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.
bidrite with goosebumps calls for a corn likker Rx IMO. Hold the bumps for the hard data. My suspicion is that the liver trialwill show marginal improvement with good safety.
Now, on with the Bavi + irradiation trials. I think that is what will bring in the humungous dollars everyone is hoping for, and I am not so sure we have to run that clinical trial. Someone will probably be happy to do it for us. An easy sell IMO.
BioBS, my take on Garnick statement is that it was a hopeful anecdotal. Does anyone know if there are any survivors from the ill-fated PII who are still using Bavi on compassionate use basis?
I imagine there are a few survivors from various experiments that the company is keeping an eye on.
greenthumb, in addition to all the Euro-US players we have the possibility of India, China, and Russia, all privy to insider info re. peregrine properties.
realist1, thanks. Steve King should revel in the fact that the benefit of Bavi with irradiation therapy has been essentially confirmed. Connect the dots. Do you have to effect a checkmate to know when the game is over?! 100% survival with bavi + irradiation therapy vs. 17% survival with irradiation alone.
I don't care if the tests were performed on conger eels. This is the second study showing increased survival with irradiation. It is irresponsible, and possibly criminal, for the FDA to NOT move this thing down the track, and fast. I would use it, wouldn't you?
smartEtrader, nice post. I was going to write that I dread the Ides of $3.00/share, when commences all kinds of funny stuff, such as margin buying and redemption of preferred shares, and...and...a seachange for our baby (another mixed mixed metaphor)...uh, a new growth stage for the company. I auppose we can get through that barrier too, like all the others. If you compare the earnings potential of PPHM anti-phospholipid platform with ImCL's Erbitux, there is no comparison, and that stock went from zero to selling for around $120 at approval.
Steven W King, PPHM CEO since 2003, would probably love to write, "I told you so"... So I'm saying it for him! As a corporation chieftain Steve has admirers and detractors, but to has led PPHM through three Phase II clinical programs,and placed Bavituximab into PIII, while positioning another MAB a-TNT MAB, Cotara, at the starting gate of PIII trials. Steve had the wisdom to NOT sell PPHM's in-house MaB manufacturing facility when the company was in desperate financial straits, and to bring it into full cGMP compliance so it may manufacture and sell FDA approved MABs in an FDA approved facility. Prior to Peregrine, Steve worked with MAB Vascular Targeting Agents and with UT Southwestern Medical Center with the inventor of Peregrine’s anti-phospholipid technology. He has to date been wholly ethical in the company's claims for Bavituximab, not once overstating its efficacy. Best about Steve: he holds BS and MS degrees in Biology from Texas Tech University. We want him to continue exploring therapy based on the anti-phospholipid platform, and to continue thwarting attempts to hijack/steal/delay this novel new therapy.
K-T, a DD fact re PPHM I forgot to mention: PPHM has its own wholly owned subsidiary AVID, an in-house boutique MAB production company now scaled for mass production. Avid is/can fill outside orders and/or in-house MAB inventions, and the MAB market is looking huge for at least the next few years
Buying today is entirely appropriate given the gravity of the preclinical findings on Bavituximab effect on irradiation therapy results in lung cancer. This latest finding ALONE is enough to turn every head in the health industry. Why? For a "preclinical result? Because of the enormous mass of preclinical work on Bavituximab which has preceded this finding, and the utter consistency of transferring the same observations of safety and efficacy to humans from lower animal models. Admittedly in most cases Bavi in humans has not shown the gobsmacking effects seen in lower animals, there is no question in my mind that Bavi + irradiation, and/or Bavi + ANY cancer treatment could easily (and shoud) become standard of care. Huge. Obviously this could turn on a dime, as do many promising (or widely prescribed) medications. For the moment, I am not looking for backfilling of any stockprice gaps. We are not yet at the adjusted split level many of us bought at. Good luck to you who joined us today!
.
