Rocky I
10 years ago
EntreMed Stockholders Approve Name Change To CASI Pharmaceuticals
Common stock to begin trading under "CASI" on June 16, 2014
ROCKVILLE, Md., June 13, 2014 /PRNewswire/ --- EntreMed, Inc. ENMD
-1.35% , a clinical-stage biopharmaceutical company developing
therapeutics for the treatment of cancer and other diseases, announced
today that at its annual meeting of stockholders held on June 12,
2014, stockholders voted in favor of changing the company's corporate
name to CASI Pharmaceuticals, Inc. The name change will occur on June
16, 2014 with the Company's common stock trading on NASDAQ under the
new symbol "CASI" and the rollout of a new website
www.casipharmaceuticals.com .
"Changing our name is an important milestone as it represents another
step toward completing our company's transformation," said Ken K. Ren,
Ph.D., EntreMed's chief executive officer. "Our operations and
strategic focus have evolved and today have little resemblance to our
legacy years. Our name change is another step towards our mission to
build a new and leading biopharmaceutical company targeting global
markets with a focus on China."
docaaron1
10 years ago
OT: HIF-1 involved with aging.
Check out this link:
http://hms.harvard.edu/news/genetics/new-reversible-cause-aging-12-19-13
"A Newβand ReversibleβCause of Aging
A naturally produced compound rewinds aspects of age-related demise in mice"
By DAVID CAMERON
December 19, 2013
........
........
"One particularly important aspect of this finding involves HIF-1. More than just an intrusive molecule that foils communication, HIF-1 normally switches on when the body is deprived of oxygen. Otherwise, it remains silent. Cancer, however, is known to activate and hijack HIF-1. Researchers have been investigating the precise role HIF-1 plays in cancer growth.
βItβs certainly significant to find that a molecule that switches on in many cancers also switches on during aging,β said Gomes. βWe're starting to see now that the physiology of cancer is in certain ways similar to the physiology of aging. Perhaps this can explain why the greatest risk of cancer is age.β"
Could daily low dose Panzem, a HIF-1 inhibitor, slow or even reverse aging. That would be something.
Aaron
Rocky I
10 years ago
EntreMed Announces Poster Presentations At ASCO On ENMD-2076
ROCKVILLE, Md., May 19, 2014 - EntreMed, Inc. (Nasdaq: ENMD), a
clinical-stage pharmaceutical company developing therapeutics for the
treatment of cancer and other diseases, announced today two poster
presentations on ENMD-2076 at the American Society of Clinical
Oncology Annual Meeting for two of its trials currently in progress.
ENMD-2076 is currently in Phase 2 advanced soft tissue sarcoma and
Phase 2 ovarian clear cell carcinoma, trials at Princess Margaret
Cancer Centre in Toronto. ASCO will be held May 30 β June 3, 2014
in Chicago, IL. The posters will be presented during separate poster
sessions listed below and will be available on the EntreMed website
after each session.
Gynecologic Cancer Track: General Poster Session
Saturday, May 31, 2014 β 8:00AM β 11:45AM (CDT)
Abstract No.: TPS5620, Poster Board No.: 397B
Title: Phase II Study of Oral ENMD-2076 Administered to Patients with
Ovarian Clear Cell Carcinoma: A Trial of the Princess Margaret Phase
II Consortium
Location: S Hall A2
Sarcoma Track: Poster Highlight Session
Time 1:
Tuesday, June 3, 2014 β 8:00AM β 11:00AM (CDT)
Abstract No.: 10528, Poster Board No.: 16
Title: Phase II Study of Oral ENMD-2076 Administered to Patients
(pts) With Advanced Soft Tissue Sarcoma (STS)
Location: S102
Time 2:
Tuesday June 3, 2014 β 11:30 AM to 12:45 PM (CDT)
Location 2: S100bc
tborges
10 years ago
Here is the other abstract for sarcoma... Not sure why it was presented/accepted. It seems unremarkable. Only 10 patients participated.
Abstract:
Background: The use of angiogenic and Aurora kinase inhibitors has been shown to abrogate tumor growth in STS. ENMD-2076 is an oral Aurora A and angiogenic kinase inhibitor that has demonstrated single-agent activity in STS cell lines and inhibition of sarcoma growth for a patient in a phase 1 clinical trial setting.
Methods: This is a single-center, open-labeled phase II study of ENMD-2076 in advanced STS pts treated with =1 line of prior therapy in the advanced/metastatic setting. Pts were commenced on 275mg daily dose (on a 28-day cycle. Treatment-emergent adverse events were assessed by CTCAE (4.0). Radiographic or clinical tumor measurements occurred every 2 cycles (RECIST 1.1).
