ZIOPHARM Presents Promising Early Data from Phase Ib Study of
Indibulin at 6th International Symposium on Targeted Anticancer
Therapies
Results Shows Indibulin Is Well Tolerated and Active Among Eight
Evaluable Patients
http://ir.ziopharm.com/releasedetail.cfm?ReleaseID=300540
BETHESDA,
Md., Mar 20, 2008 (BUSINESS WIRE) — ZIOPHARM Oncology, Inc.
(NASDAQ:ZIOP) announced today that it presented promising early data
from a Phase Ib study of indibulin, the Company's novel, orally
administered, synthetic tubulin targeted agent, at the 6th
International Symposium on Targeted Anticancer Therapies held in
Bethesda, Maryland, March 20 to 22.
A
total of 14 patients with a variety of cancers, including sarcomas and
carcinomas, have been treated to date in the study. Following a total
of 30 cycles of treatment, indibulin has been shown to be very well
tolerated, with no drug-related Grade 2 or higher toxicities reported.
Of note, no neurotoxicities, a common and serious side effect typically
associated with microtubule targeting agents, have been observed.
In
addition to confirming indibulin's safety profile, this study evaluates
early treatment responses by PET scans. Among 8 evaluable patients,
these PET scans demonstrated a substantial anti-tumor effect by
indibulin. Week 7 PET scans identified 1 complete reduction in uptake,
4 with partial reduction in uptake, and 3 with increased uptake. Tumor
responses measured by PET scan are generally referred to as metabolic
responses, and usually correlate with treatment responses in cancer.
“Safely
and effectively targeting microtubules in cancer cells has long been a
goal of researchers as it leads to a variety of anti-cancer activity,
including antiangiogenesis and antimetastasis,” commented Sant P.
Chawla, MD, Director, Sarcoma Oncology Center and a lead investigator
of the study. “Yet to date, these agents have all demonstrated serious
side effects. Oral indibulin, by contrast, has been very well
tolerated, with none of the neurotoxicity or bone marrow suppression
seen with taxanes and vinca alkaloids. Indibulin has also demonstrated
promising early activity by PET scan, including a complete response in
Ewing's Sarcoma and a partial response in a neuroendocrine cancer.
Taken together, these results are highly compelling, making ongoing
study a priority.”
For more details on these trials please see www.clinicaltrials.gov.
About Indibulin
Indibulin
is a novel synthetic anti-mitotic agent that binds to tubulin,
destabilizes microtubule polymerization, arrests tumor cell growth at
the G2/M phase and inhibits cell mobility and metastasis. Microtubules
are well-established targets for anti-cancer drug development and
tubulin-binding drugs such as taxanes and vinca alkaloids are currently
widely used to treat cancer. Indibulin is orally available, lacks
neurotoxicity and has efficacy in taxane refractory preclinical models.
About ZIOPHARM Oncology, Inc.
ZIOPHARM Oncology, Inc. is a
biopharmaceutical company engaged in the development and
commercialization of a diverse, risk-sensitive portfolio of in-licensed
cancer drugs to address unmet medical needs. The Company applies new
insights from molecular and cancer biology to understand the efficacy
and safety limitations of approved and developmental cancer therapies
and identifies proprietary and related molecules for better patient
treatment. For more information, visit www.ziopharm.com.
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 the results of clinical trials may not support the Company's
claims, and risks related to the Company's ability to protect its
intellectual property and its reliance on third parties to develop its
product candidates. The Company assumes no obligation to update these
forward-looking statements, except as required by law.
ZIOP-G
SOURCE: ZIOPHARM
Oncology, Inc.
ZIOPHARM Oncology, Inc.
Suzanne McKenna, 646-214-0703
smckenna@ziopharm.com
or
Argot Partners
Andrea Rabney, 212-600-1902
andrea@argotpartners.com