LUGANO, Switzerland--(BUSINESS WIRE)--Epizyme,
Inc. (NASDAQ: EPZM), a clinical stage biopharmaceutical company
creating novel epigenetic therapeutics for cancer patients, today
reported results from the ongoing phase 1 trial of tazemetostat
(EPZ-6438), a first-in-class EZH2 inhibitor, showing meaningful clinical
activity when used as an oral monotherapy in patients with advanced
B-cell non-Hodgkin lymphomas (NHL) and solid tumors. In NHL, treatment
with tazemetostat continues to demonstrate an encouraging profile with
nine of 15 evaluable NHL patients achieving an objective response,
including a partial response in the first treated patient with an EZH2
tumor mutation. Buy Zyvox (Linezolid) The data, which include patients from the dose
escalation and dose expansion cohorts of the phase 1 study, as well as a
food effects sub-study, were presented today by Vincent Ribrag, M.D.,
Institut Gustave Roussy, at the 13th International Conference
on Malignant Lymphoma.
“The breadth, depth and durability of responses seen in NHL patients
among multiple histologies continue to impress, as does the safety and
tolerability of tazemetostat in this phase 1 study,” said Dr. Buy Proscar (Finasteride) with no prescription Ribrag. Buy 3TC pill with no Rx
“Among the patients in the dose escalation cohorts, we have seen a
noteworthy deepening of responses over time, and in the first treated
patient with an EZH2 tumor mutation, we have seen a partial response,
which is very encouraging.”
Summary Results
As of June 8, 2015, the following clinical data were observed:
Nine of 15 evaluable NHL patients have achieved an objective response,
including two patients with an ongoing complete response (CR).
Five of nine evaluable diffuse large B-cell lymphoma (DLBCL) patients
achieved an objective response. Zyvox (Linezolid) without Rx One patient with a CR remains on study
at 18 months of treatment.
Three of five evaluable patients with follicular lymphoma achieved an
objective response. Buy 5-HTP online One patient with a CR remains on study at 13
months, and one patient with a PR remains on study at 13 months.
One patient with a marginal zone lymphoma achieved a partial response
and continues on study at 11 months.
All treatment responses were observed between two and 10 months on
therapy.
One of 14 patients evaluated for EZH2 status possesses a specific EZH2
tumor mutation (Y646H). http://asthmareview.wordpress.com This patient, who had relapsed or been
refractory to six previous treatment regimens, achieved a partial
response after 16 weeks of therapy and remains on study.
The majority of adverse events were grade 1 or grade 2 within the
evaluable for safety population of 45 patients with NHL and solid
tumors.
The most common adverse events regardless of attribution were
asthenia, anorexia, anemia, dyspnea and nausea. Five grade 3 or
greater treatment-related adverse events were observed including one
each of: grade 3 anorexia, grade 3 hypertension, grade 3 transaminase
elevation, grade 4 thrombocytopenia, and grade 4 neutropenia.
“These results highlight the therapeutic potential of tazemetostat in
NHL, with a number of patients achieving durable remissions with time on
treatment at or beyond one year,” said Peter Ho, M.D., Ph.D., Chief
Development Officer, Epizyme. “We look forward to exploring further the
clinical utility of tazemetostat in NHL in a robust phase 2 development
program.”
The NHL patients enrolled on study were heavily pre-treated, with 85
percent of patients having received three or more prior therapies and 37
percent of patients having received more than five or more prior
therapies. Thirty-seven percent of patients were refractory to their
last prior regimen and 26 percent of patients had received a prior
autologous hematopoietic stem cell transplant.
Drug pharmacokinetics showed rapid absorption with a mean terminal
half-life of three to five hours. Cmax and AUC1-12hr were
dose proportional at steady-state throughout the dosing range.
Steady-state Ctrough levels were reached by day 15.
The company plans to report a further update from the phase 1 trial by
the end of 2015.
Study Design
This open-label, multi-center, phase 1 study is investigating
tazemetostat as monotherapy in patients with relapsed or refractory
B-cell non-Hodgkin lymphomas or advanced solid tumors. The study
objectives include identification of the recommended phase 2 dose or
maximum tolerated dose, safety, tolerability, pharmacokinetics and
preliminary evaluation of anti-tumor activity. Five cohorts were studied
in the dose escalation phase: 100 mg, 200 mg, 400 mg, 800 mg and 1600
mg; and two cohorts, 800 mg and 1600 mg, were evaluated in the dose
expansion phase. All doses were given twice daily.
