SST0001 (Roneparstat) in Advanced Multiple Myeloma
Status:
Completed
Trial end date:
2016-11-01
Target enrollment:
Participant gender:
Summary
Heparanase cleaves heparan sulfate (HS) chains, a natural substrate for heparanase, and
participates in degradation and remodelling of the extra-cellular matrix (ECM) facilitating,
among other activities, cell invasion associated with cancer metastasis, angiogenesis, and
inflammation. The heparanase enzyme is a promising target for development of new anticancer
drugs. HS and the structurally related heparin are present in most animal species. As an
analogue of the natural substrate of heparanase HS, heparin is considered to be a potent
inhibitor of heparanase. SST0001 is a polymer with a heparin-like structure. It is a reduced
oxidized N-acetyl heparin, these modifications cause the reduction of anticoagulant activity
and are strictly related to the anti-heparanase activity. In preclinical murine models
SST0001 showed a significant anti myeloma effect in multiple myeloma mice xenograft models,
with a significant reduction of subcutaneous growth of different multiple myeloma cell lines,
when SST0001 was administered either alone or in combination with dexamethasone. The purpose
of this study is to determine the safety and tolerability of escalating doses of SST0001 in
the treatment of advanced refractory multiple myeloma.