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spanky, I cannot imagine FDA allowing armed Bavi- without clinical trials because safe doses must be established, as well as safety of the combination, but an abbreviated PI and PII is conceivable, but probably without precedent. Do I think it will happen and be successful? Yes. Further, from an investment point of view, any "armed-Bavi" being brought into clinical trials would almost certainly be accompanied by an appropriate share price run-up. That DOES have precedence, and would be fully justifiable. Also, I foresee a markedly accelerated FDA clearance process for MABs in the near future. The footwork has already been done.
thanks CJ: PLytle talk was concise, informative, compelling. A good recap and outline of what/where PPHM is, and a great reference for current and prospective investors. Only one problem: no problems. All positive, and all movement is forward. A good way to end the week. Good luck all.
keep_trying, you're probably right about Avid and DTRA. But Avid is gravy in this grubstake. Anyone know what percentage of revenues DTRA is? I've always thought the gov'ment, DTRA, anti-viral, naked Bavi are interesting subjects, but the goal line is FDA approval of fully-armed and fully human Bavituximab, and ditto Cotara. Bavi has been piggy-backed on conventional chemotherapy, and this week has been shown to probably play a role in longer survival. The improvement patients would have if the MAB were fully humanized and could be given repeatedly without allergic reactions from its mouse parts, is mind-boggling...and real. PPHM's lead missile systems are capable of delivering cancercidal payload to unique sites on almost all solid tumors, even the toughest, Glioblastoma multiforme. Bavi un-loaded is safe and stimulates the immune system to help fight the cancer. Let's keep our eyes on where we're headed, and ask, "did this week at ASCO move the ball forward appreciably? You bet. That is a bright bunch at ASCO. They're curious and atuned to hype, if there is any. Bavi has an established safety profile as of this week, and that is big...huge.... human safety established for another anti-cancer agent, the likely progenitor of a bewildering assortment of spinoffs. And the stock price tanks. Pretty silly and painful...35% in two weeks...while company execs. hobnob with the elites of the oncology world this week. It's a tough play, PPHM. Maybe getting tougher. Hang in. This stock is going to fly...when Moby returns from a much deserved vacation.
summerblaze, great post, great article. The glyco(carbohydrate)protein being used may be compared to the lipo(fat)protein MABs. I'm not sure there is an advantage glyco- over lipo- as a vehicle for the cancercidal agent. Bavi- is capable of carrying the same cancecidal agent, and we know now that Bavi is not only safe, but put some "naked" Bavi in with the armed Bavi, and you have immunological stimulation too. This round of reporting at ASCO was quite successful. "Naked" Bavi didn't knock out cancer, but we know it is safe and has cancercidal properties alone. Imagine what it is going to be like when it's armed. Yes summerblaze, the glycoproteins are represented on cancer cell membranes, and probably can be exploited, but Bavi has already been there, about 5-7 years ago, and it looks as good or better than the glycoprotein rockets.
Bungler, nice post. Accurate PR construction is critical for credibility--a non-fiction narrative with a long and checkered history. Sensationalism,innuendoes, and rosy predictions about the universal application of the snakeoil being sold is one extreme. PPHM experienced the counterproductivity of PR hype in another incarnation, as Techniclone, and knows firsthand that street and retail traders have long memories. I agree with you: management has improved most parameters within its purvue, and the lab guys and inventor gurus are producing. PPHM has gotten into bed with some rough players, and now we're paying the price of survival in the business jungle. There will be more of what we just witnessed, but hopefully at a higher level as old investors move their high interest dollars into other startups and new big money comes in to replace them. As stockholders we must stick together and continue to communicate.
someone correct me if I am wrong, but when I was following ImClone in its early days, it seemed like ASCO and similar events were targeted dates for early investors to cash out, one of the many reasons why "sell the news" is such a reality. With most small corporations, the PIPE, seed, VC money targets a certain percentage gain, and settles for that...by the clock, not by the ticker. What appears to have happened in the past few weeks is standard operating procedure for the occasion--both cancer conferences were targeted in advance--and the sell-offs occurred whether or not there was buying. So another way of looking at all of this (enormous) loss is that the only atypia is the absence of buyers. That is bolstered by the fact that at the opening there has been only a yawn's worth of buying. Further, I thought PPHM PRs were timely, honest, and well-constructed, so I don't think management can be blamed for the general economic/market risk-adverse climate.
