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Introgen Preclinical Studies Identify mda-7 as a Novel Member Of Cytokine Gene Family (PR Newswire)...an adenoviral vector encoding the mda-7 gene, will selectively kill tumor cells and suppress the growth of tumors in animal models,......Introgen is also conducting a Phase II clinical trial for INGN 201 in lung cancer and Phase I trials for INGN 201 in additional cancer indications including prostate, ovarian, bladder, brain and breast cancer....- Apr 07 3:30 AM ET


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Posted on: 04/07/2001

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Press Release

SOURCE: Introgen Therapeutics, Inc.

Introgen Preclinical Studies Identify mda-7 as a Novel Member Of Cytokine Gene Family

Results Presented at 3rd International Workshop on Interleukin-10 and Related Molecules and Published in Genes and Immunity

BERLIN, April 7 /PRNewswire/ -- Introgen Therapeutics, Inc. (Nasdaq: INGN - news) announced today its discovery that the mda-7 gene is a novel member of the Interleukin-10 family of cytokines. Sunil Chada, Ph.D., Introgen's director of research and development presented these data at the 3rd International Workshop on Interleukin-10 and Related Molecules. A separate complementary study conducted in collaboration with The University of Texas M. D. Anderson Cancer Center was also presented at the conference. Both studies are published in the current issue of the journal Genes and Immunity.

"This discovery demonstrates the power of an integrated genomics approach for discovery and validation of therapeutic genes," said Dr. Chada. "In previous preclinical studies we have shown that INGN 241, an adenoviral vector encoding the mda-7 gene, will selectively kill tumor cells and suppress the growth of tumors in animal models, indicating that the mda-7 gene has tumor suppressor activity. The new studies demonstrate that the mda-7 gene belongs to a class of cytokines that play a role in regulating a wide variety of cellular processes in both healthy and diseased tissues. The findings of this research complement our expanded understanding of mda-7 mechanisms of action and we plan to integrate these new discoveries into the design of our ongoing clinical programs with this drug."

The preclinical study results were discussed in a presentation entitled "mda-7 is a novel member of the IL-10 family," and involved bioinformatics, database mining and structure prediction coupled with sequence analyses of the mda-7 gene from a variety of tumor and normal specimens. Introgen is collaborating with The University of Texas M. D. Anderson Cancer Center to study the cytokine-like activity of the mda-7 protein.

Cytokines are proteins that are produced by many different cells in the body and play a role in controlling important cellular activities such as the immune response to foreign antigens, including tumors.

"The discovery that the mda-7 gene is a novel member of the IL-10 family is very exciting," said Elizabeth Grimm, Ph.D., Ashbel Smith Professor of Molecular and Cellular Oncology at The University of Texas M. D. Anderson Cancer Center. "Our data indicate that the MDA-7 protein behaves as an immune regulator and thus has cytokine properties. The ability of INGN 241 to directly kill cancer cells via apoptosis, and that the protein product MDA-7 can stimulate the immune system, may offer important advantages in the fight against cancer."

Introgen is a leader in the development and production of gene-based drugs for the treatment of cancer and other diseases. Introgen's product candidates engage precise molecular targets to produce a highly specific therapeutic effect. Introgen specializes in combining appropriate gene delivery systems and therapeutic genes to make its gene-based drugs. Introgen's lead product candidate, INGN 201, is currently in Phase III clinical trials for the treatment of head and neck cancer. INGN 201 has been used in numerous clinical trials worldwide either alone or in combination with conventional treatments such as chemotherapy and radiotherapy. Introgen is also conducting a Phase II clinical trial for INGN 201 in lung cancer and Phase I trials for INGN 201 in additional cancer indications including prostate, ovarian, bladder, brain and breast cancer. New applications using the human immune system with INGN 201 are being explored. Introgen's second product candidate, INGN 241 (Adenoviral-mda7), for the treatment of solid tumors, is in Phase I clinical development.

Certain statements in this press release that are not strictly historical may be "forward-looking" statements, which involve risks and uncertainties. Such forward-looking statements include, but are not limited to, those relating to safety and efficacy of drug product candidates, including mda-7 as a member of the Interleukin-10 family of genes. 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 without limitation, Introgen's stage of product development and the limited experience in the development of gene-based drugs in general, its dependence upon proprietary technology and current competition, history of operating losses and accumulated deficits, Introgen's reliance on collaborative relationships, and uncertainties related to clinical trials, safety, efficacy, the ability to obtain the appropriate regulatory approvals, 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 prospectus dated October 12, 2000, filed with the Securities and Exchange Commission and the 10-Q filed with the Securities and Exchange Commission on February 14, 2001. Introgen undertakes no obligation to publicly release the results of any revisions to any forward-looking statements that reflect events or circumstances arising from the date hereof.

SOURCE: Introgen Therapeutics, Inc.

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