Zacks_Analysts' Blog : CTIC Posts Positive Pixantrone Data - Analyst Blog

Cell Therapeutics Inc. (CTIC) recently announced that data from an early stage study of its lead pipeline candidate, pixantrone, for an additional indication, was published in Cancer, an online journal.

The study (n=28) tested the efficacy and safety of pixantrone as a combination therapy with fludarabine, dexamethasone and Biogen/Roche’s (BIIB/RHHBY) Rituxan (FPD-R) for the treatment of relapsed or refractory indolent non-hodgkin’s lymphoma (INHL). In this study pixantrone was substituted for mitoxantrone in the FPD-R regimen compared to the standard FND-R regimen. The data revealed that pixantrone in combination with fludarabine, dexamethasone and Rituxan was highly active in patients with relapsed or refractory INHL and produced complete response (CR) in 63% of patients. The overall response rate (ORR) was 89%. The response lasted for 40 months in the longest responding patient in remission. The median lasting time of response was 23 months.

Pixantrone has been developed for the treatment of relapsed or refractory aggressive NHL in patients who have not responded to other treatment options. It is currently under review in the European Union for the indication and Cell Therapeutics will re-submit a new drug application to the US Food and Drug Administration (FDA) later in 2011.

In another combination study, called RAPID or PIX203, pixantrone is substituted for doxorubicin in the CPOP-R regimen compared to the standard CHOP-R regimen for the first-line treatment of aggressive NHL. Data presented in early April 2011 showed that substitution of pixantrone for doxorubicin in CHOP chemotherapy regimen produced high rates of complete remissions and long-term disease free survival.

Our Recommendation

We currently have a Neutral recommendation on Cell Therapeutics.

We believe the uncertainty surrounding the approval of Cell Therapeutics’ lead pipeline candidate pixantrone for aggressive NHL in the US has eased following the opportunity given by the FDA to resubmit the NDA. Moreover, the drug is also under review in Europe and is expected to be approved in 2011. However, we prefer to remain on the sidelines since Cell Therapeutics is heavily dependent on the approval of pixantrone. Therefore, any delay in gaining approval would be a major blow for the company.