Gendux Announces Acceptance of its ADVEXIN Marketing Authorization Application for Review by the EMEA
Gene therapy targeting inherited cancer is world's first
According to the company, ADVEXIN is the first treatment specific for an inherited cancer syndrome. ADVEXIN acts by reversing one of the most common cancer genetic defects, abnormal p53 tumor suppressor levels that are inherited in Li-Fraumeni patients and which are found in the majority of non-inherited cancers. ADVEXIN is also being developed for head and neck cancer and filings for this indication are anticipated before the end of 2007 both in Europe and the US.
The acceptance of the MAA for ADVEXIN will initiate the regulatory review of the Application's preclinical, manufacturing and clinical data by the EMEA. Gendux is utilizing the Exceptional Circumstances Approval rules available in Europe to expedite review of potential breakthrough therapies. The review will be based on clinical efficacy and safety results from the use of ADVEXIN in LFS and in a wide variety of non-inherited cancers with abnormal p53 tumor suppression, the target of ADVEXIN treatment. Abnormal p53 is inherited in LFS and is also the most commonly identified defective gene in all solid cancers whether inherited or acquired. An important aspect of ADVEXIN therapy is that patients' tumors can be checked to determine if they have the p53 abnormality targeted by ADVEXIN using widely available diagnostic tests.
Other news from the department research and development
Get the life science industry in your inbox
By submitting this form you agree that LUMITOS AG will send you the newsletter(s) selected above by email. Your data will not be passed on to third parties. Your data will be stored and processed in accordance with our data protection regulations. LUMITOS may contact you by email for the purpose of advertising or market and opinion surveys. You can revoke your consent at any time without giving reasons to LUMITOS AG, Ernst-Augustin-Str. 2, 12489 Berlin, Germany or by e-mail at revoke@lumitos.com with effect for the future. In addition, each email contains a link to unsubscribe from the corresponding newsletter.
Most read news
More news from our other portals
See the theme worlds for related content
Topic world Gene therapy
Genetic diseases once considered untreatable are now at the center of innovative therapeutic approaches. Research and development of gene therapies in biotech and pharma aim to directly correct or replace defective or missing genes to combat disease at the molecular level. This revolutionary approach promises not only to treat symptoms, but to eliminate the cause of the disease itself.
Topic world Gene therapy
Genetic diseases once considered untreatable are now at the center of innovative therapeutic approaches. Research and development of gene therapies in biotech and pharma aim to directly correct or replace defective or missing genes to combat disease at the molecular level. This revolutionary approach promises not only to treat symptoms, but to eliminate the cause of the disease itself.