To: zeta1961 who wrote (690 ) 3/15/2007 10:49:53 AM From: zeta1961 Respond to Advexin Biomarker data at AACR..this was given in a PR last Q..I'd love to know how this is received..otoh, it seems to me that this data is validating in humans what's been the premise of p53 research in the first place..its absence or mutation is what accounts for at least 50% of cancers and that Advexin formulation was able to infect itself into these tumors...that's why the belly-aching by the bashers saying this was retrospective, yadda, yadda doesn't hold water for me..but for sure, I'd want to hear this opinion from the experts in oncology..I'm working on that..Samples were available from 28 patients with recurrent SCCHN who were subsequently treated with Advexin in Phase II clinical trials. p53 protein overexpression (>20% positive cells) had a statistically significant correlation with locoregional tumor disease control (CR, PR, or SD, all of >3 months duration) and increased median survival following Advexin treatment. 75% (12/16) of patients with p53+ tumors demonstrated locoregional disease control, compared to only 18% (2/11) of patients with p53- tumors (p=0.0063; Fisher’s Exact Test). In addition, the median survival of patients with tumors overexpressing p53 protein (p53+) was 11.6 months, compared to only 3.5 months in patients whose tumors were p53- (p=0.0007; Log-Rank Test). In conclusion, analysis of pre-treatment tumor samples has revealed that overexpression of p53 protein is a predictive biomarker that identifies a subset of patients most likely to benefit from p53 gene therapy, as indicated both by increased tumor response and survival. The subpopulation of patients identified by this biomarker is known to have a poor prognosis and is generally the most resistant to conventional treatments. Our findings indicate that p53 overexpression identifies a population of patients with defective apoptotic pathways that can benefit from treatment with the normal p53 gene.
