Healthcare Industry News: p53
News Release - June 2, 2006
Introgen's ADVEXIN p53 Therapy Demonstrates Clinical Benefit in Inherited CancerKey Prognostic and Therapeutic Mechanisms Confirmed in Successful Molecular Treatment of Li-Fraumeni Cancer
BALTIMORE, June 2 (HSMN NewsFeed) -- Introgen Therapeutics, Inc. (Nasdaq: INGN ) presented important data describing the beneficial effects and key markers of clinical activity in a cancer patient with Li-Fraumeni Syndrome (LFS), a genetic disorder characterized by inherited mutations in the p53 tumor suppressor gene. The treatment of Li-Fraumeni tumors with ADVEXIN, Introgen's p53 therapy, represents the epitome of targeted therapy as the cause of these cancers is due to abnormal p53 function that is directly addressed by ADVEXIN treatment. The data were presented last evening at a symposium at the annual meeting of the American Society of Gene Therapy.
"In addition to providing targeted therapy for Li-Fraumeni cancer patients who need novel treatments, the results of our study defined important markers to guide ADVEXIN therapy of other cancers with p53 abnormalities that are very common in most types of cancer," said Neil Senzer, M.D., Scientific Director, Mary Crowley Medical Research Cancer Center, the lead clinical investigator of the study.
Treatment of a tumor in an LFS patient with ADVEXIN led to improvement of tumor-related symptoms and resulted in a complete response as determined by positron emission tomography (PET) scans. PET scans measure the metabolic activity of tumors and are being increasingly utilized in the management of cancer patients because they provide more sensitive assessments of treatment effects compared to conventional computerized tomography (CT) and magnetic resonance imaging (MRI) scans.
In addition, performance of molecular studies with biopsies of the tumor before and after treatment identified key markers of p53 pathway abnormalities that are used to predict and evaluate the effects of ADVEXIN therapy. These markers included detection of abnormal levels of p53 protein that identify aberrant p53 pathways and the induction of molecular markers of tumor growth control and tumor cell death validating ADVEXIN's mechanisms of action.
Robert E. Sobol, M.D., Introgen's senior vice president, Medical and Scientific Affairs commented, "This landmark study defines key principles for effectively evaluating and applying ADVEXIN therapy. These findings are as significant as the initial case reports that identified key assessments that lead to the successful development of GleevecŪ, which is another targeted molecular cancer therapy. Conventional measurements may significantly underestimate the activity and clinical utility of these targeted molecular treatments."
Max Talbott, Ph.D., Introgen's senior vice president, World Wide Commercial Development and Regulatory Affairs stated, "The encouraging data reported today will support the Li-Fraumeni Syndrome Orphan Drug Designation Request recently filed in Europe. In addition, the identification of novel clinical and molecular markers of ADVEXIN activity complies with recent FDA initiatives to accelerate the approval of oncology products through the application of predictive markers that can define patient populations most likely to benefit from a specific cancer therapy."
Introgen will also be reporting the application of these markers to identify patients most likely to benefit from ADVEXIN therapy in recurrent head and neck cancer during presentations at ASGT in Baltimore taking place May 31 - June 4 and a corporate sponsored symposium at the annual meeting of the American Society of Clinical Oncology (ASCO) in Atlanta June 3-6. Following these conferences, Introgen will hold a conference call with an expert panel of cancer specialists who will comment on the importance of its findings.
About Li-Fraumeni Syndrome
The majority of LFS families contain mutations in the p53 tumor suppressor gene. Affected individuals often develop multiple primary tumors, which typically occur at a young age. Conventional therapy of patients with the Li- Fraumeni Syndrome is frequently unsuccessful due to the occurrence of multiple malignancies that share a common p53 genetic defect fundamental to cancer progression and the development of treatment resistance. Defects in p53- mediated cell death pathways cause these tumors to develop resistance to standard therapy, resulting in early death. Additionally, because affected individuals lack p53-mediated DNA repair function, treatment with DNA damaging agents such as radiation and some types of chemotherapy can induce genetic changes that give rise to additional tumors. Introgen is making ADVEXIN p53 therapy available to qualified Li-Fraumeni Cancer patients.
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 function, associated with cancer initiation, progression and treatment resistance. Prognostic biomarkers can identify patients most likely to respond to ADVEXIN. ADVEXIN has demonstrated clinical activity in a number of solid tumor types in multiple phase 1, 2 and 3 clinical trials conducted worldwide.
About Introgen Therapeutics, Inc.
Introgen Therapeutics, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted molecular therapies for the treatment of cancer and other diseases. Introgen is developing molecular therapeutics, immunotherapies, vaccines and nano-particle therapies to treat a wide range of cancers using tumor suppressors and cytokines. Introgen maintains integrated research, development, manufacturing, clinical and regulatory departments and operates multiple manufacturing facilities including a commercial scale cGMP manufacturing facility.
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 the treatment of patients with Li-Fraumeni Syndrome. 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 and Form 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: http://www.introgen.com .
Source: Introgen Therapeutics
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