FOR IMMEDIATE RELEASE
July 25, 2007

Roswell Park Cancer Institute Seeking Patients for Clinical Trial  
With a New Human Anti-CD20 Antibody for Chronic Lymphocytic Leukemia

BUFFALO, NY - Researchers at Roswell Park Cancer Institute (RPCI) are participating in a four center clinical trial in the United States of an investigational drug, called HuMax-CD20 (ofatumumab), for patients with B-cell chronic lymphocytic leukemia (CLL). This study is most appropriate for patients who have not received any treatment for CLL.  

HuMax-CD20  is a new anti-cancer drug.  It is an example of a new generation of antibodies that were developed from human genes (and not from other antibody models that may include human and/or animal genes)  and has shown encouraging results in the laboratory and in an international clinical trial.  In previous clinical trials, patients receiving HuMax-CD20 experienced fewer side effects, such as fever and shaking chills, than those receiving rituximab. This study will investigate how well it works in conjunction with chemotherapeutic agents that have proven their effectiveness against B-Cell CLL (Fludarabine and Cyclophosphamide).

For information about joining this study, contact 1-877-ASK-RPCI (1-877-275-7724).

Patients in this open label study will be randomized into two treatment groups of 28 patients each. Each patient will receive six  monthly infusions of either 500 or 1000 mg of HuMax-CD20 in combination with FC. Disease status will be measured every four  weeks until week 24 according to National Cancer Institute Working Group Guidelines and every  three  months thereafter until disease progression or 24 months. Patients not having progressed on their disease at 24 months, will be followed for disease progression at  six  month intervals until 48 months.

The objective in the study is to determine the efficacy of HuMax-CD20 in combination with FC in previously untreated CLL patients. The primary endpoint is complete remission measured at any time during the treatment period.

Chronic lymphocytic leukemia, one of the most common types of adult leukemia, affects approximately 50,000 patients nationwide. A cancer of the mature lymphocytes, CLL compromises the immune system predisposing patients to infectious complications. CLL remains incurable with all patients eventually relapsing with leukemia. These patients have limited treatment options.

Roswell Park Cancer Institute, founded in 1898, is the nation's first cancer research, treatment and education center and is the only National Cancer Institute-designated comprehensive cancer center in Upstate New York. RPCI is a member of the prestigious National Comprehensive Cancer Network, an alliance of the nation's leading cancer centers. For more information, visit RPCI's website at http://www.roswellpark.org, call 1-877-ASK-RPCI (1-877-275-7724), or e-mail askrpci@roswellpark.org.

-30-