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.
Funny !!!
Wonder what kind of costume the Vet wears ? And how much does he charge and how does he describe it on the bill ? Seriously, just find any old bitch in heat and that should do the job unless the old pure bred guy is awfully choosy.
doc a-1:
I like this part too:
"Working backward from responses in clinical trials is unusual, Thomas said. Responses observed in clinical studies led researchers back to the laboratory. Their laboratory findings will be tested in further clinical studies, bringing the observation full circle, from the patient to the lab and back to the patient again."
Thanks.
Question re CELG rights:
(1) Good looking row of ducks you assembled there Jento. Think Aflac would partner with us ?
(2) Does anyone know whether, with the Miikana closing, CELG now has a window, pursuant to its pre-emptive rights, to purchase ENMD shares for an equalized amount of $ per share and if so how many and for what ?
It is questionable since Miikana's EMND shares were issued for Miikana stock. Here is link to contract on EDGAR:
http://yahoo.brand.edgar-online.com/doctrans/finSys_main.asp?formfilename=0000950133-05-005747&n...
I'm not quick enough in the time I have to figure out what the per [ENMD] share contract value is. At least the contract linked tells us that there were exactly 50,072,569 shares out before this deal, disregarding I think the 3,350,000 convertible [at 5 for 1 ?] preferred shares held by CELG and unexercised options; and ENMD tells us it will issue "up to" 9,964,000 shares to Miikana shareholders; a business journal summarized the Miikana deal as having a value of about 21.2 million for 9.96 shares; this would put it at about $2.12 per share, if CELG has rights at this price, they can buy at less than today's market but that would give ENMD an additional 21 million working capital.
rkopenec I agree with you
as far as feelings of regret but analyzing from
hindsight, I think what happened was that Holoday had
so anticipated success for ES and AS that he thought that getting some $$ out of Thalidomide to develop those was well worth the giving up. On the analogs, we probably folded the patent lawsuit too cheaply but by then needed the money even worse. There is no question though that Celgene has mined a lot of gold from ENMD..and probably will again.
Look at the side effects of Thalidomide and dexamethosone [sp.?] vs, the dex stuff alone, in the myeloma release.. is a comparison of Panzem plus dex. vs. multiple myeloma available yet?
docaaron1
Why do you suppose an American pharma with lots of $ and big drugs with patents running out-e.g., PFE, Lilly, BMS, etc. doesn't license ES and AS from Childrens Hospital and then work out a deal with the Chinese co. for non-Asia Endostar and (for the Chinese Co.) Asia ES and AS which would in effect extend the life of the U.S. patent for ES which otherwise by itself is getting shorter all the time, isn't it ? Or is it?
With the anecdotal successes in the article, Folkman's statement that Endostar is more potent than ES, dawning of recognition of the value of "stable disease", adjuvant therapy, and metronomic chemo, the risk seems less than it was. It is ironic that a Communist country plunges ahead to bring our science advancements to the market place .
CELG: Elephant in ourliving room,fox guarding our henhouse,or white knight?
Here's an interesting paragraph from the agreement I referenced:
"4.6 Disclosure of Material Non-Public Information . Upon the written request of the Purchaser [CELG], the Company [ENMD]shall not and shall cause each of its affiliates (as defined in Rule 405 under the Securities Act) and other Persons acting on behalf of the Company not to divulge to the Purchaser any information that it believes to be material non-public information unless the Purchaser has agreed in writing to receive such information prior to such divulgence. The Purchaser may rescind and deliver such written request at any time and from time to time."
Like, don't tell me unless I tell you to tell me after you say you have some material non-public information to tell me if I want to hear it. Of course, you can tell me whether the news is good or bad on a scale of 1 to 10. And when the clinical trials are up-dated to you, my two directors must sit outside with hands over ears, unless I have already told you that you can tell me. Oh yeah.
This was the link I meant:
http://yahoo.brand.edgar-online.com/fetchFilingFrameset.aspx?FilingID=2116964&Type=HTML
George, that is helpful.
