Entremed (ENMD)

[justwaitandsee]

Hi Doc, I found I could get to it by searching for "enmd message board" on yahoo search...and by the way Razor has returned...probably signifies good news!

[docaaron1]

I noticed that too. Anyway the only real news is what comes from the company. Most of the rest is just fluff to help pass the time. It would be nice if the company would put out news more often to keep us updated. Maybe a patient could chime in now and then.

Aaron

[justwaitandsee]

"Message boards" is no longer "hot" on my yahoo entremed page. Other stocks I follow don't have the problem...strange?

[Dr Jerry]

Compassionate use programs provide experimental therapeutics to patients prior to final FDA approval. Initially, the compassionate use program for PV-10 will only be available for cancer indications that do not involve visceral organs and are not subject to enrollment in ongoing clinical trials. These indications include certain breast cancers, basal cell carcinoma, squamous cell carcinoma, certain head and neck cancers and melanoma.

[tborges]

This is pretty old info... the suppositions are based upon preclinical trials... clinical trials have not yet begun and there was much criticism of the original press release last June... i.e.,

http://www.theglobeandmail.com/news/national/take-news-of-cancer-breakthrough-with-a-big-grain-of-salt/article12735079/

[Rocky I]

LONG-TERM DONOR SUPPORT HELPS FUND CANCER BREAKTHROUGH - YouTube -- Dr. Tak Mak of Entremed

[tborges]

The China State FDA (SFDA) was renamed last year to the China FDA (CFDA). This is what their org chart looks like. http://eng.sfda.gov.cn/WS03/CL0763/

[Rocky I]

EntreMed Files New Drug Global Clinical Trial Application For ENMD-2076 With China CFDA




To Expand Clinical Trial for Advanced Ovarian Clear Cell Carcinoma

ROCKVILLE, Md., Jan. 13, 2014 - EntreMed, Inc. (ENMD), a
clinical-stage pharmaceutical company developing therapeutics for the
treatment of diseases, announced today that it has moved to expand its
Phase 2 clinical trial for its drug candidate ENMD-2076 in advanced
ovarian clear cell carcinoma (OCCC) with the submission of a new drug
global clinical trial application with China's Food and Drug
Administration (CFDA). The ongoing Phase 2 trial is currently being
conducted at Princess Margaret Cancer Centre in Toronto, along with
participation from up to seven additional cancer centers in Canada and
the U.S.

This application is the Company's third new drug global clinical
trial application with the CFDA. The first was announced in January
2013 for triple-negative breast cancer, which is being conducted at
the University of Colorado and at Indiana University. The second was
announced in June 2013 for the advanced/metastatic soft tissue sarcoma
trial, which is being conducted at Princess Margaret Hospital. More
information about the Company's clinical trials can be found at
www.clinicaltrials.gov.

Ken K. Ren, Ph.D., EntreMed's Chief Executive Officer, commented, "We
are advancing our clinical trials in targeted patient populations in
North America, while expanding the trials into China to reach our goal
of achieving clinical inflection points more cost-effectively. This
North America/China business model is compelling because it not only
will enable us to develop more drugs with efficient resources, but
also will accelerate product entry into China's market at least three
years earlier compared with more traditional approaches. In addition,
the U.S. FDA recently has accepted the data from our crossover
bioavailability study for ENMD-2076, thereby approving the use of
ENMD-2076 in formulated dosage form for our clinical studies based on
its pharmacokinetic equivalence to the non-formulated dosage form.
This provides us with a significant advantage in future product
manufacturing."

Dr. Ren added, "We are actively pursuing in-licensing opportunities
for additional drug candidates for development under this same global
approach. We have further strengthened our internal product
development capabilities in China with the recent establishment of an
R&D Center in Beijing, and have added a technology leader with
extensive large pharma experience in pharmaceutical technology and
product development, along with a proven track record of bringing
products from early stage proof-of-concept development to late-stage
clinical trials."

[tborges]

some more info...

