Epizyme Announces Tazemetostat Fast Track Designation for Follicular Lymphoma and Plenary Session on Phase 2 NHL Data at ICML...
April 25 2017 - 6:30AM
Interim Efficacy and Safety Data from Ongoing
Phase 2 Study in Follicular Lymphoma and DLBCL Selected for Plenary
Presentation at the International Conference on Malignant
Lymphoma
Epizyme, Inc. (NASDAQ:EPZM), a clinical-stage biopharmaceutical
company creating novel epigenetic therapies, today announced that
the U.S. Food and Drug Administration (FDA) has granted Fast Track
designation to tazemetostat, the Company’s first-in-class EZH2
inhibitor, for the treatment of patients with relapsed or
refractory follicular lymphoma, either wild type EZH2 or with EZH2
activating mutations. Fast Track designation is intended to provide
expedited processes for the development and FDA review of drugs
that may reduce development time and costs associated with bringing
a drug to market.
Epizyme also announced that interim efficacy and safety data
from all five study cohorts in its ongoing Phase 2 study of
tazemetostat in patients with relapsed or refractory follicular
lymphoma and diffuse large B-cell lymphoma (DLBCL) has been
selected for a plenary session on Wednesday, June 14, 2017 at 2:00
p.m. CET at the International Conference on Malignant Lymphoma
(ICML) in Lugano, Switzerland. In addition, results from a
biomarker study of tazemetostat in patients with NHL will be
presented in a poster session during ICML. The Company plans to
hold a conference call to discuss these clinical findings on
Wednesday, June 14 at 10:30 a.m. ET.
“This is an important milestone for our NHL program, with
tazemetostat now having FDA Fast Track designation for relapsed or
refractory diffuse large B-cell lymphoma with EZH2 activating
mutations and for relapsed or refractory follicular lymphoma,
regardless of EZH2 mutation,” said Robert Bazemore, president and
chief executive officer, Epizyme. “In addition to this regulatory
recognition of tazemetostat’s therapeutic potential, the selection
of interim Phase 2 data for the opening plenary session underscores
the lymphoma community’s enthusiasm for our lead product candidate.
Our development goal is to bring tazemetostat to patients as
quickly as possible and we look forward to advancing this study
throughout 2017.”
The FDA Fast Track program is designed to facilitate the
development of important new drugs and to provide patients access
to those drugs more quickly. The designation enables early and
frequent communication between FDA and a product sponsor throughout
the drug development and review process. Through the Fast Track
program, a product may be eligible for priority review at the time
of a new drug application (NDA) filing and may also be eligible to
submit completed sections of the NDA on a rolling basis before the
complete application is submitted.
About the Tazemetostat Clinical Trial
ProgramTazemetostat, a first-in-class EZH2 inhibitor, is
currently being studied in ongoing Phase 2 programs in both
follicular lymphoma and diffuse large B-cell lymphoma (DLBCL) forms
of non-Hodgkin lymphoma; certain genetically defined solid tumors,
including INI1-negative and SMARCA4-negative tumors and synovial
sarcoma; and mesothelioma, as well as in combination studies in
DLBCL. Tazemetostat has been granted Fast Track designation by the
U.S. Food and Drug Administration for both relapsed/refractory
follicular lymphoma with or without an EZH2 activating mutation and
DLBCL with EZH2 activating mutations, as well as Orphan Drug
designation for malignant rhabdoid tumors.
About Epizyme, Inc. Epizyme, Inc. is a
clinical-stage biopharmaceutical company committed to rewriting
cancer treatment through novel epigenetic medicines. Epizyme is
broadly developing its lead product candidate, tazemetostat, a
first-in-class EZH2 inhibitor, with studies underway in both solid
tumors and hematological malignancies, as a monotherapy and
combination therapy and in relapsed and front-line disease. Using
the Company’s proprietary platform, Epizyme has pioneered the
identification and development of small molecule inhibitors of
chromatin modifying proteins (CMPs), such as tazemetostat. CMPs are
part of the system of gene regulation, referred to as epigenetics,
that controls gene expression. Genetic alterations can result in
changes to the activity of CMPs, which can allow cancer cells to
grow and proliferate. By focusing on the genetic drivers of
cancers, Epizyme's science seeks to match targeted medicines with
the specific patients that need it. For more information, visit
www.epizyme.com and connect with us on Twitter at
@EpizymeRx.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations,
plans and prospects for Epizyme, Inc. and other statements
containing the words "anticipate," "believe," "estimate," "expect,"
"intend," "may," "plan," "predict," "project," "target,"
"potential," "will," "would," "could," "should," "continue," and
similar expressions, constitute forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of
1995. Actual results may differ materially from those indicated by
such forward-looking statements as a result of various important
factors, including: uncertainties inherent in the initiation of
future clinical studies and in the availability and timing of data
from ongoing clinical studies; whether results from preclinical
studies or earlier clinical studies will be predictive of the
results of future trials; whether results from clinical studies
will warrant meetings with regulatory authorities or submissions
for regulatory approval; expectations for regulatory approvals to
conduct trials or to market products; whether the Company's cash
resources will be sufficient to fund the Company's foreseeable and
unforeseeable operating expenses and capital expenditure
requirements; other matters that could affect the availability or
commercial potential of the Company's therapeutic candidates; and
other factors discussed in the "Risk Factors" section of the
Company's most recent Form 10-K filed with the SEC and in the
Company's other filings from time to time with the SEC. In
addition, the forward-looking statements included in this press
release represent the Company's views as of the date hereof and
should not be relied upon as representing the Company's views as of
any date subsequent to the date hereof. The Company anticipates
that subsequent events and developments will cause the Company's
views to change. However, while the Company may elect to update
these forward-looking statements at some point in the future, the
Company specifically disclaims any obligation to do so.
Contacts:
Cheya Pope, Epizyme, Inc.
media@epizyme.com
617-229-7561
Monique Allaire, THRUST IR
monique@thrustir.com
(617) 895-9511
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