Momenta Announces Temporary Pause of Patient Enrollment in the Necuparanib (MOM-M402-103) Phase 2 Study
November 13 2015 - 8:00AM
Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA) today announced that it
has put a temporary hold on patient enrollment in its ongoing Phase
2 portion of the trial, “A Phase I/II, Two-Part, Multicenter Study
to Evaluate the Safety and Efficacy of M402 in Combination with
nab-Paclitaxel and Gemcitabine in Patients with Metastatic
Pancreatic Cancer,” pending the institution of a protocol amendment
following receipt of recommendations from its independent Data
Safety Monitoring Board (DSMB).
The DSMB met to discuss a limited number of
specific toxicities, including thrombocytopenia, risk of bleeding,
and thromboembolic events. After thorough review, the DSMB found no
safety signals to suggest the need to unblind results, close the
study, or discontinue dosing in patients already enrolled in the
trial. The DSMB did recommend that the company amend its protocol
to standardize the approach to diagnosing and managing
thrombocytopenia and consider holding new patient accrual until the
amendment is instituted. The DSMB also noted that the causes of
thrombocytopenia and subsequent bleeding in these patients can be
multifactorial. The Company is assessing whether its protocol
amendment and enrollment pause will delay release of top-line data
beyond the first half of 2017.
“We support the DSMB’s recommendations regarding
the most appropriate path forward for the Phase 2 portion of the
trial. As always, patient safety is our primary concern, and we
will work diligently to institute their recommendations and resume
enrollment in this study,” stated Jim Roach, M.D., Senior Vice
President of Development and Chief Medical Officer of Momenta
Pharmaceuticals.
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.
A Phase 2 randomized, double-blind, controlled study to evaluate
the antitumor activity of necuparanib in combination with
nab-paclitaxel (Abraxane®) plus gemcitabine, versus nab-paclitaxel
plus gemcitabine alone in pancreatic cancer is currently underway.
Necuparanib has received Orphan Drug and Fast Track designations
from the U.S. Food and Drug Administration (FDA) for the treatment
of pancreatic cancer.
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.
Our 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, are forward-looking statements
within the meaning of the Private Securities Litigation Reform Act
of 1995, including but not limited to statements about the
Company's future conduct of its necuparanib study; the timing of
regulatory submissions and enrollment following the current
enrollment pause; the availability and announcement of clinical
data; and the review of the necuparanib study plans by the U.S.
Food and Drug Administration. Forward-looking statements may
be identified by words such as "anticipate," "believe," "continue,"
"could," "hope," "target," "project," "goal," "objective,"
"guidance," "plan," "potential," "predict," "might," "estimate,"
"expect," "intend," "may," "seek,” "should," "will," "would," "look
forward" and other similar words or expressions, or the negative of
these words or similar words or expressions. Such forward-looking
statements involve known and unknown risks, uncertainties and other
factors, including those referred to under the section "Risk
Factors" in the Company's Quarterly Report on Form 10-Q for the
quarter ended September 30, 2015, filed with the Securities and
Exchange Commission, as well as other documents that may be filed
by the Company 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. The Company 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 Aug 2024 to Sep 2024
Momenta Pharmaceuticals (NASDAQ:MNTA)
Historical Stock Chart
From Sep 2023 to Sep 2024