ADVEXIN® therapy combines the p53 tumor suppressor with a non-replicating, non-integrating adenoviral delivery system we have developed and extensively tested. The p53 gene is one of the most potent members of a group of naturally-occurring tumor suppressors, which act to kill cancer cells, arrest cancer cell growth and protect cells from becoming cancerous. Introgen's clinical trial strategy for ADVEXIN® is to test it in a variety of life-threatening cancers for which there are no effective treatments. Introgen is seeking to register ADVEXIN® for the treatment of head and neck cancer and Li-Fraumeni Syndrome. Additional late stage clinical trials in breast and lung cancers will enable Introgen to add follow-on indications.
ADVEXIN® -- Clinically advanced, late-stage oncology product development program. Phase I through Phase 3 trials currently ongoing.
FDA designated Fast Track Drug Product Development program
# FDA and EMEA designated Orphan Drug status for ADVEXIN® in head and neck cancer.
ADVEXIN® therapy well tolerated and clinically active.
How It Works
Li-Fraumeni Syndrome (LFS) Li-Fraumeni Syndrome (LFS) is a genetic disorder that greatly increases the risk of developing several types of cancer, particularly at a young age. The majority of LFS families have mutations in the p53 tumor suppressor. ADVEXIN® p53 therapy has been successfully used on a Compassionate Use basis under a protocol accepted by the FDA. Based upon its initial findings, Introgen has decided to continue to make ADVEXIN® p53 therapy available on a compassionate use basis to qualified LFS patients through physician-sponsored protocols at qualifying institutions. As a result of the success in treating LFS with ADVEXIN®, Introgen’s subsidiary, Gendux Molecular Limited, submitted an Orphan Drug Designation Request to the EMEA for the use of ADVEXIN® to treat LFS. The EMEA granted the Orphan Medicinal Product Designation in Europe for the treatment of LFS. Gendux Molecular Limited also submitted a Marketing Authorization Application to the EMEA, which has been accepted for review, for ADVEXIN® for the treatment of Li-Fraumeni Syndrome cancers.
For information regarding participation criteria, please contact Introgen’s Clinical Trials department.
ADVEXIN® Clinical Trials**
Cancer Indication
Status
Head and Neck (both monotherapy and combined with chemotherapy)
Non-Small Cell Lung (combined with radiation therapy)
Breast (combined with chemotherapy)
Perioperative (and surgery)
Esophageal
Prostate
Intravenous Administration
Ovarian
Bladder
Bronchoalveolar
Brain (glioblastoma)
* Conducted in conjunction with the National Cancer Institute.
** We hold the worldwide commercial rights to the product candidates related to each of these programs.
