Rocky that looks like a google translation of a foreign language (Chinese (?))translation of ENMD's 2007 announcement. Entertaining. Especially "close-fisted" intestine for "small intestine" and "grub" for food. Any way to find out just what the intermediate language was ?

OT, from The Street.com.
"Five Biotech Events to Look For 2010"
Unfortunately ENMD not mentioned. Adam Fuerstein writer of this piece,wrote a lot about ENMD during the endostatin days:

http://finance.yahoo.com/news/Five-Biotech-Events-to-Watch-tsmf-2812186927.html?x=0

Happy New Year. My only prediction is that I will not be holding ENMD stock at 80 cents per share at the end of 2010. If I hold it at all it will be worth substantially more. Otherwise, a tax loss I hope I can use. A decade with no return on an investment is long enough. Did we get any primary results on the myeloma trial in December as was expected ? Regards to all and thanks for your contributions to my knowledge----or entertainment!

Senate health bill- biological products.
Re my post 9485 the provision summarized there is in fact in the final Senate version of the health care bill, H.R. 3590. It is section 7002, in Subtitle A of Title VII of the bill. It seems to me that it, in conjunction with other laws, gives protection against commercial use of a generic version of a patented biological product for at least 12 years after the first commercial use of the patented product.If so this seems eqitable since a substantial portion of the patent life of a drug may have expired by the time FDA approves it for use.That worried me about Panzem. But maybe it doesn't say that. (Google H.R. 3590; select the Thomas full text Senate version; scroll way down to Section 7002 and decide for yourself.)

Ain't nobody left but me ? George, where you gone ? VK ?

Any way, the NCI cancer trials site re multiple myeloma trial for ENMD-2076 states estimated time for report of primary data as December 2009. Yet it shows the trial is still enrolling.Would failure to obtain full enrollment postpone this report date ? :

http://clinicaltrials.gov/ct2/show/NCT00806065

Merry Christmas and joy to the world Ihub if anyone still comes here.

The following is a Senate committee summary (July 2009) of A version of a provision in the pending federal health care act. I'm not sure it is in the version of that bill just coming out or if it is, whether changes will occur . Not that it has direct relation to your health,but I expect biotech companies are interested in the final wording if it stays in there:

"Title VI: Improving Access to Innovative Medical Therapies
Subtitle A—Biologics Price Competition and Innovation
Synopsis: This section establishes a pathway for licensure of a biological product based on its similarity
to a previously licensed biological product (reference product).
The Biologics Price Competition and Innovation Act of 2009 requires HHS to license a biological product that is
shown to be biosimilar to or interchangeable with a licensed biological product, commonly referred to as a reference
product.
The Act prohibits the approval of an application as either biosimilar or interchangeable until 12 years from the date
on which the reference product is first approved.
If FDA approves a biological product on the grounds that it is interchangeable to a reference product, HHS is
prohibited from making a determination that a second or subsequent biological product is interchangeable to that
same reference product until 1 year after the first commercial marketing of the first interchangeable product.
The Act authorizes HHS to issue guidance with respect to the licensure of biological products under this new
pathway, and it includes provisions governing patent infringement concerns such as the exchange of information,
good faith negotiations, and initiation infringement actions.
The Act also requires HHS to develop recommendations for Congress with respect to the goals for the process for
the review of biosimilar biological product applications for the first five fiscal years after FY 2012."

Rocky 1-- Your posted trial description indicates this 2-location trial is still recruiting/enrolling, while ENMD's web-site states it is ongoing but with enrollment closed ( which I hope is a good sign) so I am a litle confused :

http://www.entremed.com/clinic/#ongoing

Doc, could you translate ? Under their conclusions, is it good or bad for breast cancer that aurora A tyrosine kinase is inhibited ? To control two types (Ovarian and breast) of cvancer with one drug would be great but I'm not sure that follows from this . Just say good , bad or inconclusive; thanks as always.