...Pharmaceuticals, Inc. (Nasdaq:ICPT) (Intercept) today announced that the FLINT trial of obeticholic acid (OCA) for the treatment of nonalcoholic steatohepatitis (NASH) has been stopped early for efficacy based on a planned interim analysis showing that the primary endpoint of the trial has been met. FLINT is a multi-center, double-blind, placebo-controlled clinical trial assessing the safety and efficacy of a 25 mg oral dose of OCA administered daily to biopsy-proven adult NASH patients over a 72-week treatment period. The trial has been sponsored and conducted by the National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK), a part of the National Institutes of Health, at eight leading US academic hepatology centers comprising the NIDDK's NASH clinical research network (CRN).

The decision to stop FLINT has been based on the recommendation of the Data Safety Monitoring Board (DSMB) which reviewed liver biopsy data from before and at the end of the treatment period in approximately half of the 283 randomized patients, in accordance with a planned interim efficacy analysis. This analysis demonstrated that OCA treatment resulted in a highly statistically significant improvement (p=0.0024 on an intention-to-treat [ITT] basis) in the primary histological endpoint, defined as a decrease in the NAFLD Activity Score (NAS) of at least two points with no worsening of fibrosis, as compared to placebo. Those patients who had not yet completed the trial and therefore did not have a second biopsy were treated as non-responders in the ITT analysis. The pre-defined threshold of statistical significance for stopping FLINT was p < 0.0031.

[Broadway1430]

I know. Would be thrilled to death with 5 bucks,let alone 4 or 5 hundred!!!!!

[rubberchicken]

Whoa.

[Broadway1430]

Doc,TB, Izzy,Sunday,Retired,
Take a gander at ICPT. Tiny biotech, 19million shares outstanding, no product on the market but great trial results . Up hundreds of dollars in the last couple of days. Saw this in today's WSJ. Why not us. We can always dream.
Broadway

[tborges]

Hey Broadway… Never an imposition… the on-going TNBC and Soft Tissue Sarcoma will provide an answer to your question… the primary data collection for the TNBC trial is to be completed this month… but we may not hear anything until??? …ASCO? The STS trial will be completed in January of next year.

I am cautiously optimistic… I do believe that Entremed is on the right track… they have gone from a shotgun approach to narrowing down on the science of cause and effect. If the trials successfully identify a biomarker to select patients who are responsive to Enmd 2076…one does not need to be a genius to understand the value… However, I think it is important to understand that the patient populations are low in these trials, and if there is a significant response, it will most likely have to be validated in larger patient populations…

I am impressed with the current trends and responses occurring in gene therapy… it is almost a “boutique” treatment… specific to the individual with hope for a cure rather than just disease management… it will be interesting to see where this leads…

[Broadway1430]

TB,
Could I impose upon you to relate the lecture to what your understanding of what EMND is doing regarding
P53. Do you think they are on the right track? Has this talk made you more or less optimistic about ENMD or
had no affect on your view of ENMD's work.
Thanks in advance.

[tborges]

P53 regulation...

[retired_retread]

Excerpts from an article in today's online Wall Street Journal entitled "Hospital, Celgene Fight Over Royalties for Cancer Drugs" on Celgene's legal battle with Boston Children's Hospital over royalties for Revlimid (if only we could have kept those licenses):

"....In the Celgene case, Children's says one of its researchers, Robert D'Amato, helped pave the way for the Celgene drugs through a series of breakthroughs in the early 1990s. In a 1994 paper, Dr. D'Amato theorized that thalidomide inhibited blood-vessel growth, which he said helped explain why the drug caused stunted limbs in children born to mothers who took the drug—a theory supported by later research. Dr. D'Amato also said this effect could be useful in cutting off blood supply for tumors, and obtained patents on thalidomide and its derivatives for that use.

Around that time, a biotech company run by a former mentor of Dr. D'Amato's, EntreMed Inc., signed a deal with Children's to license Dr. D'Amato's thalidomide patents in exchange for funding Children's research and agreeing to pay the hospital royalties on future sales.

Dr. D'Amato, who isn't a party to the Children's lawsuit, declined to comment.

Celgene, then a small biotech company, was also trying to resurrect thalidomide, and in 1998 won FDA approval to sell the drug as a leprosy treatment. By 2002, Celgene and EntreMed both were racing to develop thalidomide derivatives to treat multiple myeloma.

