CAMBRIDGE, Mass., June 1, 2015 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, will present updated data from the Phase 1 trial evaluating necuparanib in combination with nab-paclitaxel (nabP; Abraxane®) and gemcitabine (GEM) in patients with advanced metastatic pancreatic cancer (ClinicalTrials.gov Identifier NCT01621243) at the 2015 ASCO Annual Meeting, today from 8:00 to 11:30 am CDT (Abstract #4114).
Necuparanib was administered daily in combination with 125 mg/m2 nabP and 1000 mg/m2 GEM (Days 1, 8, and 15 of each 28-day cycle). The necuparanib starting dose was 0.5 mg/kg, which was increased via a modified 3+3 design until a maximum tolerated dose (MTD) was determined. nabP was added to the treatment regimen starting with Cohort 3. Thirty-nine patients (12 patients in the first two cohorts and 27 patients in the five subsequent cohorts) received necuparanib and were included in the analyses. Top-line results included:
- Adding necuparanib to GEM or nabP + GEM did not appear to increase the incidence, severity, or duration of the expected AEs associated with these regimens. The most common (≥30% of patients) AEs were anemia (56%), fatigue (51%) neutropenia (46%), leukopenia (36%), nausea (36%), thrombocytopenia (36%) and ALT increased (31%). Two patients had dose-limiting toxicities: AST/ALT increased at 0.5 mg/kg and cellulitis at injection site at 6 mg/kg necuparanib. There were mild aPTT increases at 4-6 mg/kg necuparanib.
- 5 mg/kg necuparanib was determined to be the MTD and the recommended Phase 2 dose.
- Encouraging signals of activity were observed:
- For the 24 patients in cohorts 3-7 who received at least one dose of necuparanib + nabP + GEM, the median overall survival (OS) was 14.2 (95% CI, 9.3-16.0) months.
- Sixteen patients were treated with necuparanib + nabP + GEM, completed Cycle 1, and had ≥1 scan on treatment; of these, eight (50%) achieved RECIST partial response (PR) and six (38%) more achieved stable disease (SD), for a disease control rate (PR+SD) of 14/16 (88%). Median OS was 15.3 (95% CI, 9.7-16.0) months in this subset.
- Fifteen patients were treated with necuparanib + nabP + GEM, completed Cycle 1, and had ≥1 follow-up CA19.9 measurement; of these, 15 (100%) had >20%, 14 (93%) had >50%, and seven (47%) had >90% decreases from baseline (CA19.9 is a biomarker predictive for long-term outcome and treatment response in pancreatic cancer).
"Both the tolerability profile of necuparanib, as well as signals of antitumor activity observed to date, are encouraging," said Eileen O'Reilly, MD of David M. Rubenstein Center for Pancreatic Cancer Research, Memorial Sloan Kettering Cancer Center and lead author on the poster. "It is notable that necuparanib does not seem to add to the toxicity profile associated with gemcitabine and nab-paclitaxel. We will continue to evaluate the potential of necuparanib as a novel therapeutic for patients with metastatic pancreatic cancer in the ongoing Phase 2 study."
"With its differentiated, multi-targeted mechanism of action and positive early clinical results, necuparanib represents a promising oncology candidate," said Jim Roach, M.D., Senior Vice President of Development and Chief Medical Officer of Momenta Pharmaceuticals. "We are very pleased with the Phase 1 results and continue to enroll patients in the randomized Phase 2 trial."
Necuparanib (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 in pancreatic cancer is ongoing, which will evaluate the antitumor activity of necuparanib in combination with nab-paclitaxel (Abraxane®) plus gemcitabine, versus nab-paclitaxel plus gemcitabine alone. Necuparanib has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer.
Momenta 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.
Statements in this press release regarding management's future expectations, beliefs, intentions, goals, strategies, plans or prospects, including without limitation statements regarding future evaluation and development of necuparanib and its potential safety profile and activity, 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 "anticipate," "believe," "could," "could increase the likelihood," "hope," "target," "project," "goals," "potential," "predict," "might," "estimate," "expect," "intend," "is planned," "may," "should," "will," "will enable," "would be expected," "look forward," "may provide," "would" 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, 2015 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.
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