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BioBS, as an ear, nose, and throat doctor I respectfully disagree. The work on Bavituximab absorption through nasal mucous membranes has already been done, and that route of administration appears to be excellent. I don't have time to find the article. Cheers!
Bidrite, wonder if Friday's Level III "incredibly large buyer" sighting was seen by more than one person
Sunstar, nice post. Sounds like Bavi might be necessary long-term for these patients. I suppose that's where the Bavituximab intranasal spray application comes in.
CP,On Thursday, when PPHM price was approx. $1.48, you said to Harry Crumb,"I have been looking at NASDAQ Level III for PPHM. I think we may go MUCH higher today. There is a 75% chance." Wonder how many feel burned. Any thoughts?
good hunting john,There are actually several physicians and doctorates aboard, and I can think of several who has been aboard for a decade or more enhancing the credibility of PPHM science ... even before clinical trials began. Believe it or not, the pre-clinical (animal trial) resistance to MAB Bavituximab was even greater than after clinical (human) trials began. Some of those with advanced degrees in the sciences are sitting back when things are going well, letting someone else carry the ball for awhile. Facts are facts, and we are waiting for a few more to finally clarify the situation.
edcpf...VERY nice post. thanks. eom
md1225, "WHY is Peregrine withholding "value" driving information?" Because whoever "owns" PPHM tells them
to. Our fractional ownership is a drop the bucket.
ol blue: altho adding Bavi might be helpful for your bladder cancer, you should be all right with current protocols. Good luck. If you can find an oncologist willing to deviate from the standard of care for your stage cancer, and decide to apply for Bavi for "compassionate use" off-label, I would like to hear how you fare in that quest. Best wishes! Fingers crossed for you.
Cloaked protector,I am reluctant to "pull rank" on you, but those of us who have been "into" PPHM since early pre-clinical years have lived through a barrage of negativity not being close to equaled in the past 4 years since you've been aboard (or has it been longer?). PPHM continues to be a cheap research and development pod for at least one large pharma, the government, and finally...way down the line...the public: stockholders and suffering patients with serious disease. We are here to facilitate this movement, and keep close tabs on the oligarchs running this charade. And that would not be SK and PPHM management, but the aforementioned large stakeholders and, thankly, UTSW Board of Regents, et.al. Huge considerations beyond our conception. The Chinese are involved. The Russians.
We can only hope to be proportionate beneficiaries after being benefactors for so long. I'll say it again for the umpteenth time: the share price will go up when the money interests are aligned to big money's satisfaction.
Chill, nobody is going to beat us to the finish line with anti-PS technology, and Bavi is almost certainly not going to be used extensively in the applications it is being tested in (advanced non-operable, non-curable liver and lung cancer). We have established safety for the platform, and are still looking for its most efficacious and cost-effective application.
Bavituximab is PPHM flagship, but just as Microsoft/Google/Apple CEOs have said they are looking for new CATEGORY entries which create a market for related spinoffs, ANTI-PS is a new category in biotech. I would be terribly disappointed if Bavi does not make the grade, but it would not surprise me if a month before or after that decision there appeared confirmation of an equally impactful application of anti-PS, and it will probably be in the realm of inflammation and infectious disease, but could be as disparate as vasculitis or Alzheimer's disease. I hope Bavi is approved, but find it difficult to believe that Bavi vs. incurable bulky solid cancers is the best and highest (and only) application of PPHM's anti-PS patents. To feel reassured, simply read the patents. I'm still on board. Haven't bought much lately though. Cheers! And have a great weekend. It is sunny and warm in Carmel.
purpledawgs:thanks re. Cotara in China and hepatocellular carcinoma. A very good find. For me, like a sailor looking for land! Everyone here knows my advocacy of I131 in general, and Cotara delivering that load. I suppose when the infatuation (and limitations) of immunomodulation are fully appreciated (again...and again), then we will be able to get back to basics. Since Cotara cost us (stockholders) $60 million, I would like to know exactly how it is being prudently "mothballed". My recollection is that we gave China the rights to it for lung cancer app. Strange that it has fallen off the radar.
