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Moby, agreed that SK's revelation re. Bavi and lung cancer is a bit unusual, but fair warning. He characterized it as "most remarkable [results to date]," and >50% response, "showing up in the 6 mo. progress free data." He characterized Bavi as having "high tumor response rate." The 'take away' on viral was a reinforced Bavi safety profile in the Hepatitis C trials, but only "signs of antiviral activity similar to other antivirals."
Bavi dose will continue to be 3mg/kg dose, for what that's worth. And SK said the FDA feels that the promising Bavi data supports continued clinical trials. They have decided to go "all-in" for the next FDA approved clinical study of Bavi with Docetaxil for lung CA. That p2 will be in 120 patients and will be double-blinded/placebo. SK said if the results are whopping, they will apply for accelerated approval, and if only "good" results, they will move into pIII with Bavi.
He DID mention that both Chemotherapy and irradiation therapy "upregulate" -PS, another way of saying those treatment modalities speed up cellular death/apoptosis, so Bavi, which ties up the -PS (down-regulates), increases macrophage (scavenger) ingress into tumor environ.
The webcast was the first time I've seen the PPHM CEO in action. He is presentable and obviously knowledgeable, and I think he did a good job. The company could use stronger graphics to support the narrative, because the terminology is complex, but the concepts are pretty basic.
If he didn't move much money across the table at the meeting, he is going to get some more of mine tomorrow. Cheers. PPHM has sumpin' worth cheering about.
RobertCJ, afford Obamacare? I've posted for nigh onto eight years that the biggest thing PPHM stockholders have to fear is a political system that eliminates the outrageous profits drug companies have enjoyed to date. The medical industrial complex is a bit more easily diktated to than the banking/finance system or the military/industrial complex.
r622, couldn't get into that website. Can you summarize. Is PPHM being defacto specified?
cj, thanksa million. This SK statement is interesting because he emphasizes that Bavi is immunostimulative, and when used in combination with chemotherapy is synergistic for that reason
[12-8-06, at Qtly. Conf. Call (King/Lytle)transcript http://tinyurl.com/y2smkf...SK:]. ”We continue to believe that Bavituximab has the potential to be a major addition to cancer therapy, with its novel immunomodulatory mechanism & potential for synergistic effects..."
Bavi- as synergist. Proud Bavi-. The idea of being associated with, subordinate to, or synergistic with chemotherapy. "Bavi is a logical companion to many new and exciting cancer drugs," SK said.
Bavi- is probably much more helpful when used in combo with irradiation.
Bavi is a "double armed" MAB that can carry a payload. This potential for Bavi is seldom mentioned. Bavi latches onto inverted PS with one arm, and has a spare arm for carrying payloads, either irradiation (I131), small quantities of oncology "drugs", or both.
There must be plans for Bavi trials in combination with irradiation. If there's a problem with that, other than money, we should be told what the problem is.
The choice of strategies, Bavi with chemo combo, was probably all that was possible at the time. Y'all probably remember those days before the India/Georgia "break-out", when PPHM took Bavi trials off-shore, were financially scary.
Showcasing Bavi as an immune-modulator or enhancer is a good idea, but that mechanism of action was noted as a "spin off" benefit of the double armed MAB missile which was to deliver destruction directly to cancer. We all know that the immune systems in the present "clinical-trials cohort" are mostly gone, so we are actually gathering irrefutable safety data in an immuno-incompetent cohort and reporting an end-point related to survival. This is the opening salvo for Bavi. Necessity dictated the strategy. Tiny PPHM has climbed onstage now with the cancer giants and plunged headlong into advanced virology. Now the action begins.
grine, suppose it was Asian and E.European money?
looks like they're being more reasonable about the number of shelf shares going out. Anyone selling in the next few minutes? Maybe a pop at the finish? Or the usual. I put in three buy orders today at lower prices and missed ALL three. Shows to go ya.
