Recently, Cell Therapeutics, Inc. (CTIC) announced that data from a phase I/II study which evaluated its cancer candidate pixantrone as a combination therapy was published in a medical journal, Leukemia & Lymphoma.
The early-stage study evaluated the impact of pixantrone, in combination with cyclophosphamide, vincristine, and prednisone (CPOP regimen) for treating patients suffering from aggressive non-Hodgkin’s lymphoma (NHL). Before being evaluated under the CPOP regimen, the patients had undergone treatment with a combination of cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP regimen). They had responded unfavorably to treatment by the CHOP regimen.
Data from the randomized, multicenter study revealed that the replacement of doxorubicin by Cell Therapeutics’ candidate in the combination resulted in high rates of complete remissions and overall response. It was also observed that the replacement of doxorubicin by pixantrone in the combination resulted in durable remission from NHL in some patients.
We note that uncertainty surrounds the approval of pixantrone, Cell Therapeutics’ lead pipeline candidate, in the US. In April 2010, the US Food and Drug Administration (FDA) issued a complete response letter for pixantrone based on concerns that studies failed to prove sufficiently the effectiveness of the drug.
In December 2010, Cell Therapeutics filed an appeal against the FDA decision on pixantrone. A decision from the FDA on the matter is expected in the second quarter of the current year.
Our Recommendation
We believe that the uncertainty surrounding the US approval of pixantrone is the main reason behind the Zacks #4 Rank (short-term Sell rating) carried by the company. However, we are more cautious in the long-term with a Neutral stance on the stock. We prefer to remain on the sidelines until there is more visibility on the approval of pixantrone.
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