Results: 10 pts were enrolled from 2/2013 β 11/2013 and evaluable for efficacy. Median age is 58 yrs (41 β 72). Male: Female 1:9. Histology: Leiomyosarcoma / pleomorphic sarcoma / angiosarcoma: 7/2/1. Pts received the following prior systemic therapies: doxorubicin/gemcitabine/others: 2/3/5.
At time of abstract submission, median follow-up is at 7 months (2-12). 3 pts continue on study. Median number of cycles administered per pt = 2 (1-8). 2 pts had confirmed partial response (PR) and 1 pt with confirmed stable disease (SD) of > 6 months. Clinical benefit rate (PR+SD >6 months) was 30%. Median OS has not been reached. Median PFS at 1.8 months (95% CI: 1.2 β not reached).
ENMD-2076 has generally been well tolerated with primarily grade 1 and 2 adverse events (AEs). Specifically, drug-induced hypertension occurred in 6 pts (grade 1-2: 4 pts, grade 3: 2 pts). Proteinuria, all grade 1-2, occurred in 6 pts. Other drug related grade 3 or 4 AEs include (pts): elevated transaminases (1), leukopenia (1), and diarrhea (1). 1 pt developed Posterior Reversible Encephalopathy Syndrome (PRES) presenting as grade 4 loss of consciousness at Cycle 1 Day 15 required ICU admission. Full neurological recovery was attained after cessation of treatment.
Conclusions: ENMD-2076 has shown activity in patients with advanced STS, with meaningful clinical benefits and a side effects profile typical of this class of agent. PRES is a rare but fully reversible side effect of ENMD-2076. Clinical trial information: NCT01719744.
tborges
10 years ago
The abstracts are now available to the public at the ASCO website... here is the one you are inquiring about... TPS5260
The 58% refers to partial response or stable disease... I think this is is actually old data from an earlier trial... the current trial is to assess that and other data...
Background: Ovarian clear cell carcinoma (OCCC) represents nearly 15% of all epithelial ovarian carcinomas (EOC). This histology is associated with resistance to chemotherapy and a worse prognosis. VEGF has been found to be strongly expressed in OCCC. Somatic mutations in the ARID1A (the AT-rich interactive domain 1A gene that encodes BAF250a, a key component of the SWI/SNF chromatin remodeling complex) has also been demonstrated in 46-57% of OCCCs. Alteration of this chromatin remodeling complex may result in upregulation and overexpression of Aurora A.
ENMD-2076 is a multi-target kinase inhibitor, which has selective activity against Aurora A and multiple antiangiogenesis and lymphangiogenesis targets.
In a Phase II study in platinum-resistant EOC, 58% of the patients treated with single agent ENMD-2076 showed partial response or stable disease, the PFS at 6 month was 22% with a median time to progression of 3.6 months. Two out of 3 patients with OCCC who were enrolled had a longer PFS than the median.
Methods: This is a multi-center, Phase II study, in patients with recurrent OCCC to assess response rate and progression free survival rate, as primary endpoints, and duration of overall response, as a secondary endpoint, of single agent ENMD-2076 275 mg/day. Exploratory endpoints include association of somatic mutations in PI3KCA, ARID1A and PTEN, and ARID1A and PTEN expression with outcome and response. Patients ECOG =2, with histologically documented diagnosis of recurrence OCCC, any number of prior treatment regimens (chemotherapy, biologics or other target therapies except for Aurora A targeted therapies), and measurable disease (RECIST criteria 1.1) are eligible.
Based on data from previous studies, a sample size of 36 patients will provide 95% power to detect an improvement in response rate from 10 to 30% and 90% power to detect an increase in 6 month PFS from 20 to 40%.
Since September 2013, 6 patien Clinical trial information: NCT01914510.
Rocky I
10 years ago
EntreMed Reports First Quarter 2014 Financial Results
ROCKVILLE, Md., May 15, 2014 - EntreMed, Inc. ENMD, a clinical-stage
pharmaceutical company developing therapeutics for the treatment of
cancer and other diseases, today reported financial results for the
three months ended March 31, 2014.
The Company reported a net loss for the first quarter of 2014 of
($1.5 million), or ($0.05) per share, compared with a net loss of
($1.1 million), or ($0.05) per share, for the same period last year.