Later that year, the two companies settled a patent dispute in a deal requiring EntreMed to license its Children's patents to Celgene. According to court documents and regulatory filings, that deal also required Celgene to pay Children's a 1% royalty on any future sales of Revlimid, which was still in development, and a 2.5% royalty on certain derivatives of the drug, which Children's in its lawsuit says includes Pomalyst, which was approved for sale in 2013.

In its lawsuit, Children's says the contract requires Celgene to make payments through February 2013, but allows for an extra three years if Revlimid's patents are extended past their original expiration date. U.S. patent authorities granted Celgene a patent extension for Revlimid in 2008, but the company argues in court filings that it isn't the type of patent that would trigger extra payments to Children's.

[Broadway1430]

And to you and family, TB.

[tborges]

Seasons Greetings to all with best wishes to Entremed for a prosperous New Year!

[tborges]

I tend to agree with you... I do believe that the group assembled by Tak and Mak are extremely capable and most importantly have a working knowledge of doing business in China... being fluent in the language as well as world class scientific credentials is a major asset...

The articles recently posted do make it clear that China is not going to be a quick and devious path to approval, but rather a progression through rigidly structured pre-clinical and clinical trials in which efficacy must be demonstrated.

The market potential in China cannot be overstated...but there is much work to be done...

[rubberchicken]

Honestly, I think this is a really strong business strategy. I love the way they're going with this and think it optimizes their chance for success. It's just that it's taking so looooooooooong to move 2076 through the trials.

I feel like this China strategy does a great job of moving them from snail's pace to turtle's pace. It's a hell of a lot faster, and it's still damn slow.

[justwaitandsee]

http://ebdgroup.com/partneringnews/2013/05/want-success-in-china-find-an-experienced-chinese-partner/

[tborges]

Very interesting article on China Operations recently received...

http://ebdgroup.com/partneringnews/2013/12/entremed-leverages-best-of-china-and-the-west-and-seeks-to-expand-pipeline/

[tborges]

Your last sentence says it all... there were no choices...costly suit and no money...

Revlamid/lenalidomide is attracting a lot of attention at the ASH symposium...

http://www.myelomabeacon.com/tag/ash-2013-lenalidomide/

[nottadoc2]

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.

[tborges]

There have been quite a few anecdotal successes using this type of therapy reported recently. This year's ASH symposium currently underway has established a separate category for gene therapy and transfer.

This new paradigm of research and treatment just makes sense... going to the core of the disease to determine the treatment/correction... The unique feature of this personal approach is that it is specific to the individual... and, most importantly, presents an opportunity for a cure rather than treatment as a manageable disease.

The results have been remarkable in clinical trials, some of which will be reported out at the current ASH meeting.

[docaaron1]

I’m passing on these links concerning cancer treatments from George:

“Watch the video at the following link

http://www.chop.edu/service/oncology/patient-stories-cancer/leukemia-story-emily.html

Read the follow up story 20 months later.

http://www.ctvnews.ca/health/blood-cancer-breakthrough-doctors-see-success-using-gene-therapy-1.1579315 “

[rubberchicken]

I never know how much faith to have in stories like this, but I sure WANT to believe.

http://www.cnn.com/2013/12/07/health/cohen-cancer-study/index.html?hpt=hp_t2

[tborges]

The Drug Registration Process in China... James Yan...

http://www.healthinlink.com/down/An%20Overview_New%20Drug%20Registration%20System%20and%20Approval%20Process%20in%20China.pdf

[tborges]

The future of cancer treatment...

http://www.huffingtonpost.com/2013/12/01/patrick-soon-shiong_n_4351344.html?ref=topbar

[Rocky I]

EntreMed Reports Third Quarter 2013 Financial Results




ROCKVILLE, Md., Nov. 14, 2013 - EntreMed, Inc. (ENMD), a
clinical-stage pharmaceutical company developing therapeutics for the
treatment of a variety of cancers, today reported financial results
for the three and nine-month periods ending September 30, 2013.

