MimiVax malignant glioma vaccine SurVaxM Phase II study positive
May 24, 2018 Source: Sina Pharmaceutical
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Recently, MIMIVAX, a biotechnology company focused on cancer immunization and targeted therapy, announced the positive interim results of the multicenter phase II study of SurVaxM for the treatment of patients with newly diagnosed malignant glioma (nGBM). These promising interim results will support the development of SurVaxM in combination with standard therapy as a malignant glioma potential therapy. The company has plans to conduct a randomized trial of malignant glioma treatment before completing this study and review in the fourth quarter of this year.
Key interim results included 91% of patients receiving SurvAxM combination therapy for 12 months of overall survival (OS-12), 61% for historical standard therapy, and 96% for 6 months. Progression free survival (PFS-6), compared with 54% of historical standard treatment. In this study, 13 of 63 patients did not progress within 12 months. Evidence to date indicates that SurVaxM is easy to administer, safe, well tolerated, and has few side effects.
Dr. Robert Fenstermaker, co-inventor and senior researcher at SurVaxM, said: "The mid-term results of phase II trials in these newly diagnosed patients with malignant gliomas are very promising for the long-term survival of this group, and in this group. There is still a large medical need that has not been met. We believe that this drug may change the treatment mode of malignant glioma.
SurVaxM is the world's first peptide-simulated tumor vaccine that targets a cell viable protein called Survivin, which is present in 95% of patients with malignant glioma and many other cancer patients. SurvAxM has a dual mechanism of action that stimulates T cell immunity and antibody-directed inhibition of the survivin pathway, which can control tumor growth and prevent or delay tumor recurrence. SurVaxM has received the US FDA orphan drug title.
MMIVAX CEO Dr. Michael Ciesielski said: "Glioblastoma is the most common and invasive type of brain tumor, and there are few effective treatment options. Since Survivin accounts for a large proportion of cancer in general, we expect SurVaxM to be Widespread applicability in many cancers other than malignant glioma."
The interim analysis included an analysis of 63 patients aged 20 to 82 years (median 60), male: female = 32:23.
PFS-6 was 96.3% (2.8, -10.3) (n = 55), and OS-12 was 90.9% (6.1, -16.5) (n = 33). The program is generally well tolerated and drug-related adverse events are mild. The drug is very active in stimulating the immune response of tumor cells and produces anti-Survivin-specific antibody (IgG) and CD8+ T cell responses. The drug also has the ability to stimulate immune helper cell support, which is important for enhancing and maintaining anti-tumor CD8+ activity. (Sina Pharmaceutical Compilation / David)
Reference Source: MimiVax Announces Positive Interim Results from Phase II Trial of SurVaxM Immunotherapy for the Treatment of Newly Diagnosed Glioblastoma
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