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Introgen's Nanoparticle Cancer Therapy INGN 401 Demonstrates

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http://www.prnewswire.com/cgi-bin/stori ... 079&EDATE=

ORLANDO, Fla., May 17 /PRNewswire-FirstCall/ -- Introgen Therapeutics,

Inc. (Nasdaq: INGN) today provided an update of its ongoing clinical

development of INGN 401, a nanoparticle formulation of the tumor suppressor

gene FUS1. New preclinical data highlighting the potential of INGN 401 alone

and in combination with Iressa® (Gefitinib) in the treatment of non-small

cell lung cancer were reported. The data were presented today (Abstract

#7081) at the 41st Annual Meeting of the American Society of Clinical Oncology

(ASCO) in Orlando. Introgen researchers and their colleagues at The M. D.

Anderson Cancer Center (MDACC) and The University of Texas Southwestern

Medical Center are conducting the studies of INGN 401.

"The preclinical data presented today are very encouraging because they

suggest that INGN 401 may have utility as a monotherapy and may also help to

improve chemotherapy response rates in patients with lung cancer," said Sunil

Chada, Ph.D., associate vice president, Clinical Research at Introgen. "The

five-year survival of patients with non-small cell lung cancer is only

15 percent, and these patients have significant unmet medical needs. These

preclinical findings support the utility of INGN 401 in the treatment of lung

cancer, and support our ongoing Phase 1 clinical trial of INGN 401 in this

disease. The data illustrate that our nanoparticle delivery system may

provide a novel approach to the systemic delivery of gene-based cancer


Significant inhibition of tumor growth in animal models of lung cancer was

observed following INGN 401 monotherapy treatment compared with untreated

animals. In addition, INGN 401 demonstrated synergistic activity with

Gefitinib, a novel class of anti-cancer agents that decrease tumor growth by

inhibiting growth factor receptors that promote tumor proliferation. While

Gefitinib can produce dramatic responses in a small subset of lung cancer

patients, most lung cancers are refractory to its effects. In the reported

studies, nanoparticle delivery of INGN 401 synergized with Gefitinib in

killing lung tumor cells resistant to Gefitinib alone. Furthermore, in

Gefitinib-sensitive tumors, INGN 401 delivery significantly enhanced anti-

cancer activity.

A Phase 1 clinical trial of INGN 401 in patients with stage IV non-small

cell lung cancer is in progress. This study is evaluating intravenous

delivery of INGN 401 as monotherapy for patients with advanced lung cancer who

have experienced disease progression while on chemotherapy.

About Introgen

Introgen holds a licensing agreement with M. D. Anderson 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 own stock in Introgen. These arrangements are managed in

accordance with M. D. Anderson's conflict of interest policies.

Introgen is a leading developer of biopharmaceutical products designed to

induce therapeutic protein expression using non-integrating gene agents for

the treatment of cancer and other diseases. Introgen maintains integrated

research, development, manufacturing, clinical and regulatory departments and

operates a commercial-scale, CGMP manufacturing facility.

Certain statements in this press release that are not strictly historical

may be "forward-looking" statements, which are based on current expectations

and entail various risks and uncertainties. Such forward-looking statements

include, but are not limited to, those relating to Introgen's future success

with its clinical development program for INGN 401 for lung and other cancers.

There can be no assurance that Introgen will be able to commercially develop

gene-based drugs, that necessary regulatory approvals will be obtained or that

any clinical trials or studies undertaken will be successful or that the

proposed treatments will prove to be safe and/or effective. The actual

results may differ from those described in this press release due to risks and

uncertainties that exist in Introgen's operations and business environment,

including, but not limited to, Introgen's stage of product development and the

limited experience in the development of gene- based drugs in general,

Introgen's 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 annual

report on Form 10-K filed with the Securities and Exchange Commission on

March 15, 2005 and its quarterly report on Form 10-Q filed with the Securities

and Exchange Commission on May 10, 2005. 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.

Editor's Note: For more information on Introgen Therapeutics, or for a

menu of archived press releases, please visit Introgen's Website at:

http://www.introgen.com .


Introgen Therapeutics, Inc.

C. Channing Burke

(512) 708 9310 Ext. 322

Email: c.burke@introgen.com

SOURCE Introgen Therapeutics, Inc.

Web Site: http://www.introgen.com


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