SANTA MONICA, Calif., Nov. 17, 2014 (GLOBE NEWSWIRE) -- Kite Pharma, Inc.,
(Nasdaq:KITE), a clinical-stage biopharmaceutical company focused on
developing engineered autologous T cell therapy (eACT™) products for the
treatment of cancer, today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products
(COMP) has adopted a positive opinion recommending KTE-C19 for
designation as an orphan medicinal product for the treatment of diffuse
large B cell lymphoma (DLBCL). KTE-C19 is an anti-CD19 CAR T cell
therapy that involves genetically modifying a patient's T cells to
express a CAR that is designed to target CD19, a protein expressed on
the cell surface of B cell lymphomas and leukemias.
The COMP, a committee of the EMA, adopts an opinion on the granting of
orphan drug designation, after which the opinion is submitted to the European Commission for endorsement of the opinion. Orphan drug designation by the European Commission
provides regulatory and financial incentives for companies to develop
and market therapies that treat a life-threatening or chronically
debilitating condition affecting no more than five in 10,000 persons in
the European Union (EU), and where no satisfactory treatment
is available. In addition to a 10-year period of marketing exclusivity
in the EU after product approval, orphan drug designation provides
incentives for companies seeking protocol assistance from the EMA during
the product development phase, and direct access to the centralized
DLBCL is an aggressive type of non-Hodgkin lymphoma for which the
treatment options include chemotherapy, anti-CD20 antibodies, and, in
selected patients, autologous transplant. Although most patients with
DLBCL can be cured by either chemotherapy or transplant, a significant
proportion of patients have disease that is resistant to chemotherapy or
that relapses after transplant. For these patients with refractory
DLBCL, there is a substantial unmet need for more effective therapies.
About Kite Pharma, Inc.
Kite Pharma, Inc.,
is a clinical-stage biopharmaceutical company engaged in the
development of novel cancer immunotherapy products, with a primary focus
on eACT™ designed to restore the immune system's ability to recognize
and eradicate tumors. In partnership with the NCI Surgery Branch through
a Cooperative Research and Development Agreement (CRADA),
Kite is advancing a pipeline of proprietary eACT™ product candidates,
both CAR (chimeric antigen receptor) and TCR (T cell receptor) products,
directed to a wide range of cancer indications. Kite is based in Santa Monica, CA. For more information on Kite Pharma, please visit www.kitepharma.com.
This press release contains forward-looking statements for purposes of
the safe harbor provisions of the Private Securities Litigation Reform
Act of 1995. We may, in some cases, use terms such as "predicts,"
"believes," "potential," "proposed," "continue," "estimates,"
"anticipates," "expects," "plans," "intends," "may," "could," "might,"
"will," "should" or other words that convey uncertainty of future events
or outcomes to identify these forward-looking statements.
Forward-looking statements include statements regarding our intentions,
beliefs, projections, outlook, analyses or current expectations
concerning, among other things: the success and timing of the ongoing
and anticipated clinical trials for our current product candidates,
including statements regarding the timing of initiation of our clinical
trial of KTE-C19; the ability and willingness of the NCI to continue
development activities relating to eACT™ pursuant to the CRADA; our
expectations regarding the clinical effectiveness and safety of our
product candidates and results of the NCI's clinical trials; our ability
to manufacture our product candidates; the timing of and our ability to
obtain and maintain U.S. Food and Drug Administration or
other regulatory authority approval of, or other action with respect to,
our product candidates and advancing a clinical trial of KTE-C19; and
our ability to protect our proprietary technology and enforce our
intellectual property rights. Various factors may cause differences
between Kite's expectations and actual results as discussed in greater
detail in Kite's filings with the Securities and Exchange Commission, including without limitation in its Form 10-Q for the quarter ended September 30, 2014.
forward-looking statements that we make in this press release speak only
as of the date of this press release. We assume no obligation to update
our forward-looking statements whether as a result of new information,
future events or otherwise, after the date of this press release.
CONTACT: Kite Contacts:
Cynthia M. Butitta
Chief Financial Officer and Chief Operating Officer
For Media: Justin Jackson
For Investor Inquiries: Kimberly MinarovichBurns McClellan
Source: Kite Pharma, Inc.
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