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Long time not here. Was what ENMD transferred to Celgene a few years back essential to CELG's Revlimid development ? I note from the ASH news Revlimid is now considered A COMPONENT of the "gold standard" for multiple myeloma. I think we made a bad deal. But maybe ENMD had to to survive.
A link to a 2010 article re clear cell ovarian ca:
http://ovcare.ca/Anglesio_personal_copy_OCCC_REVIEW_Final.pdf
Since the 2076 trials to date seem to indicate a better result in the clear cell patients ( I do not necessarily equate "better" with "good") the article might be intersting. While the molecular references are beyond me I thought the observation that Asian women seem be more susceptible to "CCC" perhaps suggests that continuing trials in that part of the world will produce more encouraging data for 2076.
It seems to me that Dr. Bray's termination marks the end of ENMD as a US research and development company. I doubt if Dr. Sidor spends any time at all there. Anyone have a different take ? Just how many employees in total are left ?
Thanks for posting this..
The increasing ability to identify "sub-types" of cancer, and probably "sub-sub" and "sub-sub-sub" types should enable more focused and less lengthy (and hopefully less expensive) clinical trials. I wouldn't be surprised if this study was benefited by the ongoing Human Cancer Genome Project. Google this, or the NCI has a good online description of it. The project is also mentioned as a source of hope as a research tool in a book I've just finished reading: the Pulitzer prize winning "The Emperor Of All Maladies" - a "Biography of Cancer", by Siddhartha Mukherjee, with a 2010 copyright. I recommend it highly.
Thanks retread. Note abou8t item 5, it says:
"In connection with the Transaction, it is expected that Michael Tarnow, the Executive Chairman of the Board of Directors, and Donald Brooks will resign from the Board of Directors, effective upon the Closing. It also is anticipated that the Board of Directors will fill the vacancies created by the resignations of Messrs. Tarnow and Brooks with two nominees to be designated by the Investors."
Has Brooks been the patent lawyer ?
I guess that's what you do when the alternative is bankruptcy. That penalty payable if the shareholders don't approve seems a little like blackmail of the shareholders.
Avastin on NBC nightly news?
There may be an interview on NBC nightly news tonight with an ovarian cancer patient on Avastin.
My sympathy as well, Kenlassen.
Re Avastin: Found this excerpt on a support group post:
By Anna Azvolinsky, PhD | June 21, 2011
________________________________________
"Two large-scale Phase 3 trials that add bevacizumab(Drug information on bevacizumab) to standard chemotherapy regimens in advanced ovarian cancer reported results at ASCO this year. The ICON7 trial adds bevacizumab (Avastin) to a standard chemotherapy regimen for newly diagnosed ovarian cancer patients. The OCEANS trial tests the therapeutic benefit of bevacizumab in conjunction with chemotherapy followed by maintenance dosing of bevacizumab in previously-treated ovarian cancer patients. The OCEANS trial reported a 52% risk reduction in disease progression for women in the bevacizumab arm, while the ICON7 trial found that treatment-naive ovarian cancer patients had a 36% reduced risk of death among those patients that are high-risk.
The OCEANS Trial Results
• "The OCEANS study is a positive study," said the presenter and lead investigator, Carol Aghajanian, MD during a press briefing. Dr. Aghajanian is a medical oncologist and the head of Memorial Sloan Kettering Cancer Center's chemotherapy program. The combination of bevacizumab and chemotherapy "provides a clinically meaningful benefit in recurrent ovarian cancer." This is the first advanced stage trial of an antiangiogenic agent that has demonstrated
The data showed that adding bevacizumab to platinum-based chemotherapy reduced the risk of progression in women with recurrent platinum-sensitive ovarian, peritoneal, or fallopian tube cancer by one-half (p<0.0001). Women with added bevacizumab during their chemotherapy regimen and following chemotherapy treatment as a maintenance therapy were 52% less likely to progress than those women who were given a placebo. The median progression-free survival (PFS) was 12.4 months compared to 8.4 months for the placebo group. The PFS finding was consistently better for the bevacizumab group regardless of patient factors such as age and cytoreductive surgery for recurrence.
