EntreMed Files New Drug Global Clinical Trial Application For ENMD-2076 With China CFDA To Expand Clinical Trial For Advanced/Metastatic Sarcoma
ROCKVILLE, Md., June 27, 2013 - EntreMed, Inc. (ENMD), a
clinical-stage pharmaceutical company developing therapeutics for the
treatment of a variety of cancers, announced today that it has
submitted a new drug global clinical trial application with the China
Food and Drug Administration (CFDA) for its proprietary oncology drug
candidate, ENMD-2076. The purpose of the application is to expand the
Company's Phase 2 clinical trial in advanced/metastatic sarcoma which
currently is being conducted at Princess Margaret Hospital. This
submission is the Company's second new drug global clinical trial
application with the CFDA. The first application when approved will
expand the Company's Phase 2 clinical trial for triple-negative breast
cancer which currently is being conducted at the University of
Colorado and Indiana University. More information about the clinical
trials can be found at www.clinicaltrials.gov.
Ken K. Ren, Ph.D., EntreMed's Chief Executive Officer, commented, "We
are advancing our global development program in sarcoma because we
believe that ENMD-2076, with its unique dual targets of Aurora A and
VEGFR, may provide therapeutic benefits to the targeted patient
population with unmet medical needs. We are excited about expanding
the trial and are encouraged by the support from our investigators.
We look forward to working with the CFDA to move our application
forward towards approval. Regarding our application for
triple-negative breast cancer, we are currently working with the
Center for Drug Evaluation of CFDA on the technical review and have
begun laying out the groundwork for the trial, which is targeted to be
launched by the fourth quarter of this year after approval is
received.
Dr. Ren continued, "We are pleased with the continued execution of
our integrated US-China drug development plan. Expanding our trials
into China will enable us to explore the potential of ENMD-2076 at an
accelerated pace due to faster patient recruitment and lower study
costs, while obtaining data that will lead to advanced global drug
development as well as China import drug registration."
"In parallel with the advancement of our ENMD-2076 program," Dr. Ren
further continued, "we are also evaluating additional drug candidates
to add to our pipeline, with emphasis on compounds that have the
potential for gaining widespread market acceptance globally or in
China and for which development can be carried out cost-effectively
under our global drug development strategy."
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