake studies), and as a fully humanized anti-PS MAB capable of packing a load in its second arm...A missile that can attach to exteriorized -PS with one arm, and lob an anti-neoplastic small molecule with the other.
great posts lately! And congratulations to everyone involved in this incredible effort at ASCO this year! Believe me, PPHM will be noticed bigtime.
ftm, agreed, but from a clinician's POV, all 3 of these reports are attention-getters. It is getting easier and easier for almost anyone to connect the dots. Breast cancer results are dynamite imo. Lung cancer is impressive. Soon we will be able to assess effects of Bavi in earlier disease after determining that side-effects with Bavi are no greater than those of control group. Not a home run, but methinks there we have a runner in scoring position.
volgoat, too funny. eom
DockRocker,respectfully disagree, "Even historic MOS numbers in the Bavi arm could be nullified here as FTM noted. All that matters is the difference between the two arms in the same trial." I have said from the day after the discovery of the coding errors that it is very simple math, and I don't think anyone is going to be thrown off track by an unusually high MOS number of control group. There are too many test results from other trials that can reference the approximate control outcomes. Simply unimaginable that Bavi trials will not move foreward. The only thing that will beat Bavi is the passage of time, and the competition seems to be prevailing on that score. I've also said for years that the stock price goes up when all the players are lined up to get their (un)fair share.
|
dockRock: I suppose the "clear evidence of dose-switching" would not have been so evident, or even noticed, if Bavi- mixed with control had resulted in no improved survival in the control group. I can't imagine why IR said 1st line Bavi/NSCLC would not "move the needle"...that means ?either way. Makes absolutely no sense.
drrock, thanks.IR report mirrors my thinking. Koman, please elaborate on, "There won't be a partner for it [Cotara]because pharmas don't want to deal w/ a radio-labeled antibody therapy."
I don't think radio-labeled antibodies are a problem for provider or patient if they do the job. One problem with the Cotara GBM brain cancer trial is, why do you need a monoclonal antibody (Cotara) to deliver the RAI if you are delivering it directly into tumor with a special catheter? A study to answer that question would be difficult.
CP, glad you're sticking around despite Ayer leaving.eom
paul, not sure you have a majority on this, "let's agree that every day we go without an MOS number, it improves the odds that the MOS number will be good...."
Antibody Drugs: Technologies and Global Markets 2012 The global market for therapeutic monoclonal antibodies (mAbs) was estimated at $44.6 billion in 2011. With the rollout of at least eight new therapeutic mAb products and expanded indications for existing products expected during the forecast period, the global mAb market is expected to rise at a compound annual growth rate (CAGR) of 5.3% to nearly $58 billion in 2016.
The U.S. is projected to be the largest single market for therapeutic mAbs from 2011 to 2016. This particular market was nearly $19.8 billion in 2010 and reached $20.1 billion by 2011. BCC projects this market will grow to $27.4 billion by 2016, a CAGR of 6.4%.
Sales of mAbs in the rest of the world will remain higher than in the U.S.—despite a higher CAGR in the U.S. versus the rest of the world. This market is expected to grow from $24.6 billion in 2011 to $30.3 billion in 2016 at a CAGR of 4.3%. http://www.bccresearch.com/report/antibody-drugs-technologies-markets-bio016h.html
BCC Research LLC, 49 Walnut Park, Building 2, Wellesley, MA 02481, USA | Tel: 866-285-7215 | Fax: 781-489-7308 | Email: help@bccresearch.com
biopharm, nice posting. The puzzle piece I can't fit into the overall picture is that if biotech is supposed to be a sector for big gamblers with enormous returns as the lure, why isn't anyone taking the bait lately? Clearly PPHM today is an emormously better bet than it has ever been. And I'm not just talking institutions. There is something missing here that some of us cannot see. And how many longs here with money "trapped" would get out at this stage of R&D if they could do so with a decent profit? Part of the problem for me is that I have always thought Cotara, or at least DNA-histone seeking I131-bearing MABs make a huge amount of sense. Where is the discussion of the potential of a smaller sized, more-humanized Cotara-type construct? Such should be worth huge sums. Why is there not one word out of China on clinical trials? That country has fabulous scientists who publish in the world scientific literature. What would be the downside to publishing that it does/doesn't work for lung cancer, and why? And Bavituximab? Where are the frank discussions of the current outlook for immunomodulating MABs for solid tumors. None of this seems to be real science OR real business, but some game of informational hide-and-seek.