EntreMed reported a net loss for the third quarter of 2013 of ($1.4
million), or ($0.05) per share. This compares with a net loss of ($1.2
million), or ($0.05) per share, for the same period last year. For
the first nine months of 2013 the reported net loss was ($4.4
million), or ($0.17) per share as compared to ($14.2 million), or
($0.81) per share for 2012. The 2012 year to date reported net loss
included non-cash interest charges associated with our financing in
2012 ($10.0 million for the nine months ended September 30, 2012).
Excluding this non-cash interest, net loss for the first nine months
of 2012 was ($4.1 million), or ($0.23) per share.

As of September 30, 2013, EntreMed had cash and cash equivalents of
approximately $15.9 million.

Sara B. Capitelli, EntreMed's Vice President, Finance & Principal
Accounting Officer, commented on the third quarter results, "Our
financial results for the third quarter are in line with our
expectations. Our research and development expenses for the third
quarter increased compared to the previous year primarily due to costs
associated with the Company's crossover bioavailability and food
effect study of ENMD-2076, along with the clinical development of
ENMD-2076 in China during 2013. We anticipate fourth quarter
operating expenses to increase as we execute on our clinical
development plan in the US and China."

Dr. Ken Ren, EntreMed's Chief Executive Officer, further commented,
"We are pleased with the progress made in the third quarter. Our
clinical trials in triple-negative breast cancer, soft tissue sarcoma
and ovarian clear cell carcinoma are underway in the US and Canada
with plans to expand the trials into China. At the same time, we
continue to seek additional drug candidates to add to our pipeline,
strengthen our internal development capabilities, and look forward to
continuing to execute our strategy and advance the company."

[Rocky I]

EntreMed Commences Phase 2 Trial For ENMD-2076 In Ovarian Clear Cell Carcinomas




ROCKVILLE, Md., Oct. 31, 2013 - EntreMed, Inc. (ENMD), a
clinical-stage pharmaceutical company developing therapeutics for the
treatment of a variety of cancers, announced today the commencement of
a multi-center Phase 2 study entitled "Phase II Study of Oral
ENMD-2076 Administered to Patients with Ovarian Clear Cell
Carcinomas." The study is led by principal investigator Amit M. Oza,
MD at Princess Margaret Cancer Centre in Toronto, Canada with
participation of up to seven additional cancer centers in Canada and
the United States. More information about the clinical trial can be
found at www.clinicaltrials.gov.

Amit M. Oza, MD, principal investigator of the study, commented,
"Ovarian clear cell carcinomas (OCCC) account for approximately 5-13%
of all epithelial ovarian cancers and compared to other subtypes, are
associated with poorer prognosis and can be resistant to conventional
platinum-based chemotherapy. It presents a considerable clinical
challenge and there is a need to develop new therapeutics in the
management of this disease. ENMD-2076 has demonstrated single agent
activity in tumor models of multiple cancers including ovarian cancer.
In a recent Phase 2 trial where ENMD-2076 was administered to
platinum-resistant recurrent ovarian cancer patients, some OCCC
patients had prolonged disease control, suggesting that it may be
effective in this subset of patients. We want to explore this further.
The purpose of this study is to examine the response and PFS rates of
ENMD-2076 in this difficult to treat patient population. We look
forward to working closely with EntreMed and colleagues from other
sites in this Phase 2 trial."

Ken K. Ren, Ph.D., EntreMed's Chief Executive Officer commented, "We
are very pleased to have Dr. Oza lead this trial. Dr. Oza was a
principal investigator in our Phase 2 study in platinum resistant
ovarian cancer and has been instrumental in advancing our development
program targeting this indication. The cumulative evidence has
indicated the potential effectiveness of a combined anti-angiogenic
and anti-Aurora A targeted approach in OCCC, and we believe ENMD-2076
presents strong clinical and scientific rationale for the treatment of
this subset of patient population. This trial will provide us with
more insight into the drug's clinical activities and its correlation
with biomarkers."

Dr. Ren further commented, "Together with our trials in triple
negative breast cancer and soft tissue sarcoma, this is the third
clinical trial we have initiated for ENMD-2076 under our US/China
development model. We intend to expand the trial into China once we
have it underway in Canada and the US. Our goal is to reach a
clinical inflection point using a cost-effective approach that
combines speed, quality and lower costs, in order to maximize the
value proposition of ENMD-2076. We are confident that we will reach
this goal."