Jess, I've done quite a lot of studying on Stason, and come away convinced that it is mostly Chinese big-money interest behind the company with appropriate front men,etc. You said, "Stason deal doesn't come close," what ever that means. What is your sense of "the Stason deal" since terms were not disclosed and the company is a closely held private corporation?"
In the post you also said, "these other drugs may be inferior to bavi, but there is one important difference. Many are on the market and making billions for their companies." If you are indexing Avastin and Erbitux, you are right. Medarex products are not on the market?"
Lessons #2 today: BMY and Medarex. BMY is up $1.83 (8%) on "news" that every MAB student already knew years ago.
Medarex alone, if they could have somehow swung the Asco lime-
light (without such media luminaries as Martha Stewart, Sam Waxsal,and Iconic Carl), could have easily been up 100% or more.
Question at this point is: Does PPHM go it alone and down the road reap IMClone-like rewards, or be swallowed up by Roche? Do we get $6-8/share or $30 by waiting a bit longer? This punishment today is not from people disenchanted with clinical results, or anyone who understands PPHM science and its possibilities, but instead from greedy money people as care-less about the science as I am about marketplace manipulation.
DNA PR on Avastin long-term for ovarian CA was pathetic. Pfizer's new products will hopefully neutralize some of its horrible reverses lately. BMY did its DD and got a good-to-great pipeline when it bought Medarex. PPHM is at least equal to Medarex. Recent stock price manipulation can only be attributed to one thing: making stockholders happy to get 3-4x bonus when the big buy-out is announced instead of the huge amount this company is worth. I keep wondering, why do the continue to enter Bavi in trial arena with one-arm empty? Connect the dots now that we know it is safe. Mark my word...when Bavi is stolen it won't be six months before a fully humanized and fully armed Bavi will be in trials...and will be a blockbuster. Where will we be? We'll see.
Some perspective: PPHM pipeline is still intact, and can only be described as excellent. Questions remain, but even bigger questions arise when analyzing data from BigPharma PRs today.
As members of the knot hole gang we stockholders are getting a glimpse of the big leagues, and how the game is played at the top. This is far from a strikeout, a 4-bagger, or even a close loss. PPHM is a minor league player with assets, but there are lots of hopefuls and only room enough for an occasional successful player now being sidelined by guys who have been at it a lot longer and in a more competitive environment. Get used to it. I've never seen such...uh...capitulation? I just bought 15000 shares at about $3, and plan to buy more. Let's learn sumpin' here, and it is not all bad.
In the enTIRE world less than $50k worth of PPHM stock purchased in the first 1/2 hour of trading, and that is mostly MMs establishing the start line. There seems to be a credibility gap, or simply yawning non-interest. Unbelievable. the MMs are smart. Instead of a dream balloon opening which would allow some weak sisters out, they decided to hold all the bolters in the corral. And then there is BMY which did an incredibly stupid thing when it bought IMCL, but covered the error with the Medarex purchase which was brill. Medarex DOES have some good MAB tickets, but probably no better than PPHM, possibly complementary or synergistic.
patiently...good one...I love it. speaking of grovel grovel.
dia, precisely. Early-stage disease is really what naked Bavi should be best at. And fully- armed?!
For the naysaying nabobs here (and you know who you are): this data is good stuff, and the most BASIC knowledge of statistics dictates that the sample size is WAY adequate to establish a significant difference in the Bavi-treated group. On the basis of this report, how much money would you wager against Bavi- having biological activity and a significant anti-cancer effect? This is not trivial information. And for those of you who denigrate the results, or criticize management, the latter has done a brilliant job under critical financial restraints of bringing this information to light, and deserve congratulations. To intimate that the scientific community is not aware of PPHM and anit-PS inquiries is simply not true. Why the stock price? A pants-down investigation of shenanigans last week would be telling. And what if the investment community, in the aggregate, is as bad off financially as you? The attacks and inquiry here should be directed at whoever BOMBED the stock last week in a continued campaign to scare away investors and portray PPHM and its management as losers. I repeat, this is very good news in a continuous string of good news. No setbacks in the clinic or lab for years. Why the shock treatment of the stock? Market mechanics? Market crooks. I would love to see the light of investigation shining on all of them.
