Craig W. Philips Takes Helm at CTI ((FDA) in September todiscuss label expan...)

Craig W. Philips Takes Helm at CTI

Date:8/4/2008

(FDA) in September to discuss label expansion in the U.S. The phase III First-line Indolent Trial (FIT) evaluated the benefit and safety of a single dose of Zevalin in patients with CD20-positive follicular lymphoma who had achieved a full or partial remission following first-line chemotherapy treatment.

In addition CTI has submitted an application for approval to market its lung cancer drug candidate OPAXIO in Europe and expects to receive a response from the European Medicines Agency (EMEA) regarding that application in 2009, and also expects final data on another late stage phase III drug, pixantrone, for relapsed or refractory aggressive NHL in the second half of 2008. Positive pixantrone data could allow CTI to submit an application for FDA approval in early 2009. OPAXIO is also being studied independently in a phase III trial for ovarian cancer, with interim data results expected in late 2009.

Pixantrone is an investigational agent under development for the potential treatment of various blood cancers. It was developed to improve the activity and safety of the anthracycline family of anti-cancer agents and to reduce the potential for the most common side effects of anthracyclines, severe cardiotoxicities and cumulative heart damage.

CTI has a worldwide licensing agreement with Novartis on OPAXIO. Novartis also holds an option for an exclusive license for pixantrone.

CTI is also developing brostallicin, another cancer drug for sarcoma currently in phase II/III trials. Brostallicin, a novel synthetic second- generation DNA minor groove binder, has potent cancer killing activity and has demonstrated activity in combination with standard cytotoxic agents as well as with newer targeted therapies in preclinical, experimental tumor models.

Since 2006, Philips has been leading Bayer's U.S. oncology operations following the integration of the U.S. oncology businesses from Berlex and Bayer. In this capacity, he oversaw the U.S. oncolog
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