[Rocky I]

Data Presented For ENMD-2076 In Xenograft Models Of Human Hepatocellular Carcinoma




ROCKVILLE, Md., Oct. 22, 2013 - EntreMed, Inc. (ENMD), a
clinical-stage pharmaceutical company developing therapeutics for the
treatment of a variety of cancers, announced today the presentation of
preclinical data for a study comparing the efficacy of ENMD-2076
against that of standard of care agents including sorafenib,
doxorubicin, and 5-FU for human hepatocellular carcinoma (HCC)
models. The results of the study were presented at AACR-NCI EORTC
International Conference being held this week in Boston,
Massachusetts.

The data presented demonstrate significant in vivo activity of
ENMD-2076 against three different human hepatocellular carcinoma
xenograft models and concluded that ENMD-2076 showed robust antitumor
activity against the cell line-derived xenograft models of human HCC
superior to that of sorafenib, doxorubicin, and 5-FU.

Ken K. Ren, Ph.D., EntreMed's Chief Executive Officer, commented,
"HCC represents the third leading cause of cancer deaths worldwide.
There are unmet medical needs for drugs with better safety and
efficacy. This in vivo preclinical study data is affirmative with
our previous in vitrofindings that greater than 60% of 21 liver
cancer-derived cell lines we screened are significantly inhibited by
ENMD-2076 treatment. It also indicates that ENMD-2076 may be
effective in patients resistant to sorafenib or 5-FU. In our Phase 1
trial of ENMD-2076, partial response with prolonged progression free
survival was observed in a patient with liver cancer who relapsed from
standard care including liver transplantation and sorafenib treatment.
This preclinical study provides support for further clinical
investigation of the drug candidate in HCC patients who do not
tolerate, or have failed or relapsed from other systemic treatment,
particularly sorafenib or 5-FU. We believe that ENMD-2076 has
potential in the HCC market, especially in China, where more than 50%
of global incidence occurs."

To view the poster presentation, visit the Company's website at
http://www.entremed.com.

About ENMD-2076
ENMD-2076 is an orally-active, Aurora A/angiogenic kinase inhibitor
with a unique kinase selectivity profile and multiple mechanisms of
action. ENMD-2076 has been shown to inhibit a distinct profile of
angiogenic tyrosine kinase targets in addition to the Aurora A
kinase. Aurora kinases are key regulators of mitosis (cell
division), and are often over-expressed in human cancers. ENMD-2076
also targets the VEGFR, Flt-3 and FGFR3 kinases which have been shown
to play important roles in the pathology of several cancers.
ENMD-2076 has shown promising activity in Phase 1 clinical trials in
solid tumor cancers, leukemia, multiple myeloma, and is currently
completing a Phase 2 trial for ovarian cancer. EntreMed is currently
conducting a Phase 2 study of ENMD-2076 in triple-negative breast
cancer, a Phase 2 study in advanced/metastatic soft tissue sarcoma,
and expecting to initiate a Phase 2 study in ovarian clear cell
carcinoma. ENMD-2076 has received orphan drug designation from the
FDA for the treatment of ovarian cancer, multiple myeloma and acute
myeloid leukemia.

About EntreMed
EntreMed is a clinical-stage pharmaceutical company employing a drug
development strategy primarily in the United States and China to
develop targeted therapeutics for the global market. Its lead
compound, ENMD-2076, a selective angiogenic kinase inhibitor, has
completed several Phase 1 studies in solid tumors, multiple myeloma,
and leukemia, and is currently completing a multi-center Phase 2 study
in ovarian cancer. EntreMed is currently conducting a Phase 2 study
of ENMD-2076 in triple-negative breast cancer, a Phase 2 study of
ENMD-2076 in advanced/metastatic soft tissue sarcoma, and is expecting
to initiate a Phase 2 study in ovarian clear cell carcinoma. The
Company is headquartered in Rockville, Maryland and has a wholly-owned
subsidiary in Beijing, China. Additional information about EntreMed
is available on the Company's web site atwww.entremed.com and in
various filings with the Securities and Exchange Commission (the SEC).