KT, buen idea re.linkage between PPHM preferred shares which are convertible at $3/common share, and the awareness among, say (for example) "Texas money", which might be classified as retail/wholesale buyers, or the "pre-institutional" big guy investors who want to know what's happening next in the Pharm Dept of their alma mater (in this case, UTSW), and before the big institutional buyers step in.
you're right, threes: safety of Bavituximab in humans appears to be well-established. Actually, when I look back over the years of following Bavituximab's progress the most outstanding aspect of it is the elegance and thoroughness of the preclinical trials and the theoretical rationale upon which it is all based. Hats off to Dr Thorpe and his coworkers at the department of pharmacology at UTSW who have produced truly Nobel-quality work. Antiphospholipid monoclonal antibody therapy appears to have a bright future...mindboggling in its potential.
for those doing DD here (lord help you sort through it all), PPHM has patents on not only a new and different type of anti-cancer monoclonal antibody, Bavituximab, but on an entirely new PLATFORM of potential new treatments for a wide array of inflammatory and neoplastic diseases. The platform is based on the fact that oxidatively stressed cells "flip" inside-out a group of compounds which are components of their cell membranes---phospholipids--- and these flipped phospholipids (example: phosphatidylserine [e.g.,-PS], become an exclusive docking site for attack by PPHM monoclonal antibody {"MAB"} constructs such as Bavituximab. The preclinical work and human trials with Bavituximab have been extensive, and positive. Recent preclinical trial results with Bavituximab combined with irradiation have been very positive. Bavituximab, combined with standard chemotherapy, is in Phase III clinical trials in humans for treatment of advanced lung cancer.
eastcoast guy, thanks. I want to rethink the bubble metaphor!! Not a good analogy...at all.
cheynew and bioBS, thanks for abstract news re. PPHM's Bavituximab combined with irradiation therapy. As stated here for years, it is the worst kind of misfortune that PPHM was forced to begin clinical trials in combination with chemotherapy rather than in combination with irradiation and/or surgery. That supposition appears to be fact at this point, with apparent spectacular results using Bavi in combo with irradiation. Think of the lives that could have been saved in the 5+ years PPHM and anti-PS therapy has been held back...by whatever forces. Now it appears to be like a bubble heading for the surface. GLTA!
dukes boy: AA=accelerated approval; FT=Fast track. Website to review these: http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm
cj, condolences...a loss words cannot describe. eom
Chris, great SeekingAlpha PPHM article. Thanks: http://seekingalpha.com/article/2032071-the-race-for-a-cure-for-cancer-the-final-chapter?source=email_rt_article_readmore&uprof=45
genecloner;What?! Pinworms (oxyuriasis) and mononucleosis? Crohn's Disease? Well, maybe. Most people (and possums)have them (pinworms). Handwashing and more discriminate French kissing would be more cost effective than Bavi for "impacting" on that, uh, GI cycle.
gene: efficacy and safety. At this point if Bavi works the PR will be plentiful and cheap. PPHM has established safety in Bavi. It has established proof of principle, and shown strong evidence of efficacy in advanced, hopeless lung cancer. You said you worked for ethical pharmaceutical houses. The very definition of ethical is to induce end-user (physician) trust through education and evidence-based recommendatons. Bavi- is what it is, and what that is become clearer with the passage of time. We want to facilitate efficient passage through the pipeline through meaningful clinical trials, and try not hype the product prematurely for stock traders. In the end slow accumulation over time will create wealth here. PPHM management has not set a foot wrong in the above respect.
it takes efficacy and safety to move a new drug. period. marginal players like Provenge would have problems no matter. We'll see what margins we have with Bavi. I have said for a decade Bavi will not win this race in a walk, but I think it will be approved.
so if we compare Provenge and Bavituximab, one product to one, rather than one marginal product to a vast platform, it seems that Bavituximab will actually have an easier time of it from here on in. Gotta go or I am in trouble! cheers everyone. Yes, dear. I have the car keys.
