SGN-30 简介
这个帖子发布于 21 年零 223 天前，其中的信息可能已发生改变或有所发展。
Description
SGN-30是一种基因工程生产的单克隆抗体,对CD30 抗原有较强的亲和力,CD30在许多血液恶性病变中有高表达.SGN-30可以在表达CD30的肿瘤细胞中发挥直接的抗肿瘤活性.
SGN-30 is a genetically engineered mAb that reacts with significant affinity to the CD30 antigen, which is highly expressed on a variety of hematologic malignancies. SGN-30 has been shown to induce direct anti-cancer activity towards tumor cells expressing CD30.
Development Rationale
In preclinical studies, SGN-30 induced tumor cell death in culture and demonstrated efficacy in models of Hodgkin's disease. The first phase I study of SGN-30 was completed in July 2002. The results demonstrated that SGN-30 was well-tolerated up to a single dose of 15 mg/kg with no significant drug-related toxicities observed. While the study focused on safety and the measurement of various clinical parameters, antitumor activity was also observed.
Status
A phase I/II multi-dose clinical trial of SGN-30 was initiated in November 2002 for patients with Hodgkin's disease, certain non-Hodgkin's lymphomas and specific leukemias. Accrual to the phase I portion of the study is complete and we expect to initiate the phase II study by the end of 2003.
Due to the highly restricted expression of CD30 on activated immune cells, SGN-30 may also be therapeutically applicable for immunologic diseases such as multiple sclerosis and lupus. We are pursuing these opportunities in preclinical studies.
SGN-30是一种基因工程生产的单克隆抗体,对CD30 抗原有较强的亲和力,CD30在许多血液恶性病变中有高表达.SGN-30可以在表达CD30的肿瘤细胞中发挥直接的抗肿瘤活性.
SGN-30 is a genetically engineered mAb that reacts with significant affinity to the CD30 antigen, which is highly expressed on a variety of hematologic malignancies. SGN-30 has been shown to induce direct anti-cancer activity towards tumor cells expressing CD30.
Development Rationale
In preclinical studies, SGN-30 induced tumor cell death in culture and demonstrated efficacy in models of Hodgkin's disease. The first phase I study of SGN-30 was completed in July 2002. The results demonstrated that SGN-30 was well-tolerated up to a single dose of 15 mg/kg with no significant drug-related toxicities observed. While the study focused on safety and the measurement of various clinical parameters, antitumor activity was also observed.
Status
A phase I/II multi-dose clinical trial of SGN-30 was initiated in November 2002 for patients with Hodgkin's disease, certain non-Hodgkin's lymphomas and specific leukemias. Accrual to the phase I portion of the study is complete and we expect to initiate the phase II study by the end of 2003.
Due to the highly restricted expression of CD30 on activated immune cells, SGN-30 may also be therapeutically applicable for immunologic diseases such as multiple sclerosis and lupus. We are pursuing these opportunities in preclinical studies.
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