Also bearing on ENMD -Celgene is the asset purchase agreement of 12/31/02 referenced in your posted document and found in an SEC filing shortly thereafter which I can't seem to paste a link to. Bet you can do it.Exhibit 99.3 to that agreement in turn is the agreement for CELG's securities purchase and in there the matter of its preemptive rights to purchase matching additional shares when a new issue is made is covered. It's not clear to me whether this right would attach to let them match by purchase the 9.+ million shares to be issued to Miikana. The definition of "New Securities" in the agreement may possibly exclude the stock to be issued to Miikana from triggering the CELG right. The question is significant to the amount of potential dilution resulting from the Miikana transaction.
A good investment
Peace on Earth Good Will towards Man. Oh, and to Women and children.
Especially children.
doc a, in the
conference call which can be print-accessed As an exhibit to the sec filing on ENMD web-site, he states : "****and we neeeded to add key positions to support our growth naturally, so that we're anticipating that a number of key Miikana employees will fill these positions."
As i remember, Celgene has preemptive rights with regard to any additional new issue. Does anyone remember whether that would apply to a stosk for stock deal like this triangular merger ? (I guess the ENMD stock comes from the shelf registration.) If Celgene is diluted also, that that would make me feel better about a takeover by it at an unfair price.
Real good find, George.
that experiment may be the very impetus for the deal.
To be accurate, I think, the 20% comes out of what Children's might receive and not out of the gross non-asia revenue. And of course somebody has to license it and get approval before
that happens; and the patent life is diminishing; and anybody that thinks China is going to pay any attention to U.S. Patents believes in---well I believe in Santa Claus so that's not a good analogy..
And this abstract from 2003
ASCO annual mtg. reporting on phase II metastatic NET trial:
http://www.asco.org/ac/1,1003,_12-002636-00_18-0023-00_19-00103748,00.asp
could that be possibly ongoing ?
mobery,
There was one announced for ES only for neuroendocrine cancer in November 2001 before things kind of fell apart financially. See:
http://www.acor.org/drugs/pipeline/news/parsed/7125215.news
I doubt if that's what Alchemgem was referring to so that's news to me too. Was there an AS in combination with something in Pa. that was classified as a phase 2 ?
Q re phase 2 "endpoints."
What will they be ? Time to progression [recurrence ]? Survival for statistically significant period [Is this "stable disease ?] ? Different for different cancers, or will they try to limit the number of cancer types to the potentially most susceptible to Panzem ? The ideal would seem to be the most aggressive form which is susceptible and which is presently less treatable. Based only on Chimney's Cousin (hope she is still doing well) I'd guess ovarian. Of course you need patients for trials, so that may dictate the types.
goodbug, thanks. I'm not "close to the industry" but I would think the "industry" would welcome the new direction he discusses. Of course what the FDA cannot do is provide insulation from Vioxx-type lawsuits...for failure to "tease out" a statistically minor side effect in clinical trials, etc.
George, in a nutshell,what the heck does that say that makes it a must read re Panzem? Are we to infer that inhibitors of those HSD17beta thingies will enhance bioavailability of Panzem ?
Please help the biologically illiterate here. . thanks as always.,
"Although ENMD-1198 shares many of the mechanisms of 2ME2, its activity profile is significantly different and, as such, we expect that the two compounds will be used to treat different tumors. " C.Sidor quote.
Consistently with this, Docaaron's comment that Panzem may work better vs. some types of cancer than others is probably correct. Hopefully, though an analog,ENMD-1198 will work better on what Panzem NCD does worse on, and vice versa. What they should be respectively combined with, if any thing, will also be tricky. Someday maybe a cancer patient can give a blood and urine sample , a biopsy for solid tumors, feed it all into a computer with his /her DNA sequence, and out pops here's what you need , down to the milligram and optimum precise minute for dosing. (Plus the suitable diet and exercise regimen.)
In the meantime, for phase 2 Panzem ENMD needs to target the cancers with the best odds of success, based on the phase 1 data; leaving out the bad targets; and so a timing question arises: do they have enough data now, or do they wait for more data? Is phase 1 still enrolling ?
