[November 20, 2015] |
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Mipsagargin Demonstrates Clinical Benefit in Subset of Glioblastoma Patients
GenSpera
Inc. (OTCQB: GNSZ), a biotech company developing a novel prodrug
therapeutic for the treatment of cancer, today announced results from
the Phase II study investigating the use of mipsagargin (G-202) for the
treatment of glioblastoma multiforme. The results will be presented
today in a poster titled, "Phase II study of mipsagargin (G-202), a
PSMA-activated prodrug targeting the tumor endothelial cells, in adult
patients with recurrent or progressive glioblastoma," at the Society
for Neuro-Oncology (SNO) Annual Scientific Meeting in San Antonio,
Texas. The poster
is available on the company website.
"We are seeing disease stabilization in a subset of patients and,
importantly, clinical benefit appears to be correlated with PSMA
expression, which offers enrichment strategies to enroll only potential
responders in future clinical trials," said David Piccioni, M.D, Ph.D.,
the study's Principal Investigator. "These results demonstrate
mipsagargin's potential to treat a patient population with few therapy
options."
In addition to Dr. Piccioni, the two-stage, single-arm, open-label study
(NCT02067156) is led by neuro-oncologist Santosh Kesari, M.D., Ph.D.,
and is being conducted at the UC San Diego Moores Cancer Center in La
Jolla, Calif. The Phase II results indicate that mipsagargin appears to
confer clinical benefit in a subset of patients and is well tolerated by
glioblastoma patients. The results are as follows:
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Three of 11 efficacy evaluable patients demonstrated at least stable
disease at the first disease assessment (2 stable disease, 1 partial
response), one of which has met the primary endpoint of six-month
progression-free survival.
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No dose-limiting toxicities have occurred. Preliminary evidence
suggests that mipsagargin is well tolerated and may induce disease
stabilization or treatment response.
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PSMA (Prostate-Specific Membrane Antigen) staining of tumor tissues
shows variability of expression but all three responders have >2+
staining. Biomarker evaluation is ongoing.
"We are very encouraged with the positiveresults from this interim
Phase II trial that demonstrate the tolerability and indications of
effectiveness of mipsagargin in advanced brain cancer patients," said
Craig Dionne, Ph.D., chief executive officer at GenSpera. "Mipsagargin
is a first-in-class agent with a novel mechanism of action that is
unlike any other drug being tested in patients with advanced brain
cancer."
Potential Advantages of Mipsagargin in Glioblastoma Patients Glioblastoma
is the most common and most aggressive malignant primary brain tumor in
humans. There are approximately 10,000 new cases of malignant
glioblastoma diagnosed each year in the United States and, despite
optimal treatment, the median survival for these patients is only 12 to
15 months. Treatment commonly consists of surgery followed by radiation
and the drug temozolomide. A few drugs have been approved in patients
that have recurrent tumors, but none have been shown to promote
long-term tumor stabilization or survival. Glioblastomas are
particularly resistant to conventional chemotherapy drugs as most cannot
cross the blood-brain barrier. This disadvantage of conventional
chemotherapy does not apply to mipsagargin because mipsagargin directly
attacks the PSMA-expressing cells of the tumor-associated blood vessels
that comprise the blood-brain barrier.
About GenSpera GenSpera, Inc. is a clinical-stage oncology
drug discovery and development company. Its lead drug candidate
mipsagargin demonstrated positive data in a Phase II clinical trial in
hepatocellular carcinoma (liver cancer) patients and has demonstrated
highly encouraging interim data in an ongoing Phase II trial for
glioblastoma multiforme (brain cancer). GenSpera's technology platform
combines a powerful, plant-derived cytotoxin, thapsigargin, with a
patented prodrug delivery system for the targeted release of drug
candidates within solid tumors without the side-effect profile of
traditional chemotherapeutic agents. Mipsagargin was granted Orphan Drug
designation by the U.S. Food and Drug Administration (FDA) in 2013 for
evaluation in patients with hepatocellular carcinoma.
For additional information on GenSpera, visit www.genspera.com
and connect on Twitter,
LinkedIn,
Facebook,
YouTube
and Google+.
Cautionary Statement Regarding Forward Looking Information This
communication may contain forward-looking statements. Investors are
cautioned that statements in this document regarding potential
applications of GenSpera's technologies or the future prospects of the
company constitute forward-looking statements that involve risks and
uncertainties, including, without limitation, risks inherent in the
development and commercialization of potential products, uncertainty of
clinical trial results or regulatory approvals or clearances, need for
future capital, dependence upon collaborators and maintenance of our
intellectual property rights and the acceptance of GenSpera's proposed
therapies by the health community. Actual results may differ materially
from the results anticipated in these forward-looking statements.
Additional information on potential factors that could affect our
results and other risks and uncertainties will be detailed from time to
time in GenSpera's periodic reports filed with the Securities and
Exchange Commission.
View source version on businesswire.com: http://www.businesswire.com/news/home/20151120005105/en/
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