NEW YORK--(BUSINESS WIRE)--
ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), a drug development company
employing small molecule and synthetic biology approaches to cancer
therapy, today announced the presentation of promising preclinical data
with palifosfamide (Zymafos™ or ZIO-201) in a pediatric sarcoma model.
The data was detailed in an oral session of the 2011 meeting of the
combined Connective Tissue Oncology Society (CTOS) Musculoskeletal Tumor
Society (MSTS), being held October 26 — 29, 2011 in Chicago, IL.
The presentation, entitled "Palifosfamide, a Bifunctional DNA Alkylator,
Inhibits Growth of Pediatric Sarcoma Xenografts Across a Wide Dose Range
Following Oral and Parenteral Dosing," addressed, among other findings,
the impact of palifosfamide activity in the presence of overexpression
of aldehyde dehydrogenase (ALDH), an enzyme thought to confer resistance
to alkylators like cyclophosphamide and ifosfamide. The authors reported
that palifosfamide, a bi-functional DNA-alkylator in class with
ifosfamide, cyclophosphamide and bendamustine, did not exhibit ALDH
resistance. This important finding, combined with the use of oral
administration and a potentially favorable toxicity profile, are
particularly relevant for the pediatric population.
In vivo modeling for the study was conducted in the Cancer
Therapeutics Laboratory of the Alfred I. DuPont Hospital for Children.
The authors included E. Anders Kolb, M.D., Director, Blood and Bone
Marrow Transplantation and Head, Cancer Therapeutics Laboratory as lead
author and Richard Gorlick, M.D., Vice Chairman of Pediatrics at Albert
Einstein College and Chairman of the Children's Oncology Group (COG)
Bone Sarcoma Committee as senior author. Results showed that orally
administered palifosfamide was found to have broad in vivo
preclinical activity comparable to parenteral administration in an
osteosarcoma model. This activity was measured by tumor growth delay,
relative tumor volume (RTV) and event-free survival across all doses.
Investigators also found palifosfamide active in xenografts with
overexpressed levels of ALDH. Overexpression of ALDH is present in
diverse tumor types including breast cancer, colon cancer, pancreas
cancer, Ewing's sarcoma and other cancers, and is a marker of cancer
stem cells. Ongoing testing of dose and schedule in both sarcoma and
breast cancer models will define future clinical evaluation of the oral
form and was supported through mathematical applied Norton-Simon
modeling, as established by Larry Norton, M.D., deputy
physician-in-chief for breast cancer programs, at Memorial
Sloan-Kettering Cancer Center and an author of the study.
"The overexpression of ALDH in cancer cells may confer cancer stem
cell-like activity and resistance to treatment, including chemotherapy
and, in particular, ifosfamide and cyclophosphamide," stated Dr. Kolb.
"As a stabilized form of the active metabolite of ifosfamide,
palifosfamide bypasses resistance mediated by ALDHs, in addition to
conferring a potentially favorable toxicity profile compared to
ifosfamide, which is known to generate toxic metabolites such as
acrolein and chloroacetaldehyde. These results are compelling and merit
further exploration in the clinic."
The study was funded through a grant awarded to Dr. Lewis and Dr.
Gorlick by the Kristen Ann Carr Fund (KACF) for the development of a
novel treatment for pediatric sarcoma. The study's objectives were to
set the stage for further clinical study in pediatric sarcoma and other
childhood cancers. Formed in 1993 in honor of Kristen Ann Carr
(1971-1993), the KACF provides funding for the research and treatment
sarcoma as well as the education of young physicians through the Kristen
Ann Carr Fellowship at the Memorial Sloan-Kettering Cancer Center. Dr.
Lewis was the first Kristen Ann Carr Fund Fellow (1993-1995), an honor
awarded to him while at Memorial Sloan-Kettering.
Dr. Gorlick commented: "Sarcoma is a disease of high mortality which
affects proportionately far more children than adults. It is, therefore,
a critical goal of pediatric oncology research to find safer, more
effective treatment options for this population. An oral drug could be a
breakthrough in pediatric oncology treatment. These early, yet
promising, results show the potential of palifosfamide to address this
unmet medical need."
