Drug Candidate INGN 201 Looks Promising.(Brief Article)

2002 JAN 16 - (NewsRx.com & NewsRx.net) -- Introgen Therapeutics, Inc., announced additional safety data for its p53 gene drug candidate, INGN 201, adenoviral-p53 at the 10th International Conference on Gene Therapy of Cancer held in San Diego, California, December 17, 2001.

Preclinical studies demonstrated the risk of insertion of the p53 DNA into the host cell genome is very low and furthermore is not increased when cells are exposed to conventional treatments used in cancer therapy. These data provide further evidence in support of the use of INGN 201 in the treatment of cancer.

Lou Zumstein, PhD, Introgen said, "Introgen's safety and clinical trials databases demonstrate that our adenoviral vector is very effective at delivering our therapeutic genes, and is a very safe and nontoxic vector. We cannot detect INGN 201 adenovirus integrating into genomic DNA, even with a very sensitive assay and extensive investigation. This data, when combined with our data on the almost 600 patients we have treated with INGN 201, offers a safety profile with which we are extremely comfortable. I believe that Introgen continues to set the standard by which our industry is defined."

In the study, scientists examined the insertion frequency of INGN 201 into the genomic DNA of human lung cancer cells. Adenoviruses have historically been shown to insert into host cell genomic DNA at a very low rate. The results of this study show that INGN 201 integration into the host cell DNA cannot be detected. It also showed that the frequency is lower than the frequency seen in studies with other adenoviral vectors and that the use of DNA damaging agents such as radiation and cisplatin, agents often used in cancer therapy, does not increase the integration frequency of the adenovirus. These results provide additional support for the safety profile of INGN 201 in the treatment of cancer.

Introgen also presented data at the conference on flow cytometry to study the biological activity of p53 following treatment with INGN 201 in vitro. As a result of this work, Introgen and its collaborators have developed a new assay for p53 function which may provide a more sensitive analysis of p53 expression and activity in patient samples.

High-level expression of the p53 protein is known to increase the levels of certain other proteins, and thus increased levels of these proteins provide potential markers for the activity of overexpression of p53 inside the cell. Introgen's collaborator, Keith Shults of Esoterix Center for Innovation in Tennessee, presented these data.

Using flow cytometry to measure protein expression, scientists measured the relative expression levels of p53, and several proteins that p53 activates, in cells transduced with INGN 201. Several of these proteins showed increased expression after ...