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KT, wow. nice post.
golfho, sorry but good posts often go unanswered. I did read your first one on StockRightsOffer and thought it a good idea. After reading it a second time, and the web site reference, it seems even better. I'll send a letter to that effect. Wonder why all companies would not employ the concept...or be required to. Daylight all these shenanigans I say. How about you, Tek nu Loof?
djohn, interesting, listed under Utah State research support is Bavi by another name: HDTRA1-08-C-0003 (B. Friemark/B. Gowen - PI)
07/1/08 - 06/30/11Department of Defense, Defense Threat Reduction Agency Anti-Phosphatidylserine Antibodies as Therapeutics for Hemorrhagic Fever Virus Infections. Looks like DOD is taking it underground. As I fretted before, DTRA/DOD already knows what it needs to know about Bavi, about whether it is worth pursuing, and that's what PPHM was establishing last year. This year USGov Bavi money might be going to clinical research facilities for human trials, and a lot of it probably secret. After the classified info is sorted out hope growth of the civilian anti-cancer leg of Bavi treatment is not cut short. Not getting a government contract is not always bad, and not always an indictment on product. We've had time to adjust to the reality and see that the company will carry on. I will be pleasantly surprised if the contract is renewed.
thanks djohn, hi-note appreciated: "The contract for monoclonal antibody (ch TNT 1/B) labeling wing with Iodine-131 by BRIT for M/s. Peregrine Pharmaceuticals Inc., USA was further extended for 2010." Gearing up for mass production...mah baby Cotara.
cj, interesting stuff. read most of it and learned a lot. thanks.
thanks jess: amazinger and amazinger. "...Therefore, these results indicate that r84 may be more effective at
controlling tumor take and growth than bevacizumab independent
of dose in certain models. We propose that the appropriate
therapeutic antibody dose should be determined independently for
different tumor types to maximize therapeutic benefit with
minimal induction of toxicity [23–25]." Truly stuff worth reading. Great paper. congrats to all involved.
okay, I re-read it. Sullivan, et.al. at UTSW (+ProfBrekken) have a novel VEGF agent r84. In the tumor environment r84, a VEGF MAB, docks on overexpessed VEGF, and selectively blocks pro-growth elements, thus blocking angiogenesis and limiting tumor size.
Hmm. Wonder who manufactured the MAB?
thanks djohn, so does VEGF-1 alone = VEGF1+2-2? Two different approaches to ampliflying EGFV-1 effect? Or should I re-read it. Good find.
jess, you asked what PPHM has marketed: PPHM markets specialty MABs for in-house purposes, but also for other small and medium-size MAB orders. All from PPHM's wholly owned and FDA-approved subsidiary, MAB-brewer Avid. As evidenced here this week PPHM is definitely known now in the biotech sector, or "has more press," and has one fortune-teller piping about a billion dollar plus blockbuster (or two) at PPHM, and even more pipeline in the wings. A huge amount of MAB know-how at PPHM. Will the company fly? Yes. Will it stay on course? Glass half-full view of potential for financial gain with PPHM securities: good and getting better. Volume a better indicator than price. A good week-end to ye' all.
moby,moby..."Our enhanced ability to precision-guide irradiation is paying huge dividends..." relates to medical science in general, and radiation therapy in specific, and was not meant to include PPHM. As you know, I've lamented the fact that management went with chemo-Bavi combo rather than Radiation therapy-Bavi combo trial. Cotara would also be a logical "finisher" in combination with Bavi, or Bavi-chemo combo.
mojojo, I don't get it, the intro. Iteresting stuff though
djohn.wow.goodfind,aboutsays it all. Our enhanced ability to precision-guide irradiation is paying huge dividends in cancer therapy, and, incidentally, naked Bavituximab makes that irradiation kill even better. Now I am REALLY impressed there is an interim therapeutic role for naked Bavi while fully-human and fully loaded Bavi is being developed. Naked Bavi almost certainly enhances irradiation kill more than it facilitates chemotherapy agents, by spiking the immune system WBC-clean-up crew. And there is talk of specific the body's cancer-immunization system being enhanced by Bavi. Cancer immunity? Fascinating.
djohn, thanks. looks good. maybe I can work that conference into my schedule. appreciate the "heads up".
Moby, a slippery slope, thee argument that safety isn't a pivotal part of every trial...and every prescription for that matter. Human safety in prescription medications is never assumed. It is axiomatic that a positive medication effect sometimes correlates with negative effects, and the patient may have to decide if side-effects are worth amelioration of the disease. In the biotech arena almost all safety data is obtained prior to human trials, and the inference of safety is always being reassessed in human use.