...nobody buying the narrative. Probably think goal line is too remote at this point.
Re.Cotara: recently PPHM entered an agreement with Stason, a privately held company whose pres. Harry Fan, president and CEO of Stason, stated, "This agreement represents a unique opportunity to acquire a novel, cutting-edge pharmaceutical technology package and bring innovative and promising treatments to millions of cancer patients in Asia and the Pacific Rim. We will also continue developing new applications and bioproducts based on TNT technologies to complement Peregrine's activities in the glioblastoma arena and will aggressively pursue new, diverse biotechnology markets. To advance these efforts, a new spin-off biopharmaceutical company headed by Dr. Eugene Mechetner will be formed which will focus on commercializing TNT technologies."
"Stason's focus on oncology products for growing Asian markets expands the development of our TNT technologies to reach patients in this region who urgently need new options for the treatment of cancer," (SWKing, pres/CEO PPHM "As we advance our clinical-stage pipeline of innovative products for oncology and viral infections, we will continue to pursue select partnering opportunities while retaining future potential value for our products in the major pharmaceutical markets." Headquartered in Southern California, the Stason group employs approximately 120 people worldwide. "We have R&D and manufacturing facilities in California, USA, and Taiwan. Additional R&D facilities are located in Massachusetts, USA, and China. Our licensing offices are located in California, USA and Tokyo, Japan."
Stason Generic Pipeline: Brand Name/Approval Status/Dosage Form/Indication
Acyclovir Zovirax
Approved 200 mg capsule
Herpes Zoster, Chicken Pox, Genital
Herpes
Anastrozole
Arimidex Tentatively approved in US
1 mg tablet Breast cancer in post-menopausal
women/ estrogen receptor (ER) positive
Aripiprazole IR Abilify
ANDA submitted
2, 5, 10, 15, 20,
30 mg tablet Schizophrenia including maintaing
stability in patients with schizophrenia
Bicalutamide Casodex
ANDA submitted 50 mg tablet Prostate cancer
Captopril Capoten
Approved
12.5, 25, 50, 100
mg tablet Hypertension
Cyproheptadine HCL Periactin
Approved 4.0 mg tablet Allergic conditions
Selegiline HCL Eldepryl Approved 5.0 mg tablet
Adjunct in the management of
Parkinsonian patients being treated with
levodopa/carbidopa who exhibit
deterioration in the quality of their
response to this therapy.
Tamsulosin
Flomax
Approved/overseas 0.4 mg capsule Benign prostatic hyperplasia
Cotara: from clinical trials website:"A new experimental drug being investigated for the treatment of newly diagnosed and recurrent high grade brain tumors...an antibody combined with radioactive iodine. Cotara binds to proteins within the nucleus of necrotic (dead and dying) cells which are present in most malignant tumors. These cells may account for 50% of tumors and are primarily found at the center of the tumor. Cotara is given directly into the brain tumor as a continuous infusion through catheters. Once Cotara is delivered, it remains within the tumor and the attached radioactive iodine bombards the neighboring living tumor cells with radiation. Each successive treatment with Cotara kills more tumor cells and increases the necrotic regions, allowing it to be more effective with each treatment. Cotara has been used in patients who have previously received chemotherapy and/or radiation therapy.
TRIALS 1 to 6 of 6 Location Last Updated (still open?)