Forward Looking Statements
This release contains forward-looking statements within the meaning
of the Private Securities Litigation Reform Act with respect to the
outlook for expectations for future financial or business performance,
strategies, expectations and goals. Forward-looking statements are
subject to numerous assumptions, risks and uncertainties, which change
over time. Forward-looking statements speak only as of the date they
are made, and no duty to update forward-looking statements is assumed.


Actual results could differ materially from those currently
anticipated due to a number of factors, including: the risk that we
may be unable to continue as a going concern as a result of our
inability to raise sufficient capital for our operational needs; the
possibility that we may be delisted from trading on the Nasdaq Capital
Market; the volatility of our common stock; the difficulty of
executing our business strategy in China; our inability to enter into
strategic partnerships for the development, commercialization,
manufacturing and distribution of our proposed product candidate or
future candidates; risks relating to the need for additional capital
and the uncertainty of securing additional funding on favorable terms;
declines in actual sales of Thalomid® resulting in reduced or no
royalty payments; risks associated with our product candidates; any
early-stage products under development; results in preclinical models
are not necessarily indicative of clinical results; uncertainties
relating to preclinical and clinical trials, including delays to the
commencement of such trials; the lack of success in the clinical
development of any of our products; dependence on third parties; and
risks relating to the commercialization, if any, of our proposed
products (such as marketing, safety, regulatory, patent, product
liability, supply, competition and other risks). Such factors, among
others, could have a material adverse effect upon our business,
results of operations and financial condition. We caution readers
not to place undue reliance on any forward-looking statements, which
only speak as of the date made. Additional information about the
factors and risks that could affect our business, financial condition
and results of operations, are contained in our filings with the U.S.
Securities and Exchange Commission ("SEC"), which are available
atwww.sec.gov.

http://www.entremed.com/news/data-presented-for-enmd-2076-in-xenograft-models-of-human-hepatocellular-carcinoma/

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[Rocky I]

ROCKVILLE, Md., Oct. 21, 2013 - EntreMed, Inc. (ENMD), a
clinical-stage pharmaceutical company developing therapeutics for the
treatment of a variety of cancers, announced today the presentation of
preclinical data from a study to assess the role of p53 family tumor
suppressors in mediating response to ENMD-2076 in triple-negative
breast cancer (TNBC). The study was led by Dr. Jennifer R. Diamond of
University of Colorado and the results were presented at the
AACR-NCI-EORTC International Conference being held this week in
Boston, Massachusetts.

Dr. Diamond commented, "The purpose of this study is to utilize TNBC
cell line gene knockdown models to investigate further the role of p53
and p73 in mediating sensitivity to ENMD-2076. Data from the study
demonstrate that ENMD-2076 exhibited robust anticancer activity in
both p53 mutated and p53 wild type (WT) cell lines. The data also
illustrate that both p53 and p73 mediate sensitivity to ENMD-2076 in
p53 WT TNBC, while p73 is essential for induction of senescence
following exposure to ENMD-2076, providing support on the development
of predictive biomarkers of response to ENMD-2076 in p53 mutated TNBC
currently underway."

Ken K. Ren, Ph.D, EntreMed's Chief Executive Officer, commented,
"ENMD-2076 is currently in Phase 2 clinical trials in patients with
TNBC and advanced/metastatic soft tissue sarcoma, and we expect to
begin enrolling in a multi-center Phase 2 trial in ovarian clear cell
carcinomas. We have also been conducting additional preclinical
studies on the drug candidate primarily to support our clinical trials
with better understanding of its mechanism of actions, predictive
biomarkers, and scientific rationale for new clinical applications.
Taken together, we believe they will shed additional light on more
advanced clinical trials and enhance the value of ENMD-2076."

To view the poster presentation, visit the Company's website at
http://www.entremed.com.

[docaaron1]

"8,399,440 Disease modifying anti-arthritic activity of 2-methoxyestradiol" is still "In Force" and owned by ENMD.