CP, any insider insight into Ayer?
nice. thanks cj. eom
The question is what role will MABs play in treatment of solid cancers. We've gone from the unrealistic hope/expectation of a cure with an MAB to using one or more of them as adjunctive therapy with chemo, irradiation, and surgery, a strategy which makes sense. As usual with scientific inquiry, the spinoffs may be as valuable as the intended use. In the case of Bavi, it actually seems to make sense to use it for tumor treatment imaging,to monitor tumorcidal effects of various drugs on various solid cancers. That includes both prospective medications in the developmental pipeline, AND established medications. It is one thing to do genetic tumor typing, but the proof is in the pudding when it comes to whether or not medication actually kills cancer, and Bavi has the ability to dial that in. Do I think Roche is controlling events here? I've thought that for several years, and no event during that time has altered that opinion. The most puzzling thing about PPHM at this point is if the market is a gamble, nobody seems to be taking the bet, and that is a bit scary VERY strange in my experience. I just do not see how the company can defer truly important results for weeks in deference to the rules of a meeting such as the upcoming clinical oncology confab. We've been down that road too many times. To come out on this stock you have to be dollar cost averaging in at regular intervals, and I am simply too exhausted with it all, and broke, to keep doing it. This is a very convoluted way of saying I am still hoping...and holding...
Biopharm: Foundations similar to that funding Thorpe and Brekke are common funding agents for scholars of all stripes in almost all universities. Brekke has for some time been an up-and-coming star in the UTSW stable of prime movers more importantly for conspiring with Affitec in developing PPHM's "2C3". Its side effect profile is much better than Avastin, and 2C3 is more specific than Avastin. PPHM's "Better-than-Avastin" 2C3 is an anti-angiogenesis PPHM pipeliner partnered with Affitec, and is undergoing human trials in Russia, a state-of-the-art MAB that could easily replace Avastin. Like Cotara in China, 2C3 outcomes have disappeared behind the iron curtain, much like Cotara for Glioblastoma Multiforme has fallen off the radar screen. And we haven't even mentioned PPHM's showboat MAB, Bavituximab. As a physician, I went on record here and on another board that I would prescribe either or both (together) in a heartbeat for lung cancer. So who is in chargein this country? Not patients or doctors. Not the FDA. Could it be Wall Street? Madison Avenue? Apple? The Media? Gov'ment? Who is it out there that moves good therapeutics to the treatment table? Its MONEY people.Anyone out there try to get Bavituximab on a "compassionate use" basis? I would love to hear from youif you or a friend has tried to get Bavi. Congress was supposed to have made made it easier with some bill or other they passed, remember? Now Anyone should be able to request Bavi and get it. My impression is part of the problem can be the doctors (and patients). Example: The oncologist who apparently does bit want to be bothered by the paperwork it takes to get Bavi for an informed patient. And they do not get paid for writing letters to government agencies, or making telephone calls. It's easier to get illegal drugs than Bavi. Pot? No problem. I encouraged a dying friend to talk to his oncologist about Bavi, and the oncologist wouldn't hear of it. "I believe it is not approved for your cancer", he said. Same with another cancer patient, a family member. I ask again, who is in charge here? Not our CEO, SK. He's a physician, and he's convinced Bavi "works". Believe me, SK would LOVE to move this thing along. Granted, those invested heavily in a concept usually are more convinced of its efficacy. But let's face it, entrepreneurial greed is what controls access to almost all medicinals. And as you've noticed with the "socialization" of medicine, doctors are not the best entrepreneurs. Worse, doctors don't even get a pass in the greed blame-game. MAB appearance on the treatment scene was greeted with exuberant skepticism by almost all branches of the cancer treatment bureacracy, and obtaining a foothold on the cancer treatment table was enormously costly for Roche, Genentech, and ImClone. So why the stock price if Bavi- appears to be the best out there for 2ndline Nsclc? Today, it's "Ayer is getting out". Ridiculous. What should that have to do with Cotara sitting idle, and Bavi in a statistical stew. 1st-line NSCLC results remain unexplainably shrouded in mysterious obscurity. The inventor dies. The trials are subverted. Come on!I thought we were trying to cure cancer. This is like living a novel...
What happens to Roche money flow when Bavi....? Roche=PPHM=Bavi. Among the most incredible attributes of Bavi is that in medium to late-stage disease (cancer) it will be used in conjunction to SOC, and not displace it. Avastin is taking a much-deserved back-seat at this point, but MABs appear to have an rapidly increasing market. Anyone here on top of the MAB market globally? How is China coming along with the Mega-MABreactors we heard were going to on line about now. I suppose that's when we hear results of Cotara vs. lung cancer trials conducted there. How many years has Cotara been approved there for lung cancer, and not a single publication of results, pro- or con. Anyone else think it strange?
pphm2long, a common sense explanation for no obit?
Anyone know of PEThorpe's cause of death? eom
Thorpe was a hero of mine, easily in the top echelon of contemporary scientists in his field. I echo the sorrow
expressed here, and regret that society is deprived of his
potential future contributions, and his family, friends, colleagues are denied his presence. A tragic loss. It is
unfortunate that Nobels are not awarded posthumously because
I think history will reflect that his work was truly of that
quality and importance.