ROCKVILLE, Md., Aug. 16, 2016 /PRNewswire/ -- CASI
Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company
dedicated to innovative therapeutics addressing cancer and other
unmet medical needs, today announced that its Phase 2 trial of
ENMD-2076 in fibrolamellar carcinoma (FLC) has met its Stage 1
endpoint of objective response for non-futility based on the
pre-specified interim analysis criteria and will advance to Stage 2
development.
Rong Chen, M.D., CASI's Chief Medical Officer, commented, "The
trial is to evaluate safety and efficacy of ENMD-2076 as a single
agent in a total of 29 locally-advanced or metastatic FLC patients.
It uses a Simon's optimal two-stage design to allow for an early
determination of potential futility in the 16 patients of Stage 1.
An additional 13 patients will be recruited in Stage 2 to allow an
overall final analysis with sufficient power. Having met the Stage
1 endpoint, we will now advance the trial to Stage 2 development.
Meanwhile, the Stage 1 remains ongoing with approximately one-third
of the patients still under treatment. A full interim analysis will
be conducted and reported after all 16 patients have reached study
endpoint of responses."
Ken Ren, Ph.D., CASI's Chief
Executive Officer, commented, "We are pleased to see our FLC trial
advance into Stage 2, which upon completion will increase the
amount of data of ENMD-2076 in FLC patients. FLC is a
life-threatening disease that typically affects young adults and is
currently without any systemic treatment. Based on results to date,
we are encouraged by the potential of ENMD-2076 to address the
unmet medical needs of these patients. We are thankful to our
investigators for their dedication to the program and to our FLC
patients who make the trial meaningful and drive our purpose."
More information about the trial can be found at
www.clinicaltrials.gov.
About ENMD-2076
ENMD-2076 is an orally-active, Aurora A/angiogenic kinase
inhibitor with a unique kinase selectivity profile and multiple
mechanisms of action. ENMD-2076 has been shown to inhibit a
distinct profile of angiogenic tyrosine kinase targets in addition
to the Aurora A kinase. Aurora kinases are key regulators of
mitosis (cell division), and are often over-expressed in human
cancers. ENMD-2076 also targets the VEGFR, Flt-3 and FGFR3 kinases,
which have been shown to play important roles in the pathology of
several cancers. ENMD-2076 has shown promising activity in Phase 1
clinical trials in solid tumors including ovarian, breast, liver,
renal and sarcoma, as well as in leukemia and multiple myeloma.
ENMD-2076 is currently in Phase 2 clinical trials in multiple
indications, including triple-negative breast cancer, soft tissue
sarcoma, ovarian clear cell carcinomas and fibrolamellar carcinoma.
ENMD-2076 has received orphan drug designation from the U.S. FDA
for the treatment of ovarian cancer, multiple myeloma, acute
myeloid leukemia, and hepatocellular carcinoma. ENMD-2076 has
received orphan drug designation from the European Medicines Agency
Committee for Orphan Medicinal Products for the treatment of
hepatocellular carcinoma, including fibrolamellar carcinoma.
About CASI Pharmaceuticals, Inc.
CASI is a biopharmaceutical company dedicated to the
acquisition, development and commercialization of innovative
therapeutics addressing cancer and other unmet medical needs for
the global market with a commercial focus on China. CASI's product pipeline includes
exclusive rights to MARQIBO® (vinCRIStine sulfate
LIPOSOME injection), EVOMELA® (melphalan) for Injection
and ZEVALIN® (ibritumomab tiuxetan) for the greater
China market (including
Taiwan, Hong Kong and Macau). CASI's development pipeline also
includes its proprietary drug candidate ENMD-2076, a selective
angiogenic kinase inhibitor currently in multiple Phase 2 oncology
studies, and 2ME2 (2-methoxyestradial) currently under
reformulation 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,
including, without limitation, with respect to the closing of the
private placement offering and the anticipated use of the net
proceeds. 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: the risk that
the remaining closing or closings of the private placement offering
does not occur, 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, including as a result of the closing of the private
placement offering; the difficulty of executing our business
strategy in China; 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
jmacdonald@torreyhillscapital.com
|
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SOURCE CASI Pharmaceuticals, Inc.