ROCKVILLE, Md., April 14, 2017 /PRNewswire/ -- CASI
Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company
dedicated to innovative therapeutics addressing cancer and other
unmet medical needs, reported today that along with the
investigators a decision has been reached to stop further
patient enrollment in its Phase 2, open-label study of ENMD-2076 in
previously treated locally advanced or metastatic triple-negative
breast cancer (TNBC) conducted at the University of Colorado, Denver and the Indiana University Melvin and Bren Simon Cancer
Center. The study was a 2 stage design which targeted an
accrual of 35 patients. The patient number was expanded to take
into consideration those patients which may not be evaluable for
efficacy analysis as per the protocol. In this uncommon tumor type
and challenging setting to recruit, a total of 41 patients have
been enrolled which has been determined to be sufficient to assess
the potential efficacy of ENMD-2076 in this patient population and
for our ongoing biomarker analysis. The Company continues to
collect and evaluate data in those patients enrolled in the study,
and the biomarker program which evaluates potential markers that
could be predictive of a response to ENMD-2076 is ongoing. In
addition, the ongoing Phase 2a study in China in patients with TNBC continues to
accrue patients in the dose escalation phase, the primary objective
of which is to determine the recommended Phase 2 dose in Chinese
study subjects. This dose escalation phase is expected to
reach the full accrual target in Q3 2017.
Dr. Alex Zukiwski, CASI's Chief
Medical Officer, commented, "We continue to evaluate the maturing
data including the biomarker analysis to determine the potential
future development path in patients with TNBC. Identifying markers
predictive of response to ENMD-2076 in patients with TNBC would be
helpful to future development as a single agent, as well as
consideration of any additional trials where ENMD-2076 could be
combined with approved agents to increase clinical benefit."
Along with the investigators, the Company plans to present the
study results at the next available opportunity.
About CASI Pharmaceuticals, Inc.
CASI is a U.S. based, late-stage biopharmaceutical company
focused on the acquisition, development and commercialization of
innovative therapeutics addressing cancer and other unmet medical
needs for the global market with a focus on commercialization in
China. CASI's product pipeline
features (1) our lead proprietary drug candidate, ENMD-2076, in
multiple Phase 2 clinical trials, (2) MARQIBO®,
ZEVALIN® and EVOMELA®, all U.S. Food and Drug
Administration (FDA) approved drugs in-licensed from Spectrum
Pharmaceuticals, Inc. for China
regional rights, and currently in various stages in the regulatory
process for market approval in China, and (3) proprietary early-stage
candidates in preclinical development. CASI is headquartered
in Rockville, Maryland and has a
wholly owned subsidiary and R&D operations in Beijing, China. More information on CASI is
available at www.casipharmaceuticals.com and in the Company's
filings with the U.S. Securities and Exchange Commission.
Forward Looking Statements
This news 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, 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: that we may be unable to continue as
a going concern as a result of our inability to raise sufficient
capital for our operational needs; the volatility in the market
price of our common stock; risks relating to interests of our
largest stockholders that differ from our other stockholders; the
risk of substantial dilution of existing stockholders in future
stock issuances, the difficulty of executing our business strategy
in China; our inability to predict
when or if our product candidates will be approved for marketing by
CFDA authorities; our inability to enter into strategic
partnerships for the development, commercialization, manufacturing
and distribution of our proposed product candidates or future
candidates; risks relating to the need for additional capital and
the uncertainty of securing additional funding on favorable terms;
risks associated with our product candidates; risks associated with
any early-stage products under development; the risk that results
in preclinical models are not necessarily indicative of clinical
results; uncertainties relating to preclinical and clinical trials,
including delays to the commencement of such trials; the lack of
success in the clinical development of any of our products;
dependence on third parties; and risks relating to the
commercialization, if any, of our proposed products (such as
marketing, safety, regulatory, patent, product liability, supply,
competition and other risks). Such factors, among others,
could have a material adverse effect upon our business, results of
operations and financial condition. We caution readers not to
place undue reliance on any forward-looking statements, which only
speak as of the date made. Additional information about the factors
and risks that could affect our business, financial condition and
results of operations, are contained in our filings with the U.S.
Securities and Exchange Commission, which are available at
www.sec.gov.
MARQIBO®, EVOMELA® and
ZEVALIN® are proprietary to Spectrum
Pharmaceuticals, Inc. and its affiliates.
COMPANY
CONTACT:
CASI Pharmaceuticals,
Inc.
240.864.2643
ir@casipharmaceuticals.com
|
INVESTOR
CONTACT:
Torrey Hills
Capital
Jim
Macdonald
858.456.7300
jm@sdthc.com
|
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SOURCE CASI Pharmaceuticals, Inc.