TREANDA Demonstrates Substantial Efficacy in Patients with Relapsed Indolent Non-Hodgkin'...(peutic agent the most common adverse eve...),Health

"The data presented at ASH, as well as from other studies using bendamustine, gives us great optimism that TREANDA may have an important role to play in the treatment of NHL, chronic lymphocytic leukemia (CLL) and other cancers," said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations, Cephalon.

About the Phase 3 Study Design

The Phase 3, multicenter, single-arm study evaluated the efficacy and safety of single-agent bendamustine in 100 patients with indolent NHL whose disease has progressed during or following treatment with rituximab. Patients received bendamustine 120 mg per meters squared intravenously over 60 minutes on days one and two every 21 days for six cycles. At the investigator's discretion, patients could receive up to two additional cycles for a maximum of eight.

In addition to the pivotal Phase 3 data, an abstract of an interim analysis by Dr. Mathias J. Rummel and colleagues reports that the combination of bendamustine plus rituximab appears to be non-inferior to the standard CHOP-R while showing a better tolerability profile. Updated results will be presented on Monday, December 10, 2007 at 11:00 am during the ASH meeting [Abstract #385].

About TREANDA (bendamustine HCl)

TREANDA is a novel chemotherapeutic agent, a hybrid of a purine analog and an alkylator. Preclinical data demonstrate that TREANDA acts in two distinct ways to kill cancer cells. TREANDA damages the DNA in cancer cells, which leads to cell death by a process known as apoptosis (programmed cell death) as well as by an alternate cell death pathway known as mitotic catastrophe (a disruption of normal cell division). This dual-effect of TREANDA may be attributable to its unique chemical design.

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