Cell Therapeutics Inc. (NASDAQ: CTIC) surged 8% in today’s pre-market trading to $0.43. The company last week announced that it had submitted an expanded Pediatric Investigation Plan (PIP) to the EMEA for its lead candidate pixantrone.
Pixantrone is being developed to treat relapsed or refractory aggressive non-Hodgkin’s lymphoma (NHL) in patients who have not responded to other treatment options. The PIP was submitted to outline the plan Cell Therapeutics has to study the drugs effectiveness in children. The aim will be to compare the performance of pixantrone in comparison to chemotherapy drug doxorubicin in children aged 6 months to 18 years.
A Marketing Authorization Application (MAA) is also said to be in the pipeline to get marketing approval for pixantrone in the European Union later this year. The company had originally submitted the PIP in the second half of 2009 but an expanded PIP was requested by the EMEA committee, given the potential but unconfirmed benefit of pixantrone for children. In early 2010, the U.S. FDA had denied approval to pixantrone owing to the lack of sufficient clinical data.
The company is also among the top five pharmaceutical companies by beta, with a beta of 2.
Cell Therapeutics is invoved in the development, acquisition and commercialization of cancer treatments. The compay’s focus is to build a portfolio of oncology drugs. The focus of Cell Therapeutics’ research, development, acquisition and in-licensing activities concentrate on identifying and developing less toxic ways to treat cancer. The company is focused on developing pixantrone, OPAXIO, brostallicin and bisplantinates.
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