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NEW YORK(BUSINESS WIRE)
ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), a biopharmaceutical company that
is seeking to develop and commercialize a diverse, risk sensitive
portfolio of in-licensed cancer drugs addressing unmet medical needs,
today reported its financial results for the quarter ended September 30,
2009 and provided an update on the Company's clinical programs.
The Company reported a net loss for the third quarter 2009 of $2.9
million, or $(0.13) per share, compared with a net loss for the third
quarter of 2008 of $5.5 million, or $(0.26) per share. The significant
decrease in operating expenses is attributable to a continuing focus of
resources as well as tight management of operating expenses. For the
third quarter of 2009, as compared to 2008, Research and Development
expenses declined $2.6 million while General and Administrative expenses
declined by $0.4 million. Net cash used in operations was $2.1 million
in the third quarter of 2009 as compared with $5.9 million during the
comparable 2008 period. The decrease in net cash used in operations was
primarily attributable to a decrease in net loss of $2.7 million. Net
cash used in operations for the nine months ended September 30, 2009 and
2008 was $8.9 million and $19.7 million, respectively. Again, the
decrease in net cash used in operations was primarily attributable to a
decrease in the net loss of $12.0 million. The Company ended the
September 2009 quarter with cash of approximately $7.1 million which is
expected to support operations into the second quarter of 2010.
During the third quarter, the company completed an offering of its
common stock and warrants resulting in net proceeds of approximately
$4.6 million after paying offering expenses of $0.5 million.
The Company's clinical programs have progressed well. The palifosfamide
(ZymafosTM, ZIO-201) randomized Phase II trial in metastatic
or unresectable soft tissue sarcoma achieved the study-specified
efficacy milestone following planned safety and efficacy review by the
Data Committee, a panel of international sarcoma experts, and the
Company's Medical Advisory Board. It was determined that the data are
compelling and sufficient to proceed to a pivotal study in support of
product registration and to conclude enrollment. The company is in
dialogue with the U.S. Food and Drug Administration (FDA) on the design
and implementation of a registration trial, a study the Company expects
could initiate as early as the first half of 2010. The Company is also
in dialogue with FDA on the intravenous Phase II darinaparsin (ZinaparTM
or ZIO-101) study results in lymphoma with the intent of conducting a
registration trial in peripheral T-cell lymphoma, also as early as the
first half of 2010. The oral darinaparsin Phase I trials continue
enrollment in order to establish the best dose and schedule. Oral
indibulin (ZybulinTM or ZIO-301) is scheduled to enter into a
Phase I/II study in breast cancer patients using the Norton-dosing
schedule developed preclinically with Dr. Larry Norton and initiating in
early 2010 with the teams of Dr. Clifford Hudis (Memorial
Sloan-Kettering Cancer Center) in the United States and Dr. Jose Baselga
(Vall d'Hebron University Hospital) in Spain.
About ZIOPHARM Oncology, Inc.:
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 is 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 alkylating drugs used to treat certain cancers.
Palifosfamide does not have the toxic metabolites of ifosfamide that
cause the debilitating side effects of fuzzy brain? (encephalopathy)
and severe bladder inflammation. 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, a study expected
to establish the basis for a registration trial as early as the first
half of 2010.An oral form of palifosfamide has been developed
preclinically to the investigational new drug application stage.
Darinaparsin (ZinaparTM or ZIO-101) is a novel 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. Phase I and Phase
II testing of the intravenous form of darinaparsin in solid tumors and
hematological cancers has been completed or is nearing completion. The
Company has reported clinical activity and, importantly, a safety
profile from these studies as predicted by preclinical results.
Favorable results from the trial with IV-administered darinaparsin in
lymphoma, particularly peripheral T-cell lymphoma (PTCL?), were
reported at the American Society of Clinical Oncology (ASCO) in May.
Supported by these data, the Company expects to advance into a
registration trial in peripheral T-cell lymphoma as early as the first
half of 2010. Also as reported at ASCO, in ongoing Phase I trials the
oral form is active and well tolerated.
Indibulin (ZybulinTM or ZIO-301) is a novel, oral
tubulin binding agent that targets both mitosis and cancer cell
migration. 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)
were presented at this 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. The Company expects
to initiate a Phase I/II study of oral indibulin in breast cancer
patients employing this dosing schedule established preclinically. Once
the maximum tolerated dose is established in the Phase I portion of the
trial, Phase II will proceed with an expanded population.
ZIOPHARM's operations are located in Boston, MA with an executive office
in New York City.Further information about ZIOPHARM may be found at www.ziopharm.com.
ZIOP-E
Forward-Looking Safe Harbor Statement:
This press release contains forward-looking statements for ZIOPHARM
Oncology, Inc. that involve risks and uncertainties that could cause the
Company's actual results to differ materially from the anticipated
results and expectations expressed in these forward-looking statements.
These statements are based on current expectations, forecasts and
assumptions that are subject to risks and uncertainties, which could
cause actual outcomes and results to differ materially from these
statements. Among other things, there can be no assurance that any of
the Company's development efforts relating to its product candidates
will be successful, or such product candidates will be successfully
commercialized. Other risks that affect forward-looking information
contained in this press release include the possibility of being unable
to obtain regulatory approval of the Company's product candidates, the
risk that final trial data may not support interim analysis and that the
results of clinical trials in general may not support the Company's
claims, risks related to the Company's ability to protect its
intellectual property, risks related to its reliance on third parties to
develop its product candidates, risks related to the sufficiency of
existing capital reserves to fund continued operations for a particular
amount of time and uncertainties regarding the Company's ability to
obtain additional financing to support its operations thereafter. The
Company assumes no obligation to update these forward-looking
statements, except as required by law.
S.A. Noonan Communications, LLC
Susan Noonan, 212-966-3650
susan@sanoonan.com
or
Media
Rx
Communications Group
Eric Goldman, 917-322-2563
egoldman@rxir.com
Source: ZIOPHARM Oncology, Inc.
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