A company called Introgen Therapeutics has asked the FDA to grant priority review for a gene-based medication called Advexin p53, a treatment for recurrent head and neck cancers. This is the first application in the USA for approval to market a gene-based medicine.
The therapy has demonstrated efficacy, with moderate side effects that cause flu-like symptoms, and can be used in combination with chemotherapy and radiation, according to analysts.
One can expect the FDA to study this application with great care because it is the first application of this type. However, if the FDA agrees to Invitrogen’s application, a final ruling on the medication could be handed down by early 2009. Whatever the precise situation, this is another very promising step forward in the development of innovative therapeutics for the treatment of cancer.
Filed under: Drugs in development, Management, Treatment, Uncategorized
An Advexin update: Shares of Introgen Therapeutics tumbled 20 percent yesterday after TheStreet’s Adam Feuerstein questioned whether Advexin was as effective as the company has billed it. Feuerstein used Introgen’s studies to make the case that the drug failed to measure up to the company’s comments.
Feuerstein is unapologetic. In his story he notes that he panned Introgen back in December with the following: “Introgen is a terrible company. Advexin is junk. The drug doesn’t work. The data are manipulated and false. Management misleads.”
Such are the trials of bringing new biotechnology to the healthcare market in the modern world. Is Advexin a valuable drug? Clearly you would need to ask people wiser than we are!