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."
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