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Farg,
If by "sides" you mean side effects and not hash browns, I guess I would say good for at least one person because one or more would be comfortably alive without progression; otherwise you would get a median,is that the way it works? Or is median a moving thing, so that whoever progressed first is compared at a given time with whoever has gone the longest without progressive disease? I'm notta stats. guy either. I only got 10 digits on two paws to count because it's too cold where I am take off shoes, so I'll take your word. Knowing how many were still with stable disease would be easier for me. Hope we do get a report at the ASCO and that ENMD has not expired by then. Tell your pal thanks and I'll look into those other metastatic carcinoid trials for comparison but I bet George will beat me to it . Bow-wow and a wag to you. Nottadoc2.
George, Docs, anyone:
Interim results of The phase 2 study of combination of 2ME2 and bevacizumab (Avastin) on carcinoid tumor patients reporting 27 out of 31 patients or 93% having stable disease after median follow-up time of 8.9 months seemed pretty good even though no even partial responses were observed by that time.
I was trying to find some study with which these results could be fairly compared, as an evaluation of 2ME2 as a combination therapy. Avastin is going to be around for good while regardless of immediate FDA consideration, and it would be pretty good if every third scrip for Avastin was accompanied by one for Panzem NCD even if a chemo treatment was ordered at the same time. But, what are the characteristics of another study that would assure a fair comparison ? Do you know of any such studies ?
From George's posted abstract:
"The levels of XN in beer indicate, however, that a daily intake of numerous liters might be necessary to attain significant chemoprevention effects. Therefore, enrichment of XN in the beer extraction in brewing and/or the isolation of XN administered as a dietary supplement will be needed for future trials. This work is the first complete demonstration of preclinical cancer prevention in vivo by this agent and should open the way to human investigation."
I know several people who might volunteer for such "numerous liter" trials if they didn't have to incur cancer to do so.
Doubts expressed in this article as to patentability of enzyme action MIGHT also be applicable to 2ME2, an endogenous metabolite. I recognize that there are patents for new uses, analogs, etc., but a patent is only profitable if it survives legal challenges. I would hate to see ENMD do all this research, trials etc. and then have a big outfit come in and say thanks for pointing us in the right direction but your patent (which by then might have only a few years left) is no good. Of course there is always China anyway... "Patent ?? what is that ?"
George, in order for me to understand these
research reports, please explain the chemical structures and differences of :
2 methoxyestradiol 3-Phosphate
2 """"""""""""" 17-Phosphate
2 """"""""""""" 3-17 Diphosphate.
Which one if any constitutes Panzem ?
Thanks as always.
Comments on the phase 2 ovarian cancer trial? 2 out of 18 remaining on study; one partial response; not real impressive (even Sidor says "modest") but these were/are advanced cancer patients and platinum refractory. What now for ovarian cancer and 2 ME ? What are the best prospects for combinatiuon therapy with 2ME for ovarian ca? (Sorry George, I don't think they could find anyone to take on a watercress-Panzem NCD trial but they probably wouldn't prohibit a trial pt from a little watercress-snacking on the side, if in a combo trial with some kind of recognized therapy.)
OT, is there any anecdotal info in the trials with cancer pts. who also have arthritis, re any improvement in the arthritis ?
Re NC and Sidor MD:
That may be just where her permanent residence is. I think somebody once posted her contract with ENMD and it permitted her to keep her practice office open and I believe be there one day a week, and it was somewhere down in that neighboorhood. I can't recall whether she had any affiliation with UNC.
Rocky1 nice to hear your good news. Are Avastin and bevacizumab the same thing? Have you looked at YASG.com? If not, go there and click on forums and you will see a lot of anecdotal info. Read any post someone named Amnia makes. I think she (?) is an oncology nurse but anyway very knowledgeable and very helpful to people with GBM problems.
rubberchicken this was speculation on my part, but I would hope rational conjecture. Till now at least eligibility for a cancer trial depends on having failed approved therapies, and since cancer is so frequently deadly they don't want people skipping approved therapies, however weak, for experimental ones. I wouldn't think they'd require the same degree of prior failure with RA, as it is not so deadly ( except my mother-in-law was physically devastated by all the cortisone and other stuff they used to treat the pain of her arthritis, years ago.) If a drug has already been proven safe, as Panzem has in phase 1 cancer trials, hopefully they wouldn't have to have lengthy phase 1 trials for RA with a similar dosage. Further, I would think it easier and quicker to demonstrate statistical efficacy in RA trials--no >50% tumor shrinkage etc. At least it seems to me that if you relieve the pain and restriction of movement, it works for RA.. That shouldn't be hard to prove or disprove. However I guess if you could ascertain how long it took Enbrel to get approved you could get an idea as to whether my speculation has any merit. With all the Panzem trials for cancer going on, I would think odds are a few of the trial pts. have RA. Wonder if any anecdotal improvements have been seen there.