The increase in the net loss for the 2014 period is primarily due to
higher costs associated with the Company's research and development
operations in China, as well as additional costs related to corporate
business development initiatives in 2014.
As of March 31, 2014, EntreMed had cash and cash equivalents of $14.2
million.
Sara B. Capitelli, Vice President, Finance and Principal Accounting
Officer, commented, "Our research and development expenses for the
first quarter increased over the prior year due to the growth of our
China operations including personnel and other clinical development
costs of ENMD-2076 in China. Our general and administrative expenses
for the first quarter increased over the prior year due to an increase
in business development and investor relations activities, in addition
to an increase in non-cash stock based compensation expense. As we
continue to execute our clinical development plan, we expect operating
expenses to increase in 2014 compared with 2013."
Dr. Ken Ren, Chief Executive Officer, commented, "We are pleased with
our progress with ENMD-2076 as we continue enrollment in our Phase 2
trials in triple-negative breast cancer, advanced/soft tissue sarcoma
and advanced clear cell ovarian carcinoma. As we continue to advance
ENMD-2076 as our lead program, we will continue to implement our
business development strategy to acquire additional drug candidates to
expand our pipeline. We remain on track with our plans and finances."
Broadway1430
10 years ago
TB,
Yes it's good news that there will be presentations at ASCO, but I have a question. In your opinion,
and I don't know exactly how the conference works, but if we had blockbuster results, would we be making
a major, I.e. power point presentation to a packed room instead of just a simple poster presentation?
I don't know, maybe all they have is poster presentations, but it seems to me we may be getting more of the same. Good , not great results warrenting further investigation.
tborges
10 years ago
Good news in preclinical tests of Enmd 1198 and MKC1...
"Raf Kinase Inhibitor Protein (RKIP) Blocks Signal Transducer and Activator of Transcription 3 (STAT3) Activation in Breast and Prostate Cancer
Saad Yousuf,#1 MeiLi Duan,#1,2 Erika L. Moen,1 Sam Cross-Knorr,1 Kate Brilliant,1 Benjamin Bonavida,3 Theresa LaValle,4 Kam C. Yeung,5 Fahd Al-Mulla,6 Eugene Chin,7 and Devasis Chatterjee1,*
Abstract.
Raf kinase inhibitor protein (RKIP) is a member of the phosphatidylethanolamine-binding-protein (PEBP) family that modulates the action of many kinases involved in cellular growth, apoptosis, epithelial to mesenchymal transition, motility, invasion and metastasis. Previously, we described an inverse association between RKIP and signal transducers and activators of transcription 3 (STAT3) expression in gastric adenocarcinoma patients. In this study, we elucidated the mechanism by which RKIP regulates STAT3 activity in breast and prostate cancer cell lines. RKIP over expression inhibited c-Src auto-phosphorylation and activation, as well as IL-6-, JAK1 and 2-, and activated Raf-mediated STAT3 tyrosine and serine phosphorylation and subsequent activation. In MDA-231 breast cancer cells that stably over express RKIP, IL-6 treatment blocked STAT3 phosphorylation and transcriptional activation. Conversely, in RKIP knockdown MDA-231 cells: STAT3 phosphorylation and activation increased in comparison to parental MDA-231 cells. RKIP over expression resulted in constitutive physical interaction with STAT3 and blocked c-Src and STAT3 association. The treatment of DU145 prostate, but not PC3 prostate or MDA-231 breast, cancer cell lines with ENMD-1198 or MKC-1[color=redcolor] dramatically increased expression of RKIP. Overexpression of RKIP sensitized PC3 and MDA-231 cells to MTI-induced apoptosis. Moreover, MTI treatment resulted in a decrease in Src-mediated STAT3 tyrosine phosphorylation and activation, an effect that was significantly enhanced by RKIP over expression. In stable RKIP over expressing MDA-231 cells, tumor xenograft growth induced by activated STAT3 is inhibited. RKIP synergizes with MTIs to induce apoptosis and inhibit STAT3 activation of breast and prostate cancer cells. RKIP plays a critical role in opposing the effects of pro-oncogenic STAT3 activation."
Broadway1430
10 years ago
Guys,
I note with interest that the highly touted Pfiser breast cancer drug, while keeping the cancer at bay for 20
months vs the best out there 10 months, did little to affect overall survival.
Now I know this is asking a lot, but if Enmd has good news on the triple negative trial, especially
relative to overall survival, could they possibly forego keeping it as secret as possible for as long
as possible!
Broadway
tborges
10 years ago
Thanks... Broadway... but I am no different than you when it comes to analyzing what is taking place with this company... its all speculation and to some extent, conspiracy theory...
