“The genomics effort to discover and sequence the genes in this region was led by Michael Lerman, M.D., Ph.D., of the NCI and by John Minna, M.D., our collaborator at The University of Texas Southwestern Medical Center,” said Jack A. Roth, M.D., chairman of the Department of Thoracic and Cardiovascular Surgery and Co-Executive Director of the Keck Center for Cancer Gene Therapy at M. D. Anderson Cancer Center. “We have now taken the next step by assigning function to them. We are excited to work with these particular genes because loss of this region is the earliest known genetic abnormality that occurs in the development of lung cancer, suggesting that these genes may be important gatekeepers in preventing the formation of cancer. The tumor suppressor genes we have identified may also be important in preventing the development of multiple types of human cancers since similar abnormalities have been found in renal, breast, head and neck, ovarian, and cervical cancers.”
In collaboration with scientists at M. D. Anderson Cancer Center, preclinical and clinical development of the genes in this region has begun. The tumor suppressor genes in this region have been incorporated into gene delivery systems and have blocked the growth of established tumors in animal models of lung cancer. Studies into the mechanism by which these genes induce apoptosis, or programmed cell death, in tumor cells are ongoing.
“We have acquired a wealth of genetic ammunition through this license that has potential for the treatment of established human cancers as well as possibly preventing cancers with early intervention techniques,” said Deborah R. Wilson, Ph.D., associate vice president of clinical research at Introgen. “The critical role of these genes in suppressing the development of lung cancer makes this particular disease an early clinical target for gene-based therapeutics that carry them. Introgen’s clinically proven delivery systems, already tested in over 500 patients, are well suited to carry these genes. Introgen’s clinical development and manufacturing infrastructure can help us accelerate programs to apply these discoveries,” she continued.
“As with our other gene identification programs, we are aggressively pursuing patent protection for this important new family of tumor suppressor genes,” said David L. Parker, Ph.D., J.D., vice president of intellectual property for Introgen. “This work highlights the ability of Introgen and its academic partners to identify and develop new therapeutic genes using its cancer genomics capabilities, which is the ultimate goal of genomics programs.”
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 is currently conducting two Phase III clinical trials for the treatment of head and neck cancer with its lead product candidate, INGN 201. Introgen’s gene therapeutics have been used in approximately twenty clinical trials worldwide either alone or in combination with conventional treatments such as chemotherapy, surgery 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. In addition, under the Cooperative Research and Development Agreement between Introgen and the NCI, NCI is sponsoring Phase I trials in lung, bladder, ovarian and brain 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 those developed with the family of ten 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-K filed with the Securities and Exchange Commission on September 19, 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.
Additional Contact:
M. D. Anderson Cancer Center
Julie Penne 713-792-0655 jpenne@mdanderson.org
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