Attached files
| file | filename |
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| 8-K - Inspyr Therapeutics, Inc. | v204335_8k.htm |
CONTACT:
|
Company:
|
Craig
Dionne, Ph.D., CEO
|
GenSpera,
Inc. (210) 479-8112
|
Investors:
|
Steve
Chizzik
|
The
Verrazano Group (908) 688-9111
|
Media:
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Deanne
Eagle
|
Planet
Communications (917) 837-5866
GENSPERA
EXPANDS G-202 PHASE I CLINICAL PROGRAM
SAN ANTONIO, Texas, November 30,
2010 – GenSpera, Inc. (OTC.BB:GNSZ) announced its intention to expand its
Phase I safety trial to study G-202 in relapsed, refractory cancer patients to
the Cancer Therapy and Research Center (CTRC) at The University of Texas Health
Science Center at San Antonio in San Antonio, Texas. The expansion is dependent
upon a successful review of the clinical protocol by the Health Science Center
Institutional Review Board (IRB). The company anticipates admitting the first
patient at this site in the first quarter of 2011.
“We are
delighted that CTRC will be joining us as an active and enthusiastic partner in
the Phase I clinical trial of our lead compound, G-202. The center has a strong
history of cancer drug development and has evaluated more than 20 drugs that
have gone on to eventual approval by the FDA,” said Craig Dionne, PhD, Chairman
and CEO of GenSpera. “Their entry into the study will allow more rapid patient
recruitment during the Phase Ib portion, in which we plan to expand enrollment
at the maximum tolerated dose to get an early signal of potential activity in a
multiple cancer types. We are also delighted to facilitate access to G-202 to
cancer patients in Southwest Texas.”
“It will
be an important milestone for the local biotech industry,” said Susan Mooberry,
Ph.D., interim director of the CTRC’s Institute for Drug Development. “It
highlights the GenSpera and CTRC partnership, and our commitment to the local
community. And it’s great for our patients.”
The G-202
study, enrolling patients with cancers that have progressed after treatment with
other therapies, has been underway since January, 2010, at the Johns Hopkins
Sidney Kimmel Comprehensive Cancer Center, in Baltimore, MD, and the University
of Wisconsin Carbone Cancer Center, in Madison, WI. The primary
endpoints of the open-label, dose-escalation study will be to determine the
safety, tolerability and pharmacokinetics of the drug, although the design
allows the collection of efficacy data as well.
About
CTRC
The
Cancer Therapy & Research Center (CTRC) at The University of Texas Health
Science Center at San Antonio is one of the elite academic cancer centers in the
country to be named a National Cancer Institute (NCI) Designated
Cancer Center, and is one of only four in Texas. A leader in
developing new drugs to treat cancer, the CTRC Institute for Drug Development
(IDD) conducts one of the largest oncology Phase I clinical drug programs in the
world, and participates in development of cancer drugs approved by the U.S. Food
& Drug Administration. For more information, visit www.ctrc.net.
About
GenSpera:
GenSpera,
Inc. is a development stage oncology company focused on therapeutics that
deliver a potent, unique and patented drug directly to tumors. GenSpera’s
technology platform combines a potent, plant-derived cytotoxin (thapsigargin)
with a prodrug delivery system that releases the drug only within the
tumor. Unlike standard cancer drugs, thapsigargin kills cells
independent of their division rate, thus making it effective at killing all
fast- and slow-growing cancers and cancer stem cells. GenSpera’s prodrug
platform is the subject of eight issued patents with four additional patents
pending.
In early
2010, GenSpera initiated a Phase I clinical trial targeting solid tumor cancers
with its lead drug, G-202, at Johns Hopkins University and the University of
Wisconsin. The Company anticipates completion of Phase I trials in Q2
2011. Upon successful completion of its Phase I trial, GenSpera
expects to initiate multiple Phase II trials for G-202 in several different
types of cancer. The company’s second drug, G-115, will directly
target prostate cancer. The company anticipates filing an application
to commence Phase I trials of G-115 in Q3 2011.
GenSpera,
Inc. owns and controls all rights to G-202 and G-115 and anticipates a strategic
partnership to maximize the value of the drugs as they progress through future
clinical trials.
For more
information, please visit the Company’s website: www.genspera.com.
Cautionary
Statement Regarding Forward Looking Information:
This
news release may contain forward-looking statements made pursuant to the "safe
harbor" provisions of the Private Securities Litigation Reform Act of 1995.
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.
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