The options are a "right to buy" and the persons awarded the options have ten years to execute their purchase... like all options, if the stock goes up, they are in a good position to buy or sell and make a profit... if the stock goes down there is little reason to excercise their option...
However, there is one other consideration, i.e., the total number of shares is significant... and if the company is taken private... this plus what is already owned by the directors constitutes a pretty large voting block...
At the end of the day... who knows what evil (or good) lurks in the minds of the directors... only Mobery knows...
Broadway1430
10 years ago
Guys,
Granted, ENMD has an infinite capacity to disappoint, but looking at the amount of
stock picked up via options at $1.83, I am seeing 100,000, 130,000, 150,000 shares
which requires a fairly decent commitment of cash. Hard to believe this would be the case
with bad news going on at the trials.
TB, am I looking at this correctly. Hope has a way of clouding judgment, so I would appreciate
your always well grounded comments. I do understand that we are probably a long way from
approval for sale. Thanks in advance.
Broadway
Rocky I
11 years ago
Letter from the Executive Chairman of the Board of EntreMed, Inc.
March 27, 2014
To Our Stockholders,
We look forward to meeting you at our 2014 Annual Meeting and
reporting on our progress in developing a leading cross-cultural
biopharmaceutical company with operations both in the US and China.
As part of our Annual Meeting, with your approval, we plan to change
our corporate name to CASI Pharmaceuticals, Inc. The new name is in
furtherance of the remaking of EntreMed and reflects our mission to
combat cancer through advanced science and innovation, and also
reflects our integrated development strategy in China and North
America. In conjunction with the name change, we expect that the
common shares of our company will be traded on NASDAQ under a new
ticker symbol, CASI.
To deliver on our mission, we are focused on building a portfolio of
products, and intend to achieve this by (1) continuing to advance
ENMD-2076 in selected cancer indications, (2) in-licensing or
partnering with others as we leverage our expertise in drug
development in China, and (3) internally developing additional drug
candidates focusing on clinically validated targets.
China is a key focus for EntreMed for many reasons. It is the
worldβs fastest-growing pharmaceutical market, and is projected to
be the worldβs second largest by 2017 with estimated sales of more
than $170 billion. In addition, Chinaβs oncology drug market is
expected to become the worldβs largest in the next five to 10 years
as cancer incidence is growing very rapidly. Furthermore, by 2020
universal healthcare coverage is expected to be in place, thereby
providing for pharmaceutical reimbursement for additional patient
populations. Needless to say, the macro environment in China is
extremely attractive for a drug developer. We have strengthened our
team during the past year by hiring talented and experienced staff
with a successful track record of drug development, from early-
through late-stage clinical trials in the U.S. and successful
commercial execution in China.
In-licensing provides an important potential avenue for creating
value and we are actively seeking opportunities in China. We believe
that our Beijing subsidiary is uniquely positioned to capitalize on
these kinds of opportunities by virtue of our scientific expertise and
experience with conducting drug trials there.
We are also working on advancing our product candidate ENMD-2076 in
ongoing trials and are currently enrolling patients. ENMD-2076 is a
novel orally-active, Aurora A/angiogenic kinase inhibitor with potent
activity against Aurora A and multiple tyrosine kinases linked to
cancer and inflammatory diseases. It is in Phase 2 trials in North
America for triple-negative breast cancer, soft tissue sarcoma and
ovarian clear cell carcinoma. We are preparing to enter a Phase 2
trial in China for triple-negative breast cancer, which would build
upon the trials underway in University of Colorado and Indiana
University.
We have worked diligently to reposition the company and to execute a
strategy that holds a great deal of promise for our stockholders,
while potentially meeting the clinical needs of millions of patients.
We are very excited about the future and the direction we have taken.
We look forward to continued execution of our strategic plan and
keeping you apprised of our progress.
Yours truly,
Ken K. Ren
Chief Executive Officer
Rocky I
11 years ago
EntreMed Reports 2013 Fourth Quarter And Full Year Financial Results
ROCKVILLE, Md., March 21, 2014 - EntreMed, Inc. (ENMD), a
clinical-stage pharmaceutical company developing therapeutics for the
treatment of cancer and other diseases, today reported financial
results for the three and 12 months ended December 31, 2013.
