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ZIOPHARM Oncology Provides Update on PICASSO 3 Trial.

ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company with small molecule and synthetic biology approaches to new cancer therapies, has announced an update on its PICASSO 3 trial, a randomized, double-blinded, placebo- controlled Phase 3 trial of palifosfamide for the treatment of metastatic soft tissue sarcoma in the front-line setting.

Rigorous patient enrollment and evaluation is currently ongoing at over 150 centers worldwide, with target enrollment of 424 patients now approaching 90% completion. This includes central review of pathology and radiology prior to randomization, placebo-control and double blinding throughout the conduct of the study. Based on current projections, the company expects data for progression-free survival (PFS), the study's primary endpoint for accelerated approval, in the second half of 2012. The outcome of the recent Oncologic Drugs Advisory Committee (ODAC) meeting, held on March 20, 2012 by the U.S. Food and Drug Administration to review the clinical benefit of two candidates for second-line treatment of sarcoma, supports the company's belief that the PICASSO 3 study is well designed and positioned in the rapidly evolving therapeutic landscape for the treatment of soft tissue sarcoma.

"As the ODAC meeting highlights, progression-free survival, an outcome we expect from PICASSO 3 before year-end, is an important measurement of clinical benefit in the treatment of sarcoma," said Hagop Youssoufian, M.Sc., M.D., president of Research and Development and Chief Medical Officer of ZIOPHARM. "This meeting also further illustrated that the need for new therapies in the front-line setting for sarcoma remains urgent."

Dr. Youssoufian also stated: "Because of the challenges of this disease, sarcoma has seen no new therapies introduced in decades. Yet a new wave of therapies under development, including palifosfamide in the front-line setting, promises to transform sarcoma treatment, with an effect not unlike what occurred in Myeloma, where care has gone from palliative to curative. Progress in the clinic has made this goal now one step closer to reality for sarcoma."

In a previously reported randomized, controlled Phase 2 trial of palifosfamide plus doxorubicin versus doxorubicin alone in patients with unresectable or metastatic soft tissue sarcoma (which trial was selected for the prestigious Best of ASCO designation in 2010) PFS showed a 3.4 month improvement over the control arm (or 7.8 months versus 4.4 months with a hazard ratio of 0.43 and a p-value of 0.02). These results correlated with positive preliminary overall survival data showing a hazard ratio of 0.78 as reported in February 2012.

About ZIOPHARM Oncology, Inc.:

ZIOPHARM Oncology is a biopharmaceutical company engaged in the development and commercialization of small molecule and synthetic biology approaches to new cancer therapies. The company's clinical programs include:

Palifosfamide (Zymafos(R) or ZIO-201) is a novel DNA cross-linker that in preclinical study has been shown to bypass resistance mediated by aldehyde dehydrogenase (ALDH), in addition to conferring a favorable toxicity profile compared to other in-class agents. Palifosfamide, administered intravenously, is currently in a randomized, double-blinded, placebo-controlled Phase 3 trial for the treatment of metastatic soft tissue sarcoma in the front-line setting. A Phase 1 trial is also nearing completion with palifosfamide in combination with etoposide and carboplatin to determine appropriate safety for initiating a potentially pivotal, adaptive Phase 3 trial in front-line, extensive SCLC expected to initiate in the second half of 2012. Additionally, an investigational new drug application has been accepted for the oral form of palifosfamide.

DNA-based therapeutics (synthetic biology), in partnership with Intrexon Corporation, include two clinical-stage product candidates, both of which are DNA IL-12 using the RheoSwitch Therapeutic System(R) to be turned on/off by an oral activator ligand and are currently in Phase 1. Additionally, multiple INDs are expected in the next 12-24 months resulting from preclinical and discovery work underway to advance multiple antibody, immunotoxin, and protein decoy candidates, systemic delivery and a next generation RheoSwitch Therapeutic System(R).

Indibulin (Zybulin(TM) or ZIO-301) is a novel, oral tubulin binding agent that is expected to have several potential benefits including oral dosing, application in multi-drug resistant tumors, no neuropathy and a quite tolerable toxicity profile. It is currently being studied in Phase 1/2 in metastatic breast cancer.

Darinaparsin (Zinapar(R) or ZIO-101) is a novel mitochondrial- and hedgehog-targeted agent (organic arsenic) currently in a solid tumor Phase 1 study with oral administration and has been developed intravenously for the treatment of relapsed peripheral T-cell lymphoma.

ZIOPHARM's operations are located in Boston, MA, Germantown, MD and New York City.

For more information, visit or call 617/778-2266.
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Publication:Biotech Business
Date:May 1, 2012
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