Novuspharma to start US trials of NHL drug

Novuspharma of Italy has been granted Investigational New Drug approvalby the US Food and Drug Administration to start clinical trials of BBR 2778, its lead compound for non-Hodgkin's lymphoma. The drug is an intercalating agent which has the potential of offering reduced cardiotoxicity compared to other products in the class.

Novuspharma intends to start dose-escalating studies of BBR 2778 at the MD Anderson Cancer Center in Houston, Texas, initially looking at the drug in combination with cisplatin and Ara-C (cytarabine), a widely-used treatment regimen for relapsed NHL. Additional combination studies and a Phase III program are expected to start by the end of the year, according to the firm.

Meanwhile, enrollment of patients in a European Phase II trial of BBR 2778 monotherapy was completed earlier this year, and preliminary results indicate an overall response rate which is "highly encouraging," according to Novuspharma. Final results from this trial will be presented at a scientific meeting later this year.