Preclinical data with
the NPRL2 tumor suppressor gene demonstrated that systemic treatment using
NPRL2 nanoparticles in combination with cisplatin resulted in a 90 percent
inhibition of tumor growth in human lung cancer cells compared to control
treatments, reported Introgen Therapeutics, Inc. (Nasdaq: INGN). The NPRL2
gene, believed to be important in the genesis of multiple types of cancer,
including lung cancer and renal cell cancer, is licensed to Introgen from
The University of Texas M. D. Anderson Cancer Center.
This study was performed in the laboratory of Dr. Lin Ji, associate
professor in the Department of Thoracic and Cardiovascular Surgery at M. D.
Anderson and collaborators in the Department of Imaging Physics at M. D.
Anderson and The University of Texas Southwestern Medical Center.
Preclinical studies evaluated the NPRL2 gene which demonstrated its
ability to exhibit tumor suppressor activity against human lung cancer. A
study published in a recent issue of the biomedical journal Cancer Research
indicated that low expression of the NPRL2 gene may predict resistance to
response to cisplatin chemotherapy in patients with lung cancer. The NPRL2
protein was analyzed in 40 lung cancers and low expression of NPRL2 was
correlated with resistance to cisplatin, one of the mainstays of
chemotherapy for lung cancer. In lung cancers that were resistant to
cisplatin, re- introduction of the normal NPRL2 gene resulted in dramatic
re-sensitization to cisplatin. This effect was confirmed in animal studies
using human cisplatin- resistant lung tumors. A 90 percent inhibition of
tumor growth was observed with systemic treatment using NPRL2 nanoparticles
in combination with cisplatin, compared to control treatments. Thus, NPRL2
may serve as an important biomarker to identify and treat patients with
tumors resistant to cisplatin chemotherapy.
These studies were further highlighted by The University of Texas M. D.
Anderson Cancer Center in the November issue of their electronic
publication Cancer Wise which may be accessed at cancerwise
.
Dr. Sunil Chada, Introgen associate vice president for Clinical
Research and Development stated, "The ability to use a simple biomarker
assay for NPRL2 to identify patients who would not derive benefit from
cisplatin represents an important advance and underscores the significance
of NPRL2 in lung cancer. Development of NPRL2 gene drugs using systemic
nanoparticle delivery may help patients whose tumors are resistant to
cisplatin by re-sensitizing tumors to this commonly used therapy."
NPRL2 has been identified by the International Lung Cancer Chromosome
3p21.3 Tumor Suppressor Gene Consortium, including researchers from M. D.
Anderson Cancer Center, The University of Texas Southwestern Medical
Center, and the National Cancer Institute. The NPRL2 gene was identified
within a "genomic hotspot" of cancer causing mutations at the region of the
third human chromosome termed 3p21. This region is frequently deleted or
mutated in early stage lung cancer. Introgen previously announced that it
acquired the exclusive worldwide license for a family of at least 10
anti-cancer genes identified by the consortium including NRPL2 and FUS1.
Introgen is developing INGN 401 which utilizes the FUS-1 tumor suppressor
gene in a nanoparticle formulation and is now in clinical testing for the
systemic treatment of metastatic non-small cell lung cancer. Additional
genes within this genomic hotspot also appear to be important in control of
cancer progression and may function as therapeutic genes as well as
prognostic biomarkers.
Mutations in the 3p21 region of chromosome 3 are found in approximately
90 percent of small-lung cancer, more than 50 percent of non-small-lung
cancer, as well as in renal, breast, pancreatic, oral and uterine cancers.
Mutations in the 3p21 region of the genome are the earliest genetic
abnormality currently detected in lung cancer, suggesting that one or more
of these genes could act as "gatekeeper," preventing cells from becoming
cancerous.
Introgen Therapeutics, Inc. is a biopharmaceutical company focused on
the discovery, development and commercialization of targeted molecular
therapies for the treatment of cancer and other diseases. Introgen is
developing molecular therapeutics, immunotherapies, vaccines and
nano-particle therapies to treat a wide range of cancers using tumor
suppressors and cytokines. Introgen maintains integrated research,
development, manufacturing, clinical and regulatory departments and
operates multiple manufacturing facilities including a commercial scale
cGMP manufacturing facility.
Introgen holds licensing agreements with M. D. Anderson Cancer Center
to commercialize products based on licensed technologies, and has the
option to license future technologies under sponsored research agreements.
The University of Texas Board of Regents owns stock in Introgen. These
arrangements are managed in accordance with M. D. Anderson's conflict of
interest policies.
Statements in this release that are not strictly historical may be
"forward-looking" statements, including those relating to Introgen's future
success with its clinical development program for treatment of cancer or
other diseases with genes located in the 3p21 region of the genome,
including NPRL2 and FUS-1. The actual results may differ from those
described in this release due to risks and uncertainties that exist in
Introgen's operations and business environment, including Introgen's stage
of product development and the limited experience in the development of
gene-based drugs in general, dependence upon proprietary technology and the
current competitive environment, history of operating losses and
accumulated deficits, reliance on collaborative relationships, and
uncertainties related to clinical trials, the safety and efficacy of
Introgen's product candidates, the ability to obtain the appropriate
regulatory approvals, Introgen's patent protection and market acceptance,
as well as other risks detailed from time to time in Introgen's filings
with the Securities and Exchange Commission including its filings on Form
10-K and Form 10-Q. Introgen undertakes no obligation to publicly release
the results of any revisions to any forward-looking statements that reflect
events or circumstances arising after the date hereof.
Introgen Therapeutics, Inc.
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