GenSpera, Inc. (OTCBB:GNSZ) announced that Devalingam Mahalingam, MD,
PhD, principal investigator of the G-202 Phase II trial in
hepatocellular carcinoma, presented final data from the G-202 Phase I
clinical trial yesterday at the EORTC-NCI-AACR Symposium on Molecular
Targets and Cancer Therapeutics in Boston, MA (http://www.aacr.org/home/scientists/meetings--workshops/molecular-targets-and-cancer-therapeutics.aspx).
In presenting a poster called, “A First-in-Human, Phase I Clinical Study
of G-202, a Thapsigargin-Based Prostate-Specific Membrane Antigen
(PSMA)-Activated Prodrug, in Patients with Advanced Solid Tumors,” Dr.
Mahalingam reported that 27% of the patients exhibited stable disease
and two of the five patients with hepatocellular carcinoma had a
prolonged stable disease of more than nine months (nine cycles of
treatment). The trial treated a total of 44 patients, with solid-tumor
cancers who had failed on earlier therapies, with increasing dose
levels. A subset of 16 patients received the recommended Phase II dosing
regimen, which appeared to be well-tolerated. Dr. Mahalingam is an
oncologist at the Cancer Therapy & Research Center at The University of
Texas Health Science Center at San Antonio.
“This final data from the Phase I G-202 study included 16 patients
treated at the recommended Phase II dose, five of whom had
hepatocellular cancer (HCC),” said Dr. Mahalingam. “That two of them
experienced a prolonged period of stable disease is a remarkable
improvement in survival, given that median survival in this heavily
pre-treated group is usually measured in weeks or months. These
encouraging results form the basis of our ongoing Phase II study of
G-202 in patients with advanced HCC who have failed standard therapy
with Nexavar.”
“This represents the first communication of our complete G-202 Phase I
data, which illustrate the safety and tolerability of G-202 in advanced
cancer patients,” said Craig Dionne, PhD, GenSpera CEO and President.
“Based on the strength of this data, particularly in the group of liver
cancer patients, we initiated the G-202 Phase II trial in HCC, which is
now open at five clinical centers. We are excited to develop what we
believe may constitute a truly innovative treatment for this group of
underserved patients.”
About GenSpera
GenSpera’s technology platform combines a powerful, plant-derived
cytotoxin (thapsigargin) with a prodrug delivery system that provides
for the targeted release of drug candidates within a tumor. Unlike
typical chemotherapeutic agents, thapsigargin results in cell death
irrespective of the rate of cell division, which may provide an
effective approach to kill both fast- and slow-growing cancers.
GenSpera’s lead drug candidate, G-202, is activated by the enzyme PSMA
which is found at high levels in liver and prostate cancer and in the
vasculature of almost all other solid tumors and is therefore expected
to have efficacy in a wide variety of tumor types.
Data from the G-202 Phase Ib program in solid tumor patients
demonstrated that G-202 is well-tolerated with prolonged disease
stabilization observed in several hepatocellular carcinoma (liver
cancer) patients whose disease had previously worsened on standard
therapy. A Phase II clinical trial in patients with hepatocellular
carcinoma is currently underway.
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Cautionary Statement Regarding Forward Looking Information
This news release may contain forward-looking statements. Investors are
cautioned that such forward-looking statements in this press release
regarding potential applications of GenSpera’s technologies 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. 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.
Copyright Business Wire 2013