Plus they own another "In Force" patent(8,158,612), which is listed on the bottom of the linked page. I'm not sure what compound this patent refers to.

http://www.patentbuddy.com/Patent/7081477

Aaron

[justwaitandsee]

Panzem still listed as a drug candidate on website http://www.entremed.com/business/

[tborges]

Hi Aaron

That is interesting if true... the confusing thing is that the reference notes that the patent was issued in 2006 and the next 7.5 year payment was not due until 2014... does that mean the original mainteance fee was never paid...

Further, the maintenance fee is just $3600... would CHB's confidence factor be that bad that they would not risk $3600 to protect their proprietary interests?

I think 1198 may be covered by the patent for Panzem/2ME2 as an analogue.

[docaaron1]

Tborges, I believe patent 7,081,477 has expired for failure to pay maintenance fees by Children's hospital.

http://www.patentbuddy.com/Patent/7081477

In the old day patents were 17 years period. Now they are 20 years but you have to pay a maintenance fee.


I hope ENMD 1198 is still active. I don't know the patent number for it so I can't look it up.

Aaron

[tborges]

You might find this interesting, if not amusing...

Dr. Wright reports that compounding pharmacists, even those who compound bio-identical hormones, find it virtually impossible to acquire 2-methoxyestradiol. "One compounding pharmacist," he writes, "told me that chemical supply sources advertising 2-methoxyestradiol for sale online refused to sell to compounding pharmacies .... Another compounding pharmacist ...was able to purchase a very small amount, which arrived in a package emblazoned with a skull and crossbones..."

http://www.thefreelibrary.com/Panzem%5BR%5D+(2-methoxyestradiol).-a0184141379

[tborges]

Sort of... Enmd was issued a patent for methods of treatment and formulations, but the licensing of 2-methoxy estradiol is still controlled by CHB:

"...EntreMed, Inc., a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, announced the issuance of a U.S. patent covering methods of treatment and formulations for its lead clinical-stage compound, 2-methoxyestradiol (2ME2). Panzem® NCD, an oral formulation of 2ME2, is currently in Phase 2 clinical trials for cancer. Panzem® is also in preclinical development for rheumatoid arthritis.

Patent No. 7,081,477, entitled "Estrogenic Compounds as Anti-Mitotic Agents," contains claims granted by the U.S. Patent Office covering methods of using 2ME2 to treat diseases that are characterized by abnormal cell division (mitosis), including cancer and non-oncology diseases. The claims are independent of mechanism and cover various cancers, tumor metastases, vascular abnormalities, inflammatory and immune disorders, and abnormal angiogenesis that accompanies diseases such as rheumatoid arthritis. The patent also covers multiple formulations for 2ME2. The inventors are Drs. Robert D'Amato and Judah Folkman from Children's Hospital Boston. Children's Hospital has licensed 2ME2 exclusively to EntreMed..."

[docaaron1]

Do we still own the rights to Panzem from Childrens Hospital?

I wonder if anyone from ENMD thought to call Celgene after they acquired Abraxane? I mean it's worth a call and let Celgene know we might have something that might help them and by the way you(Celgene) already own part of it.

Just a thought,
Aaron
PS- Start the patient on Panzem first.
Full disclosure: I own ENMD and CELG stock.

[tborges]

There were only 10 patients enrolled in the trial and any results would have to be validated in a larger patient population.

It appears that the next step was to find a biomarker to determine those patients most likely to respond to Panzem. "...Dr. Sidor further commented, “Breast cancer remains a significant health problem, killing over 40,000 American women annually, despite the introduction of new therapies. A primary resistance mechanism to chemotherapeutic agents is thought to be the upregulation of HIF-1a and Panzem® is a potent inhibitor of HIF-1a. We hope that this study will also begin to identify biomarkers that we can use to further identify patients who would most benefit from treatment with Panzem® NCD...”

My guess is that this was back-burnered after the decision was made to focus on 2076 in December 2008.

In that press release Panzem was mentioned as a potential treatment for RA not TNBC...

