PI results for AdPEDF for AMD are published:
>>GAITHERSBURG, Md.--(BUSINESS WIRE)--Feb. 7, 2006--GenVec, Inc. (Nasdaq: GNVC ) announced today the publication of results from a Phase I clinical study of its AdPEDF gene therapy in 28 patients with advanced neovascular age-related macular degeneration (AMD), a debilitating eye disorder. The findings, published in the February 2006 issue of Human Gene Therapy, showed evidence of a halt in disease progression lasting six to twelve months after patients received a single intravitreous injection of AdPEDF. There were no serious adverse events, severe ocular inflammation or dose-limiting toxicities reported.
Although the Phase I multi-center, open-label, dose-ranging study was not designed to show efficacy, patients in the group that received higher doses of AdPEDF showed no increase in the size of retinal lesions at six and twelve months post-injection, compared to patients in the lower dose group whose lesions increased over time. Visual acuity in patients in the higher dose group was stable for the entire twelve months of the study, while those treated in the lower dose group appeared to show deterioration at six and twelve months. These findings suggest that a prolonged therapeutic effect may be achieved after a single injection of AdPEDF.
AdPEDF is an adenoviral-based vector containing the gene for human pigment epithelium-derived factor (PEDF), a protein which regulates blood vessel growth in the eye and protects the cells of the retina from damage. Previous animal studies have shown the potential benefits of increasing PEDF expression in the eye to prevent the growth of blood vessels (angiogenesis) that leads to vision loss.
In a commentary published in the same issue of Human Gene Therapy, Jean Bennett, M.D., Ph.D., professor of ophthalmology, cell and developmental biology at the University of Pennsylvania School of Medicine, wrote, "It is encouraging that evidence of a sustained therapeutic effect was seen ... after one intravitreal injection. One advantage of a gene therapy approach compared with other treatment paradigms is that the molecule is produced at high levels within the target tissue and over a prolonged period of time." A copy of the publication and the supporting editorial can be found on GenVec's website by selecting Webcasts & Data/Recent Data Presentations/PEDF.
AMD is a loss of vision caused by the death of photoreceptors and retinal pigmented epithelial cells that occurs when new blood vessels grow and pockets of fluid form around the retina. Vision loss is potentially reversible at this stage of disease if the growth process can be stopped and fluid resorption takes place. The disorder affects almost thirty percent of adults between the ages of 75 and 85. New therapies to treat AMD have demonstrated benefit but these therapies must be injected every four to six weeks. GenVec believes its gene transfer approach may provide an effective and more convenient treatment for AMD.<<
snip
Don't know how this compares to the PI results of other compounds such as Lucentis; I'd have to go digging.
Cheers, Tuck |
