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estradiol conjugates
I think you can get there indirectly through this; if not search "estradiol conjugates" and you can find, any way it's a world patent application for conjugated 2ME claimed to be superior to the straight version:
http://www.wipo.int/ipdl/IPDL-CIMAGES/view/pct/getbykey5?KEY=01/27132.010419&ELEMENT_SET=DECL.
One of the inventors and applicants is one Alastair Stewart of U of Melbourne. Interesting that he was one of the "als." in the Sutherland et. al. abstract demeaning 2 methoxyestradiol as a possible breast cancer therapy, and which prompted the letter to editor from Sidor, D'Amato and Miller questioning the processes of the experiment on which the abstract was based...
asilber
Did you possibly take the footnoted reference to the Sutherland et. al article as indicating co-authorship of this letter to the editor responding to that article ?
Those are a couple of heavyweights that joined Sidor in this letter. Dr. D'Amato you would of course expect; but particularly encouraging is the willingness of Dr. Kathy Miller who was the PI of that phase 1 breast cancer trial to publicly sign off on this, as she co-authored an article in the Annals of Oncology a couple of years ago---it had a catchy title like is the Snark a Boojum or something--that posited a bunch of reasons why AI's might not make it clinically . It's nice to know that she's still interested.
OT; I can see a thoughtful tort lawyer filing away that Australian article so that 10 years down the road when thousands of lives have been extended by Panzem but somebody dies after taking it, he can pull that out a la Merck and say See they knew, they knew !! If you put on every label the truthful statement that "If you are alive when you take this drug, you are certain to die at some point thereafter" would that cover you ?
Really thoughtful posts, Jento and C_peptide.
From what I have read following the Merck Vioxx verdict, I think your FDA "gatekeeper" is going to be issuing more, not less, "no fly" orders at its checkpoint, absence of established toxicity notwithstanding. Ironic.
Expect approval will be easier in China, where those $ 50 VCRs come from. But, since our patent means nothing to them, they won't buy it since they can make it cheaper.
Re possibility that fact the Panzem NCD trials are still enrolling may be due to insufficient patient applications: How does a referring doctor have to handle this? I understand that the trials are for advanced cancers, so it is a given that some prior indicated and approved therapy has failed. But does a doc have to say look, this has promising pre-clinical possibilities, but you ought to try Avastin (or Thalidomide, or some other off-label thing)first ?
oops sorry that won't work.
just type in search for:
drug absorption merck section 22
and it will link you there.Chapter 298 I think.
drug absorption
I'm trying to build a little on what Peptide's last post on getting in to the dance of the molecules analogy taught;
here is something Merck (I'm happy to say somethihng good about that co. theses days but own no stock) puts out that I think will help me along:
www.merck.com/mrkshared/ mmanual/section22/chapter298/298d.jsp - 39k
When I have this mastered I'll see if I can get in first grade.
C_Peptide,
enjoyed your ballet. Definitely worth more than the
price of admission. I think I might have a further question but now I've got to get a little more comfortable with the
basic choreography. Thanks as always for helping to make the complex more simple. The doctors I think most of are the ones who are as concerned about the patient's understanding as they are about the treatment. They get sued less too.
Question for docs et.al:
The ASCO poster for the report from IU and Wisc. on the Phase II trial for advanced hormone-refractory prostate cancer patients for original Panzem --- are some still on it---? stated as follows under "Pharmacodynamics"--I could not copy and paste so this may have errors:
"The trough plasma levels of the different metabolic species (?) showed significant variablity among patients within each dose group of Panzem but still there was a remarkable similarity in the extent of metabolism to 2ME-1 and to their sulfonate/glucoronate conjugates among all patients.**
There is a significant oxidation at the 17 position of 2ME2, resulting in 80 to 95% conversion to 2ME 1 which is at least 10 times less active than 2ME-2.***
"There is extensive conjugation with 80%-90% conversion to the conjugated forms of 2ME2 and 2ME1**
" The shift in Tmax from 1.2 hrs at 400mg. to 6.7hrs. at 1200 mg is consistent with the dissolution in the GI tract being a rate limiting process.."
My Question: I think I understand (to a limited extent)how the nanoparticle version of Panzem would stay around longer and expose more of the surface to..what, endothelial cells, HIF-1, tumor cells..But how/why would the smaller particles reduce this conjugation --apparently not blissful--or conversion to the ineffective 2me-1 ? And what is the meaning of "2"or "1" following the 2ME which may be easier than the first question.