geo, I like your postulation that a future partner for PPHM is actually specifying consultants to be hired, sumpin' like a port requiring an experienced pilot be put aboard boats about to enter a (safe) harbor. Good thought. Makes a lot of sense. We'll see. Someone already mentioned the DNA connection, which I have harped on for years. The following is from 1997, apparently after Garovoy was at the UCSF transplantation and immunology center (another DNA association):
BERKELEY, Calif.--(BW HealthWire)--May 28, 1997--Marvin R. Garovoy, MD, has joined XOMA Corporation (NASDAQ:XOMA) as director of clinical research, medical affairs. In this position he is helping the company move its products "from bench to bedside" by developing product and indication strategies, identifying products, choosing medical targets and designing clinical trials. He is also medical monitor for XOMA's hu1124 clinical trials and for the Neuprex(TM) partial hepatectomy trial. "It's great to have such a renowned transplant immunologist join our ranks," stated Patrick J. Scannon, MD, PhD, XOMA's chief scientific and medical officer. "Marv ...
firechief, I decided against playing the "spelling card" against UMass because I have been almost as nonplussed about the spelling in some of my posts after re-reading. That said, I too was a bit, uh, surprised about the 3rd-world spelling at UMass. You know how all docs are in such a hurry. But his first post, the one about lunch with the big dawgs, was only a day after mine about dinner with UCSF chancellor and former Genentech bigwig. Co-ink-ee-dink? Not.
jake gone? hadn't notice. UMass isn't a joke? What am I missing?! Have to agree with Moby on this one. Signal seeking defined: A third-world PII trial. Y'all are the greatest. Shock and awe soon. Doc
thurly and jessme, viral encephalitis cause of coma is usually cerebral edema, and if the edema has been present long enough and is severe enough, then permanent irreversible damage is done and recovery is problematic. There are too many variables to be able to be intelligently conversant about it here, and timely obtaining of Bavi on a compassionate use basis would be a long shot for certain.
Thurly, I am sorry to hear that. It is possible they are right. There are neurologists who post here. Maybe they can address the problem.
Thurly, sorry to hear about your relative with viral encephalitis. It could, in fact, be too late for Bavi, and possibly true that the doctors have heard of Bavi. The opposite is also possible. Next question to ask: "What imaging study results,level of consciousness,etc. leads to the conclusion that it is too late for Bavi?"
Multiple choice question: Interest in some biotechs is up because of:
a. current public perception that the regime might crumble;
b. positive outlook for fewer guns and more butter, i.e., more money into healthcare;
c. favorable prospects for pharmaceutical profits to grow outrageously four years hence, after the next election;
d. all the above.
cheynew, thanks for the post re. disgruntled shareholder action against Affitech. Good stuff. Too bad lawyers and courts must be expensed out before both sides listen to each other about sharing the wealth.
CaptainCobec, nice. Affitech stock action could indeed be reflecting an amazing discovery: which anti-phospolipid antibodies have the greatest effect against cancers and viruses. A panolpy of Anti-PhosphoLipid MABs are probably being studies by Affitec, that is, all the potentially therapeutic phospholipid MABs current technology can detect. Affitech has milestone goals with PPHM. The first appears to have been handled easily, that of decoding for mass synthesis a humanized form of Bavi. That done, Affitech was next tasked with sorting through myriad phospholipid MABs for therapeutically potent agents. And now they may have closed in on the second milestone. Maybe.
The above is only one possibility, and I may be getting way too far in front of myself.
We can mass-produce fully humanized Bavi. That is know.
Affitech said it has the recipe.
Avid can cook the MAB broth.
If chimeric Bavi, PPHM's anti-PS MAB--made of mouse and human parts--is significantly useful in the short-term, then the outlook for oral fully-humanized Bavi is excellent.
Other possibilities for the price rise?
Russell index buying?
The biotech I watch were way up today.
Numbers for Bavi-chimeric are being crunched right now for release in the next few days. Exciting stuff.
Efforts of PPHM lab scientists have gained scientific community respect and attention, and the perception out there is one of "definite possibility" for PPHM agents. Why? Little downside:the apparent paucity of side-effects; enormous upside.