George, thanks for posting this
ENMD PR chart, power point summary , or whatever it is. It's well done, and I don't compliment that management often. The reference to application for IND use for RA for Panzem NCD in last quarter of this year is interesting. How long would it normally be after IND acceptance for clinical trials to begin ? If this showed immediate benefit in an RA phase 1, I would think it might even get to market for that purpose in a shorter time than for cancer,
George, 2ME-3,17-O,O-bis-sulfamate,described as STX 140 in the abstract you posted, does not sound like "our" 2ME2 or covererd by ENMD patents. Do you agree ?
George , it would appear that the study with Avastin and Panzem is no longer recruiting patients:
http://clinicaltrial.gov/ct/search?term=2+methoxyestradiol+bevacizumab&submit=Search
What to make of that ?
By the way, to demonstrate what a little success will do,clinical trials.gov shows 308 studies for Avastin and nearly all are in combination with something else - like every chemotherapy you ever heard of.
Where did the quote re endostatin in your last post come from ?
If that electrical treatment works on primary brain cancers,why not on other types of cancer as well ?
My condolences also Chimney.Ovarian cancer is a tough row to hoe and we can be thankful she is released from pain. We all recognize that she has made a useful contribution to medical science and thanks to you also for keeping us informed.
Re Panzem First:
Docaaron your theory is appealing, as the Taxol/Panzem trial info indicates the two products were given "in combination". But given that 2ME2 is metabolized pretty quickly, would the anti-Hif effect wear off or wash out so that the Hif response/chemoresistance effect could recuperate before the Taxol could whack the cells ? Are you suggesting a Panzem-Taxol; Panzem-Taxol, et seq., or or Panzem-Panzem-Panzem, etc., then Taxol-Taxol-Taxol, etc? In either case, how much time between the preceding dose of Panzem and the following dose of Taxol to begin the initial testing ? Could presently known mouse to human data be extrapolated to test these timing issues pretty quickly ?
Nice catch goodbug--
and it 's about tripled today ?
Thanks George. So, "modest" efficacy for the
abstract earlier prepared; and "minimal" per the
later prepared poster. I don't think it's likely that
the 43 patient number could include pts. on the PanzemNCD plus Temodar trial, if indeed any dosage has commenced for the latter, because that executive summary shown to be current at June 2007 refers to the combo study as "planned" for 2007. So there is an inconsistency or at best a lack of clarity in these numbers as well as the numbers in the trial Docaaron refers to. Anybody want to venture a call to the PR lady to get this cleared up ?
George. Can you compare the abstract 2065 (re GBM monotherapy)vs. recurring GBM) with the poster for that study linked in your post # 5681 here? Seems to be difference in number of patients. I remember poster concluded 2ME2NCD had "minimal" activity whereas this abstract says it has "modest" activity which to me sounds better. Did someone lobby for this change ?
Shame on them all.If there was any guts at all
among their greed they'd do this before the annual meetings.
Reason4 and Docaaron, thanks for
your reports. From both of you it sounds like
there was not much ambient enthusiasm and that's
discouraging.
George or anyone:
I can't top tborges but if you can compare Panzem with the product mentioned here I would appreciate it.Also the comparison of companies/price. IYHO of course.
http://www.forbes.com/2007/06/13/arqule-cancer-kinase-pf-ii-in_jd_0613gurusow_inl.html?partner=yahoo...
Expanded info on talc-endostatin effect:
http://news.ufl.edu/2007/06/06/talcum/
Query, among others raised: will the talc-expressed endostatin be in the blood circulation? If so, why not good for cancers other than lung. Of course lung cancer metastasizes too,like to the brain, doesn't it?
Important to note, that these results are not just mice experiments. This could be one of those examples of wonder medical events that are accompanied by the remark "Hmmm--that's funny," rather than "Eureka, I've found it !"
RRGY2K, that's a great post.
Let's all pray for Jerry, and everybody else in any cancer trial. If they are not saving their own lives, they may be saving ours.
I don't know if they still do but Pittsbuirgh used to have a pretty good beer branded Iron City. Would that do it ?
George, wouldn't the comparison to be made, for the present, be with the cilengitide as monotherapy ?:
"The results for a second trial, looking at cilengitide as a monotherapy, were also presented at the conference. However, the data was disappointing - the company had set a target of 25 per cent of patients being progression free at six months. The actual rate was 16 and 10 per cent at six and 12 months, however. "
BTW I think you are right about Jerry and the poster--The time frame does fit better.Thanks,
Re the GBM poster.
Cecee's brother appears to be the one blessed patient with a partial response. Reasonable to conclude Jerry from East Tennessee is included in the stable disease group. If I understand the poster, the pharmacokinectics were poor for those taking "EIAED"s-- Enzyme Inducing Anti Epilectic Drugs. How essential are these for patients ? Is the particular need for those with brain cancer?