Re sulphamates
I haven't read the text and don't understand the process but
this sulphamation or sulphamoylation thing from this U.K. lab and hospital, Bath and Leeds, has been out for some time and I don't know why ENMD hasn't looked into it. Note, 80 times the effect of 2-me on the cell line mentioned. Side effects ? Will Panzem NCD be pout-dateds before it gets to phase III?
Directors know what to do with new share authorizations..
Grant ourselves some more options !!!(O it's so good to be a director) Check out SEC filings on ENMD web site.
Right as usual George. I didn't scroll down far enough to see that what i thought referred to 1bs were old 1s. Sorry.EOM
Thanks DocAaron.
sounds like no surprises, pos. or neg.
One thing on the web site which gives some optimism and perhaps not just coincidental in the timing, is that the Panzem NCD trials for advanced cancer --the 1b trial, I think--have closed enrollment as of today. This means at least that there are enough oncologists around who have sufficient hope in Panzem (and in the PI's)that they will fill up the trial at both locations. Suppose that the last patient enrolled today and begins taking 2ME August 1. . How much time do you think there will be before a report on the group can be made? Next meeting of AACR ?
Was there any mention at the meeting of why Allergan dropped the Panzem program ?
Set-back for Novartis and Schering:
http://www.fortune.com/fortune/technology/articles/0,15114,1087907,00.html?promoid=yahoo
Maybe they should take a look at ENMD. Or CELG.Maybe they are.
Set-back for Novartis and Schering:
http://www.fortune.com/fortune/technology/articles/0,15114,1087907,00.html?promoid=yahoo
Maybe they should take a look at ENMD. Or CELG.Maybe they are.
docaaron1, you may not be a pro reporter
but as shown by your post # 2685, you're pretty
darn good at connecting the dots like one. Thanks in advance for attending and sharing whatever "snippets" You gather.
George, re macular d.
I would have thought so too, but then why did Allergan terminate its agreement with ENMD ? I have not seen any recited reason.
Some free pub for AI's generally:
Last night on CNN's "Larry King Live" Larry King interviwed Tammy Faye Messner (sp?) the ex-wife of evangelist Jim Baker who a few years ago I think got caught with his fingers in the collection plate so to speak (which I mention only to identify her), she being a three-time cancer survivor, and a very upbeat person, but who has had some lung cancer come back. She spoke of having commenced on some combination therapy which included a pill that stops the blood vessels from feeding the tumor and which she said , but I can't be sure of an exact quote, is very new but they are "really having some good results with it." A viewer called in and asked what it was and she couldn't remember the name. I would bet it was Avastin, if that is a pill-form drug. Right now , whatever publicity any angio inhibitor gets is good for ENMD IMO. Anybody else see this, please correct any error.
And thank you , docaaron.
As you imply, there would seem to be a serendipitous (or whatever that word is) connection here.
2 ME and renal and cardiovascular protective effects:
http://www.cardiovascularpharm.com/pt/re/jcardiopharm/abstract.00005344-200507000-00004.htm;jsession...
making the world safe for rodents anyway.
Relative to patents:
A federal statute apparently insulates certain experimental uses of patented drugs from the patent infringement laws, under certain conditions.
Here is a link to a Supreme court case decided in June which attempts to delineate the scope of that protection:
http://a257.g.akamaitech.net/7/257/2422/13jun20051230/www.supremecourtus.gov/opinions/04pdf/03-1237....
If the link doesn't work you can get it in one of many internet sites where Supreme Court decisions are reported,. The parties to the case were Merck KG AA and Integra Lifesciences I Ltd. Incidentally the case involved an angiogenesis inhibitor. Other than saying the statute insulates both pre-clinical and clinical work if the circumstances are right I'm not sure what it stands for other than that biotech companies need patent lawyers.
I suppose the statute can be beneficial or adverse to little biotech companies.
Might not be suitable for all
cancers per this abstract for a Swedish dissertation:
http://www.diva-portal.org/diva/getDocument?urn_nbn_se_uu_diva-4554-1__fulltext.pdf
view enlarger/magnifying glass tool necessary.
But what therapy is (except for an ES and AS combo having bioavailability which no one seems to want to try to make)?
docaaron, re Katie, OT,;
no, I had not heard her story.
I read the blogs you linked. This is exemplary of where "the Village" steps in to do its perceived duty with regard to a
child without regard to parents' wishes, backed by the Village experts. While there are undoubtedly situations where this may be appropriate--maybe this is one, we will have to await the outcome--it is my view that if we subordinate the parents' loving judgment to the Village, we should remember that the first rule of the Village is cover your own butt. As Haod puts it just my opinion.
chimney
prayers for both cousins.
both of those are mean cancers.
I've seen what you are talking about with
side effects of both radiation and chemo in
my own relatives and I know others here have also.
