Novuspharma SpA has opened its Phase III clinical programme for the treatment of indolent Non-Hodgkin's lymphoma (NHL) with BBR 2778, its lead compound. The company has received approval from the University of Pisa (Italy) to commence a pivotal Phase III study in patients with indolent disease who have failed at least one prior line of treatment.

The study will compare the current standard treatment, rituximab, as a single agent with a BBR 2778/rituximab combination, and assess complete response rates and time to disease progression.

The trial in indolent NHL will eventually involve approximately 800 patients at 100 centres in Europe, the USA and Canada, and will be the largest study in NHL ever carried out. A pivotal trial of similar size and scope of BBR 2778 in aggressive NHL is scheduled to start in the second half of 2002, when a dose-ranging study already underway is completed. Two additional small-scale exploratory trials in both indolent and aggressive NHL are ongoing in the US and Europe respectively.

The key features of the Phase III registration plan and trial design for both indolent and aggressive NHL were discussed at a meeting with the US Food and Drug Administration (FDA) in December 2001. Under the FDA's Special Protocol Assessment procedure, Novuspharma subsequently submitted its proposed trial protocol for review and anticipates a response from the FDA in the next few weeks. In the meantime, the selection of clinical trial centres and other preparations are already underway so that patient enrolment can begin immediately following final agreement with the FDA on the trial design and protocol.

Dr Silvano Spinelli, CEO of Novuspharma, said, "Recent events have shown that without the FDA's prior input, Phase III trial design and protocol can be deemed inadequate for product approval. Novuspharma has therefore taken a voluntary decision to submit its clinical trial plans under the FDA's Special Protocol Assessment procedure, allowing a binding agreement to be reached with the FDA before the start of Phase III studies with BBR 2778. We consider this essential to avoid unnecessary delays and additional costs at the time of NDA filing. BBR 2778 is our most advanced compound and the beginning of this Phase III programme in indolent NHL is arguably the most important milestone in Novuspharma's history. We are greatly encouraged by the clinical data seen to date and are doing all we can to increase the chances of the drug's long-term success."