这个正在三期临床的AGS 003是不是比较类似我们的DC CIK
看起来效果还挺靠谱的，不知道为什么这边很多人都觉得免疫治疗没有用，是不是国内技术不行啊FDA Approves AGS-003 SPA
Fri, 07/06/2012 - 11:15am
Get today's drug discovery & development headlines and news - Sign up now!
Argos Therapeutics Inc., a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis technology platform, announced the U.S. Food & Drug Administration (FDA) has approved the company's revised Special Protocol Assessment (SPA) for its Phase 3 clinical study of AGS-003 for the treatment of metastatic renal cell carcinoma (mRCC). The Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT) study has initiated and is expected to begin dosing patients in the second half of 2012, with a primary clinical endpoint of overall survival.
"FDA acceptance of our revised SPA is an important step forward for our continued clinical development of AGS-003 in newly diagnosed mRCC patients," said Jeff Abbey, Chief Executive Officer of Argos Therapeutics. "Based on the highly encouraging long-term survival we observed in our Phase 2 combination study of AGS-003 plus sunitinib, we amended our Phase 3 protocol to focus on a primary endpoint of improving overall survival for patients randomized to receive AGS-003 plus sunitinib versus sunitinib alone. With our revised SPA, the FDA has agreed that the pivotal ADAPT study could support a future BLA submission if the study objectives are met."
In a Phase 2 study, treatment with AGS-003 was associated with encouraging median and long-term survival for newly diagnosed mRCC patients who presented with intermediate or poor risk ("unfavorable" risk) factors. Adding AGS-003 to standard sunitinib doubled overall survival for these patients compared to historical results1 for unfavorable risk patients treated with sunitinib alone. Importantly, greater than 50 percent of patients in the study survived longer than 30 months after initiating therapy, which is four times the expected rate for sunitinib2, suggesting a pronounced survival benefit for the combination regimen with no added toxicity.
"The key to AGS-003's encouraging clinical benefit and lack of toxicity is its remarkable specificity for the tumor," stated Charles A. Nicolette, Ph.D., Chief Scientific Officer and Vice President of Research and Development of Argos Therapeutics. "Other immunotherapies use non-mutated self antigens, which are poorly immunogenic and are usually paired with non-specific immune stimulators, or adjuvants.
AGS-003 is a fully personalized active immunotherapy that preferentially targets mutated tumor antigens known to drive progression of disease. These mutated antigens are recognized as foreign by T-cells in the body, which allows AGS-003 to direct a potent and highly specific immune response against the tumor, with no collateral damage to healthy tissues."
Dr. Nicolette continued, "In our phase 2 combination study, we demonstrated a statistically significant correlation between the number of anti-tumor T-cells induced and overall survival in mRCC patients receiving AGS-003. This strong correlation validates our mechanism of action and gives us confidence to advance AGS-003 into the pivotal ADAPT study with a primary objective of improving overall survival."
The ADAPT Phase 3 study is a 2:1 randomized, multicenter, open-label study of AGS-003 in combination with standard targeted therapy, beginning with sunitinib, compared to targeted therapy alone in newly diagnosed mRCC patients. A total of 450 patients will be enrolled at approximately 100 sites in North America and ex-U.S. The study design is similar to the previous Phase 2 combination study, but with key differences that Argos believes will ensure clinical success and that are addressed in the revised SPA. The study's primary endpoint is overall survival (OS). Additional endpoints will include overall response, immune response, progression-free survival (PFS) and safety.
Date: July 2, 2012
Source: Argos Therapeutics Inc.
看不懂啊！给个翻译吧
页:
[1]