Details Open-Label Dose Confirmation and Dosimetry Study of Interstitial 131I-chTNT-1/B mAb (Cotara®) for the Treatment of Recurrent Glioblastoma Multiforme Philadelphia, PA USA 08/26/2007
Details Open-Label Dose Confirmation and Dosimetry Study of Interstitial 131I-chTNT-1/B mAb (Cotara®) for the Treatment of Recurrent Glioblastoma Multiforme Charleston, SC USA 08/26/2007
Details Open-Label Dose Confirmation and Dosimetry Study of Interstitial 131I-chTNT-1/B mAb (Cotara®) for the Treatment of Recurrent Glioblastoma Multiforme Philadelphia, PA USA 08/26/2007
Details Open-label, Dose Confirmation and Dosimetry Study of Interstitial 131-I chTNT-1/B mAb (Cotara®) for the Treatment of Recurrent Glioblastoma Multiforme (GBM) Tustin, CA USA 07/31/2007
Details Iodine I 131 Monoclonal Antibody TNT-1/B (131I MOAB TNT-1/B), in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme Detroit, MI USA 02/03/2006
Details An Open-label, Dose Confirmation and Dosimetry Study of Interstitial 131I-chTNT-1/B MAB (COTARA) for the Treatment of Glioblastoma Multiforme (GBM) at 1st of 2nd Relapse Baltimore, MD USA 11/06/2005
all from http://virtualtrials.com/tcln.cfm
thanks cj, chev,et.all. Cotara? What's happened since this 1998 update: TNT for Tumors By Sean Henahan, Access Excellence San Diego, CA (5/6/98)- Researchers believe some tumors not responsive to conventional chemotherapy might improve after a blast of TNT. In this case, they are not talking about explosive charges, rather, a new antibody based approach called tumor necrosis therapy.
Tumor necrosis therapy utilizes monoclonal antibodies targeting intracellular tumor antigens on necrotic (dead) tissue. This method overcomes some of the limitations of current antibody-based therapeutic approaches, reported Alan Epstein, MD, PhD, USC Medical Center, department of pathology, LA, CA, at the 11th International Conference on Monoclonal Antibodies for Cancer.
"Tumor necrosis therapy is a new concept in antibody cancer treatment. One characteristic of cancer unique to all tumors is that they contain large areas of necrotic lesions. Whereas most antibodies target extracellular antigens, TNT employs antibodies targeting intracellular antigens exposed on degenerating cells found in necrotic areas of tumors," said Epstein.
Over the past eight years, Epstein and colleagues have developed several antibody candidates targeting DNA antigens in necrotic cells. Two of these are being tested clinically. TNT1 is directed against DNA histone H1 complex in the nucleosome, while TNT3 has the added advantage of targeting both single and double strand DNA.
Current clinical trials link the antibody with the Iodine 131 isotope. The idea is that the antibody binds to tumor and the radiation helps kill it. Some 50 patients have been treated in the US, China, Mexico, Israel and elsewhere.
The early studies indicate that the TNT approach should be applicable to a wide range of cancers. No binding of the antibody in normal tissues has been seen, and the antibody is not subject to antigenic modulation or heterogeneity, typical problems with other antibody cancer treatments, he said.
A clinical study conducted in China recently confirmed the safety of this approach and was responsible for some dramatic remissions. In one case, a wheel chair bound brain cancer patient who presented with no affect or speech ability, was able after treatment, is now enjoying a normal life and is doing extremely well, he reported.
"We really didn't expect TNT to be very useful in brain cancer. It was through our collaboration with a Chinese hospital that saw 50,000 brain cancer patients per year that we begin to see results in some patients, when antibody was given immediately following surgery and then continued monthly for four months," he said.
A safety study of 131I-chTNT-1/B is now underway at four centers in the US for treatment of malignant glioma (brain cancer). The study will enroll up to 24 patients with recurrent supratentorial anaplastic astrocytoma and glioblastoma multiforme forms of brain cancer who are candidates for surgical treatment. The patients will receive the antibody by continuous infusion directly into the brain tumor.
It is likely that TNT therapy would prove most useful when used in combination with standard chemotherapy or radiation therapy, he added.
approx. $100k invested in buying PPHM narrative during one hour of trading,and most of that window trimming by MMs playing with themselves. Incredible. I think the weekend has already started...last Monday.
geo, you said,"..SK and Thorpe [probably]..never saw Bavi as a stand alone." Doubtful. Most inventors are the last to fully understand the true dimensions of their inventions. And there IS a chance Bavi could be a stand-alone if used as the inventor envisioned: fully armed with a small molecule cancer killer in treatment-naive, early disease. The whole idea of treating huge disease, including metastases, with chemotherapy alone is simply a pipedream. Early diagnosis and early treatment (and prevention) is what we a striving for. The spectre of PPHM corporate bankrupcy in the past was what dictated the nature of the clinical trials being quoted now. Nobody but those of us here and PPHM insiders realize how close it was back then. The India trials...ANY trials...were the only option at the time, and the gamble paid off elegantly. Today the scientific community is keyed to the prospects of anti-PS therapy, and eager to move forward in anti-viral and anti-cancer applications. Bavi had to walk before it could run. I expect it will fly someday too.