BKT:sadly, gov'ment action yes or no on contract extension is probably priced into stock already and well-hedged. A positive result will move the price up, negative down, but public government stance re. Bavi- potential, and ACTUAL potential are not the same. US funded studies, say on parasitic disease, allow the government to look at what's out there. The US Defense Dept. now knows about Bavi, and PPHM MAB production facilities are expanding, as is the corporate payroll. Doesn't look like the company is shutting down, and they know the government's answer. Summary? Government involvement, especially Dept.ofDefense and its satelites, actually leaves us clueless. Call it transparency. Or lack thereof. My preference has always been to stay on track with the business plan of advancing Bavi (and Cotara) to the marketplace as uncommonly good MABs capable of specifically targeting cancer sites now unused by other agents. Anti viral, anti parasitic, immunological adjunct...all that and more for Bavi. But come on folks. If you know biochemistry you know that Bavi is a good thing. Naked Bavi needs to be armed. Last week on this site we wrote about small variations in chemo doses. With Bavi carrying the chemo to cancer sites specifically, local dose may be increased, but total dose enormously diminished. I hope someone in PPHM executive suite is staying focused on the banana: Anti-Cancer MAB Bavi, fully loaded and fully human. Beat that.
Thurly, bravo. Thanks for following through on that. It does raise a few questions, but questions that must be answered.
Hey all, nice discussion, but I am definitely with the crowd who thinks the dose variance is insignificant, or indeterminate, and not terribly relevant. Please someone correct me, but my impression of the India trial is that it was not entirely of our PPHM design, and therein could be the problem. The nut of the story is that the "signal seeking" trial found a favorable signal that has made movers take notice, and facilitated more clinical trials for Bavi- in the US, and that is a huge accomplishment.
Weather is unusually cool in No.California. Farmers worried about your 2010 grape harvest. I'm off to Carmel. Everyone have a good weekend.
kt nice post. Hard to imagine a chemo trial with lower dosage than standard of care, so there should be a "control group" already, especially in India, using that dosage of chemo- without Bavi. This is one of the more interesting recent avenues of inquiry brought to the board, and I hope mojo (or someone with the time to do it) will research and expand on the question. Agree that "signal seeking" designation is most likely related to a retrospective realization of a design flaw that renders statistical analysis of results guesswork, and depending on the glitch, could bode well or badly for Bavi. The fact that trials...any Bavi trials...will proceed/repeat in the US is a very good prognostic sign and evidence that India was a net positive.
mojo, how interesting. Can you enlarge on the assertion that the chemo dose in India was set too low? ie what dose was used there v. what is considered standard? Wonder if/why the chemo dose would be different in India v. US. Is it a mg/kg dose? Again, I doubt if PPHM management could influence that parameter. It's probably a situation more like a hitchhiker who cannot afford to be too particular. He just needs to move forward with the funds available.
sunstar, exactly. LaFont, the lat up-down of the yo-yo was those yahoos who showed up right after our entry...er...stumble..into the Russell Index. Same crowd, some with new names some with old, who showed up same time last stumble upward on the path to BigPharma status. Every company pays its dues. Not every one gets a second and third chance. Gotta have more in the hopper than greedy parasites in the executive suites.
avichi what's a TA?
Thales, given VIX general implications, a case could definitely be made for a correlation. Contrary to my first impression, and after a little thought, the graph might be more than coincidence. Wonder if the observation is repeatable. Has history repeated itself in that respect?
Thurly,goodpost. What vaccine crazed fool virologist wrote it? Duke?They are not PPHM friends there. They pick brains,then try to apply it to vaccines that induce the body to produce antibodies. PPHM MAKES the antibody in its own FDA-approved manufacturing facility, Avid. He said they've [finally] learned that targeting a specific viral envelope epitope doesn't get it. Can't "vaccinate" against AIDS. Their strategy didn't work. "It only worked against viruses of an exact type that you used to get the envelope from. So it wouldn’t work against a wide … the majority of HIVs."
