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Pharmacyclics Reports First Quarter 2013 Results
Date:5/1/2013

in 40 preclinical abstracts presented at scientific congresses, and 15 original peer-reviewed scientific manuscripts in leading scientific journals, plus 17 review articles and commentaries in the literature. Most recently 8 presentations were made at the American Association for Cancer Research in April, where ibrutinib was evaluated preclinically in various disease settings.

Today over 1300 patients have been dosed with ibrutinib in company sponsored trials. Together with our collaboration partner Janssen, Pharmacyclics has engaged upwards of approximately 250 clinical sites, using ibrutinib in CLL, and additionally over 100 clinical sites engaged for the use of ibrutinib in MCL. These numbers are continuously growing as new studies are being initiated within the overall clinical development program. As of today there are over 28 studies registered with the U.S. National Institutes of Health. Five of these studies are Phase III trials, which each enrolling approximately 300-600 patients. Several of the trials in our clinical program are sponsored by the National Cancer Institute or other medical centers. To date ibrutinib is being clinically advanced in over 25 countries, which include the major population regions: U.S., Europe, Asia Pacific and Latin America.

Phase II / III / IV Clinical Trials Initiated with Ibrutinib Over the Last 12 Months

  • A multicenter, open label Expanded Access Program for ibrutinib in R/R MCL patients (MCL4001) is being initiated in the US by Janssen. In the time before a potential U.S. marketing approval, Pharmacyclics and Janssen will strive to provide early access to ibrutinib under an Expanded Access Program (EAP). EAPs are clinical studies allowed under certain circumstances by the FDA. They are designed to provide a mechanism for access to an investigational drug to treat patients with a serious or immediately life-threatening diseases or conditions until the time of an anticipated U.S. marketing approval. Fur
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  • SOURCE Pharmacyclics, Inc.
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