It's more than seven years since Cell Therapeutics Inc.'s (CTIC) lead cancer drug Pixantrone has been under development. Rejected by the FDA in April 2010 after the Oncologic Drugs Advisory Committee unanimously voted down Pixantrone for the treatment of relapsed or refractory aggressive non-Hodgkin's lymphomas, the New Drug Application for the drug is all set to be resubmitted this month.
For readers who are new to Cell Therapeutics, here's a brief overview of the company and its upcoming catalysts...
Founded in 1991 by James Bianco, the company went public in 1997, offering its shares at a price of $10 each. The company's stock and options are traded on the NASDAQ, AMEX, CBOE, PSEX, and on the Italian stock exchange, Nuovo Mercato.
Pixantrone came into Cell Therapeutics' fold following the 2003 acquisition of Novuspharma, a publicly traded Italian company in a share-swap deal valued at about $236 million. The transaction was completed on January 1, 2004.
The NDA for Pixantrone was submitted on a rolling basis in 2009 based on the results of a phase III trial dubbed EXTEND, or PIX301, which according to the company demonstrated that patients treated with Pixantrone attained a high rate of persistent and unconfirmed complete remissions (absence of disease activity) compared to patients treated with standard chemotherapy.
However, in March 2010, the FDA's Oncologic Drugs Advisory Committee, or ODAC, panel voted unanimously that the clinical trial data was not adequate to support approval of Pixantrone for patients with relapsed, refractory aggressive NHL who received two or more prior therapies and who were sensitive to treatment with anthracyclines.
Not long after the FDA panel voted against recommending Pixantrone, the FDA also issued a complete response letter for the drug in early April 2010. In December of that year, the company appealed the decision of the FDA regarding Pixantrone. The Office of New Drugs, which reviewed the appeal in May of 2011, denied Cell Therapeutics' request to conclude that the efficacy of Pixantrone has been demonstrated, but also disagreed with the FDA's conclusion in the Complete Response Letter that the EXTEND trial - the basis for the Pixantrone NDA submission, was a failed study, which warranted application of an interim analysis statistical thresholds.
Cell Therapeutics met with the FDA on June 14, 2011 and received guidance for the resubmission of Pixantrone NDA for relapsed or refractory aggressive non-Hodgkin's lymphoma including the potential for accelerated approval based on the PIX301 study results. Accordingly, Cell Therapeutics plans to resubmit the Pixantrone NDA as early as October 2011 for accelerated approval. The review is expected to be completed within six months from the date of resubmission, which should result in FDA decision on Pixantrone by April 2012.
The company has moved Pixantrone a step closer to potential approval in Europe also by its August 2011 response to the outstanding issues to the European Medicines Agency's Committee for Medicinal Products for Human Use in regards to the Marketing Authorization Application for the drug. The opinion of the CHMP, which is a critical step in the approval process in Europe, is expected during the first quarter of 2012.
Apart from Pixantrone, the other cancer compounds in the company's pipeline include, Opaxio, Brostallicin and Tosedostat.
- Opaxio is in phase III trial as a potential maintenance therapy for women with advanced stage ovarian cancer who achieve a complete remission following first-line therapy with paclitaxel and carboplatin and under phase II studies for brain cancer and esophageal cancer.
- Brostallicin in combination with cisplatin is in phase II testing as a potential treatment for patients with metastatic triple-negative breast cancer.
- Tosedostat is under phase I and phase II trials for acute myeloid leukemia, or AML, and myelodysplastic syndrome, or MDS. Cell Therapeutics acquired exclusive marketing and co-development rights to Tosedostat in North, Central and South America from Chroma Therapeutics Ltd. in March 2011.
A quick look at the balance sheet...
Cell Therapeutics has been in the red since inception, and as of June 30, 2011, had incurred aggregate net losses of about $1.7 billion. Unless Pixantrone receives FDA or EMA approval, the company expects to continue to incur operating losses for at least the next few years.
The company effected a 1-for-6 reverse stock split of its common stock on May 16, 2011. Two more reverse stock splits were implemented before namely, a 1-for-10 reverse split on September 2, 2008 and a 1-for-4 reverse split on April 16, 2007.
According to a SEC filing dated July 28, 2011, the company had cash of $38.9 million as of June 30, 2011, which includes approximately $5.8 million of funds received in June 2011 prior to closing of its preferred stock offering. Upon closing of the transaction, the company received an additional $24.2 million in gross proceeds and warrants to purchase up to 8.8 million shares of its common stock for an aggregate offering price of $30.0 million.
Cell Therapeutics does not expect the cash on hand to be sufficient to fund its anticipated operations beyond the first quarter of 2012, thereby raising substantial doubt about its ability to continue as a going concern.
Shares of Cell Therapeutics have thus far hit a 52-week low of $0.95 and a 52-week high of $3.33. The stock closed Friday's trading at $1.06, gaining 0.95%.
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