GenSpera
(OTCQB:GNSZ) Announces Positive Phase II Data for Investigational Agent
Mipsagargin
First-in-Class
Agent is Well Tolerated in Liver Cancer Patients
SAN ANTONIO - January 16, 2015 (Investorideas.com Biotech
Newswire) GenSpera, Inc. (OTCQB:GNSZ) today announced the encouraging results of a
Phase II study of mipsagargin (G-202), an investigational agent for the
treatment of hepatocellular carcinoma (HCC). The results will be presented
today (12:00 to 2:00 p.m. PST, Abstract #301) in a poster presentation at the
2015 Gastrointestinal Cancers Symposium in San Francisco, California.
The
Phase II results demonstrated that mipsagargin appears to be effective and is
well-tolerated by HCC patients. Mipsagargin targets the enzyme
prostate-specific membrane antigen (PSMA), which is highly expressed in tumor
vasculature and prostate cancer cells. The Phase II study results (n=25)
demonstrate that the prodrug effectively stabilizes progression of HCC by
reducing blood flow within tumors while not affecting blood flow within normal
tissues.
"We are very encouraged with the
positive results from this Phase II trial that demonstrate the tolerability and
show indications of effectiveness of mipsagargin in advanced liver cancer
patients," said Craig Dionne, PhD, 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 liver
cancer. Based on the results of this study, we intend to move forward with a
large, global Phase III trial."
Mipsagargin's targeted approach differs
from other vascular targeting agents by destroying established tumor
vasculature rather than slowing the growth of new tumor blood vessels. The
PSMA-targeting agent is designed to minimize side effects commonly observed
with other therapies, while maximizing activity against tumors.
"These results demonstrate the
potential that mipsagargin has to treat one of the world's deadliest
cancers," said Devalingam Mahalingam, MD, PhD, an oncologist at the Cancer
Therapy & Research Center at the University of Texas Health Science Center
at San Antonio and principal investigator of the study. "In addition to
observing prolonged disease stabilization in some patients, we noted anecdotal
evidence that patients had improved performance status with much less fatigue
and side effects associated with other anti-cancer therapeutics."
With Phase II complete, GenSpera is
designing a large, international Phase III study which will further define the
anti-tumor potential of mipsagargin in liver cancer patients. More information
on mipsagargin (G-202) can be found at www.genspera.com.
Hepatocellular carcinoma is the most common
form of cancer that originates in the liver. In the United States, more than
33,000 new cases will be diagnosed in 2015. Globally, liver cancer is a primary
public health issue with more than 700,000 people diagnosed and more than
600,000 deaths annually. It is the most common type of cancer in Southeast Asia
and sub-Saharan Africa. A liver cancer diagnosis is often subsequent to other
liver disease, making treatment of a highly compromised patient population
particularly challenging.
Data Establishes Foundation for Continued Investigation
The Phase II study (Abstract #301) of
mipsagargin was a multi-site, single arm study designed to assess time to
progression and response rate to treatment. The study measured disease
progression in 25 patients with advanced-stage liver disease and poor liver
reserves who had failed first line treatment with sorafenib. Patients were
administered episodic dosing of mipsagargin on the first three days of each
treatment cycle. Study participants experienced a median time to progression of
4.2 months, nearly twice the time demonstrated in prior studies with placebo or
ineffective agents. Thirty-five percent of patients received 5 or more cycles
of treatment with an average time on study of 7.1 months. Additionally,
mipsagargin demonstrated decreased blood flow in liver tumors as measured by
DCE-MRI.
Read this release
in full at http://www.investorideas.com/CO/GNSZ/news/2015/01161.asp
About GenSpera
GenSpera Inc. is a San Antonio-based
biotech company that unlocks conventional thinking to conceive, design, and
develop cancer therapies. GenSpera's technology platform combines a powerful,
plant-derived cytotoxin (thapsigargin) with a patented prodrug delivery system
that provides for the targeted release of drug candidates within tumors.
GenSpera's lead drug candidate, mipsagargin, was granted Orphan Drug
designation by the US Food and Drug Administration (FDA) in 2013 for evaluation
in patients with hepatocellular carcinoma (liver cancer).
For additional information on GenSpera,
visit www.genspera.com and connect on Twitter @GenSperaNews, 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.
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