Duke learned a lot about -PS cell surface docking sites from PPHM, helping thrust -PS chemistry to the front burner-- all the rage now judged by the mushrooming publications on that genre in the scientific literature. "So," he continues, whoever he is, "our approach [is] different....we are now focusing on regions of the envelope that cannot change, regions that must be conserved and not mutate, not change." [that sounds like -PS sites. "The virologists are looking for cell surface regions that are non-mutable and also functionally required for the virus to begin the infection process. He continues, "We have focused on such regions that are normally protected by complex mechanisms against an attack by antibodies. And we worked on a method that exposes..."[here he sounds confused]... you make a vaccine that will make antibodies that will work when these regions are exposed." [Note, "a vaccine that makes antibodies"] "We have interesting results. We’re trying to move this forward to the very beginning of clinical testing for safety. Interesting results in animals." Bunko. Gibberish. Not Bavi.
tarifa, you can always get back in. I think there is a lot of stop-loss scoopin' going on, and some huge losses on this baby. The worst case scenario from here is not the further downside, but the announcement out of the blue that PPHM has partnered, and the price takes off like a rocket. Some fat chance of that, huh. Keep postin' and we'll all keep hopin'.
Moby, BMY already has its hands full processing the effete Erbitux, but BMY did the right thing--doubled down on MABs and pulled a brilliant 2004 grab of Medarex melanoma MAB for $530 million in cash, royalties and milestone payments. And then five years later in 2009 BMY gobbled up Medarex whole for $16 per share, a steal. Look at the Medarex chart compared to PPHM. Talk about stockholders taking a beating through the years. Medarex had the goods from the beginning, 15-20 years ago, and was pummeled, stymied, and stalled year after year in the markets. PPHM needs a partner? Like it needed the Russell Index plane crash. The Medarex MAB jewel, and the entire pipeline, maybe a MAB production facility, is now owned by BMY. That MAB will be used, and not just for melanoma. So will Bavi-.
Roche/DNA will fade from the cancer treatment tableau if they don't buy sumpin' fast 'cause (I've been saying it here for years) Avastin is a done warrior. Now DNA announces that Herceptin positive breast cancers "escape" Herceptin effects. The MABs simply must pack some poison. DNA is screwed in the cancer MAB business if they don't buy Bavi. Screwed. Escape? That's another way of saying that all the cancer cells didn't get killed. TNT takes care of that. So I can see TNT and anti-PS cancer therapy as mainstays along with a good EGF. I fear that strict VEGF agents may interfere with Bavi sites, so connect the dots for DNA. When y'all money guys get finished duking it out for best percentages and points we can continue moving Bavi (and Cotara) across the goal line.
jonnyrocket, good questions. drlab, a well-constructed scream. and drontle2, you don't have grandchildren to whom you can hand off the paper? Jonny, getting knocked off on the way to the marketplace is always a risk, and anticancer treatment avenues expanding rapidly. There was once a question of whether or not MABs had a place at the treatment table, and then if in solid cancers. Now, Roche's reality notwithstanding, it appears MABs are here to stay, especially conjugated forms. My last post alluded to the fact that now Roche will be forced to blast its way through regulatory bodies with its new Herceptin conjugate which allows us to follow in its wake, and with a much better MAB than Herceptin. The point is that despite the considerable number of scientists at work on PS technology, PPHM has primacy in feeding it to humans in a proven safe form. In my opinion the Bavituximab story is so compelling, and the background investigative work so "tight", that the logic will soon become common knowledge. The lag-time in that regard [getting the public on board] is always considerable, and lengthened by adverse financial interests. When the public focuses on the race for the cure, and when Bavituximab becomes one of the favorites in the field, consdiering the considerable prize at the finish line, there will be no problem with financing, and the pps will reflect the worth of the eventual jackpot. PPHM will not have to start over. It is already almost there. It can plunk Bavi-RAI into PII studies just as Roche can do with Herceptin-RAI, and then we will see a side-by-side comparison. Any bets on that one? Sorry this is so disjointed, but I MUST get to work...
lafont, good thought, but that base is covered. BMY's humanized EGF agent will be a player; PPHM's -PS agent will be; and both will be facilitated now by Roche's hard luck with Avastin. Let Roche shoulder some of the conjugated MaB approval expense, and lead the way through approval after PII trials. It's about time reality has caught up with that crowd.
realist, "nobody interested in PPHM technology" is on the face of it an extremely unrealistic scenario. Nobody interested in pushing naked Bavi to the marketplace, or being able to see anti-PS technology strategically is appears a very likely scenario. IMO all the possible objections to moving armed and humanized Bavi forward have essentially been eliminated.
geo, we have seen the enemy and it R us. You said, "Whatever or whomever is pushing pphm down is not taking their foot off the metal..." Seems like an orderly march rather than a stampede, the sort of thing you would see with someone buying up shares put out there as stop orders, etc., with a few shorts thrown in there for spice. Volume too low for a real scare. The company will carry on at this point despite stock price. Think stocking stuffer for your grandchildren.
