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Introgen`s INGN 241 Product Potentially Useful Gene Therapy for Human Melanoma (PR Newswire)...INGN 241 is currently in Phase I clinical development for the treatment of solid tumors.......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....- Mar 02 9:00 AM ET

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Posted on: 03/02/2001

"Yahoo - Introgen's INGN 241 Product Potentially Useful Gene Therapy for Human Melanoma"
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Press Release

SOURCE: Introgen Therapeutics, Inc.

Introgen's INGN 241 Product Potentially Useful Gene Therapy for Human Melanoma

Study Results Announced at Fifth World Conference on Melanoma

VENICE, Italy, March 2 /PRNewswire/ -- Introgen Therapeutics, Inc. (Nasdaq: INGN - news) announced today that INGN 241 (adenoviral-mda7) has demonstrated antitumor activity against human melanoma cells in vitro. INGN 241 is currently in Phase I clinical development for the treatment of solid tumors. Elizabeth Grimm, Ph.D., Ashbel Smith Professor in the Departments of Tumor Biology and Surgical Oncology at The University of Texas M. D. Anderson Cancer Center, and principal investigator of the study, presented these data at the Fifth World Conference on Melanoma, sponsored by the World Health Organization.

The preclinical study showed that INGN 241 caused growth arrest and induced apoptotic death in melanoma cells derived from both early and metastatic stages of disease. The anti-tumor effects were tumor-selective, as INGN 241 did not kill normal melanocytes, the skin cell involved in melanoma development. Melanoma is the most malignant of skin cancers. In the United States, the incidence of melanoma is increasing more rapidly than any other cancer. Currently available therapies for advanced melanoma have an approximately 80% failure rate and better therapies are needed.

"Gene therapy for melanoma using a gene originally isolated from growth- arrested melanoma cells may provide a unique approach to treating melanoma," said Dr. Grimm. "Adenoviral mda-7 is a broad spectrum anti-cancer agent and uses growth control mechanisms that are different than other gene therapy approaches. These studies also demonstrate that although different genes are mutated in different tumor types, INGN 241 can re-establish fundamental growth controls leading to induction of apoptosis in melanoma tumor cells."

The melanoma differentiation associated gene-7 (mda-7) was discovered by Dr. Paul B. Fisher of Columbia University, who identified in preclinical studies that mda-7 is up-regulated during melanoma differentiation. Introgen has shown that INGN 241 (an adenoviral vector carrying the mda-7 gene) can induce cell death or apoptosis in a broad range of cancer cells.

"Introgen has demonstrated in preclinical studies that INGN 241 has activity against a wide variety of tumor types, including breast, lung and colon cancer," said Sunil Chada, Ph.D, director of research and development for Introgen. "Introgen's collaboration with Dr. Grimm provides new opportunities to evaluate development of this drug in melanoma."

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. By selectively killing cancer cells and harnessing natural protection mechanisms, Introgen's product candidates may be less toxic than conventional treatments. 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, specifically with respect to melanoma cells. 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.

Contact: C. Channing Burke of Introgen Therapeutics, Inc., 512-708-9310, Ext. 322, or; or Lora Pike of Noonan/Russo Communications, 415-677-4455, Ext. 211, or, for Introgen Therapeutics, Inc.

SOURCE: Introgen Therapeutics, Inc.

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