The objective response rate was statistically significantly higher in the combination group: 78.5% compared to 57.4% in the chemotherapy-alone group (p<0.0001). The median number of chemotherapy cycles, bevacizumab, and placebo cycles completed for each study arm were 6,12, and 10, respectively. So far, interim overall survival (OS) results favor the use of bevacizumb, with a median OS of 35.5 months for the combination compared with 29.9 months for the chemotherapy-alone arm. The OS results are not yet mature however.
Dr. Aghjanian stated that "the safety data were reassuring and consistent with the known bevacizumab side effect profile."
The OCEANS Trial Design
The OCEANS trial is a Phase 3, randomized, blinded and placebo-controlled trial that compares the use of carboplatin(Drug information on carboplatin) and gemcitabine(Drug information on gemcitabine) (C/G) chemotherapy with C/G plus bevacizumab in women with platinum-sensitive recurrent ovarian cancer who had not previously received chemotherapy for their recurrence.. The trial was started in 2007 and 487 patients were randomized to two arms consisting of chemo every 3 weeks for 6 cycles with either bevacizumab (15 mg/kg) or placebo every 3 weeks for 6 cycles followed by maintenance with bevacizumab or placebo until disease progression. The primary outcome of the trial was PFS. According to the abstract presenter, the 15 mg/kg dose was chosen based on a previous Phase II trial that compared this dose to several lower doses in ovarian cancer patients.
The ICON7 Trial Results
Mature PFS data for this study showed a 15% improvement in PFS at 12 months for patients taking bevacizumab compared with placebo (p=0.0041). The overall survival interim analysis showed that at a median followup of 28 months, the risk of death was reduced by a significant 36% among high-risk patients. "Bevacizumab is the first new active agent for the front-line treatment of ovarian cancer in more than 15 years, according to the presenter and lead investigator of the study, Dr. Gunnar Kristensen. According to Dr. Kristensen, " we see there is an overall trend for improvement of overall survival with bevacizumab." "The treatment effect is greater in high-risk patients, which may be of clinical relevance." The final overall survival results are expected in 2013.
"This treatment was tolerated well, without a substantial increase in side effects. The side effects were mild and manageable." according to Dr. Kristensen.
The ICON7 Trial Design
ICON7 is a randomized two-arm global trial that is assessing the benefits of adding bevacizumab to a standard chemotherapy regimen of carboplatin and paclitaxel(Drug information on paclitaxel) in newly diagnosed ovarian, epithelial, and fallopian tube cancer. The large-scale study started in 2006 and has since enrolled more than 1500 patients. The primary endpoint is comparing the progression-free survival of the standard chemo regimen to chemotherapy with additional bevacizumab. Patients receive paclitaxel and carboplatin (P/C) via IV every 3 weeks for 6 courses or P/C plus concurrent bevacizumab (7.5mg/kg) as an infusion.
Future of Bevacizumab in Ovarian Cancer
Although these trials are positive, adding bevacizumab to chemotherapy regimens is still being debated by oncologists because of the incremental increase in PFS. Active ovarian oncologists and researchers are split as to whether PFS is a good enough measure and whether studies should always have overall survival as a primary endpoint. The FDA has been requiring more overall survival data, partly as a result of the increased cost of oncology drugs. Researchers acknowledge that cost plays a role in consideration of treatment options. Dr. Kristensen, for example, stated that the cost of bevacizumab and a lack of substantial survival benefit in ovarian cancer patients may result in only high-risk patients being prescribed a bevacizumab regimen. Additionally, tt is not know how much of a benefit is added with a maintenance dose of bevacizumab.
How bevacizumab will be utilized by oncologists remains to be seen, but for now, there is a consistent trend of a benefit in the utilization of bevacizumab in combination with chemotherapy as well as a documented benefit as a monotherapy in ovarian cancer."
ENMD needs to find a sub-set of patients who are more likely to respond than other ovarian cancer patients . I don't know how they can financially manage to accomplish that at this point.
Do I read the 2011 poster correctly to the effect that only 8 patients of those in the study continue to receive EMND-2076 ? Thank you.
