Why it is profiled?
The company will be presenting additional data for its investigational drug Palifosfamide (ZIO-201) from a mid-stage sarcoma trial.
ZIOPHARM Oncology Inc. (ZIOP) is a biopharmaceutical company focused on the development and commercialization of small molecule cancer drugs. The shares of this development-stage company have gained nearly 97% year-to-date and trade over $5.50.
The company has three drugs under development - Darinaparsin (ZIO-101), Palifosfamide (ZIO-201) and Indibulin (ZIO-301).
Palifosfamide (ZIO-201), is the company's lead investigational drug, which is being tested as a potential treatment for advanced sarcoma. The drug is being evaluated both as a single agent and in combination with Doxorubicin, the current only FDA-approved agent in sarcoma. Ziopharm licensed worldwide rights to Palifosfamide from DEKK-Tec Inc. in 2004.
A sarcoma is a type of cancer that develops from certain tissues, like bone or muscle. There are two main types of sarcoma namely, osteosarcoma and soft tissue sarcoma. Osteosarcoma develops from bone, while soft tissue sarcoma develops from soft tissues like fat, muscle, nerves, fibrous tissues, blood vessels, or deep skin tissues.
The company has already completed a single agent phase II trial of intravenous Palifosfamide in advanced sarcoma, which demonstrated favorable activity and safety profile. Following a favorable activity and safety data from a phase I trial of IV Palifosfamide in combination with Doxorubicin, the company initiated a randomized phase II trial dubbed PICASSO.
The PICASSO trial evaluates Palifosfamide plus Doxorubicin vs. Doxorubicin in patients with soft tissue sarcoma. Orphan Drug Designation has been obtained for Palifosfamide for both the United States and the European Union for the treatment of soft tissue sarcomas.
According to ZIOPHARM, the estimated sales potential of Palifosfamide in the front- and second-line setting of soft-tissue sarcoma is $250 million. GlaxosmithKline Plc's (GSK) Pazopanib and Ariad Pharmaceutical Inc.'s (ARIA) Ridaforolimus are two other drugs being evaluated as a potential treatment for soft-tissue sarcoma and the two drugs are in late-stage trials.
Last November, ZIOPHARM reported full interim data from the PICASSO trial, which were very promising. According to the interim results, Palifosfamide prolonged progression-free survival by at least 50% in the PICASSO trial.
Based on interim analysis of all randomized and eligible patients, last week, the company announced that the median progression-free survival was 4.4 months for Doxorubicin and 7.8 months for Palifosfamide plus Doxorubicin. That means, Palifosfamide prolonged progression-free survival by at least 77% in the PICASSO trial.
The company will be presenting further data from the PICASSO trial at the ASCO (American Society of Clinical Oncology Annual Meeting) on Monday, June 7th. The company expects to initiate a worldwide Palifosfamide phase III registration trial as early as the first half of this year.
The company has also developed an oral formulation of Palifosfamide, which is in preclinical stage. A phase I study of oral Palifosfamide is expected to be initiated following further intravenous study results and subject to obtaining additional sources of financing from partnering or other arrangements.
Darinaparsin is yet another investigational drug in the company's pipeline. Darinaparsin is studied as a potential treatment for primary liver cancer, advanced myeloma and lymphomas. Last May, the company reported favorable results from a phase II trial with IV-administered Darinaparsin in lymphoma, particularly peripheral T-cell lymphoma.
Darinaparsin is also under phase I oral dose escalation studies. The preliminary data primarily in solid tumors have indicated that the oral form of Darinaparsin is active and well tolerated.
Indibulin is also an investigational drug of ZIOPHARM, which is being evaluated as a potential treatment for metastatic breast cancer. The company has completed phase I trials of an oral form of Indibulin both as a single agent and in combination, with favorable results of activity and safety profile reported for all trials. Last month, the company initiated an additional phase I/II study at Memorial Sloan-Kettering Cancer Center for oral Indibulin in the treatment of metastatic breast cancer.
Being a development-stage company, ZIOPHARM has yet to generate revenue and has incurred approximately $108.8 million of cumulative net losses since its inception in 2003.
As of March 31, 2010, cash and cash equivalents totaled about $45.0 million, and according to the company, the existing cash will be sufficient to fund its operations very early into 2012.
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