Recently, the US Adopted Names (USAN) Council has adopted necuparanib as the unique non-proprietary name for M402.
Necuparanib, a heparan sulfate mimetic, is a novel oncology drug candidate designed to have a broad range of effects on tumor cells.
The use of heparins to treat venous thrombosis in cancer patients has generated several reports of antitumor activity; however, the dose of these products has been limited by their anticoagulant activity.
Derived from unfractionated heparin, necuparanib has been engineered to have significantly reduced anticoagulant activity while preserving the relevant antitumor properties of heparin.
In the next several months, the company expects to complete the Part A dose escalation component of the Phase I/II trial assessing necuparanib in combination with Abraxane (nab-paclitaxel) and gemcitabine in patients with advanced metastatic pancreatic cancer, and to report clinical data from Part A in the second half of 2014.
Momenta intends to start the Part B randomized, controlled, proof of concept study by the end of 2014.
The Part B will evaluate the antitumor activity of necuparanib in combination with Abraxane plus gemcitabine, versus Abraxane plus gemcitabine alone.
Momenta Pharmaceuticals chief medical officer Jim Roach said the company is happy to receive Orphan Drug Designation for necuparanib, which highlights the great need for new medications for patients suffering from pancreatic cancer.
""We are encouraged by the progress of the program to date, and in the next several months, we anticipate completing Part A of our ongoing Phase 1/2 study of necuparanib in combination with Abraxane and gemcitabine," Roach said.
"We look forward to sharing the results from Part A and advancing the product into the Phase 2 part of the study in the second half of 2014."