Cell Therapeutics' Positive Data - Analyst Blog
Cell Therapeutics (CTIC) announced positive data from the pivotal phase III EXTEND (PIX 301) clinical trial of pixantrone in relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL) patients who have not responded to 2 or more prior therapies. The data were presented at the 2009 American Society of Hematology (ASH) Annual Meeting. Analysis of the additional follow-up data supports the initial clinical trial results.
We are pleased to note that for patients in follow-up period for at least 9 months from the end of treatment, pixantrone provided a 250% relative improvement in 1 year progression free survival or PFS (21% vs 6%) over comparator and a 115% increase in median overall PFS (5.6 months vs 2.6 months). Moreover, at 21 months post treatment, 14% of pixantrone patients remained free from disease progression compared to 3% in the comparator arm.
As a reminder, in August 2009, the US Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) filed by Cell Therapeutics. The company is seeking FDA approval (NDA filed in June 2009) for pixantrone for the treatment of relapsed and refractory NHL. The company was granted a ten month standard review and has been assigned a Prescription Drug User Fee Act (PDUFA) date of April 23, 2010.
We believe positive data from the follow up study should weigh in the company’s favor when the FDA meets to decide on the drug’s approvality. However, we remain concerned about Cell Therapeutics’ liquidity position. Cash and cash equivalents including securities available for sale at the end of the third quarter were $54.9 million. The company is under great pressure to raise additional cash to fund its operations, especially at a time when it is preparing for the potential launch of pixantrone in 2010.
During the quarter, Cell Therapeutics reduced debt through the exchange of $4.5 million principal in debt for common stock resulting in a total of $57.4 million principal reduction in debt through exchanges so far in 2009. Although the company has brought down its debt burden by exchanging it against common stock, we remain concerned about significant dilution in shareholder value.
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