djohn, I know it is beating a dead horse, but I am still a believer in Cotara concept, of more precise delivery of I131 to tumor site. It looks now as if more than one MAB is capable of doing that (including Bavi?), but now the fascination is with immunomodulators which may well work in combination therapy in early disease, but it still takes a bomb to shrink large, bulky tumors which, with earlier diagnosis and intervention, will hopefully go the way of Cotara. However, with the way 3rd party intervention is going, I am not certain that in the near future we are going to see a decreased incidence of large bulky tumors at time of presentation to a physician. All this is a longwinded defense of a Cotara-like MAB. I would still like to see what the Chinese came up with in their trials of Cotara in lung cancer. Apparently it was nothing remarkable. Cheers!
cramer rumor clever cover for covert buy?
very pos. feel, last few days... eom
Hypi, you're right about BigPharm money being able to shut out newcomers. And the biggest players are undeniably able to more easily market marginally effective goods. However, I think that in the past few years PPHM has demonstrated its staying power, and at this point an explosion in share price is entirely possible .... dependent on the trial numbers generated. The numbers cannot be marginal, and must be convincing. If "naked" Bavi does not come to market as an immunological stimulant, it could be a while before fully human Bavi armed with a cancercidal agent can come to market. At worst PPHM will become a boutique monoclonal antibody production company. "MABs account for 40 percent of the entire biotech drug market – and the market share keeps increasing. Sales are projected to reach more than $160 billion in the US alone over the next few years. Of the ten best-selling drugs in 2012, six of them were monoclonal antibody drugs, each with annual sales value exceeding US$5 billion.
Some biotech companies have attracted billion dollar price tags. In 2008, Eli Lilly & Co. acquired ImClone Systems, Inc. for $6.5 billion. ImClone’s only product – Erbitux®– had generated annual sales of approximately $1.3 billion in 2007. Therefore, ImClone was valued at a 5x multiple to prior year sales. In 2009, Bristol-Myers Squibb acquired Medarex, Inc. for $2.4 billion, offering $16 per share – a 90 percent premium to Medarex’s closing share price the same day." And Hypi, please believe me, Erbitux is not a patch on Bavituximab. Not even close! PPHM has other very good potential tickets in their portfolio that have not even been more than mentioned in the past few years. PPHM and Bavi are the real deal Hypi.
Monoclonal Antibodies Continue to Drive Biotech Investment
Debbie Stephenson October 23, 2013 www.firmex.com › Blog › Dealmaker News › Industry Trends
Christmas cheer: Interim reports of PPHM's Bavituximab indicate a subset of Liver cancers...probably 1/4-1/3 of them... appear to be uniquely responsive to Bavituximab + Sorafemib, producing increased immune cell infiltrates into the cancers which produce and deliver the patient's own cancer killers. "If this trend continues", as pundits say on election night, Bavituximab will be approved for Liver cancer, and probably for that subset of liver cancers (Millions of patients worldwide) associated most closely with subacute (e.g., active) hepatitis virus.
Bavituximab, a moderate immune stimulant when used as a "naked" (e.g. unarmed) antibody, will eventually be used in early cancers, those smaller than 1cm (<1/2 inch), which is the size we are now able to diagnose precisely. Extensive preclinical and human trial data confirm Bavituximab almost certain safety extends the "degrees of freedom" in its use to much more than just cancer cases. The list of possible applications anti-lipoprotein antibodies such as Bavituximab and similar, seems vast at this point, is similar to the craze now for anti-oxidants, but much more potent, specific, and/or "directed" treatment than antioxidants.
Obviously, an intact immune system, unpoisoned by "chemotherapeutics" (e.g. cytotoxins), is a plus... yet Bavituximab is currently in clinical trials against end-stage lung cancer, and also advanced "untreated" liver cancer ("untreated", wink-wink). Bulky, solid tumors.
For those who feel robbed by the apparently sabotaged early trials, this is obviously the time for you to fund your feelings and buy at bargain prices. You have been spared the agony of jumping in at a much higher price after two years of almost priceless increased knowledge about Bavituximab's potential, and its mode of action. Cheers everyone. Off for dinner now. I am frustrated too, but generally optimistic.
md1225 & cjgaddy, the synopsis is a bit confusing. Perhaps U2 or others can clarify the apparent contradictions:
"METHODS: Patients with locally advanced or metastatic HCC deemed ineligible for curative therapy with NO PREVIOUS SYSTEMIC TREATMENT:
RESULTS: 38 patients were accrued, 7 still on treatment. Patient characteristics: median age: 60.5 years, male 74%, HCV: 79%, Black: 47%/Hispanic: 29%/White: 21%, PREVIOUS TREATMENT 37%..."