Glad a bought a thousand shares a week after the split.
north40k, my understanding of the oral v. parenteral route of adminstration is cursory, but the problem of oral administration of large compounds, especially proteins, is, in part,protecting from stomach acid first, which can be easily done, and then size-related issues of passage through intestinal lining into bloodstream, and then liver deconstruction and reconstruction...yada. Obviously it can be done, and will be done, but IV administration is surer and decreases the variables immensely.
north40k, I was about to respond that MABs do not perform well when administered orally, so using Bavi once daily with other HIV cocktails didn't look likely. Most MABs are given IV. However, I did find a reference to adaptation of MABs to oral administration in trials on auto-immmune disease [http://www.hadassah-med.com/English/Eng_MainNavBar/News/Press+messages/aotoimmune+deseases.htm,] and also references to use of oral MABs for intestinal infection with protozoans when systemic absorption is not important.
r62etc: interesting stuff. Amy Brideau-Andersen, PPHM's new director of a new PPHM Anti-Viral Research Group sounds like the real thing. Her experience with viral hemorrhagic fever is a direct hit. The literature on PS has exploded, and PPHM is responding appropriately as a leader in clinical application of the principles. Anti-PS fixes the apoptotic glitch in cancer and/or virally infected cells, and unblocking the body's potential immunological ability to delete unwanted "immortal cells and parasites. The strange thing is that Bavi is also capable of transporting a payload to the problem area, a traditional treatment d'jour.
Duke paper BKT? Maybe its classified.
senrex thanks. I enjoy what chartists write. Two-dimensional, or two-axis, information is probably mostly what professional investors program into their "buy" paradigm, and PPHM is now undeniably a buy. PPHM performance last year was quite good despite fincial and credit market meltdowns. Good Bavi numbers popped up in clinical trials reports last year. And Cotara is still an item. PPHM ally with its anti-TNT platform is none other than China, and that includes china's health AND military departments. If PPHM's clinical candidates had produced less promising numbers, the present support pattern would not have held. And CJ wrote here that more study data on Bavi is forthcoming, and The numbers must be exciting. Doubters be warned:a spectacular set of numbers from any PII trial will shine the light right on our baby, and there are big leaguers in house now who are watching all this very closely and will be able to vouch for the results. Did FDA or Uncle have a hand in putting the new pros in the lineup? Will new government policies help move worthy product down the endless pipeline to treatment tables?
EZ, if you read that PII Pfizer report on figitumumab you can see there is smoke, or a smokescreen, but no fire. Who cares if response is dose related if the improvement is 3.4 months to PFS v.3.9 mo. ..."fIGF-1 appeared to be a marker for resistance to chemotherapy, with median PFS as low as 2.1 months for patients in the highest fIGF-1 quartile (P=0.11). Patients with elevated baseline fIGF-1 levels appeared particularly sensitive to figitumumab. Study findings showed that adding figitumumab (20 mg/kg) to chemotherapy in patients with high levels of fIGF-1 increased PFS, versus treatment with paclitaxel and carboplatin alone (by 3.4 months, 6 months vs. 2.6 months, respectively, P=0.001 for patients with fIGF-1 >0.6 ng/mL, and by 3.9 months, 6 months vs. 2.1 months, respectively, p=0.001, for patients with fIGF-1 >0.9 ng/mL). Pfizer should go back to tetracycline and marketing sure-winners.
realist, nice post. My prediction is $18 by next year-end. That's been my prediction for the past couple years, one that's like that old broken clock. Don't let a "glass half-empty viewpoint cloud a reality: PPHM has gained value this year, and imo by a substantial amount. The stock reverse-split did not hurt the company, and PPHM is undeniably in a better place than this time last year. And your idea that a stock price is the final arbiter of a company's worth has been wrong in a number of spectacular instances. So we are wagering that the present PPHM's stock price is a bargain, and not a true reflection of the company's value today or its potential in the near and long term. Financing is not the fright it was last year and in previous years. PPHM's technological platform has, as you correctly noted, garnered considerable interest in the most respected echelons of the scientific community, not only because of current trials, but because of a clear-cut, wide-open technological innovation with potential that expands almost monthly. At times like this, at year's end, we should send kudos to the bench troops and all the employees at PPHM for doing such a great job. Next year will be a good one...and the next even better. Good luck all. And Happy New Year.