all off the top of my head...DNDN was pushing 20 when it crashed to less than 5 because it had not established statistically significance. Huge setback. Exactly the same order of magnitude setback as PPHM's September 2012 fiasco. But I do not remember that Provenge was in anyway subverted. Its numbers simply were not good enough to overwhelm the FDA. What the Provenge trial numbers did not do, public support did, and Provenge was revived, but barely, as the previous article attests. In the case of PPHM and Bavituximab (which is only one of a number of PPHM pipeline winners), this is only the first of an enormous number of spinoffs possible by adding the simplest chemical tweak. A cinch.
positive thought for the day: if Provenge, an immunostimulant for prostate cancer, can get approved, Bavituximab can get approved. No comparison in the earning potential of the two agents. Keep in mind that Bavituximab is an anti-PS prototype, repeat: prototype. A funny thing happened at UTSW pharmacology prof.Philip Thorpe lab. While playing with a "double-armed" missile that packed a payload of anti-neoplastic small molecules, they discovered that the unarmed, naked, MAB had immunostimulatory properties...and anti-inflammatory properties as well. Anti-viral? Anti-everything that causes a normal cells to flip membrane aminophospholipids inside out. This technology has vast implications as important as discovering the importance of carbohydrates and proteins. This is "fat science"...note the lipid glued onto the amino acid/protein. Therapeutic fat science. Fats that fill and fats that kill. Anyway. No comparison between DNDN value and PPHM, although I agree the pathway to FDA approval is similarly strewn with landmines.
EastCoastGuy, your narrative about DNDN and its prostate drug, Provenge, and DNDN similarities to PPHM, mentioned stock price, financing, etc. but did not deal with a comparison in product efficacy. To all you guys still wearing a prostate, a recent article by Seal, et.al., included DNDN's Provenge (sipuleucel-T) in the mix, and concluded, "The results of this review demonstrate that the therapeutic landscape of MPC (metastatic prostate CA) has changed dramatically and many therapies in MPC now show OS improvements of about 4 months in the postdocetaxel setting. Study: Of 77 studies identified, 26 (34%) evaluated survival as an end point; 14 (18%) assessed PROs/tolerability. In chemotherapy-naive patients (no/minimal symptoms), median overall survival (OS) was 26 months for sipuleucel-T. In relapsed patients, the survival benefit of cabazitaxel/abiraterone was 15 months and that of enzalutamide was 18 months. Denosumab prolonged time to first on-study skeletal-related event (20.7 months denosumab, 17.1 months zoledronic acid; P = 0.0002, noninferiority; P = 0.008, superiority). Similar benefit was documented with radium-223, a new bone-targeted a-particle-emitting radiopharmaceutical. Radium-223 also significantly improved the OS (two-sided P = 0.00185). Specific to PROs, they were incorporated primarily as secondary end points, and improvements in pain response (most commonly evaluated) were variable among the agents. Last, the therapies were associated with unique toxicities requiring careful consideration.Value Health.
2013 Jul-Aug;16(5):872-90. doi: 10.1016/j.jval.2013.03.1628. Epub 2013 Jul 10.
Efficacy, patient-reported outcomes (PROs), and tolerability of the changing therapeutic landscape in patients with metastatic prostate cancer (MPC): a systematic literature review.
Seal BS, Asche CV, Puto K, Allen PD.2013 Jul-Aug;16(5):872-90. doi: 10.1016/j.jval.2013.03.1628. Epub 2013 Jul 10.
eyebuy, I would follow someone named Cyril Empig into the jaws of death. No matter what he's done.
freethemice, do you get the herein pictured volleyball maven by chance, or does such swimming suit advertisement come with those of enormous PPHM following here, and entourage? Frankly, I am jealous. Cheers, and keep the good work on the PPHM DEW line.
exwan, LOL. GeneC.what's this about liver leak?
