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Introgen's INGN 225 Cancer Vaccine Shows Promising Safety an


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http://www.prnewswire.com/cgi-bin/stori ... 437&EDATE=

AUSTIN, Texas, Sept. 12 /PRNewswire-FirstCall/ -- Introgen Therapeutics,

Inc. (Nasdaq: INGN) presented updated interim results from an ongoing Phase 2

trial of its investigational cancer vaccine, INGN 225, in patients with

advanced small cell lung cancer. Results presented over the weekend at the

13th International Conference on Gene Therapy of Cancer show that the vaccine

is well tolerated and that INGN 225 appears to sensitize lung tumors to

additional chemotherapy, with 62 percent of patients who received second-line

chemotherapy exhibiting objective responses.

INGN 225 is a personalized vaccine that utilizes the p53 tumor suppressor

gene to stimulate a cancer patient's immune system to destroy cancer cells.

"These promising results highlight the broad potential of p53-based

therapies in the treatment of cancer," said Sunil Chada, Ph.D., Introgen's

associate vice president, Clinical Research. "p53, the active component of

INGN 225, is typically expressed at undetectable levels in normal cells. In

cancer cells, however, levels of p53 are often significantly increased, making

this important protein a cancer-specific vaccine target."

INGN 225 is an investigational therapeutic vaccine consisting of a cancer

patient's dendritic cells, a type of immune cell, treated with an adenovector

carrying the human p53 gene (Ad-p53). In the study, patients with extensive

stage (advanced) small cell lung cancer were treated with their own dendritic

cells combined with Ad-p53. To date, 27 patients have each received at least

three doses of the vaccine. Earlier interim results of this study were

reported at the annual meeting of the American Society of Clinical Oncology in

May.

Interim results show that the vaccine was well tolerated, with no

appreciable INGN 225 related toxicity in any of the treated patients.

Following INGN 225 treatment, 62 percent of the evaluable patients in the

study had objective responses to subsequent chemotherapy by standard RECIST

(Response Evaluation Criteria in Solid Tumors) criteria.

"Historically, the expected objective response rate in patients with this

type of advanced lung cancer is less than 25 percent," said Dmitry

Gabrilovich, M.D., Ph.D., professor of oncology at the H. Lee Moffitt Cancer

Center and co-principal investigator of the study. "The results of post-

vaccination second-line chemotherapy are striking -- double what we would

predict in this patient population. These data strongly suggest that INGN 225

sensitizes lung cancer cells to the effects of chemotherapy and may in fact

significantly enhance the efficacy of subsequent chemotherapy." A Phase 1/2

trial of INGN 225 in patients with breast cancer is ongoing.

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 tumor

suppressor therapies to treat a wide range of cancers using non-integrating

tumor suppressors, cytokines and genes. Introgen maintains integrated

research, development, manufacturing, clinical and regulatory departments and

operates multiple manufacturing facilities including a commercial scale cGMP

manufacturing facility.

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 and INGN 225 in the treatment of lung and breast cancers. 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.

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 .

Contact:

Introgen Therapeutics, Inc.

C. Channing Burke

(512) 708 9310 Ext. 322

Email: [email protected]

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