As a general rule I think we have to accept that their conclusion as to "patients with recurrent GBM" --that 2ME2 as a monotherapy has "minimal activity"-- is probably true for recurrent cancers of all kinds and may be true for usage as a first treatment, which we will probably never see. As an adjuvant therapy, it still looks very promising, as far as I can see. Economically that may not be so bad. Notwithstanding lycopene, ketchup by itself is a terrible entree, but Heinz continues to sell a lot of it.
Other anti-angeogenic studies to compare:
http://www.asco.org/portal/site/ASCO/menuitem.64cfbd0f85cb37b2eda2be0aee37a01d/?vgnextoid=09f8201eb6...
Possibly answering my confusion, a poster on the Yahoo board indicated Kaepskag's linked abstract was only through December and that a poster available tomorrow would update (on GBM). Is that right ?
Thanks Kaepskag. I'm confused here.
6 out of 16 stable disease seems good if not earthshaking. We can start comparing with other trial abstracts. But I thought 43 patients had been enrolled, expanded from 34. Have I confused the trials ? Is Cecee's brother in this one ? What gives with the increase in dosage from 1000 mg? Can some one supply the poster ? Survivals thus far ?
ENMD aside, George is right about things being overdue for Folkman. Just look trhrough the abstracts re angiogenmesis inhibition. And don't forget O'Reilly either.
no applause at ASCO - yet.
http://www.forbes.com/2007/06/03/genentech-avastin-biotech-tech-cz_mh_0603biotech.html?partner=yahoo...
not panzem, but another (preliminary) indicated success for anti-angiogenic therapy (GBM):
http://www.asco.org/portal/site/ASCO/menuitem.34d60f5624ba07fd506fe310ee37a01d/?vgnextoid=76f8201eb6...
Docaaron - (slightly OT) Since you seem particularly interested in hif-1 suppression here is a link to a 2007 ASCO abstract on that:
http://www.asco.org/portal/site/ASCO/menuitem.34d60f5624ba07fd506fe310ee37a01d/?vgnextoid=76f8201eb6...
Thanks, tborges and Duey.
Might add that you need to further click on "forum". That's a great lurking site just to see how people support each other in a common adversity. If you read many of them you will see what great respect the Duke center has in the GBM
community. I'm personally a Dukey hater when in comes to basketball, so it pains a little to recognize this respect.
C-Peptide, nice, another potential use. Thanks Doc.
But, could everybody have Panzem in the bathroom cabinet, like aspirin ? BTW, that tPA is great stuff, a shot of it saved my life, if not my brain neurons, in a heart incident 8-9 years ago,(less than 1.5 hr. from first heart attack symptom to hospital). Maybe EMS vehicles could carry oral PanzemNCD for stroke cases ?
Question on that Korean abstract (ain't the world flat indeed?) do I read it right that about 12.5 times as much 2ME2 went to liver and kidney as went to implanted tumor ? Any way to reduce that ratio and thus efficiency ? Would that make Panzem a good candidate for liver and kidney cancers ?
Questions re trials:
PR says the Temodar/Panzem Phase II is for recurrent GMB patients. This will be good for those patients, I hope, but since Temodar is already approved for GBM
and since it seems obvious that Panzem has very manageable toxicity for GBM, couldn't newly diagnosed patients, such as possibly Rocky 1's relative, be included in a phase 2 trial?
Or would recruitment be difficult for those?
Is it likely that Will--what a good family-- was one of the additional patients of the expanded to 43 number ?
What is the strategy of timing the PR of the new trial today instead of after or during ASCO ?
Simcere Pharmaceuticals Group
I skimmed its prospectus for NYSE listing,(available through co. web site or Edgar. It's interesting though didn't answer all my questions. They assert on page 59 that "endu" as of 3/31/07 had been used in more than 500 hospitals in China. I assume these are not mice hospitals.
Simcere Pharmaceuticals, a Chinese corporation, recently applied to list its stock (ADRs?) on a US exchange. This says its version of endostatin (endostar; endu) has been approved for sale in China for non-small cell lung cancer.
http://www.simcere.com/english/about/about.asp
Does anyone know how if at all medicines are prescribed in China ? Could one get and use endu "off-label" as done here with,say, thalidomide, for another type of cancer ? ?
Where does Alchemgen, who has from Childrens Hospital Boston an Asian license for endostatin, fit into this?
Thanks Cecee for keeping us posted.
I have a relative with GBM that is going on Temodar and maybe gamma knife radiation; I think he's a month or two over 50 so ineligible for that under 50 board on which you posted, but I have sure made him aware of the Duke programs, even though he's more in the Sloan-Kettering neighborhood. Prayers for your brother.
I can't paste it but helpwanted on Yahoo board has posted link to today's BIO presentation. Don't overlook the 2me plus methotrexate chart vs. RA. Only mice I guess but very impressive action.
About GBM:
home.earthlink.net/~sdepesa
Dr. Kirkpatrick, presenter on GBM, is shown as professor of radiation oncology at the Tisch Center. Just wonder why he would be doing the presentation and not Dr. Reardon, the principal investigator for the study ?