Let's hope we can do better for all the cousin B's.
Here is the 2004 report/abstract; I just wondered if there has been an update:
http://meeting.jco.org/cgi/content/abstract/22/14_suppl/7105
angiostatin, paclitaxel and carboplatin
anyone know anything of this lung cancer trial at Indiana University ? (sad to say i know its OT now)
An interesting article : "Biotech finally":
http://yahoo.businessweek.com/technology/content/jun2005/tc2005062_4958_tc024.htm
I wonder if apparent efficacy of Genentech's product for macular degeneration mentioned here --Lucentis--resulted in Allergan's termination of the deal with ENMD for Panzem.
DNA is reaching some lofty heights in the market.. almost 100 PE ratio.
Article critical of FDA by former FDA official:
http://www.forbes.com/investmentnewsletters/2005/05/31/cz_sg_0531medicinemarkets_inl.html?partner=ya...
Gee, and I thought the policy was headed the other way.
Just a continuation of the first rule of bureaucracy: First, do no harm---to your own butt. The second rule supplements the first: You can never get fired for saying no.
Want to license 2 ME as a breast cancer preventative ?
It's available...from the government:
http://www.pharmcast.com/FederalRegistrar/Yr2005/Licensing/May2005/Invention052005B.htm
Scroll down further and reference to a thalidomide analog.
Well link won't work. Maybe this:
http://www.cancer.wisc.edu/clinician/trials/frametrials.html
Protocol number is CO04905.
Just in case anyone knows someone who might be interested in the U of Wisconsin trial of Panzem NCD, enrollment seems to be still open:
https://smrs.biostat.wisc.edu/sip/SIPControlServlet
Thank you, NHL for sharing your ASCO experience.
Got a corporate developer
VP;
http://ccbn.tenkwizard.com/filing.php?repo=tenk&ipage=3488400&pg=zMvHx8vPz9HOzs7Jxs7Px8/P&am...
$204K base salary, 100,000 stock options,at 3+ ; installment vesting; fully vested if change of control.
A disease our use patent (for 2ME) doesn't cover ?
http://www.mysan.de/article102951.html
Re Panzem,for macular degeneration
I believe the ENMD quarterly report mentioned that Allergen (sp?) had terminated the license they had, but the cause of them dropping it, or whether they ever tried it on anybody, I do not know.
Tborges,i couldn't come close to disputing that,
Here's another U.K. report on this.
http://www.nature.com/cgi-taf/DynaPage.taf?file=/bjc/journal/v90/n4/abs/6601591a.html&dynoptions...
Maybe our old resident expert, and our new medical resident (would that be now Doctor Peptide ?) can help us out here as to what a "sulphamoylation" is.
caveman or resident, congratulations on your emergence --I guess--I hear the money gets a little better, but now you get to be responsible for the medical decisions-- that would be even more stressful than med school to me..
Re enhancing effects :
I have never been able to find out exactly what "sulphamoylation" is; perhaps a British term not used in American chemistry--but it seems to be clear to these researchers that it gives an extra kick to 2ME 2. I don't know whether that comes under "increased biolavailablity" or not: Anybody care to tackle explaining this ?
http://www.endocrine-abstracts.org/ea/0003/ea0003oc10.htm
And from Dr. Herbst, of MD Anderson, quoted:
"“We have arrived at a stage when creative clinical trial designs are becoming important. Although a combination approach of targeted agents with chemotherapy and radiotherapy is here to stay, the future of cancer therapy will be to combine antiangiogenic agents without chemotherapy and radiotherapy.”
This from the PI, if I recall correctly, of the "failed" phase 1 clinical trial of ES at MDA. Maybe Moberylane and I should cheer up. Glass might be looking half-full after all.
From the ASCO AI forum I previously linked today:
'Indeed, in patients who have self-administered endostatin, tumor regression has occurred slowly and many patients are now asymptomatic. The failure of clinical trials that have evaluated these compounds arises because in clinical trials these patients would be considered as nonresponders."
I don't know whether "MANY PATIENTS" is Dr. F's phrase or that of whoever was summarizing his remarks.
The Chiunese folks apparently don't consider these patients as "nonresponders". Maybe after American cancer patients start going to China for their medical treatment, we can start making clothes for the Chinese market.
Summary of angiogenesis forum at ASCO:
http://www.asco.org/ac/1,1003,_12-002471-00_18-0040256-00_19-0040257-00_20-001,00.asp?CMP=EMC-7UI367...
Apologize if previously posted, haven't caught up on messages.
uh, that's bevacizumab; aka Avastin .S.A.T.(Sorry About That, eom)