ENMD is overlooked in this "summary" of ASCO meeting:
http://www.ovariancancer.org/asco-report-2011/
kind of disappointing we don't rate a "highlight" spot.
Maybe someone here can "attend" the "webinar" mentioned tomorrow ?
Thank you, bostoninternist, and nice to know you still look in on things here. Interesting observation that responders averaged higher "vascular densities" than non-responders (and interesting to me at least that they measured this). Would this mean that the drug got better distribution to the malignant cells ? Is this consistent with the claimed anti-angiogenic properties ?
In this era of individualized targeted therapies, what other conlusions from this phase 2 could be drawn to narrow the class of pts. most likely to be benefitted ?
Link to ASCO poster ?
Can anyone provide this please ? I can't seem to find it either on ENMD home site or the ASCO site. Thanks in advance.
The crucial quarter. ENMD lost 2.6 million in first quarter and has 4.8 million left; if no or little royalty income in 2nd quarter, then at that rate cannot survive to end of year without additional equity financing or a partnership. Thus it all depends on the phase 2 results for ENMD-2076 to be disclosed in June. What I think we can anticipate is that there will have been some drop-outs due to disease progression; maybe some tumor shrinkages; more likely some lowering of the CA-125 counts as was the case in phase 1, but hopefully quite a few "stable disease" patients at least under the "RECIST" measurements. If there can be shown a profile or sub-set of patients with a particular type of ovarian cancer-- say "clear cell" etc.-- that were particularly benefitted, might that give us a niche attraction over other tyrosine kinase inhibitors under development ? If results are not good, what do you think the patent rights could bring at a going out of business sale ?
Does ENMD-2076 target either or both of the targets mentioned here ? :
http://newsroom.ucla.edu/portal/ucla/experimental-drug-slows-ovarian-201547.aspx?link_page_rss
Good points both of you; though I'd probably come down on the side of rubberchicken. And of course there would be nothing like a little competition in the tyrosine kinase targeting field to bring the price of Avastin down.
If it was your own money, how much would you pay for 3.8 (extra) months of progression free survival ? :
http://www.eurekalert.org/pub_releases/2011-03/osum-oss030411.php
A link to some helpful understanding re ovarian (and maybe other) cancer terminology:
http://www.inspire.com/groups/ovarian-cancer-national-alliance/discussion/restaging-information-for-newbies/
Cost effectiveness of Avastin for ovarian cancer :
http://www.eurekalert.org/pub_releases/2011-03/osum-oss030411.php
You don't like to think of a cost limitation on a month of progression free survival, but I guess you have to. If during that one extra month of life somebody comes up with a complete cure, then the extra month would be worth whatever the cost to that patient.....
A link to article about Phase III Avastin study w/ovarian ca. pts.
which Roche says is encouraging re extension of survival:
http://www.medicalnewstoday.com/articles/215988.php
Presumably if ENMD-2076 makes it to phase III that study would
follow something like the same format.
Probably the most significant to us would be this quote from Dr. Bray, VP:
"Recently, the Company
completed enrollment for the Phase 2 study in ovarian cancer patients and, once the data have been analyzed, intends to present results of the study at an upcoming scientific meeting."
Apparently it did take longer to reach full enrollment than they originally anticipated. Perhaps that is why they expanded to include the fallopian and other cxancer patients with tumors in the same neighborhood. No doubt this announcement is PR with an eye to bolstering the stock price--the P 1 data was already availasble to the oncology community--and that more than one pt. has dropped out due to progressive disease. That said, if the preliminary phase 2 results were statistically awful, why would they take this optimistic tone now only to invite greater embarassment later ? It shouldn't take long to "analyze the data", so when is the next scientific meeting at which the results could be presented ?
Clinicaltrials.gov. re the ENMD-2076 ovca trial indicates that preliminary results would be compiled in January 2011 (estimated).Have these been announced ? If not, would the "still enrolling" status suggest a later time for the compilation/announcement ?
Correction:
"Final data collection date for primary outcome measure"
Is the "final data completion date for primary outcome" measurement of the phase 2 ovarian trial still January 2011 ? Even though all 6 trial centers are still recruiting ? and the dosage was adjusted?
http://clinicaltrials.gov/show/NCT01104675
I caused this run-up by selling half my position last month for the tax loss. You're welcome. Aaagh !