I suppose that means locally or surgically treated patients were a part of the trial?
"[Patients were treate]... until disease progression or intolerable toxicity. 38 patients were accrued
"RESULTS: 38 patients were accrued, 7 still on treatment."
So 7 of 38 are still being treated with no progression of disease. Very good.
However, Four month PFS is 76%. Great result.
But what does this mean? "...and there are no partial or complete responses."
Also, "Six patients had tissue analyzed pre- and post-treatment, 2 of 6 demonstrated increase tumor infiltration of CD4+, CD8+, and macrophages with a corresponding decrease in Tregs."
Not sure what a "Tregs" is. Surprised that only 2 of six had increased tumor infiltration of Cd4 etc. Wonder what that subgroup looks like.
Interesting stuff.
I agree with you MD1225, this could/should be a winner for Bavituximab in early liver carcinoma. AND, I have not been particularly upbeat about that possibility until reading this synopsis. Very impressive.
There must be some reserations out there in the world of liver treaters though. Possibly the 10% confidence level provided by the small cohort.
Reminds me of my favorite duble entendre:
"Life is only as good as the liver" !!
4ourRetirement, a bit of a reach on that theory, but it might indeed smooth the red tape involved in moving right into adding Bavi if 1st line treatment is failing. interesting idea. Bavi's true potential is not in failed first line treatment, but in early diagnosis and treatment. bulky solid tumors are simply not the reasonable or logical application...unless Bavi is bearing a cytotoxic warhead.
BCS Paladin, a huge difference between blood cell/bone-marrow associated cancers and solid cancers, and no definite cross-overs yet. Bavi's MOA (anti-PS or -PS docking site) seems to still be a sensible avenue of pursuit.
cloaked, a well thought-out and well-rendered treatise. thanks
hypi,an interesting point of view. Enjoy posts. eom.
md1225, re.compassionate use of Bavi and Cotara. Do you know the regulatory or corporate barriers to obtaining either or both? Does the request for compassionate use go directly to corporation, or to FDA? I would like more info on this pathway.
Anyone? Thanks
cheynew..or anyone. I hate to keep flogging this horse, but I cannot understand the BMY study in which "41% were alive at the one-year mark, while investigators tracked an overall response rate of 15%".
bioBS: 41% of 15% is 6.15%. Which is within the historical norm. We'll see.
swingtrader, I looked at that and dismissed it as applying to the entire cohort, but rather as being 41% of the 15% responding group. Can't it imagine it otherwise. BMY would be off the charts and every lung cancer patient would be on the drug.
I could be wrong, but as stated, cannot imagine it to be otherwise.
by-the-way, thanks as usual to CJGaddy for the data base he provides us with here which enables us to determine that PPHM just showed a 55% gain in over-all response rate when adding Bavi to standard of care chemo(toxins) used for fighting advanced, metastatic lung cancer. In my mind there is no question about Bavi having cancercidal effects. Now we simply must find the right application...and that is early application. These trials are (believe it or not) enabling us to move in that direction. Safety is the key. It seems at this point that we have that key.
eyebuystox, agreed. Interesting though that the BMYstudy did not have overall survival data
Correct me if I am wrong, but it looks like it is Bavi 35% vs. Standard of care 22% overall response rate; and Bavi 12% vs.
standard of care 10 months of survival. with no additional side-effects adding Bavi to the mix. My take-away from this report:
1)interesting
2) small cohort
3) not really meant to establish efficacy
4) Bavi is still in the race. Safe
5) We may feel "incrementally" more confident about the safety of trying/using Bavi in other indications
6) As CP once said, using Bavi with immune system toxins is not going to be the first indication for its use
7) This trial has not shortened the distance to the retail counter
8) Bavi needs to be used earlier as a preventative/cure; may be safely used in conditions ranging from toxic or bacteremic shock to viral infections; needs results from use with irradiation; will be a safe imaging label.
