The "news" today hasn't helped the stock.<g>
Clinical Benefit in Inherited Cancer
Friday June 2, 7:30 am ET
Key Prognostic and Therapeutic Mechanisms Confirmed in Successful Molecular Treatment of Li-Fraumeni Cancer
BALTIMORE, June 2 /PRNewswire-FirstCall/
Introgen Therapeutics, Inc. (Nasdaq: INGN - News) 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 Gleevec®, 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.
Snip
Bernard |
