Semuloparin is an investigational selectively engineered Ultra-LMWH (low molecular weight heparin) with enriched anti-thrombin binding sites.
Semuloparin reduced the risk of this type of blood clots without increasing the incidence of major bleeding over placebo (1.2% vs. 1.1%).
Patients received either a daily 20 mg subcutaneous administration of semuloparin or placebo for at least three months or until change in the chemotherapy regimen.
The primary endpoint of the study was the composite of any symptomatic-DVT, non-fatal PE and VTE-related death.
Clinically relevant bleeding (bleedings requiring medical attention) was respectively 2.8% and 2% for semuloparin and placebo.
Consistent with previous findings, there was no case of reported heparin induced thrombocytopenia in the 3,212 studied patients.
Sanofi Global R&D president Elias Zerhouni said based on the results of SAVE-ONCO they plan to submit semuloparin for regulatory filing in Q3 2011.