For the CFO, not a good Christmas present:
http://biz.yahoo.com/e/101222/enmd8-k.html
(Could be her blessing in disguise, though.)
I tried
to put my old dry honey in the microwave, but
she knocked me on my butt. .
Right; but I thought because of the name, Hemondoc was probably
in hematology which we were on, re the ASH meeting. And there were 4of6, Marcpw, Golfdad and others. Docaaron still puts in an appearance sometimes though.
Did the CRi patient have AML? According to this there are seven different sub-types of AML cells so if he/she was an AML patient what sub-type did he/she have? BTW have all the docs faded away from this board ? There was a "Hemondoc" or something like that on the old Yahoo board in the Endostatin era or maybe it was raging bull who would know this stuff. He's probably retired and fishing in the Caribbean by now.
http://www.leukemia-web.org/leukemia-symptoms-diagnosis.htm
What was it with the leukemia patient who achieved a "CRi" that was different ?
Less advanced disease at start of trial ?
Nature/extent of his/her pre-treatment ?
Metabolic differences ?
Gender differences ?
Immune system differences ?
It seems that cancer systems can produce more targets than we have ammunition...
Here's a good report at ASH: SGEN:
http://www.reuters.com/article/idUSTRE6B40WG20101206?loomia_ow=t0:s0:a49:g43:r1:c0.072165:b40053840:z0
ASH abstracts and posters relating to ENMD-2076 can be found here: (Apologies if previously posted).
http://ash.confex.com/ash/2010/webprogram/start.html#srch=words%7CENMD-2076%7Cmethod%7Cand%7Cpge%7C1
Why did SEC issue a confidential treatment order (CT order)to
ENMD on 11/23/10 ? To secrete bad news, good news , (or to give the appearance that same exists )? :
http://yahoo.brand.edgar-online.com/DisplayFiling.aspx?TabIndex=2&FilingID=7575061&companyid=10844&ppu=%252fdefault.aspx%253fcik%253d895051
OT energy and cancer cells: NY Timesa article:
http://www.nytimes.com/2010/11/30/health/30cancer.html?_r=2&src=dayp&pagewanted=all
ASH abstract ?
There was supposed to be an issue of the American Society of Hematology Journal "Blood" which reported on the clinical trial to be postererd at the December meeting I thought the PR said November 19 supplemetary issue. I can't find such an issue under the Journal's listing but, obviously I'm not a ASH member . Can anybody here access it ? Here's the link to the "Blood " home page:
http://bloodjournal.hematologylibrary.org/content/vol116/issue22/
Is anything new expected at the December 4 meeting?
ASH poster abstract MM trial:
http://ash.confex.com/ash/2010/webprogram/Paper33067.html
Comments/ Comparisons?
Poster abstract for ASH re leukemia:
http://ash.confex.com/ash/2010/webprogram/Paper33067.html
Comments re comparison with other therapies ? Clearly there are dose limiting toxicity issues. How does the dosage deemed dose limit compare with the ovarian cancewre trial dosage ? Would toxicity be the same for the same dosage in oiv, ca? Hopefully somebody thought these data and the mm data were good enough to buy, tomorrow should tell whether that is so
Abstracts in Blood magazine online Nov. 19 (Fri.):
Data for the ENMD-2076 Phase 1 studies in multiple myeloma and leukemia will be presented by EntreMed investigators at the 2010 Annual Meeting of the American Society of Hematology (ASH) to be held December 4-7 at the Orange County Convention Center in Orlando, Florida. Both abstracts were accepted for poster presentation at the meeting and will be published in the print and online November 19, 2010 supplemental volume of Blood.
Could be. It's logical to think they'd like to allocate the total enrollment equally, if there were enough volunteers to do so.
OVCA phase 2 trial still enrolling or not ?
I read on a cancer support network site a post from a patient dated October 4, 2010 that she was going on the ENMD-2076 trial, having been advised that "I should probably go into the trial because it is closing next week." However both the ENMD
site and clinical trials.gov. indicate this trial is still enrolling.