First Patient Dosed With M402 in Phase 1/2 Clinical Trial in Metastatic Pancreatic Cancer
M402 is a novel heparan sulfate mimetic that binds to multiple growth factors, adhesion molecules and chemokines to inhibit tumor angiogenesis, progression, and metastasis. The use of heparins to treat venous thrombosis in cancer patients has generated numerous reports of antitumor activity; however, the dose of these drugs has been limited by their anticoagulant activity. M402, which is derived from unfractionated heparin, has been engineered to have significantly reduced anticoagulant activity while preserving the relevant antitumor properties of heparin. Ideally, higher doses of M402 could potentially be administered to further enhance these antitumor properties.
"We developed M402 leveraging our expertise in heparin sulfate proteoglycans (or HSPGs) and their relationship to tumor growth," said
"Numerous lines of evidence support the ability of HSPGs to intercept several key contributors to tumor growth," said
"Pancreatic cancer has a particularly poor prognosis, given that it is often fairly advanced by the time these patients begin showing symptoms," said
The Phase 1/2 trial is designed to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of M402 in combination with gemcitabine, a first-line standard of care chemotherapy for advanced pancreatic cancer. The Phase 1/2 trial is a two-part study that will enroll approximately 150 patients. Part A is an open-label, multiple ascending dose study. The primary objectives of Part A are to evaluate the safety and tolerability of M402 in combination with gemcitabine and to establish the dose of M402 to take forward into Part B. Data from Part A are expected in the first half of 2013. Pending successful completion of this phase, Momenta expects to initiate Part B of the trial, which will be a randomized, controlled study investigating the safety and antitumor activity of M402 administered in combination with gemcitabine compared with gemcitabine alone.
M402 is a novel heparan sulfate mimetic with potentially broad anti-angiogenic, anti-proliferative and anti-metastatic properties. Data from multiple preclinical studies have shown that M402 inhibits angiogenesis and tumor progression and metastasis by modulating a variety of growth factors. A preclinical study in a pancreatic cancer model was conducted in collaboration with the
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Statements in this press release regarding management's future expectations, beliefs, intentions, goals, strategies, plans or prospects, including statements relating to the clinical and efficacy potential of M402, 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
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Lora Pike Momenta Pharmaceuticalslpike@momentapharma.com 617-395-5189
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