Jento
In the link you provided to the meeting abstracts in #3131--I hope it's this:
http://www.aacr.org/Uploads/DocumentRepository/pdf_files/2005MTCT/MT05_abstracts_accepted.pdf
but anyway its abstract B-40; there is a reported 2ME experiment which seems to be kind of good news-bad news (or vice versa) for 2ME and breast cancer. There's a little too much chemistry lingo for me so I'd like to see your comments, or anybody else's, on this.
docaaron1
In the Wisconsin poster, the first link in Jento's #3130, and i had to substantially enlarge with the magnifying tool to see it, in the panel captioned Duration on Study, a little red cross appears above 7 of the "patient bars" and a key to this indicates this means those patients are still on study, or were as of November 2 (?). Note that 3 of 3 in cohort 3, the 1000mg. dose, remained on study, and 2 of 3 in cohort 4, with the remaining pt. in cohort 4 only having been on 2+/- weeks. I suppose you can argue positively or negatively from the fact that no one from cohort 1 remains. What is not clear to me is the the panel following labeled "Response" which says the best response is stable disease--see above table for duration ***;
I can't tell for certain from this what they say is stable disease or as to which patients. How do you read it ? I suppose they can say that if at any given time of tumor measurement, the tumor has not enlarged from the last previous measurement, then as of that given time there is stable disease.
Also I wonder why the patient who had the minor response (the red bar) is no longer on study.. but hey, if I wanted complete answers, maybe I should have paid my way in to the meeting. Do they let not-a-doc's in to such affairs ?
Jento, thanks for your comments as always.
In the WISConsin trial 7 of 16 remain
on study.. but 2 of those are in cohort 4, less than 5 weeks on study.If all 7 can achieve stable disease (most likey too optimistic) then the SD rtesults will be comparable or slight ly better than the IU.. and yes it's too small a sample for the statisticians.
Thanks Jento
You succeded in lowering my expectations to "realistic" by your yesterday's posts re abstracts only so now the posters make me feel a little encouraged. Lots for the knowledgeable to explain to us.
Shall we assume that those still on study in the Wisconsin trial can be classified as stable disease---for the time being, I mean ?
The IU study is specific, that 5 of the 13 achieved stable disease--for the time being..seems pretty darn good considering, as compost reminded us, that these were pts. with advanced cancers.
Could you explain the significance of the "2ME1" charts? Degree of conversion from 2ME2 ?
Shall we assume that about 1000mg. 4 times a day will be the phase II dose ? What cancers are the best candidates for phase 2 ? Is there any chance that pts. with less advanced cancers can/will consent to be/ enrolled in phase 2? It looks like prostate ca. is the candidate for single agent.
Not encouraged
Posters at Philadelphia are out.
B-121 sounds better than B-14. Maybe better with more time. B-240 (ENMD1198) maybe makes this worth a further hold.Whoever dumped at 2.33 I can't blame., I hope someone else can give a more encouraging interpretation.
Good catch George..
It will be interesting to see how the separate posters compare.
If there is any liftoff
it will probably be from a poster session at the AACR-NCI-EORTCmeeting in Philadelphia which I think is what Georgejjl refers to.
Try :
http://www.aacr.org/Uploads/DocumentRepository/pdf_files/2005MTCT/2005_MolecularTargets_poster_and_p...
Look for poster number B-14 from Wed. nov. 16.
This is all I saw re Panzem NCD among the many posters and presentations listed, but I went through pretty quickly. What I wonder about this poster is that Dr. Wilding of UWCC is listed but not Dr. Sweeney of IU, and I thought this was sort of a combined trial. Lift-off maybe but I see no moon shot. Can we settle for an orbit injection ?
Anyway a lot on angiogenesis to come out of that meeting. Hope our guys go to the delivery methods sessions.
"***as we prepare for Panzem(R) NCD Phase II trials ***"
If, the PK ready-to-disclose knowledge sought of the phase 1b study has been obtained ( though not ending the 1b clinical trial, which apparently is still enrolling)and the results thereof a complete flop ( and I would view failure to obtain at least stable disease in some patients, but not necessarily tumor regression, as these were advanced patients regrettably, as a complete flop), then wouldn't it be misleading for the CFO to use the quoted phraseology ?