About the Kristen Ann Carr Fund
The Kristen Ann Carr Fund (www.kristenanncarrfund.org)
was formed in 1993, after the death of Kristen Carr, a 21-year-old who
was just about to graduate from New York University. It has raised
multiple millions for research into this group of rare and deadly
tumors, which represent about 15% of all types of cancer in children and
about one percent of all types in adults. Kristen Ann Carr Fund projects
at Memorial Sloan Kettering Cancer Center include fellowships in both
surgery and medical oncology. The KACF also built the Kristen Ann Carr
Sarcoma Laboratory, as well as funding many projects in sarcoma and the
psycho-social care of teenage and young adult cancer patients throughout
the U.S. and internationally.
About ZIOPHARM Oncology, Inc.:
ZIOPHARM Oncology is a biopharmaceutical company engaged in the
development and commercialization of a diverse portfolio of cancer
therapeutics. The Company is currently focused on several clinical
programs.
Palifosfamide (Zymafos™ or ZIO-201) is a novel DNA cross-linker in class
with bendamustine, ifosfamide, and cyclophosphamide and is currently in
a randomized, double-blinded, placebo-controlled Phase 3 trial with
palifosfamide administered intravenously for the treatment of metastatic
soft tissue sarcoma in the front-line setting. The Company is also
currently conducting a Phase 1 study of palifosfamide in combination
with standard of care for addressing small cell lung cancer; an oral
form of palifosfamide continues in preclinical study.
Darinaparsin (Zinapar™ or ZIO-101) is a novel mitochondrial-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.
Indibulin (Zybulin™ 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.
ZIOPHARM is also pursuing the development of novel DNA-based
therapeutics in the field of cancer pursuant to a partnering arrangement
with Intrexon Corporation. The partnership includes two existing
clinical-stage product candidates, both of which are currently in Phase
1.
ZIOPHARM's operations are located in Boston, MA and Germantown, MD with
an executive office in New York City. Further information about ZIOPHARM
may be found at www.ziopharm.com.
ZIOP-G
Forward-Looking Safe Harbor Statement:
This press release contains certain forward-looking information about
ZIOPHARM Oncology that is intended to be covered by the safe harbor for
"forward-looking statements" provided by the Private Securities
Litigation Reform Act of 1995, as amended. Forward-looking statements
are statements that are not historical facts. Words such as "expect(s),"
"feel(s)," "believe(s)," "will," "may," "anticipate(s)" and similar
expressions are intended to identify forward-looking statements. These
statements include, but are not limited to, statements regarding our
ability to successfully develop and commercialize our therapeutic
products; our ability to expand our long-term business opportunities;
financial projections and estimates and their underlying assumptions;
and future performance. All of such statements are subject to certain
risks and uncertainties, many of which are difficult to predict and
generally beyond the control of the Company, that could cause actual
results to differ materially from those expressed in, or implied or
projected by, the forward-looking information and statements. These
risks and uncertainties include, but are not limited to: whether
Palifosfamide, Darinaparsin, Indibulin, or any of our other therapeutic
products will advance further in the clinical trials process and whether
and when, if at all, they will receive final approval from the U.S. Food
and Drug Administration or equivalent foreign regulatory agencies and
for which indications; whether Palifosfamide, Darinaparsin, Indibulin,
and our other therapeutic products will be successfully marketed if
approved; whether our DNA-based biotherapeutics discovery and
development efforts will be successful; our ability to achieve the
results contemplated by our collaboration agreements; the strength and
enforceability of our intellectual property rights; competition from
pharmaceutical and biotechnology companies; the development of and our
ability to take advantage of the market for DNA-based biotherapeutics;
our ability to raise additional capital to fund our operations on terms
acceptable to us; general economic conditions; and the other risk
factors contained in our periodic and interim SEC reports including but
not limited to our Annual Report on Form 10-K for the fiscal year ended
December 31, 2010, our Quarterly Report on Form 10-Q for the quarter
ended June 30, 2011, and our Current Reports on Form 8-K filed from time
to time with the Securities and Exchange Commission. Readers are
cautioned not to place undue reliance on these forward-looking
statements that speak only as of the date hereof, and we do not
undertake any obligation to revise and disseminate forward-looking
statements to reflect events or circumstances after the date hereof, or
to reflect the occurrence of or non-occurrence of any events.
For ZIOPHARM:
ZIOPHARM Oncology, Inc.
Tyler Cook,
617-259-1982
tcook@ziopharm.com
or
Media:
Argot
Partners
David Pitts, 212-600-1902
david@argotpartners.com
Source: ZIOPHARM Oncology, Inc.
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