The Company reported a net loss of ($1.3 million), or ($0.05) per
share for the three months ended December 31, 2013. This compares
with net loss of ($0.4 million), or ($0.02) per share for the fourth
quarter of 2012. The increase in net loss primarily was due to the
expected decline in Celgene Corporation's sales of Thalomid® in 2013
which resulted in no recorded revenue from royalties for the Company
in the fourth quarter of 2013, compared to $0.7 million royalty
revenue earned in 2012.
The net loss for 2013 was ($5.7) million or ($0.22) per share,
compared with a net loss of ($14.5) million or ($0.78) per share for
2012. The reported net loss for 2012 included non-cash interest
charges of $10.0 million associated with the Company's 2012 financing,
recorded in accordance with U.S. Generally Accepted Accounting
Principles. Excluding these charges, the net loss for 2012 was ($4.5)
million or ($0.25) per share.
As of December 31, 2013, EntreMed had cash and cash equivalents of
$15.1 million.
Sara B. Capitelli, EntreMed's Vice President, Finance and Principal
Accounting Officer, commented, "Our research and development expenses
for the fourth quarter increased over the prior year due to costs of
clinical trials that began in 2013, along with higher personnel and
other clinical development costs of ENMD-2076 in China during 2013.
We are continuing to execute our clinical development plans in the
U.S. and China, and expect operating expenses to increase in 2014.
Whereas we recorded royalty revenue of $0.7 million in 2012, there
were no royalty revenues from Celgene's sales of Thalomid® in 2013,
which was in line with our expectations and reflects a decline in
sales of Thalomid® in the United States."
Further information regarding the Company, including its Annual
Report on Form 10-K for the year ended December 31, 2013, can be found
at www.entremed.com.
Dr. Ken Ren, Chief Executive Officer, commented, "Our financial
results for the quarter and year ended December 31, 2013 are largely
as expected. We continue to manage our operating costs prudently
while we advance our trials with ENMD-2076 for a number of cancers in
North America and China, and make progress on identifying new
compounds to license, particularly for the rapidly growing
pharmaceutical market in China."
Dr. Ren continued, "We are pleased to have achieved a number of
milestones in 2013 and recent weeks. In particular, we strengthened
our intellectual property with the issuance in China of a patent
covering composition of matter and uses to treat a number of cancers
for our lead compound, ENMD-2076. This type of patent is one of the
strongest patents one can achieve in China. In mid-2013, we filed a
new global import drug clinical trial application with China's Food
and Drug Administration (CFDA) for ENMD-2076 for the treatment of
advanced/metastatic sarcomas. We ended the year with the initiation
of a Phase 2 trial for EMND-2076 in ovarian clear cell carcinomas at
the Princess Margaret Cancer center in Toronto, and followed in early
2014 with the submission of a global import drug clinical trial
application with the CFDA for the same indication."
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 including ovarian, breast, liver, renal and sarcoma, as well
as in leukemia and multiple myeloma. EntreMed is completing a Phase 2
trial of ENMD-2076 in ovarian cancer. In addition, EntreMed is
conducting a dual-institutional Phase 2 study of ENMD-2076 in
triple-negative breast cancer, a Phase 2 study in advanced/metastatic
soft tissue sarcoma, and a Phase 2 study in advanced ovarian clear
cell carcinomas. ENMD-2076 has received orphan drug designation from
the U.S. FDA for the treatment of ovarian cancer, multiple myeloma and
acute myeloid leukemia.
silver bullet
11 years ago
recent news fom Chlna.............good thlng ENMD has a chlnese patent...........................
China Formulates Special Regulatory Pathway for Innovative Medical Device Products
Global Life Sciences: China Update
On February 7, 2014, the China Food and Drug Administration (CFDA) issued a new regulation to formulate a special pathway for review and approval of innovative medical device products, which regulation will become effective from March 1, 2014.
Under this regulation, a special approval pathway will be available for innovative medical device products that are manufactured in or outside China, to the extent that the following requirements are met simultaneously:
Key technologies of the product are protected by Chinese invention patents that are lawfully owned by or licensed to the applicant, or the relevant invention patent applications have been published in China;
The product is βfirst in Chinaβ in terms of its key functions or working mechanism, and exhibits fundamental improvements over current devices with significant clinical value; and
The early stage research of the product is completed, the research process is true and controlled, and the research data is complete and traceable.
CFDA will establish a dedicated office and a dedicated expert panel to review and approve innovative medical device products that are qualified for such review. The products under special review will be given priority in areas such as type testing, technical review, QMS certification, and the review timeline could be shortened to approximately 60 working days for local products and 40 working days for foreign products. The applicants will also be given more opportunity to communicate with CFDA in the review process.