Antitumor Activity Demonstrated in Metastatic Breast Cancer Patients ROCKVILLE, Md., June 3
ROCKVILLE, Md., June 3 /PRNewswire-FirstCall/ -- EntreMed, Inc. (Nasdaq:
ENMD), a clinical-stage pharmaceutical company developing therapeutics for the
treatment of cancer and inflammatory diseases, today announced the
presentation of clinical data for the MKC-1 Phase 2 study in patients with
metastatic breast cancer. The data were presented by Bryan P. Schneider,
M.D., Assistant Professor, Department of Medicine, Indiana University, during
the Breast Cancer -- Metastatic session at the American Society of Clinical
Oncology Annual Meeting being held this week in Chicago, Illinois.
(Logo: http://www.newscom.com/cgi-bin/prnh/20010620/ENMDLOGO )
For this Phase 2 single agent, open label study, a total of 65 patients
who had previously received at least one anthracycline and taxane therapy were
enrolled. 55 patients were evaluable for tumor response. Of the evaluable
patients, the antitumor activity observed with MKC-1 included 3 patients who
had responses and 5 patients with stable disease lasting more than four
months.
MKC-1 is a novel, orally-active cell cycle inhibitor with in vitro and in
vivo efficacy against a broad range of human solid tumor cell lines, including
multi-drug resistant cell lines. Data from previous studies with MKC-1
demonstrate broad-acting antitumor effects, showing tumor growth inhibition or
regression in multiple preclinical models, including paclitaxel-resistant
models. To date, MKC-1 has been evaluated in over 400 patients in multiple
Phase 1 and 2 clinical trials.
Carolyn F. Sidor, MD, MBA, EntreMed Vice President and Chief Medical
Officer commented on the results, "Although we did not meet our overall goal
for this study, we are encouraged by the number of patients who did respond or
have stable disease in this heavily pre-treated patient population. Going
forward, further work may enable us to define why some breast cancer patients
responded to MKC-1 treatment. Combining information from these studies with
new mechanistic insights that have revealed mTOR and HIF-1alpha as molecular
targets of MKC-1, we will be in a better position to design future clinical
studies in defined, less refractory patient subsets that will benefit from
MKC-1 treatment. Additionally, based on data from several preclinical models,
we believe that by administering MKC-1 on a continuous dosing schedule, we
should be able to enhance the compound's antitumor activity. Additional
clinical studies utilizing continuous dosing are already underway."
"EntreMed has made significant progress towards an understanding of MKC-1
mechanism since the initiation of this Phase 2 study," commented EntreMed Vice
President of Research, Mark R. Bray, PhD. Dr. Bray continued, "Refinements to
dose and schedule, and translational studies based on MKC-1's newly-discovered
activity towards the mTOR/PI3-kinase pathway have been incorporated into
ongoing and planned MKC-1 trials. Additionally, we are exploring the
molecular basis for resistance and sensitivity of cancer cells to MKC-1 both
internally and through collaborations. We feel that the information derived
from these mechanistic and clinical studies will assist in defining how best
to utilize MKC-1, which has demonstrated activity in drug resistant patient
populations."
To view a copy of the poster presentation, visit the Therapeutic Pathways
section of the Company's website at www.entremed.com .
About EntreMed
EntreMed, Inc. is a clinical-stage pharmaceutical company developing
therapeutic candidates primarily for the treatment of cancer and inflammation.
MKC-1 is currently in multiple Phase 2 clinical trials for cancer. MKC-1 is an
oral cell-cycle regulator with activity against the mTOR pathway. ENMD-1198, a
novel antimitotic agent, and ENMD-2076, a selective kinase inhibitor, 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 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 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
SOURCE EntreMed, Inc.