Just to put a face on it,
here's a link to the Dana Farber web site
with a picture of Dr. Geoffrey Shapiro who
leads the clinical trial team including that on the phase 1 trial of ENMD-2076:

http://www.dana-farber.org/pat/adult/eddc/the-treatment-team.html

Wonder if they have yet determined the maximum tolerated dose. Presumably they couldn't start a phase 2 till they knew that.

What would be the possibilities of getting the NCI or other governmental (or non-profit?) funding, via grants etc., of the phase 2 for ovarian if the phase 1 going on now at Colorado and Dana-Farber show reasonable success but perhaps not enough to attract a business partner. What does a company have to give up to get NCI grants?

I'll go with you, in general. You raise a good point; any partnership agreement that they do make should specifically provide for prompt and uninterrupted development of 2076 as prudence and the law permit, without regard to conflict with any partner's products.

I guess Thalomide royalties were down because Revlimid sales were up. We get no royalties from Revlimid, claim to the patent for which we gave up. According to this, Revlimid accounted for 59% of Celgene's revenue last year.

http://ih.advfn.com/p.php?pid=nmona&cb=1260568311&article=40686611&symbol=N%5ECELG

Hindsight's easy, but I keep wanting to ask present and past management "What were you thinking ?" (Same question to Tiger, but I guess he might say if you had thousands of idiots always yelling "Get in the Hole!" to you and a sponsor insisting "Just Do IT " you'd give in too.)

SOS, 2076 !

Pretty bad royalty estimate, wasn't it ?

George here's a link you might want to add to what must be your enormous watch list:

http://healthinfoispower.wordpress.com/developmental-drugs/

Perhaps once the ovarian cancer clinical trials start to enroll ENMD will get a more comprehensive coverage. Meantime what is covered now provides aome basis for comparison.

How significant that both Phase 1 trials at Dana Farber and Colorado are now closed ?

Will the 2010 phase 2 ENMD-2076 trial for ovarian cancer have a placebo cohort ?

Sorry that OT was from Medscape and I guess shouldn't be copied without their permission. Basically Dr. Messersmith was commenting on some biomarker developments to narrow down possibilities of response to colorectal cancer treatment, and was mildly critical, I took it, of BMY and AMGN for not releasing data in this regard that he apparently thought they had.

Yeah tb, we better stop there. OT, here's a hint that Dr. Wells Messersmith has little patience for keeping data in the closet...I think I like the guy:

http://www.medscape.com/viewarticle/710574

Are they inhibited there in Aurora ?

Go Abonour go ! :Hope he did good:

http://www.clarian.org/portal/Clarian/cancer?ContentID=/medical-services/cancer/news-announcements/20091001_multiple-myeloma-research-bike-ride.xml

Fargo: Our dog has lots of pets. He carries them wherever he goes and scratches them a lot to keep them happy. I bet he would be glad to share with you.

I like your scenario, if there is enough revenue potential in the AML application to justify such a deal.

docaaron : Can you determine :
1. Of the 7 ovarian cancer patients reported in the June ASCO poster, did the 3 who were NOT included in the slide 16 drop from the study due to progressive disease, death , dose limiting toxicity , or other, or is it possible 1 or more of them was still on study but not evaluable for slide 16 purposes ( Just started on study; just started the 160mg. dose, whatever) ?

2. How likely is it that the 4 in slide 16 who had apparently favorable responses then ( at least by the CA-125 count method) continue to be on study,which should mean that their disease is either being reduced, held in check, or at the very least not progressing at the rate otherwise consistent with its status when they started study ? Since durability of response is the ul;timate determinant, what has happened to these 4 seems most significant. Hope that lack of specificity on this point in the announcement is not bad news; though I would think that if all 4 of these "originals" had to be dropped, a phase 2 for ovarian would be a doubtful decision.

Interesting quote from Dr. Sidor in company announcement yesterday:

"Clinical data presented to date support the compound’s activity in a variety of solid and hematological cancers, including patients who have failed prior antiangiogenic treatments.”

What "prior antiangiogenic treatments? Avastin ? Gleevec ? Another tyrosine kinase inhibitor ?

