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Introgen Therapeutics and the University of California Collaborate to Study Gene Therapy Approaches to Arthritis (PR Newswire)...This discovery established the concept of using therapies based upon tumor suppressor genes to treat rheumatoid arthritis and potentially o......additional cancer indications including prostate, ovarian, bladder, brain, and breast cancer.......candidate, INGN 241 (Adenoviral-mda7), for the treatment of solid tumors, is in Phase I clinical development....- Jun 05 7:30 AM ET


Posted on: 06/05/2001

"Yahoo - Introgen Therapeutics and the University of California Collaborate to Study Gene Therapy Approaches to Arthritis"
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Tuesday June 5, 7:30 am Eastern Time

Press Release

SOURCE: Introgen Therapeutics, Inc. and University of California San Diego

Introgen Therapeutics and the University of California Collaborate to Study Gene Therapy Approaches to Arthritis

AUSTIN, Texas and SAN DIEGO, June 5 /PRNewswire/ -- Introgen Therapeutics, Inc. (Nasdaq: INGN - news) and The Regents of the University of California announced today that they have signed a research agreement to evaluate the potential use of gene therapy in the treatment of rheumatoid arthritis (RA) in preclinical studies. Introgen and collaborators at the University of California San Diego (UCSD) will evaluate multiple genes in Introgen's portfolio in laboratory-based studies as a novel approach for the treatment of rheumatoid arthritis. The research will be conducted as a collaborative effort between Gary S. Firestein, M.D., professor of medicine and chief of the Division of Rheumatology, Allergy and Immunology at the UCSD School of Medicine and Introgen.

In 1997, Dr. Firestein and colleagues discovered the first somatic gene mutations in arthritis patients. The mutations were found in the p53 gene. Loss of function of p53 during the course of this disease may increase joint destruction. This discovery established the concept of using therapies based upon tumor suppressor genes to treat rheumatoid arthritis and potentially other chronic inflammatory diseases. The studies conducted under the research agreement by Dr. Firestein and his collaborator, Dr. David L. Boyle, will evaluate Introgen's gene drug candidates in various models of rheumatoid arthritis to determine the effects on disease progression. Dr. Firestein is executive director of the UCSD Center for Innovative Therapy, a clinical and research center based at UCSD's Thornton Hospital, dedicated to bringing new treatments to people with arthritis and inflammatory disease. In 1998, Dr. Firestein was awarded the Carol-Nachman Prize, a prestigious international award given for outstanding research in rheumatology.

"Introgen's gene therapy expertise provides a unique opportunity to evaluate novel molecular targets in arthritis," said Dr. Firestein. "Pre- clinical data support the feasibility of this approach, and the biologic similarities between destructive arthritis and some forms of cancer suggest that anti-cancer treatments might be applicable to non-malignant conditions like rheumatoid arthritis. These drug candidates work by fundamentally different mechanisms and modulate different intracellular signaling pathways. While the therapeutic agents have demonstrated potential as anti-cancer drugs, this will be their first evaluation as 'molecular weapons' to treat rheumatoid arthritis. What we learn may aid in the development of new therapies to treat this disease."

"This research agreement provides Introgen's entry into a new disease indication, rheumatoid arthritis, which affects millions of people," said Sunil Chada, Ph.D., director of research and development at Introgen. "We are very pleased to collaborate with Dr. Firestein, one of the leaders in the development of molecularly targeted approaches to treat this terrible disease."

Background of Arthritis

Rheumatoid arthritis is a disease which afflicts approximately 1% of the world's population and more than 2,000,000 people in the U.S. The consequences of this debilitating condition are joint swelling, pain and disability. Rheumatoid arthritis is a chronic, progressive disease which, when in late stages, can lead to destruction of bone and cartilage often resulting in joint replacement surgery.

About University of California San Diego

Founded in 1959, the University of California, San Diego -- the southernmost of 10 campuses in the world-renowned University of California system -- has risen in stature as one of the nation's premier institutions for higher education and scientific exploration. Led by UCSD Chancellor Robert C. Dynes, UCSD is a powerful magnet for talented students and faculty, supporting 20,200 undergraduate and graduate students, and 4,900 faculty members among its 19,000 employees. The National Research Council ranks UCSD's overall graduate program 10th in the nation, including 14 academic programs ranked in the top 10. U.S. News and World Report ranked UCSD seventh among national public universities for educational excellence. UCSD's $1.4 billion operating budget is composed of federal, state and private revenue sources, including $461 million in research funding, placing UCSD sixth in the nation for federal R&D expenditures. UCSD is an economic and research engine that has spun off 150 companies, including 40% of the region's burgeoning biotechnology industry. The UCSD Health Sciences division, led by Vice Chancellor Edward W. Holmes, encompasses the School of Medicine, which opened in 1968; the UCSD Healthcare system, which includes two hospitals and the UCSD Medical Group of physician practices; and a new School of Pharmacy which will open in 2002.

About Introgen Therapeutics, Inc.

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. In an announcement earlier this year, Introgen published results of preclinical studies which indicate a possible application of INGN 201 whereby the human immune system may be directed to attack tumor cells. Introgen's second product candidate, INGN 241 (Adenoviral-mda7), for the treatment of solid tumors, is in Phase I clinical development. Introgen controls a broad intellectual property portfolio that includes more than 200 pending and issued patents for a variety of gene therapy technologies. Introgen owns a fully staffed and validated Good Manufacturing Practices (cGMP) production facility that is producing Phase III and commercial inventory of INGN 201. Introgen has received a U.S. patent for the commercial scale production of adenovirus.

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 and Introgen's ability to complete its clinical trials, or successfully commercialize any product candidates for the treatment of rheumatoid arthritis. 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 and the 10-Q filed on May 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.

Editor's Note: For more information on Introgen Therapeutics, or for a menu of archived press releases, please visit the Company Website at:, or call Introgen's toll-free Investor Relations hotline at 1-877-776-GENE (4363).

Editor's Note: For more information on the University of California San Diego Center for Innovative Therapy, please visit the website at http://CIT.UCSD.EDU.


     Introgen Therapeutics, Inc.            Leslie Franz
     C. Channing Burke                      University of California San Diego
     (512) 708 9310 Ext. 322                (619) 543-6163
     Email:            Email:

     Noonan/Russo Communications
     Matthew J. Scampoli
     (212) 696 4455 Ext. 243

SOURCE: Introgen Therapeutics, Inc. and University of California San Diego

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