EntreMed Reports Clinical Program Progress and Company Update
November 12 2008 - 7:00AM
PR Newswire (US)
EntreMed, Inc. (NASDAQ: ENMD), a clinical-stage pharmaceutical
company developing therapeutics for the treatment of cancer and
inflammatory diseases, reported corporate and clinical program
updates for the third quarter 2008 and remaining fourth quarter
2008 objectives. The updates were given during a podium
presentation by EntreMed President & CEO, James S. Burns, and
web cast at the Rodman & Renshaw 10th Annual Healthcare
Conference, being held this week in New York. An archive of Mr.
Burns' live presentation is available on the Company's web site at
http://www.entremed.com/ and can be accessed for 60 days. (Logo:
http://www.newscom.com/cgi-bin/prnh/20010620/ENMDLOGO ) During the
presentation, Mr. Burns reiterated the development status of the
Company's pipeline of multi-mechanism drugs for the treatment of
cancer and inflammatory diseases. Remarks during the presentation
were focused on corporate objectives as they relate to the status
of multiple oncology clinical trials currently underway, the
Company's partnering goals, and financial position. Highlights of
the presentation are listed below. Corporate Highlights --
EntreMed, Inc. reported third quarter royalty revenues of
approximately $3.5 million from sales of Thalomid(R). Royalty
revenues for the full year 2008 are expected to increase over 2007
based on additional sales of Thalomid(R) resulting from Celgene's
acquisition of Pharmion. -- EntreMed, Inc. ended the third quarter
2008 with approximately $28 million in cash and short-term
investments. The $28 million, together with anticipated royalty
inflows, is expected to fund planned operations for more than 12
months. -- Research and development expenses are expected to
decline further in 2009 as the Company seeks partners for its
ENMD-2076 kinase inhibitor and rheumatoid arthritis programs and
focuses down on its key clinical programs. The Company is
undergoing a review of its programs andexpects to implement
cost-saving measures in areas that are not essential to meeting or
accelerating its strategic clinical objectives for 2009. These cost
reductions, along with royalty revenues, are expected to provide
sufficient cash into 2010. -- The Company is actively engaged in
partnering discussions for its Aurora/angiogenesis kinase
inhibitor, ENMD-2076, and for Panzem(R) in rheumatoid arthritis.
EntreMed's goal is to select an appropriate partner to accelerate
the development for ENMD-2076 in the first half of 2009, and to
partner Panzem(R) in RA by 2H09. -- On October 3, 2008, the
Company's stock was transferred from the Nasdaq Global Market to
the Nasdaq Capital Market. Trading of the Company's stock was
unaffected by the transfer. More recently, as a result of Nasdaq's
determination to temporarily suspend the minimum $1.00 closing bid
price rule based on the current extraordinary market conditions,
EntreMed received notification that it will have until July 6, 2009
to regain compliance with the minimum bid price rule. Clinical
Program Status -- ENMD-2076 - Patients are currently being enrolled
in the third cohort of the Phase 1 clinical trial in advanced solid
tumors. The longest-treated patient on study has received six
months of daily dosing. Phase 1 results are anticipated in the
first half of 2009. A second Phase 1 study in patients with
multiple myeloma is planned to begin later this year. The Company
is engaged in partnering discussions for the ENMD-2076 program. --
MKC-1 - The primary response rate endpoint has been met for the
efficacy portion of the MKC-1 Phase 1/2 study in combination with
Alimta(R) (pemetrexed) in patients with non-small cell lung cancer.
EntreMed is considering possible options for further studies in
NSCLC patients which could include continuation of the current
single arm study or a randomized Phase 2 study in the same patient
population if additional financial resources are available. --
ENMD-1198 - The Phase 1 study in advanced cancer patients is
nearing completion. A dose-limiting toxicity has been reached. The
Phase 1 program may be expanded to identify combination therapies
and target indications. The mechanism-of-action for ENMD-1198
indicates that prostate cancer may be a key indication. Possible
next steps for the clinical development of ENMD-1198 are being
considered in light of our objectives for 2009. -- Panzem(R) RA -
The Company completed a healthy volunteer study and results were
submitted to the FDA. The study results reaffirmed the safety of
Panzem(R), even at higher doses than are anticipated for the
treatment of rheumatoid arthritis. Based on the FDA's review, the
Company now has a clear path forward for clinical development and
will consider its options relative to our objectives for 2009.
Possible next steps for the RA program could include a drug-drug
interaction (DDI) clinical trial with methotrexate and chronic
animal toxicology studies, followed by a Phase 2 study in RA
patients. The Company is engaged in partnering discussions for the
Panzem(R) RA program. Mr. Burns commented on the update, "Increased
royalty revenues and strategic cost reductions should place the
Company in a position to weather the current market conditions into
2010. Aggressive partnering efforts for our Aurora/angiogenesis
inhibitor, ENMD-2076, are underway, which will help accelerate
development of this exciting compound and provide the financial
resources to maintain our clinical development plan. These are
difficult market conditions but we will continue to be resilient in
our strategies. While our stock price has suffered, we have
continued to make excellent clinical progress. I am confident in
our pipeline of multi-mechanism drugs for cancer and inflammatory
diseases and I believe that we remain on course to achieve our
clinical and partnering milestones." About EntreMed EntreMed, Inc.
is a clinical-stage pharmaceutical company developing therapeutic
candidates primarily for the treatment of cancer and inflammation.
MKC-1, an oral cell-cycle regulator with activity against the mTOR
pathway, is currently in multiple Phase 2 clinical trials for
cancer. ENMD-2076, a selective angiogenic kinase inhibitor, and
ENMD-1198, a novel antimitotic agent are in Phase 1 studies in
advanced cancers. The Company also has an approved IND application
for Panzem(R) in rheumatoid arthritis. EntreMed's goal is to
develop and commercialize new compounds based on the Company's
expertise in angiogenesis, cell cycle regulation, cell signaling
and inflammation - processes vital to the treatment of cancer and
other diseases, such as rheumatoid arthritis. Additional
information about EntreMed is available on the Company's web site
at http://www.entremed.com/ and in various filings with the
Securities and Exchange Commission. 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 (including the timing of royalty revenues and future
R&D expenditures), 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 those set forth in Securities and Exchange
Commission filings under "Risk Factors," including risks relating
to the need for additional capital and the uncertainty of
additional funding; variations in actual sales of Thalomid(R),
risks associated with the Company's product candidates; the
early-stage products under development; results in preclinical
models are not necessarily indicative of clinical results,
uncertainties relating to preclinical and clinical trials; success
in the clinical development of any products; dependence on third
parties; future capital needs; and risks relating to the
commercialization, if any, of the Company's proposed products (such
as marketing, safety, regulatory, patent, product liability,
supply, competition and other risks). CONTACT: Ginny Dunn Associate
Director, Corporate Communications & Investor Relations
EntreMed, Inc. 240.864.2643 DATASOURCE: EntreMed, Inc. CONTACT:
Ginny Dunn, +1-240-864-2643 Web Site: http://www.entremed.com/
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