|Amgen Receives Marketing Authorization For XGEVA. Inovio Demonstrates T Cell Immune Response.|
|By Staff and Wire Reports|
|Friday, 15 July 2011 20:34|
Amgen, Inc. (NASDAQ:AMGN) announced the European Commission (EC) has granted marketing authorization for XGEVA (denosumab) for the prevention of skeletal-related events (SREs) (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumors.
This approval of XGEVA applies to all 27 European Union (EU) member states. The EC also granted XGEVA an additional year of data and market exclusivity in the EU since the indication was considered new for denosumab and based on the significant clinical benefit of XGEVA in comparison with existing therapies.
The primary goal of treatment for bone metastases is to prevent the occurrence of these debilitating and costly SREs. The marketing authorization for XGEVA is based on three pivotal, Phase 3 head-to-head trials that evaluated the effectiveness of XGEVA versus zoledronic acid at delaying SREs.
The SRE clinical program for XGEVA spanned more than 50 tumor types in over 5,700 patients. In the SRE trials, XGEVA demonstrated a clinically meaningful improvement in preventing SREs compared to zoledronic acid.
Inovio Pharmaceuticals, Inc. (AMEX:INO) announced it has reported data demonstrating long-term durability of T cell immune responses of up to over two years (at the latest time measured) in 7 of 8 evaluated patients following a fourth vaccination of VGX-3100, its investigational SynCon DNA vaccine for treating cervical dysplasia and cancer caused by human papillomavirus (HPV) that is delivered using intramuscular electroporation.
The data further highlights the viability of using multiple booster vaccinations with a DNA vaccine delivered using electroporation, in contrast to other non-replicating vaccine vectors that may induce unwanted immune responses against the vector after multiple vaccinations. Inovio's original phase I, designated HPV-001, treated 18 women who had previously been diagnosed with and surgically treated for high grade cervical intraepithelial neoplasia (CIN 2/3), a premalignant lesion that may lead to cervical cancer, with a three-vaccination regimen of its VGX-3100 therapeutic DNA vaccine delivered with its CELLECTRA electroporation device.
Amgen (NASDAQ: AMGN) today announced that the European Commission (EC) has granted marketing authorization for XGEVA® (denosumab) for the prevention of skeletal-related events (SREs) (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumors.
Anavex Life Sciences Corp. ("Anavex") (OTCBB: AVXL) today announced that new data on ANAVEX 2-73, the company's lead compound for Alzheimer's disease (AD) currently in Phase I clinical trials, will be presented in two poster sessions at the 2011 Alzheimer's Association International Conference on Alzheimer's Disease (AAICAD) in Paris, France.
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The current issue of Popular Science magazine includes a feature story profiling William H. Andrews, a member of the Genesis Biopharma, Inc. (OTC/BB: GNBP) Board of Directors, and his work on the anti-aging properties of the human telomerase gene.
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