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ZIOPHARM, INC.
(NASDAQ:ZIOP)
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ZIOPHARM Oncology is a biopharmaceutical
company engaged in the development and commercialization of a diverse
portfolio of cancer drugs. The Company is currently focused on three
clinical programs.
Palifosfamide (ZymafosTM or ZIO-201) references a
novel composition (tris formulation) that comprises the functional
active metabolite of ifosfamide, a standard of care for treating
sarcoma, lymphoma, testicular, and other cancers. Palifosfamide
delivers only the cancer fighting component of ifosfamide. It is
expected to overcome the resistance seen with ifosfamide and cyclophosphamide,
two of the most commonly used DNA-alkylating drugs used to treat
cancers. Palifosfamide does not have the toxic metabolites of ifosfamide
that cause the debilitating side effects of "fuzzy brain"
(encephalopathy) and severe bladder inflammation. It may also have
other advantages. Intravenous palifosfamide is currently in a randomized
Phase II trial to treat unresectable or metastatic soft tissue sarcoma
in the front- and second-line setting with the Company having reported
interim positive results at the 2010 ASCO Annual Meeting; a registration
trial in the same setting is expected to initiate following U.S.
Food and Drug Administration (FDA) review as early as the first
half of this year. An oral form of palifosfamide has been developed
preclinically to the investigational new drug application stage.
Darinaparsin (ZinaparTM or ZIO-101) is a novel mitochondrial-targeted
agent (organic arsenic) being developed for the treatment of various
hematologic and solid cancers. Preclinical and clinical studies
to date have demonstrated that darinaparsin is considerably less
toxic than inorganic arsenic, particularly with regard to cardiac
toxicity. The Company has reported favorable results from a Phase
II trial with IV-administered darinaparsin in lymphoma, particularly
peripheral T-cell lymphoma ("PTCL"), at the American Society
of Clinical Oncology (ASCO) in May of 2009 which would serve as
the basis for ongoing clinical study in PTCL following regulatory
review and available financial resources. Phase I trials with the
oral form are ongoing in both hematological malignancies and solid
tumors.
Indibulin (ZybulinTM or ZIO-301) is a novel, oral
tubulin binding agent that targets both mitosis and cancer cell
migration. In addition, indibulin is expected to have several potential
benefits, including oral dosing, application in multi-drug resistant
tumors, no neuropathy and minimal overall toxicity. In multiple
Phase I trials in cancer patients, oral indibulin has been administered
both as a single agent and in combination with favorable activity
and a promising safety profile that does not include the neurotoxicity
seen with all of the other classes of tubulin binding agents. Most
recently, results of oral indibulin in combination with oral capecitabine
(Xeloda(R)) were presented at last year's American Society of Clinical
Oncology (ASCO) along with the preclinical findings of a novel dosing
schedule conducted under the direction of Dr. Larry Norton; employing
this dosage schedule, the Company has initiated a Phase I study
in breast cancer patients with the Breast Cancer Medicine Service
at Memorial Sloan-Kettering Cancer Center.
ZIOPHARM's operations are located in Boston, MA with
an executive office in New York City.
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