InternetForU: Nice post. Best question: "Why is it that the COMPANY everyone so dearly loves and invested in is the one which is bringing down the PPS by diluting the shareholders? Why did they need to run ATM after the FTD?"
dia and bioBS, the results of Bavituximab and Sorafenib vs. liver cancer will in all likelihood not be a knockout, but a scorecard decision based on statistical significance. If statistically significant improvement is noted in the required metrics it will establish that, indeed, Bavituximab has anti-cancer effects, something we know already, and it would (hopefully) ratchet up the urgency of adding Bavi to early stage cancer treatment strategies...and to add Bavi to irradiation protocols. It is possible in some situations, depending on trial design, to show statistical significance which does not dictate future use of a pharmaceutical because of cost:benefit ratio, etc. Our experience with Bavi to date does not presage a home-run, but then even pitchers know balls out of the park on unusual occasions.
FTM..I almost wrote the same re. liver and pancreas. We have to be realistic about these horrendous diseases, and the limited role chemotherapy can play in advanced disease. In Bavi we have a great candidate compound for early solid cancers, and for adjunctive use in surgery, irradiation, and chemo...possibly a great preventive...and probably for other inflammatory diseases. Let's be pleasantly surprised with incremental improvement, and not crash this thing if it does not perform miracles.
I can't think of a single oar PPHM has in the water that, if broken on the 19th, is going to sink the ship. A couple I can mention would float the boat higher. I do not have outsized expectations for Bavi-liver cancer results, so hope to be pleasantly surprised.
genecloner, agreed, the cost of the Sept. massacre is/was incalculable.
I suppose the most enigmatic factor here is that at the beginning of PIII, and at the point we are now, there is almost no speculation manifested in share sales. For all the optimism and hyperbole, the share price and volume remains a pittance. There appear to be multiple crimes being committed multiple times before our eyes, and all of us are powerless...except to express our power of speculation...and continue to inject hopium. hohum.
Genecloner, VERY interesting CV. I too worked for Parke-Davis for a summer before med school. Your comments about tostitumomab and I131(aka Bexxar) are also interesting, vis a vis Cotara, and similar. What is your take on Cotara? Sounds like it might be the opposite of mine. Is the bone marrow/platelet suppression serious in either? Thanks.
jim, you have probably seen this summary of current concepts in MAB treatment of CLL, Curr Cancer Drug Targets. 2008 Mar;8(2):156-71.Novel monoclonal antibodies for the treatment of chronic lymphocytic leukemia. Robak T.
Obviously I would fight like crazy to obtain Bavituximab treatment for myself in such circumstances, and it would be a battle because oncologists are held to "the standard of care", and can be sued for suggesting something which is clearly outside that standard. Also, it is a huge hassle for an oncologist to jump through the hoops. Even though congress and the FDA are on record as supporting easier access, the reality is often the opposite. It can be done. Start early on the "compassionate use" pathway. You can help a lot of people here while helping yourself if you keep us posted on your progress along that path. Good luck!
sindoe, very cool question re. a very cool technology. The surface biomarker in this particular article you are referencing [which is very interesting: thank you!]is an integrin which binds to a commercial product, Integrisense 750. PPHM does have patents applicable to the near infra-red visibility imaging field for better mapping and visualization of cancers pre-op and intra-operatively. Obviously, instead of integrin Bavi binds to "flipped" cell surface phosphatidylserine )-PS). You can see all the cross-referencing of new patents in this field with Bavituximab in this field by simply googling "bavituximab and near infrared luminescence". Thanks for the "heads up".
Genecloner, UTSW holds the Thorpe patents which are licensed to PPHM. Cotara patents are another matter.
the most incredible part of the Bavituximab/PPHM story is that nobody/nothing has come along to destabilize the anti-PS platform of which Bavituximab is a pioneering iteration, but in its present form, Bavituximab, as such, is not the final solution to cancer. It is true that PPHM needs a product such as Bavi to insure cash flow to pay for the almost limitless possible R&D to expand the various pathways which have sprouted already from the anti-ps platform: armed Bavi; fully humanized Bavi; Bavi-imaging; and Bavi as a nasal spray which may be used as apreventative and/or immunologic adjunctive treatment for myriad infectious disease.