You said,"didn't Duke indicate in their last article that a Bavi-like (anti-PS) agent would be a likely component of any vacine attempt for Hiv?" Yes, sumpin' like that.
Today's posts on this board reflect the reason for flat retail market response today...so many questions about statistical significance of published results, as well as possible increased survival rates with Bavi to be published in the future. Bavi is obviously a good ticket, and IMO has moved from "Possible" to "Probable" re. FDA approval. Clearly Bavi needs more time in PII cooker to clarify. India trial results, characterized by those in the know as "signal seeking" trials, are definitely encouraging. It would have been a dream come true for Bavi to knock Avastin out of the box. It has not done that. But Bavi has a different MOA from Avastin and all other chemotherapeutic agents. Bavi improves the body's ability to clean up messes cancers and cancer treatment create, and because of the unique MOA as an immunological stimulant, a case can be made for including Bavi in the therapeutic mix, whether in combination with other agents in treatment naive patients who still have a credible immune system capable of responding, or in combination with irradiation therapy, a PII trial begging to be initiated. PPHM is possibly saving the best ASCO PR for last, probably Cotara-Brain cancer results which I suspect will accelerate Cotara's long-delayed move down the pipeline toward much-deserved FDA approval.
speaking fo the conspiracy crowd, does anyone know the time relationship between PPHM press announcement and stock drop?
Don't must PIPE folks have a semi-programmed sell formula to sell at various benchmark gains on investment? And don't most sell on the day of a favorable announcement? Sell the news? I thought that always happened. Only problem this time is no investors came to the party. Embarrassing for PPHM MarketMakers?. So they screwed up and it cost all of us big. At least the PIPE man got his. All interesting, even today's market close, huh.
mojojo, interesting that Avastin threw in that towel also in the PII you quoted yesterday.
lafont, "Then why do you think it was not simply from natural causes?" Natural, huh. Like things just live and then die? Go up 20% and down 20% "naturally". Nature at work. Never thought of that.
lafont, you're right...but a near-20% hit in one day isn't small change...at least to me, and why be here if we don't do a post-mortem and hopefully learn sumpin' from it. Seems healthy to me. Doc
thanks again mojojojo for the chart comparing Avastin and Bavi Phase II in metastatic breast ca. The complete and partial responses for Bavi are interesting, and very encouraging, but I'm not sure where you got the "partial" and complete response numbers you listed for Avastin since the abstract did not give that information. Did the entire article list it? Let me know on that one. The stated Avastin study primary end points were to assess toxicity, OVERall response rate, and progression-free survival. Overall response rate was higher with Bavi, 61% v. 50%, but progress-free survival and duration of response were dead even (no pun(. Avastin side-effect profile is probably somewhat worse than Bavi, a guess, because that information probably still requires teasing out of background noise. Because of the different MOAs, and Bavi's capability of carrying a payload, it looks like we might have a winner!
Other thoughts while pulling weeds. A paradigm shift? If Bavi does not completely knock Avastin out of the treatment box, there is an excellent case for trying the two together, and that means adding a bit of Bavi to all treatment regimens. We already know it is an irradiation enhancer. We've established that it enhances standard chemotherapy. Add it to treatment regimens for ALL solid cancers? That's big. This is an excellent example of why so much time and money are spent at the lab bench and in lower animal. Remember that? All the complaints? Imagine if we had no idea about MOA, and thought for instance that Bavi and Avastin work identically. I agree that side-effect profile is probably still okay. It sounds like a lot at first blush, but there was a low drop-out rate, and investigators must report every queasy stomach.
dia, I don't see evidence that Bavi is better than Avastin, and over-all imo are similar in over-all effect. Both agents appear to amplify chemotherapy success. Bavi is better than Avastin because it facilitates the body's ability to clean up the mess cancers and cancer treatments leave behind. Naked Bavi works in a different "zone" than Avastin. Think of how much better it would be in a patient with no previous poisoning of the patient's immune system. Since neither agent is a "knock-out", but both are helpful in about the same amount, the obvious next step is use both together. It is no longer tenable to continue a policy of only one MAB in the cancer cocktail. When multiple MABs are used in tandem, PPHM has 2C3, a better anti-VEGF than Avastin, and will be ready when multiple agents are used. Think Naked Bavi, small-molecule(tTF)-armed Bavi, and 2C3. PPHM has it all.
