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Pharmacyclics Announces Promising Results From Phase 2 Clinical,Trial of Xcytrin in Recurrent, Metastatic Non-Small Cell Lung,Cancer

n of response in patients with recurrent NSCLC who are treated with Xcytrin. Patients in the trial are randomized to receive either a 10mg/kg dose of Xcytrin every week, or a 15mg/kg dose every three weeks. Tumor response rate is being evaluated using Response Evaluation Criteria in Solid Tumors (RECIST), the standard parameters used to document response for solid tumors.

Of 58 evaluable patients there was a confirmed response rate of 5.2%, or three partial responses. Twenty patients (34.5%) had stable disease. One of the responders received Xcytrin after having progressed through two prior lines of therapy: carboplatin, gemcitabine and bevacizumab, followed by erlotinib. The other two had previously failed either carboplatin/gemcitabine or cisplatin/vinorelbine. Median time to progression was seven weeks for all patients. Twenty (34.5%) patients received four or more cycles of Xcytrin, of whom seven did not respond to first line chemotherapy. Thirteen percent were free from progression at six months. Median survival was eight months, with 62% and 30% of patients alive at 6 and 12 months, respectively. Xcytrin was well-tolerated in this study. The most common grade 3 or 4 adverse events were hypophosphatemia (24%), dyspnea (12%), fatigue (10%), hypoxia (7%), and finger blisters (5%).

About Non-Small Cell Lung Cancer

The American Cancer Society predicts that there will be more than 213,000 new cases of lung cancer in the U.S. in 2007. Lung cancer is the leading cause of cancer death, and accounts for over 160,000 deaths in the U.S. each year. The most common form of lung cancer, non-small cell, is incurable in advanced stages. Lung cancer frequently spreads to other body parts, including the brain.

Xcytrin in Second-Line Lung Cancer

Pharmacyclics is developing Xcytrin as an anti-cancer agent with a novel mechanism of action that is designed to selectively concentrate in tumors and induce apoptosis (programmed cell death). Xcytrin is
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