It seem inevitable that Anti-PS, and/or anti-aminophospholipid treatment will be a whole industry with myriad applications. It's all there: Full support in the peer-reviewed literature: in-vitro testing, lower animal testing, and numerous human trials. Apparently tight PPHM patents cover it all.
Why the slow-down? For PPHM, the company, a few miscalculations have been made: 1) beginning trials in competition with, and then in concert with chemotherapy agents, mostly systemic poisons, rather than in combination with irradiation therapy; and 2)trusting that China would be forthcoming with Cotara vs. lung cancer.
Bavi has not delivered a knock-out blow that brings the howling crowds through the gate. The most convincing trial data to date was contaminated (whether intentionally or not), but still compelling enough for the FDA to allow development and human trials to continue. The other slow-down is that the only iteration/example of the platform today is Bavituximab, an unarmed (eg, "naked")MAB which was found incidentally on the way to market to have anti-cancer immunology properties even when (especially when) unarmed. What is important to remember is that even if Bavituximab is not a solo slayer of large tumors, that does not devalue the vast value of the platform.
Given Bavi's performance to date it is predictable that entrenched pharma interests are [at the very least] passively obstructive re. its march to market while scratching their heads in disbelief that their scientists have not come up with a better Bavi in all these years. Remarkable actually.
What happens if the liver data is only "so-so"? Nnot the end of the world. There exists an entire realms of cancer therapy that has not even been touched investigationally with Bavi, and that is irradiation therapy and surgery where we can expect much more dramatic improvement when the two, irradiation and Bavi are combined. Or post op cancer surgery Or post op anything. Anti-aminophospholipid therapy has a tremendous future. Let's not give it away.
cloaked, wow! nice post. eom
sunstar, a "must read". thanks
So what does Duramycin and phosphatidylethanolamine have to do with anything PPHM Patent portfolio covers much more than apparent on the surface while attention is turned (rightfully) to Bavituximab, there is considerable other aminophospholipid research (anti-PS, anti-PE, etc) going on. Neoplasia. 2011 Apr;13(4):299-308.Increased exposure of phosphatidylethanolamine on the surface of tumor vascular endothelium. Stafford JH, Thorpe PE. "We have previously shown that oxidative stress within the tumor microenvironment causes phosphatidylserine (PS) to redistribute from the inner to the outer membrane leaflet of the endothelial cells (EC) creating a highly specific marker for the tumor vasculature. Because the distribution of phosphatidylethanolamine (PE) and PS within the membrane is coregulated, we reasoned that PE would also be localized in the outer membrane leaflet of tumor EC. To demonstrate this, the PE-binding peptide duramycin was biotinylated and used to determine the distribution of PE on EC in vitro and in vivo. Exposure of cultured EC to hypoxia, acidity, reactive oxygen species, or irradiation resulted in the formation of membrane blebs that were intensely PE-positive. When biotinylated duramycin was intravenously injected into tumor-bearing mice, it preferentially localized to the luminal surface of the vascular endothelium. Depending on tumor type, 13% to 56% of the tumor vessels stained positive for PE. PE-positive vessels were observed in and around hypoxic regions of the tumor. With the exception of intertubular vessels of the kidney, normal vessels remained unstained. To test the potential of PE as a biomarker for imaging, duramycin was conjugated to the near-infrared fluorophore 800CW and used for optical imaging of RM-9 prostate carcinomas. The near-infrared probe was easily detected within tumors in live animals. These results show that PE, like PS, becomes exposed on tumor vascular endothelium of multiple types of tumors and holds promise as a biomarker for noninvasive imaging and drug targeting.