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The big day day arrived for Cell Therapeutics (CTIC) and the data did not disappoint investors. CTIC’s ASCO presentation on Pixantrone (Pix) sent CTIC shares up over 40% past $2 ($2.07 at the time of this post).

Ruth Pettengell, M.D. of St. George’s Hospital, University of London led the presentation on Pix and presented the final pivotal results of the EXTEND (PIX 301) trial, which showed an increase in complete remissions, overall response rates and PFS (Progression Free Survival).

Here’s the data, based off an intent-to-treat (ITT) analysis per CTIC’s SPA (special protocol assessment):

• Significant Increase in Complete Remission Rates 20% vs. 5.7%; p=0.021

• Significant Increase in Overall Response Rate 37.1% vs. 14.3%; p=0.003

• Significant increase in percent of all patients whose response lasted greater than or equal to four months 25.7% vs. 8.6%; p=0.012

• Significant Increase in Progression Free Survival 4.7 months vs. 2.6 months; p=0.007

• Positive trend in Overall Survival even though data not fully mature with median 8.1 month vs. 6.9 month; p=0.544

Dr. Pettengell had this to say:

“Anthracycline-related drugs can be effective salvage agents in aggressive NHL, but our use of them is limited by the significant increase in risk of cardiac failure associated with high cumulative doses of these drugs. These results represent a breakthrough in that pixantrone could extend our ability to use a highly active anthracycline-like drug in such patients and deserves to be examined in anthracycline naive patients as a potential alternative to currently available standard anthracycline drugs.”

And Bianco:

“We are pleased that the PIX 301 EXTEND trial of pixantrone demonstrated a long-lasting clinical benefit in this heavily pretreated relapsed/refractory group of patients with aggressive NHL and look forward to completing the New Drug Application submission later this month. Given the lack of approved therapies for this resistant group of patients with aggressive NHL, we believe pixantrone offers a valuable therapy for this unmet medical need.”

But what about the cardiac problems?!? Read here for the full scoop.

The news today provides an update to our ongoing coverage of CTIC and Pix, which has been gaining a significant following in recent weeks. For more on Pix, check out our Pix write-up, OPAXIO/Pix deal analysis and Pix safety data commentary, or just check out every post we’ve done on CTIC!!!

Stay tuned…

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