Here's a piece about early-stage and late-stage testing for ovarian cancer.

http://www.webmd.com/ovarian-cancer/news/20090310/new-test-for-early-stage-ovarian-cancer

I recall reading more recently about more improved testing.
Would the protocol for phase 2 trial include only those meeting the progressed-disease standards of phase 1 or could it include early-diagnosed cases? (Of course these patients would be harder to recruit, I guess; it's not as though there were no approved therapies. )

Way to be on the ball, Rocky.
I think they got enough to stay above a dollar for awhile anyway. I will look forward to comparing the ASCO reported results for the ovarian ca pts. with the current results for ovarian.

12:30 pm EST for poster sessions. . Abstracts were available to meeting attendees yesterday did ENMD folks submit any ?

Kenlassen, here is another link to mention of GSK tyrosine kinase inhibitor (Tykerb) for breast cancer :

http://www.drugdevelopment-technology.com/projects/lapatinib/

Use as a combination drug seems most effective and I have to think that would ultimately be so for ENMD 2076.

There are a number of tyrosine kinase inhibiting drugs under development besides ENMD's. Are any of them also being reported at the upcoming conference, whether for multiple myeloma or any other caqncer ? That would give us a basis for comparison and estimated durable efficacy.

Sympathy, rubberchicken. Lost my mom to cancer also (ovarian)years ago. Logic tells us to be glad they no longer suffer; acceptance of the empty space is more difficult.

Kenlassen, Glaxo-Smith Kline has an approved tyrosine kinase inhibitor apparently available for metastatic breast cancer that you might want to check out here, if you haven't looked into iot already:

http://www.drugdevelopment-technology.com/projects/lapatinib/

Ken, all I can offer is prayers, which have been sent; and am sure you can find all the online support groups and clinical trials. Some of the published material that that Kathy Miller MD who did the Panzem breast cancer study at Indiana University Cancer in Indianapolis has impressed me as from a very knowledgeable breast cancer researcher; don't know whether they have any trials going now that would fit your situation but hopefully she would take your call. All the best, Nottadoc2

Of interest, re independent review boards/clinical trials:

http://upislandeggs.blog-city.com/rumination_24_building_destructive_empires.htm

Why down on high volume ? Any ideas ?

OT: Gina Kolata, who many wish had never written a certain piece on endostatin, has co-authored a report on Senator Kennedy's treatment in the NY Times:

http://www.nytimes.com/2009/08/28/health/28brain.html?pagewanted=2&_r=1&partner=rss&emc=rss

Sounds like she stole the idea from Judah Folkman. Odd that she waits till he's dead to sue. But who knows ?

anti-angioigenic effect, that is.

Thanks Doc, should have checked that out myself.
Something they'll have to deal with; wonder if a blood-pressure lowering drug administered simultaneously would counter-act the angio-genic effect ?

Docaaron, re blood pressure increase:
Surely in all the phase 1 trials of anti-angiogenic drugs, blood pressure of all patients has been measured. Have adverse signs in humans been noted ?

OT sort of. This is a link to a 2006 NCI announcement regarding methods of delivering chemo to ovarian cancer patients which seemed to establish that intraperitonial (sp?)or shooting it right into the abdominal cavity via catheter had better results than iv and that maybe both methods could be used. Maybe things have changed in the 3 years since, but assuming not, and since ovarian seems to be a good target for ENMD-2076, I'm wondering whether its effects could vary with method of administration also. Just where do those Aurora A kinases hang out ?

http://www.cancer.gov/newscenter/pressreleases/IPchemotherapyrelease

George, when was that notice about the carboplatin-ENMD combination trial re breast cancer issued ? It is not (Yet ?) on ENMD's web site of enrolling trials . Did you scoop the PR lady ? Dr. Jennifer Diamond was on the list of "fellows" at that Vail Asco workshop last week (Those docs know good places to get educated on tax deductible accounts !) Dr. Diamond presented data for ENMD-2076 and apparently a rationale for the combination trial at a hematology meeting in February:

http://www.entremed.com/news/entremed-presents-initial-clinical-results-for-enmd-2076