ROCKVILLE, Md., Sept. 7, 2017 /PRNewswire/ -- CASI
Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company
dedicated to innovative therapeutics addressing cancer and other
unmet medical needs today provided an update to its pipeline.
EVOMELA®:
China's Food and Drug
Administration (CFDA) has granted priority review for CASI's import
drug registration clinical trial application for EVOMELA
(melphalan) for Injection. The CFDA cited the following three
reasons for granting the priority review:
- EVOMELA is indicated for the treatment of multiple myeloma,
which is classified as a rare disease in China;
- There is no melphalan in any formulation available in
China to address this unmet
medical need;
- EVOMELA has clear therapeutic advantages to currently available
therapeutics.
MARQIBO® and
ZEVALIN®
The CFDA review of CASI's MARQIBO import drug clinical trial
application (CTA) is in process. The Company anticipates that the
CFDA will complete its review of the CTA in the next four to six
months, and expects to initiate the confirmatory trial within six
months after CTA approval. The confirmatory trial is required as
part of the registration process for the import drug
registration.
The CFDA filing and review of CASI's ZEVALIN import drug
clinical trial application (CTA) is in process. The ZEVALIN
antibody kit and the radioactive Yttrium-90 component of the
clinical trial application require separate submissions to the
CFDA, which the first part is currently under review and the latter
part is in the submission process. The Company expects to initiate
the confirmatory trial within six months after the CFDA's approval
of both the ZEVALIN kit and the Yttrium-90 submissions.
Ken Ren, Ph.D., CASI's Chief
Executive Officer, commented, "We are pleased that the CFDA in
granting priority review for EVOMELA has recognized the superior
therapeutic advantages of EVOMELA to address the urgent unmet
medical need in the rare disease of multiple myeloma in
China. Melphalan is extensively used worldwide in the
treatment of patients with multiple myeloma, however, no
formulation of melphalan is currently available in China. We appreciate the CFDA opening this
accelerated pathway for this critical medicine to reach patients in
China; it also is a positive
signal from the CFDA to accelerate the import drug registration
process for U.S. FDA approved drugs in order to address the
significant unmet medical needs of the Chinese population in an
accelerated time frame. We also are pleased with the progress of
MARQIBO and ZEVALIN and are looking forward to their continued
advancement in the import drug registration process."
ENMD-2076:
- Clear Cell Ovarian Carcinoma (CCOC) and Soft Tissue
Sarcoma (STS). The data from the investigator-sponsored Phase 2
study in patients with CCOC was presented at the 2017 Annual
Meeting of the American Society of Clinical Oncology. The data from
the investigator-sponsored Phase 2 study in patients with STS was
presented at the 2015 Annual Meeting of the Connective Tissue
Oncology Society. The correlative genomics testing has been
completed and a publication is expected to be submitted in 2017.
Based on the clinical data, CASI has determined it will not pursue
company sponsored development of ENMD-2076 in CCOC and STS.
- Triple Negative Breast Cancer (TNBC). The accrual to the
investigator sponsored Phase 2 study in patients with previously
treated advanced and metastatic TNBC is complete and the
correlative biomarker/genomics analysis is ongoing. The data will
be presented at the 2017 San Antonio Breast Cancer Symposium.
- Fibrolamellar Carcinoma (FLC). The accrual to this
ongoing Phase 2 study is complete and is in the follow up phase. It
is anticipated that the data from this study will be submitted to a
medical conference for presentation in 2018.
Dr. Alex Zukiwski, M.D, CASI's
Chief Medical Officer, commented, "ENMD-2076 has been investigated
in a number of tumor types based on the known mechanism of action
and the oncogenic pathways of the specific malignancy. Although
anticancer activity was observed in the clear cell ovarian
carcinoma and soft tissue sarcoma studies, the level of single
agent activity does not support the development of ENMD-2076 in
these two tumor types as a monotherapy. We look forward to
providing an update on the ENMD-2076 Triple Negative Breast Cancer
and Fibrolamellar Carcinoma data in the next few months."
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) EVOMELA®,
MARQIBO® and
ZEVALIN®, 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
and clinical process for market approval in China, (2) our proprietary drug candidate,
ENMD-2076, ongoing in one Phase 2 clinical study, and (3) CASI-001
and CASI-002, proprietary preclinical candidates in
immune-oncology. 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 CASI's filings with
the U.S. Securities and Exchange Commission.
CASI's China rights to
EVOMELA® (melphalan) for
Injection, MARQIBO®
(vinCRIStine sulfate LIPOSOME injection) and
ZEVALIN® (ibritumomab
tiuxetan) were previously licensed from its partner Spectrum
Pharmaceuticals, Inc. Based on the U.S. FDA's approval of these
three licensed products, CASI is pursuing the Import Drug
registration path for approval in China.
About
EVOMELA®
EVOMELA was commercially launched in the U.S. by Spectrum in
2016 for the following approved indications: (1) use as a high-dose
conditioning treatment prior to hematopoietic progenitor (stem)
cell transplantation in patients with multiple myeloma and (2) the
palliative treatment of patients with multiple myeloma for whom
oral therapy is not appropriate. EVOMELA has been granted
Orphan Drug Designation by the FDA for its use as a high-dose
conditioning regimen for patients with multiple myeloma undergoing
autologous stem cell transplantation (ASCT). EVOMELA's melphalan
formulation does not contain propylene glycol. The use of the
Captisol® technology to
reformulate also contributes to the 4-hour admixture stability of
EVOMELA at room temperature. This is in addition to the 1 hour
stability of reconstituted EVOMELA drug product at room temperature
and 24 hour stability at refrigerated temperature (5ºC).
Please see the Important Safety information available at
www.evomela.com. EVOMELA is not yet available in China; more information on EVOMELA for
countries outside the greater China region is available at
www.sppirx.com.
About MARQIBO®
MARQIBO is a novel, sphingomyelin/cholesterol
liposome-encapsulated, formulation of vincristine sulfate.
Vincristine, a microtubule inhibitor, is FDA-approved for the
treatment of adult patients
with Philadelphia chromosome-negative (Ph-) acute
lymphoblastic leukemia (ALL) in second or greater relapse or whose
disease has progressed following two or more anti-leukemia
therapies. (The encapsulation technology, utilized in this
formulation, has been shown to provide prolonged circulation of
vincristine in the blood). Please see the Important Safety
information available at www.marqibo.com. MARQIBO is not yet
available in China; more
information on MARQIBO for countries outside the greater
China region is available at
www.sppirx.com.
About ZEVALIN®
ZEVALIN® (ibritumomab
tiuxetan) injection for intravenous use is a prescription
medication that has three parts: two infusions of rituximab and one
injection of Yttrium-90 (Y-90)
ZEVALIN. Rituximab is used to reduce the number of B-cells in your
blood and Y-90 ZEVALIN is given to
treat your non-Hodgkin's lymphoma (NHL). The ZEVALIN therapeutic
regimen is used to treat patients with: (1) low-grade or follicular
B-cell NHL that has relapsed during or after treatment with other
anticancer drugs, and (2) newly diagnosed follicular NHL following
a response to initial anticancer therapy. Please see the
Important Safety information available at www.zevalin.com. ZEVALIN
is not yet available in China;
more information on ZEVALIN for countries outside the greater
China region is available at
www.sppirx.com.
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
the China Food and Drug Administration 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 and early
clinical models are not necessarily indicative of later 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.
EVOMELA®,
MARQIBO® 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.