Avid shines brightly. Glad the MAB production facility is still in PPHM hands. A seriously under-valued asset. A boutique MAB manufacturing facility...fully FDA approved...with those great (!) MAB scientists (chefs) able to cook up virtually any MABs. Bravo. PPHM continues to reflect honesty and integrity to the science community, and is acknowledged to be in the vanguard of a very important process.
ASCO PPHM surprise, if any, may be Cotara (my baby), an oversized MAB with proven safety capable of carrying payloads of I131, a proven cancer obliterator. Results with Cotara in numerous human trials have shown safety and efficacy, and it appears PPHM has excellent treatment numbers for the toughest brain cancer, glioblastoma multiforme, GBM. Scientist in several countries have looked at TNT therapy for a long time. Absolutely no news out of China (a good sign?). Attack of tumor directly and specifically with a cancercidal agent in hand. Minimize collateral damage. U a specialized catheter in GBM, fluoroscopic needles delivery in other solid tumors, and IV for other cancers of smaller size. TNT is sensible.
PPHM ASCO announcements good, but not excellent, and not a blockbuster. Financial constraints dictated Bavi- clinical design and off-shore testing. Anti-PS--and the entire phospholipid, PS cell membrane phenomenon--is today a vital national scientific pursuit, and PPHM has the clinical experience with it. Side effect profile is "all right," not wonderful. Numbers on the side-effect profile of other concomitant chemo agents would be helpful here. Bavi clearly has an effect on tumor progression. As a "naked" chemo adjunct Bavi is a curiosity--a facultative immunologically-driven scavenger. All that immunology stuff is fascinating. Applicable too. But back on track now: to destroy cancer, a bomb must be delivered. Fully-armed and fully human Bavi can do it....deliver the bomb. Events are moving our direction regarding -PS therapy.
djohn,thanks. Isaac Winehouse, huh.
djohn, good thought. Double U Hedge Fund, with millions of shares of PPHM, is a good bet.
geo, the odds on such market events being OTHER THAN manipulation are small to the vanishing point imho. Interesting, the timing.
Huge stop losses tripped today? Probably is a good time to buy...if I had some cash.
thales, nice. thanx
djohn, good website. amazing. eloquent testimony that the scientific community is reading about Thorpe's endeavors. So his (collaborative) efforts made #33 on the most-read hit parade. Good on him, and thanks for the find.
Dr. Pojen Chen: Excellent publications:
Pierangeli SS, Chen PP, González EB. Antiphospholipid antibodies and the antiphospholipid syndrome: an update on treatment and pathogenic mechanisms. Curr Opin Hematol. 2006 Sep;13(5):366-75. Review.
Yang YH, Hwang KK, FitzGerald J, Grossman JM, Taylor M, Hahn BH, Chen PP. Antibodies against the activated coagulation factor X (FXa) in the antiphospholipid syndrome that interfere with the FXa inactivation by antithrombin. J Immunol. 2006 Dec 1;177(11):8219-25.
Lu CS, Horizon AA, Hwang KK, FitzGerald J, Lin WS, Hahn BH, Wallace DJ, Metzger AL, Weisman MH, Chen PP. Identification of polyclonal and monoclonal antibodies against tissue plasminogen activator in the antiphospholipid syndrome. Arthritis Rheum. 2005 Dec;52(12):4018-27.
thanks djohn, following Dr Chen's career will be interesting.
jess,interesting re.UCLA-PPHM anti-PS connection and Chen. Mass General, a beacon in the NE medical axis, is aboard. The blossoming UCLA-PPHM connection will be interesting to follow. The Univ.Texas SW? Great institutions. But academic medicine climbs aboard when all the risky PR events are buried in early clinical trials. The academia-PPHM connection, including UCLA, will be an interesting one to follow.