My thinking in 1-8?
The overall response rate of 35% vs. 22% is a head-turner when considering the awful disease Bavi is fighting. I have said here for years that you cannot expect a chemotherapeutic agent, especially an immunologic agent, to deal with this amount of tumor bulk. In this trial it would be interesting to look at what Bavi addition does to micro-metastases, but I doubt we have the capacity to look at that.
biopharm, interesting find. thank you eom
phosphatidyl: wow, thanks. I repeat (for the 2nd time): It would be shocking to discover that Bavi has not already been tried in Vivo in humans for Ebola. We might already be unwittingly witnessing Bavi effects in newly infected patients. There must be a 'tipping point' in Ebola, as with cancer, when the body's immune system is simply swamped...overwhelmed. Bavituximab intervention early is the key to Ebola AND cancers. The tragedy is how long it is taking to prove the hypothesis. Hopefully this sad saga will trigger reform in the process.
sunstar and biopharm, thanks. to repeat,I would be flabbergasted if Bavituximab has not already been tried with Ebola. It would be borderline criminal at this point. As we all know, some 3rd world countries have lower experimental/investigational thresholds than others. I am equally certain that Bavi vs. Ebola is similar to Bavi vs. cancer: the earlier the treatment the more chance of a cure. By the time clinical symptoms are present it will probably require combination therapy, and we are at the point now of getting that right. Cheers!
copper888:nice,thanks.
hawkfan1,well-done.thanks for QA summary eom
jimsgtx, "what's notable?" So what's new! "Empig noted that the company is in the process of figuring out a strategy to explore possible applications of bavituximab and PS-targeting antibodies to target Ebola." It's not like this awareness and testing of Bavi with Ebola started yesterday or today. Interesting dance going on here.
eBo and Dukesboy, we'll do it next year for sure. you guys need sparethemice and entdoc to make it happen. I think our biotech genius sparethemice is lurking and will reappear when his writer's cramp abates. he carried a large load for a long time. cheers.
"dukesboy" have a blast at the meeting, and send word to us pony express. your input here is respected.
CJ, your filing system is max-enviable. Unbelievable actually.
As you pointed out, when the British Ministry of Defense and the US Department of Defense are sitting of experimental data on PPHM's MAB Bavituximab, and the People's Republic of China are interested in PPHM's Cotara,clamping down on 100% of the trial information on that PPHM product, and clinical trials are going on in Russia with 2C3 PPHM's "better-than-Avastin" anti-angiogenesis MAB, and there remains absolutely no word out of Putin's Soviet Socialist Republic about trials on PPHM's 2C3..and even trials on fully humanized Bavi...it all makes for some interesting conjecture. Maybe it's as simple as nobody can recipe and cook those MABs like PPHM's wholly owned subsidiary and in-house MAB producer, Avid. Funny, isn't it? PPHM not only has the recipe for all these MABs, but also the cooking instructions.
Eyebuy, you're kidding about sell, sell, sell,,,I hope. I am not really expecting a mushroom shaped cloud tomorrow. They are still into information control at this point because the financier-stars are not quite in alignment, and department of defense it upside-down about information control...and until all that high level stuff with UTSW and DOD and...is solved... we can't uncork the champagne. I just think it is getting more and more difficult to contain the inevitable. The remarkable fact here is we are forced by "the establishment" to test fabulous technology (Bavituximab)in hopeless cases, and extrapolate therefrom its value in something as far afield as Ebola and Alzheimer's. Bavi is not a cancer cure, but simply an adjunctive treatment which should be a part of any cancer (and viral?) treatment regimen. We are therefore in a position of seeking Bavi's best application. It is a tragedgy the executive suite was forced into clinical trials of far-advanced lung cancer, and a equal tragedy that Bavi Phase II trials were sabotaged. Preposterous on its face. We slow-learners here have learned first-hand the dues newcomers to the biotech space must pay. Quite a journey. I expect a solid performance from the team in Tustin, and think they have reason to feel a little-bit smug at this point. The PPHM team has performed admirable in this dog-fight. Just too bad we couldn't have started with Bavi + irradiation. Have a great meeting y'all. And congratulations on a year of progress. Well Done!
Dukesboy, you at the meeting this year? eom