Recently, ZIOPHARM Oncology Inc. (ZIOP) commenced an early-stage study of its candidate palifosfamide as a combination therapy in patients suffering from small cell lung cancer (SCLC) and other cancers.

ZIOPHARM intends to enroll 12 to 15 patients for the single arm, dose escalation study which is designed to evaluate the safety of the combination of palifosfamide, etoposide and cisplatin/carboplatin for the planned mid-stage study in patients suffering from extensive SCLC. The combination of etoposide and cisplatin/carboplatin is the current standard of care for extensive SCLC.

SCLC, which accounts for approximately 15% of cancer cases annually, according to data released by the American Cancer society, affects mostly cigarette smokers. ZIOPHARM is also evaluating palifosfamide for other cancer forms.

Apart from palifosfamide, the other pipeline candidates at ZIOPHARM include indibulin and darinaparsin for treating various cancer forms. We remind investors that in September 2010, ZIOPHARM received a boost from the US Food and Drug Administration (FDA) when the agency granted orphan drug status to darinaparsin. The candidate is being developed to treat patients suffering from peripheral T-cell lymphoma (PTCL). The company intends to commence a pivotal trial of the candidate for the indication as a front-line therapy late next year.

We believe that the successful development and commercialization of the candidate as a front-line therapy for PTCL would boost the top line significantly at ZIOPHARM. Darinaparsin would address a market with a huge unmet need as currently there are no FDA approved front-line therapies for treating PTCL.

We remind investors that darinaparsin has been proved to be effective in a mid-stage study as a monotherapy in some lymphoma patients who did not respond to other drugs. Currently, Allos Therapeutics’ (ALTH) Folotyn is the only FDA approved drug for treating patients with relapsed or refractory PTCL.

Currently, we have a long-term ‘Neutral’ stance on ZIOPHARM Oncology. However, the company carries a Zacks #4 Rank (‘Sell’ recommendation) in the short-term, highlighting near-term pressure on the stock mainly because of the absence of any marketed product and the thin pipeline.

 
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