Here's the deal: PPHM's monoclonal antibody Bavituximab has been used now in combination with standard chemotherapy and found to "not interfere" in any way with results of chemo/cancer treatment, but probably actually improves results. PPHMs MAB Bavituximab now has an established safety profile. That is Huge! Huge, and that safety profile is for an inferior grade MAB, one made up, in part, of mouse parts which may cause increased levels of allergic reaction. So Bavi may be safely added to standard chemotherapy. "Naked" [unarmed] Bavi was NEVER NEVER intended to be a stand-alone cancer killer. NEVER! But a lagniape that we never imagined is that BAvi is probably an immunological stimulant even when "unarmed" and used in the cancer treatment mix. And that immune boost is documented in severely immunologically crippled advanced cancer cases. But we are not, repeat NOT, in this because Bavi showed some measurable improved survival even unarmed. We, like BMY, are after the biggie: fully-armed a fully humanized MAB cancer bomb. That's the cancer killer. Not chemo. Not naked Bavi. Read my lips: it is fully armed and fully humanized Bavi. BMY has their full-humanized MAB that docks on anti-EGF. PPHM's MAB has a better, more universally applicable cancer docking site, -PS. The science is a done deal. The animal trials are finished. The theory is sound. The patents are there. The strategy is to add two known quantities together to fight cancer, fully-armed and fully human MAB Bavi. It's a no-brainer, that's where we're going. Things evolve. We're at there now. The coup de grace is to move fully armed and fully human Bavi directly into PiiB human trials. That's why we're here. That's when the PPS share kickstarts.
drontle2, duh. Welcome to the board by-the-way. A "reasonable" [?] segment of the board sees that scenario as being a valid one. You said, "Without any phase II news yet to drive the PPS up, is it feasible that a BP company is using it's cash to purchase short positions to drive down PPS and for PPHM to sell for a portion of its real value?" The "ace-kicker" hole card here is the biosimilar scene where all the puzzle pieces, MAB and chemotherapy payload, come together as having safety and efficacy profiles, and voila, all-human Bavi, conjugated with a proven chemo agent (pick one) is suddenly in FDA-approved PII trials. Will the stockholders see any of the fantastic upside? Stay tuned.
Hope everyone's not selling the news.
mojo, let's revisit your graph on Chemo v. Chemo+Bavi. What's your take on the huge divergence in PD, progressive disease, in the two studies? Other parameters are about even.
Long- and short-term strategic outlook: India data confirms safety and "non-interference" of MABs added to the chemotherapy brew. We knew that. Witness Cotara carrying radioactive iodine (one of my favorites). Chemo agents have FDA safety and efficacy profiles, and need no more testing. Chemotherapy cancer treatment doses will fall radically. If a "chimeric Bavi-, is safe with chemo, and if as a naked MAB Bavi- also stimulates the immune system, then fully-humanized Bavi carrying a traditional chemotherapy payload is a no-brainer. So now, as in the past with Avastin and ERbitux entry into the anti-cancer market-place, the "chemo- manufacturing crowd" continues its conspicuous contribution to...uh...the inertia we witness. Who are the winners, and most important, the losers, when MABs continue to expand their usefulness in medical therapy.
chey, thanks. look familiar?
A Public Utility listed on NASDQ? PPHM.
swingtrader, interesting scenario. One of many. Ironic about how in this game it is not immoral for pros to have their way with retail trade. Bavi should have been launched already. Anti-PS technology and therapy is here to stay as long as MABs are used for therapy, and it appears that "large molecules", like MABs, are being FDA approved faster than small particles. What transpires from this point to retail shelf for Bavi is money talk, not technology. If institutions do not hold much PPHM stock, then who but us?
thatresult is suspect because of its spectacularity...
mojo, so your graph and comparison shows that Bavi pushes back recurrent disease incidence to 2.3% during trial period v. 8+% for chemo alone?
mojo, thanks for all your graphing efforts!@!#. The numbers on the left are P/C chemotherapy without Bavi? Most startling are the favorable PD [progressive disease] numbers. Please confirm. thanks again.
lafont, yes absolutely