"...While the Company’s other product candidates, including MKC-1, ENMD-1198 and Panzem® in rheumatoid arthritis, continue to be promising, the Company will consider further clinical development only if additional financial resources are available. As a result, the Company expects to reduce all research activities to the minimal level necessary to continue its efforts to realize their potential value through arrangements with third parties. The Company’s plan for these programs is not expected to affect ongoing trials and current patients..."

...and we all know that there were no "third parties" stepping forward...

[docaaron1]

Tborges, I would think if 2me2 did help Abraxane(paclitaxel, Celgene would jump on this. How could they let another company take over a drug that would be synergistic with their own drug?

Maybe the results were not that good? I don't remember the results of the Panzem/paclitaxel test.

Aaron

[tborges]

Equally interesting is the Mayo Clinic pre-clinical study...

http://www.news-medical.net/news/2007/11/02/32073.aspx?page=2

...in which the following comment was made: "...Although clinical trials of 2ME2 for breast cancer patients have not taken place, other clinical studies of 2ME2 have been conducted. These trials are based on an oral version of 2ME2 to treat primary tumors, but this method has its limitations, as the oral version of 2ME2 is poorly suited to getting into the blood system and reaching tumors. The new Mayo Clinic study resolves this by delivering 2ME2 by injection and in a lower dose -- eight times lower than the comparable oral version used in mouse models..."

...and this...

http://www.lef.org/magazine/mag2009/nov2009_The-Unimportant-Molecule-That-May-Help-Cure-Cancer_01.htm

Clearly, Panzem was left to founder after the decision was made to abandon/shelve the ENMD pipeline in favor of Enmd 2076... Sidor's departure has had further negative implications on future Panzem research...

Having said that, I do believe we will soon see a resurgence in the interest in methoxy-estradiol. Unfortunately, because CHP controls the licensing rights, it may end up with a more aggressive pharma.

[docaaron1]

I forgot how the Panzem with Paclitaxel study ended up. Did it ever go to phase II?

June 2007
“Patients also underwent sequential biopsies of their tumors to evaluate biomarkers of hypoxia and angiogenesis. Paclitaxel causes an increase in tumor HIF-1a expression, which is downregulated by 2ME2. Changes were observed in HIF-1 regulated proteins, including tissue VEGF, VEGFR-2, plasma PAI-1, and osteopontin. Based on these findings, enrollment is continuing to further define the relationship between 2ME2 therapy and the effects on these biomarkers with the goal of identifying patients who would most benefit from 2ME2’s unique mechanisms of action.”

http://www.entremed.com/news/clinical-results-from-entremeds-panzem%C2%AE-ncd-and-taxol%C2%AE-breast-cancer-study-presented-at-asco/

June 2010
“Celgene Corporation (NASDAQ: CELG)and Abraxis BioScience Inc. (Nasdaq: ABII) today jointly announced the signing of a definitive merger agreement in which Celgene has agreed to acquire Abraxis BioScience…The acquisition of Abraxis BioScience accelerates Celgene's strategy to become a global leader in oncology. The transaction adds ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) to the Company's existing portfolio of leading cancer products…”


So Celgene has Abraxane (a form of Paclitaxel) and owns part of Entremed which has Panzem which in theory could improve Abraxane. Any thoughts if the two will ever be used together. I don’t know but if they ever try it I will repeat my mantra, start the patient on Panzem first before Abraxane.

Aaron

[docaaron1]

Just wish the company would say something, even if they have nothing to report. A letter to stock holders now and then would be nice. Where's the vision?

Aaron

[tborges]

Hey Broadway

Selleck is one of many biochemical supply houses. They provide a variety of products to the research community. It is doubful that an individual would be able to purchase from them.

http://www.selleckchem.com/aboutus.html

[Broadway1430]

TB, Doc,
Any comment on the previous post? Is there anything new there or all old news? If something you did not know
Is it good or bad. As always, thanks,

[justwaitandsee]

Check out the reviews for enmd 2076...the yelp culture moving to medicine lol
http://www.selleckchem.com/products/ENMD-2076.html

[tborges]

...I think he may be in treatement for EEOD... Excessively Exurbiant Optimism Disorder...

[dingodave]

Has Dr. Steve given up? I notice he is now the board moderator, a job which has rotated through the ranks. Where has he been the last month or two?