r622, interesting article. thanks.eom
patent,part0005 paraphrased: Biotechnology plays an important role in human and veterinarian medicine, agriculture and many others. One great advance in these fields, radio-labeling, requires ongoing biotechnological development, such as increasingly efficient production of radiolabeled proteins, such as antibodies and peptides, and other applications requiring electrophilic modifications necessary to attach a radiolabel.
cj thanks. New PPHM patent a natural, and obvious winner. Let's see how many years it takes for a Cotara-like (or Tarvacin-like) injection with radioactive iodine in the cargo hold. What more does the medical establishment want?! Radioactive iodine delivered to THE spot: necrosis, turmor, or virus infection. And almost nowhere else. The iodine lights up x-ray like crazy. Acts as a marker. A homing device. Diagnostics with MABs is a natural. RAI is one proven weapon. Diagnositic AND therapeutic. RAI kills cancer, and with Cotara from the inside-out. Good patent. Great application. We'll see if the regime will speed or retard movement of effective biologicals to us common folk.
r622. What Duke paper? How related? Help.
UmassOnc: thanks for the posts. Last one was a humdinger. Things seem to be going all right for PPHM in the lab and clinic so the gulf to bridge right now is the disconnect between demand for stock v. apparent [Christmas party] enthusiasm for product. Granted the economy has tightened investment/risk parameters for all, but there really should be more growth at this point, given the excitement at social and scientific gatherings. We all know Boston area docs have money,that is, not all are being salaried by the state (or universities) yet, so we welcome them as stockholders too. All tongue in cheek. Have a good weekend, and thanks again.
north 40k,appreciate your posts,all learning experiences. What I did not state clearly, probably because I am definitely out of my field of expertise in this regard, is that [first] I am certain that viral [HIV,etc] investigators would welcome any therapeutic agent that helps, but my impression of the interest and expertise of the Haynes/Duke group is that of virus vaccines, and by vaccine I mean administration of any agent that causes the body to mount an immune response to that agent or agent component by producing antibodies, hopefully with recall, that can attack viruses directly, or neutralize them. As you know, Bavi and other MABs ARE antibodies designed to home on antigens, and then do their work, either by delivering cytotoxic agents, amplifying body defenses, or blocking mischief. Without going further into why and how Bavi acts, in part, as a vaccine, with immunicity that involves recognition and protetion from reinfection in some cases, monocyte activity, apoptosis,etc., Bavi's MOA is in a different realm of inquiry than that in which most immunologist, vaccinologists have trained and applied for grants. They have other theories and "pet cures" which they are striving to get funded and prove.
reify, you read between the lines perfectly. However, it is merely an impression I formed while scanning publications and protocols out of Duke, and is only that. I hope your mother's treatment was successful. That's a tough decision. If you want to discuss that more you can contact me thru the moderators. The thing about acoustic neuromas, especially at her age, is there is no hurry because they are not malignant. In fact, proof of growth, and rate of growth are prime considerations.
geo, not sure of the answer to the question, but it seems to me that the thrust of the immunology community(at least that one at Duke) is a direct attack on the virus or viral particles. Bavi has immunological properties, to be sure, but it appears that HIV, for instance, has the savvy to blunt an attack on its surface -PS, in large part but not entirely. Bavi also acts to prevent newly hatched virus babies from getting an outer envelope to hold its innards inside.
azure, protozoans are the lowest forms on the animal chart, being single-cell. The parasites apparently use the everted -PS on the outer leaf of the cell membrane as an escape, or host immune-blunting mechanism. anything that homes-in on -PS, such as Bavi's anti-PS, should be able to cause the parasite some problems. The question is route of administration; penetration into inflammatory tissue and poorly vascularized areas such as abscesses and fibrotic scar which is built up at infected sites. I suppose that early treatment at exposure and first symptoms should show beneficial response. And this does not even take into account the immune-boosting/monocyte enhancing garbage-pickup at site of lesion. Seems a legitimate avenue of pursuit.
hi geo, my take on neutralizing antibodies is that they attach to the viral coat, whether it is carbohydrate, lipid, or protein components of the virus, and "neutralize" the virus by interfering with infectivity, expressivity, or reproduction.
