Cell Therapeutics: Worth Buying Ahead of FDA Decision

| About: CTI BioPharma (CTIC)

Cell Therapeutics (NASDAQ:CTIC) is worth buying, in my opinion. There are only seven trading days until CTIC investors may get some very exciting news.

On February 10, 2010 the U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) will review the New Drug Application (NDA) for pixantrone for the treatment of relapsed/refractory aggressive non-Hodgkin's lymphoma (NHL). NHL is the fifth most common cancer in the United States.

"The upcoming ODAC meeting is a very important milestone in the NDA review process and we look forward to discussing the efficacy and safety data for pixantrone with the members of the panel and the FDA review team," stated James A. Bianco, M.D., CEO of CTI. "As there are no other drugs currently approved in this setting, we believe that pixantrone would fulfill a significant unmet medical need for patients with relapsed/refractory aggressive NHL."

At the ODAC meeting, committee members evaluate presentations of efficacy and safety data made by the pharmaceutical sponsor of the drug under review, FDA review staff, and occasionally third-party oncology experts in an open forum. Following the presentation, the committee members discuss questions posed by the Agency review staff and the meeting concludes with the committee voting on a recommendation to the FDA regarding approval.

Pixantrone is a fast track designated product which has been accepted for review by the U.S. Food & Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) date of April 23, 2010. Results of the PIX301 phase III trial presented demonstrated improvement across primary and secondary endpoints of the study at a minimum of nine-month follow-up from end of treatment.

Pixantrone showed benefits over other chemotherapy agents as follows:

  • A greater overall response (ORR), including a greater overall cure rate (CR).
  • A more durable response a response (> 4months).
  • Overall survival with a 48% increase in median overall survival for the pixantrone arm (10.2 months) versus the comparator arm (6.9 months).

Results presented also included a patient subgroup analysis demonstrating that complete response (CR), partial response (PR) and PFS were robust irrespective of risk factors or prior therapy. Pixantrone also provided superior disease control rates over comparator arm with 22 of comparator recipients progressing within the first evaluation point versus 14 for pixantrone recipients.

Zacks believes positive data from the follow up study should weigh in the company’s favor when the FDA meets to decide on the drug’s approval.

I expect CTIC stock could very well rally 25% or more ahead of the February 10th review, and beyond the 52 week high of $2.23 if Pixantrone is approved. CTIC short sellers will likely be squeezed.

Disclosure: Author holds a long position in CTIC

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