Introgen Presents Biomarker Data Demonstrating Abnormal p53 Predicts ADVEXIN Efficacy in Head and Neck, Lung, Prostate and Li-Fraumeni Cancers.Data to Be Used to Support U.S. and European Regulatory Filings DALLAS & AUSTIN, Texas -- Introgen Therapeutics, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :INGN) today reported the results of new data analysis from multiple Phase 2 clinical studies showing a statistically significant correlation between the abnormal p53 biomarker and tumor response after treatment with ADVEXIN in patients with head and neck, lung, prostate and Li-Fraumeni Syndrome Li-Fraumeni syndrome SBLA syndrome An AD condition with ↑ risk of multiple malignancies––eg, sarcomas, carcinomas of adrenal cortex, breast, larynx and lung, brain tumors, leukemia and lymphomas at any time from infancy to adulthood, due to a cancers. These data were presented at the Mary Crowley Medical Research Center Conference on Cancer Gene Therapy in Dallas. The Company will utilize these biomarker findings for its ongoing analyses of its randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. Phase 3 trial comparing ADVEXIN therapy to methotrexate methotrexate, drug used in halting the growth of actively proliferating tissues. Introduced in the 1950s, it is used in the treatment of leukemia, psoriasis, and non-Hodgkin's lymphoma. for the treatment of recurrent head and neck cancer. Prior to the initiation of the Phase 3 analyses, the Company gained consent from the U.S. Food and Drug Administration to amend the ADVEXIN Investigational New Drug Application and Statistical Analysis Plan to include analyses of patient populations identified by the abnormal p53 biomarker. These prospective analyses and evaluations will be included in the ADVEXIN U.S. and international regulatory submissions. "These findings provide important support for our regulatory filings," said Max W. Talbott, Ph.D., Introgen's senior vice president of Worldwide Commercial Development and Regulatory Affairs Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals usually have responsibility for the following general areas: European Community application for ADVEXIN in Li-Fraumeni Syndrome, an inherited cancer disorder characterized by the development of multiple tumor types with abnormal p53." In 54 late-stage cancer patient samples evaluated from the Company's Phase 2 studies, tumor response after ADVEXIN monotherapy was observed in 35 percent of patients with the abnormal p53 biomarker and all tumor responses occurred in the abnormal p53 biomarker group (p = 0.0013). The majority of these patients had recurrent disease after receiving standard therapies. Introgen has previously reported study results demonstrating a statistically significant correlation between the abnormal p53 biomarker and increased survival after ADVEXIN therapy in head and neck cancer patients. "The results presented today confirm and extend previous biomarker data correlating the abnormal p53 biomarker with increased tumor responses following ADVEXIN treatment and support its use as a biomarker to predict ADVEXIN efficacy," said John Nemunaitis, M.D., a principal investigator Noun 1. principal investigator - the scientist in charge of an experiment or research project PI scientist - a person with advanced knowledge of one or more sciences of the studies and executive director of the Mary Crowley Medical Research Center. "Importantly, the data from multiple tumor types indicate an absolute correlation of tumor response and abnormal p53 as 100 percent of the responding tumors had the abnormal p53 biomarker." About ADVEXIN ADVEXIN p53 therapy is a targeted molecular therapy with broad applicability in a wide range of tumor types and clinical settings because it targets one of the most fundamental and common molecular defects, abnormal p53 tumor suppressor sup·pres·sor n. 1. or sup·press·er One that suppresses: a suppressor of free speech. 2. A gene that suppresses the phenotypic expression of another gene, especially of a mutant gene. function, associated with cancer initiation, progression and treatment resistance. Introgen believes that ADVEXIN has demonstrated increased survival and tumor growth control in recurrent head and neck cancer patients. In addition, ADVEXIN has demonstrated clinical activity in a number of solid tumor types in multiple phase 1, 2 and 3 clinical trials conducted worldwide. Introgen's first clinical trial was initiated in 1995 and approximately 30 clinical trials have been conducted to date in more than ten different oncology indications. Neither ADVEXIN nor any of Introgen's other adenovirus adenovirus Any of a group of spheroidal viruses, made up of DNA wrapped in a protein coat, that cause sore throat and fever in humans, hepatitis in dogs, and several diseases in fowl, mice, cattle, pigs, and monkeys. products have ever been put on clinical hold by FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. or other regulators due to safety concerns or for any other reason. About Introgen Therapeutics, Inc. Introgen Therapeutics, Inc. is a biopharmaceutical company focused on the development, manufacturing and commercialization of targeted tumor suppressors, a new class of therapies for the treatment of cancer. Introgen's technology delivers targeted molecular therapies that increase production of normal cancer-fighting proteins and cytokines Cytokines Chemicals made by the cells that act on other cells to stimulate or inhibit their function. Cytokines that stimulate growth are called "growth factors. . The Company is developing a proprietary pipeline of product candidates utilizing molecular biomarkers to identify patients most likely to benefit from its therapies which target central cancer-causing mechanisms. ADVEXIN[R], its lead product candidate, targets abnormal p53, a fundamental cancer defect present in over 50 percent of all tumors. Introgen is analyzing its phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study. for recurrent head and neck cancer using ADVEXIN as a monotherapy. The Company plans to complete regulatory filings in both the United States and in Europe by the end of 2007. Statements in this release that are not strictly historical may be "forward-looking" statements, including those relating to Introgen's future success with its ADVEXIN clinical development program for treatment of cancer. 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 Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. and Form 10-Q Form 10-Q See 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: www.introgen.com. |
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