Barton Haynes and the crowd at Duke appear to be 100% committed to an immunological kill or neutralization of virus via vaccine.
Bavi is a joker in the deck, and not at all compatible with all the wonks in that particular corner of investigation, and could render their efforts and grant money past history, so I don't expect a lot of enthusiasm out of that crowd, unless of course BAvi enhances the activity of their agents, which it may well do.
One of the primary modes of action of Bavi is that it attaches to the human outer cell layer (not necessarily the virus). Viruses lack cell walls and when the infected cell dies, bursts open, and liberates the incubating viral newborns, the virus particles co-opt the cell membrane particles to make up their own. If the inverted -PS component of the cell membrane is tied up by an anti-PS antibody, then the virus particles cannot become "whole," or encapsulated. That is at least a part of the story/mechanism, and why the Duke group is not exactly running on the same tracks.
realist, it's a reach to say "...that we're actually heading back to the start of phase II." Nothing could be farther from the truth. The semantic problem here is that straight line movement in trials, as in moving through a neighborhood, is not always possible for a number of reasons that should be obvious. Within the matrix referred to as PII there are many streets and cross-streets, and not all paths lead to the goal. No question that Bavi has moved closer to the goal-line during initial Phase II studies. The fact that more elegantly designed phase II studies are possible, and might even forestall the need for PIII prior to marketing, is evidence that Bavi is not starting all over again. If nothing else, the PII results to date have garnered some critically needed information, interest and (hopefully) financing. Said another way, the PII results in hand could have been much worse. I think the company did what was necessary at the time, a time of dire finances, and threw a forward pass to India and Russia. No touchdown. No hail Mary crash and burn. But definitely a first and 10.
moby, you asked, "where are we now with the PPHM pipeline?" Moving ahead nicely imo.
cj, it wouldn't surprise me if this "now-crowd" at PPHM could "pole vault" a fully humanized Bavi onto the stage to take over for current chimeric model. Biosimilars, or sumpin' like that. Let's get real. The medical profession knows it is there. Or at least I do.
McTavish, nice post and archival find. True, referrals are important in the medical business, and also public demand. India Russia and China connections appear good. The most intriguing phase II trial that is double-blinded and randomized, and one which will satisfy mobyinvestor, would be the trial construct I mentioned, which was also used with Rituxin, and that would be continued treatment with Bavi (or Cotara) past the [now] current "end" of medical treatment. A hard look at those numbers could possibly vault product onto shelf quicker.
Moby, you said, "From an ethical perspective, the only time a placebo is used in cancer trials is when it's for a new indication that doesn't already have an SOC [standard of care treatment] in place."
Close, as is frequently the case, but not "spot-on". Garnick mentioned that they will be using some tried and proven Rituxin approval strategy on Bavi, and one trial was a randomized, double-blinded continuation of treatment with the MAB after standard of care treatment was exhausted and tumor persisted.
Re. "signal-seeking," I agree with other posters who feel it is a synonym for what is supposed to happen in IIa trials, investigators are "seeking signals" indicative of serious side-effects...and efficacy. When used in combination whith chemo, many of the "signals" are difficult to assign cause and effect to, and some side-effects can be traded off for increased efficacy and survival.
Garnick said in the cc: This [all info from PI and PII trials to date] sets the stage for planning our next step [for] bavituximab cancer trials, and we are actively embarking on that... Our goal is to implement a clinical and regulatory strategy that will maximize getting bavituximab approval, and to get it in the shortest feasible timeframe.
volume makes me wonder if I am living in a dream world. IR/PR budget should allow for at least a bit of window dressing [read market massage] at times like this.
incredible absence of interest...
djohn, interesting website, thanks. DrLu, huh. DrLien? Viral vaccines. The last part of the announcement told about the University of Massachusetts Medical School, a world-class research institution,with $200 million research funding annually. Craig Mello, PhD, at UMMS Howard Hughes Medical Institute (HHMI), and Andrew Fire, PhD, of the Carnegie Institution won the 2006 Nobel Prize for discovering RNA interference, a momentous observation. UMMS partners with UMass Memorial Health Care, the largest health care system in Mass. Wonder how THAT funding is going.