Momenta Discontinues Further Accrual of its Phase 2 Trial of Necuparanib in Patients with Pancreatic Cancer Following Planned...
August 04 2016 - 7:50AM
Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA), a biotechnology
company specializing in the characterization and engineering of
complex drugs, today announced that the Company has discontinued
further accrual in its Phase 2 trial evaluating necuparanib in
combination with Abraxane® and gemcitabine in patients with
advanced metastatic pancreatic cancer.
The decision to discontinue enrollment into the
study was based on the recommendation from the independent Data
Safety Monitoring Board (DSMB) following a planned interim futility
analysis conducted once 57 deaths (50% of the target number of 114
events required for trial completion) had occurred. Data were
assessed from 120 randomized patients as of July 20, 2016. While no
new safety signals were observed and the toxicity profile was
considered manageable, the DSMB determined that necuparanib in
combination with Abraxane and gemcitabine did not show a sufficient
level of efficacy to warrant continued enrollment. Additionally, no
new toxicities were observed that necessitate immediate
discontinuation of study drug in patients currently active on
protocol. The DSMB also recommended that the company consider
unblinding the data to provide more information to determine how
best to address ongoing patients.
“We are extremely disappointed with the outcome
of the futility analysis – in particular, for those patients with
pancreatic cancer where there is still so much unmet need for safe
and effective therapy,” said Jim Roach, M.D., Senior Vice President
of Development and Chief Medical Officer of Momenta
Pharmaceuticals. “We agree with the DSMB recommendations and plan
to confirm the futility analysis and determine next steps for the
necuparanib program.”
“We are saddened that necuparanib did not
produce the outcome we had hoped for in this patient population,”
said Craig A. Wheeler, President and Chief Executive Officer of
Momenta Pharmaceuticals. “We would like to thank the investigators
and their brave patients for participating in this trial as well as
our staff and external advisors for their support throughout this
program.”
The Phase 1/2 necuparanib trial is a two-part
study in patients with advanced metastatic pancreatic cancer. Part
A was a Phase 1, open-label, multiple ascending dose study of
necuparanib given first as a single dose and then daily in
combination with Abraxane and gemcitabine; final data from Part A
was reported at the 2016 ASCO Annual Meeting. Part B is a Phase 2,
randomized, placebo-controlled, double-blind study investigating
the antitumor activity of necuparanib combined with Abraxane and
gemcitabine compared with placebo combined with Abraxane and
gemcitabine.
About NecuparanibNecuparanib
(M402) is a novel oncology drug candidate engineered to have a
broad range of effects on tumor cells. The use of heparins to treat
venous thrombosis in cancer patients has generated numerous reports
of antitumor activity; however, the dose of these products has been
limited by their anticoagulant activity. Leveraging its experience
in deciphering the structure-function relationships of complex
therapeutics, Momenta engineered necuparanib from unfractionated
heparin to have significantly reduced anticoagulant activity while
preserving relevant antitumor properties associated with
heparins.
About MomentaMomenta
Pharmaceuticals is a biotechnology company specializing in the
detailed structural analysis of complex drugs and is headquartered
in Cambridge, MA. Momenta is applying its technology to the
development of generic versions of complex drugs, biosimilar and
potentially interchangeable biologics, and to the discovery and
development of novel therapeutics for oncology and autoimmune
indications.
To receive additional information about Momenta,
please visit the website at www.momentapharma.com, which does not
form a part of this press release. The company’s logo, trademarks,
and service marks are the property of Momenta Pharmaceuticals, Inc.
All other trade names, trademarks, or service marks are property of
their respective owners.
Forward-Looking
StatementsStatements in this press release regarding
management's future expectations, beliefs, intentions, goals,
strategies, plans or prospects, including without limitation
statements regarding confirmation of the futility analysis and the
next steps for the necuparanib program, are forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements can be
identified by terminology such as "plan" or similar terms,
variations of such terms or the negative of those terms. Such
forward-looking statements involve known and unknown risks,
uncertainties and other factors referred to in the Company's
Quarterly Report on Form 10-Q for the quarter ended March 31,
2016, filed with the Securities and Exchange
Commission under the section "Risk Factors," as well as other
documents that may be filed by Momenta from time to time with
the Securities and Exchange Commission. As a result of
such risks, uncertainties and factors, the Company's actual results
may differ materially from any future results, performance or
achievements discussed in or implied by the forward-looking
statements contained herein. Momenta is providing the
information in this press release as of this date and assumes no
obligations to update the information included in this press
release or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.
Investor Relations:
Sarah Carmody
Momenta Pharmaceuticals
1-617-395-5189
IR@momentapharma.com
Media Relations:
Karen Sharma
MacDougall Biomedical Communications
1-781-235-3060
Momenta@macbiocom.com
Momenta Pharmaceuticals (NASDAQ:MNTA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Momenta Pharmaceuticals (NASDAQ:MNTA)
Historical Stock Chart
From Apr 2023 to Apr 2024