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

a redox-active drug that has been shown to disrupt redox-dependent pathways in cells and inhibit oxidative stress related proteins such as thioredoxin reductase. Its multifunctional mode of action, including its magnetic resonance imaging detectability, provides the opportunity for Xcytrin to be used in a broad range of cancers. In previously conducted randomized trials, Xcytrin combined with whole brain radiation therapy (WBRT) has been shown to prolong time to neurologic progression in patients with brain metastases from NSCLC.

The target for Xcytrin is the enzyme thioredoxin reductase, which is frequently over expressed in lung cancer cells. This enzyme has been shown to confer to cancer cells characteristics of aggressive tumor growth and resistance to chemotherapy. First line therapy for advanced NSCLC includes combination chemotherapy using drugs such as carboplatin, cisplatin, Gemzar(R) (gemcitabine), taxanes and others. Currently approved agents for second-line treatment of NSCLC include Alimta(R) (pemetrexed), Tarceva(R) (erlotinib) and Taxotere(R) (docetaxel), which have tumor response rates ranging from 4-10%.

Xcytrin, either in combination with Alimta or Taxotere, is now being evaluated in two other ongoing Phase 2 trials as second-line therapy for NSCLC. Interim data from these trials will be presented in late June at the International Lung Cancer Congress Meeting.

About Pharmacyclics

Pharmacyclics is a pharmaceutical company developing innovative products to treat cancer and other serious diseases. The company is leveraging its small-molecule drug development expertise to build a pipeline in oncology and other diseases based on a wide range of targets, pathways and mechanisms. Its lead product, Xcytrin, has completed Phase 3 clinical trials and several ongoing Phase 1 and Phase 2 clinical trials are evaluating Xcytrin, either as a single agent or in combination with chemotherapy and/or radiation in multiple cancer types. A
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