Expanded Tazemetostat Phase 2 Plans
Epizyme is now enrolling patients in an international five-arm,
multi-center, phase 2 study during the second quarter of 2015 that will
assess the safety and efficacy of tazemetostat in patients with relapsed
or refractory NHL, stratified by cell of origin and EZH2 mutation
status. A second planned phase 2 trial of tazemetostat in adult patients
with INI1-deficient solid tumors is expected to begin later in 2015.
Patients in both studies will be treated with the recommended phase 2
dose of 800 mg twice daily. A phase 1 study in pediatric patients with
INI1-deficient solid tumors is also expected to start later in 2015.
In addition to these previously announced studies, the company plans to
initiate additional trials of tazemetostat, including:
A combination study of tazemetostat with R-CHOP in patients with
DLBCL. R-CHOP, which represents current first-line treatment for
patients with DLBCL, is comprised of rituximab, cyclophosphamide,
doxorubicin, vincristine, and prednisone.
A combination study of tazemetostat with a B-cell signaling agent or
other emerging targeted therapies for B-cell lymphomas.
“Conducting combination studies in B-cell lymphoma will further
elucidate the clinical potential of tazemetostat,” said Dr. Ho.
“Scientists here at Epizyme have demonstrated pre-clinical synergy with
both current standard-of-care therapeutics and emerging investigational
agents, and we believe that tazemetostat has a safety and tolerability
profile that will lend itself well to combination regimens.”
About EZH2 in Cancer
EZH2 is a histone methyltransferase (HMT) that is increasingly
understood to play a potentially oncogenic role in a number of cancers.
These include non-Hodgkin lymphomas, INI1-deficient cancers such as
malignant rhabdoid tumors, epithelioid sarcomas and synovial sarcoma;
and a range of other solid tumors.
About Tazemetostat
Epizyme is developing tazemetostat for the treatment of non-Hodgkin
lymphoma patients and patients with INI1-deficient solid tumors.
Tazemetostat is a first-in-class small molecule inhibitor of EZH2
created by Epizyme using its proprietary product platform. In many human
cancers, aberrant EZH2 enzyme activity results in misregulation of genes
that control cell proliferation resulting in the rapid and unconstrained
growth of tumor cells. Tazemetostat is the WHO International
Non-Proprietary Name (INN) for EPZ-6438.
Tazemetostat is the second HMT inhibitor to enter human clinical
development (following Epizyme s DOT1L inhibitor, pinometostat, also
known as EPZ-5676).
Additional information about this program, including clinical trial
information, may be found here: clinicaltrials.gov/ct2/show/NCT01897571
Conference Call Information
Epizyme will host a conference call and live audio webcast with slides
on Monday, June 22, 2015, at 8:00 a.m. ET to discuss results from the
phase 1 study.
To participate in the conference call, please dial 1-877-844-6886
(domestic) or 1-970-315-0315 (international) and refer to conference ID
64265218. The live webcast can be accessed under “Events and
Presentations” in the Investor Relations section of the Company’s
website at .epizyme.com.
Slides will be available on the Company’s website prior to the
conference call.
About Epizyme, Inc.
Epizyme, Inc. is a clinical stage biopharmaceutical company creating
novel epigenetic therapeutics for cancer patients. Epizyme has built a
proprietary product platform that the Company uses to create small
molecule inhibitors of a 96-member class of enzymes known as histone
methyltransferases, or HMTs. HMTs 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 HMTs,
making them oncogenic (cancer-causing). By focusing on the genetic
drivers of cancers, Epizyme s targeted science seeks to match the right
medicines with the right patients.
For more information, visit .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 or expansion of ongoing clinical
studies; availability and timing of data from ongoing clinical studies;
whether interim results from a clinical trial such as the results
referred to in this release will be predictive of the final results of
the trial or the results of future trials; expectations for regulatory
approvals to conduct trials or to market products; development progress
of the Company’s companion diagnostics, availability of funding
sufficient for 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 or companion diagnostics; and other factors
discussed in the "Risk Factors" section of the company’s Form 10-Q filed
with the SEC on April 28, 2015, and in our 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. 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.
These forward-looking statements should not be relied upon as
representing the Company s views as of any date subsequent to the date
hereof.
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