Thanks Rocky 1.
GSAO trial 2006 -- maybe.
http://www.acrf.com.au/page/university_of_nsw.html
GSAO
another AI
jncicancerspectrum.oxfordjournals.org/ cgi/content/abstract/jnci;97/20/1539
worth reading again:
http://www.news.harvard.edu/gazette/daily/2005/07/12-folkman.html
Goodness Graciousness !
I love it. Is that "grind" a nsnotechnology ?
Doubt if they'll get the Taiwan patent, but that's Alchemgen's problem.
OT - re clinical trials ethics.
A pharmaceutical trade organization's statement of ethical principles re clinical trials:
http://www.phrma.org/publications/policy/2002-07-18.490.pdf#search='clinical%20trials%20and%20stock%...
Of course the medical institutions where trials are conducted would likely have their own rules for the investigators, concerning stock ownership, etc. Does the AMA have ethical rules re stock ownership in this regard ? AACR ?
George, that is certainly a logical supposition based on an assumption that early responses were positive, but actually if they wewre goning to test on all the cancers listed those protocol parameters would be very restrictive. I count 23 and possibly 24 diffrerent listed cancer types. If you wanted four patients, one at each dose level throughout, for each cancer type, then you would need 96 enrollees. If they were going to expand the number, it would seem they would amend the announced protocol.
The 12 months I believe started January 2005, so that would be reached January 2006. But I agree that if they can't enroll 24 patients in a year's time, that doesn't seem encouraging.
George, re Pulmolar; 2ME bioavailability::
"PulmoLAR is PRP's proprietary sustained release injectable formulation. Animal studies conducted to date suggest a single low-volume injection may provide therapeutic levels of drug for up to one month."
Did we miss out on something here? PS good guess on the EORTC meeting.
At what meeting this fall
should we guess that ENMD will present the results of the Phase 1b trial after having met the study objectives this quarter (which ends tomorrow)? The CEO says they anticipate presenting the results at a "scientific meeting this fall" The AACR web-site, subsite for programs, shows a meeting in Boston on anti-angiogenesis beginning November 9, with Jain, Kerbel, Folkman, Hanahan and i suppose other stars of the science, and which should produce some interesting things, but that program will be sponsored by Genentech, so ENMD might not be too welcomed there. What else is scheduled ? I don't call some investment firm symposium a "scientific meeting."
Re the article by Sweeney et al., what is PSA velocity ? rate of change in PSA ?
inoperative link, sorry. Had reference to Dr. Joanna Horobin appointed CEO of a German co., U3 Pharma.
A previous ENMD officer now with U3
(not a band):http://www.hbanet.org/resource_bin/2005/7/2556_CEO_Appointment_Joanna_Horobin.pd
C_peptide and Jento, thanks for sharing this.
I'm trying to reconcile a couple of the statements.
The conclusion posted by C Peptide stated that"As clinical activity of 2ME2 in this study was modest, and the majority of patients experienced stable disease, stable levels of angiogenesis factors were expected and observed." It also states that the patients were kept on study until the patient or the physician felt there was no clinical benefit. Also that the median time on study was 126 days for the 1200 mg. dose group.
At what point would one say that stable disease was achieved ? When the PSA stopped rising for a given period ? If someone achieved stable disease why would they ever conclude there was no clinical benefit ? What exactly is PSA "velocity"? Rate of increase, like 0 to 60 mph in 10 seconds ?
I confess to not buying the whole online article.
Jento, re AACR article:
Dr. Sweeney, one of the authors and investigators in that ph. 2 trial, is also an investigator at the U of Indiana site for the still-enrolling 1b NCD trial. If you want to take a half-full view of the glass, you might conclude that if the preliminary results from the NCD were a complete flop he wouldn't want a repeat of the phase 2 poster presentation in such a prestigious journal. Or, maybe a patient or so that was stabilized then is still stabilized.Or maybe not.
BTW, I noted in the projected table of contents you posted that there is to be an article on the synergestic effects of curcumin and a cox-2 inhibitor. Bet George will like that .