505(b)(1)
LXPA1788
LXPA1788是全新药物分子，目前规划将用于消化道系统相关之癌症治疗。
适应症
实体肿瘤
- 肾脏肿瘤
- 肝癌
- 胰脏癌
Science
多靶点激酶抑制剂(Multi-target Kinase Inhibitor)
LXPA1788 是一种多靶点激酶抑制剂，能同时抑制多条对癌细胞增生至关重要的讯息传递路径
优势::
- 更有效的抑制癌细胞生长
- 降低副作用
- 克服抗药性
最新进展
- 于2024年进入第一阶段临床试验
- 美国FDA及台湾TFDA IND申请中
临床前
申请
第一阶段
第二阶段
第三阶段
上市
Phase1
Pre-clinical 临床前研究
LXPA1788可有效抑制 胰脏癌及肝癌 (动物试验)
胰脏癌
肝癌
Compare to other drug 相对于其他药物
LXPA1788具有 better inhibitory effect
癌症细胞株说明
MOLM-13
Acute Monocytic Leukemia Cell Line
The cell line was established from the peripheral blood of a patient at relapse of acute monocytic leukemia which had evolved from myelodysplastic syndrome (MDS).
MV4-11
Acute Monocytic Leukemia Cell Line
The cell line was established from the peripheral blood of a patient at relapse of acute monocytic leukemia which had evolved from myelodysplastic syndrome (MDS).
RS4-11
Acute Monocytic Leukemia Cell Line
A lymphoblast cell line that was isolated from the marrow of a White, 32 years old, female patient with acute lymphoblastic leukemia.
HCC827
Non-Small Cell Lung Cancer Cell Line
An epithelial cell that was isolated from the lung of a White, 39-year-old female patient with adenocarcinoma.
H1975
Non-Small Cell Lung Cancer Cell Line
The cell line was isolated from the lungs of a nonsmoking female with non-small cell lung cancer.
H2228
Non-Small Cell Lung Cancer Cell Line
The cell line was isolated from a lung adenocarcinoma derived from a female nonsmoker with non-small cell lung cancer.
HCT-116
Colon Cancer Cell Line
The cell line was isolated from the colon of an adult male with colon cancer.
Mia-PaCa2
Pancreatic Cancer Cell Line
An epithelial cell line that was derived from tumor tissue of the pancreas obtained from a 65-year-old, White male.
比较药物相关说明
Linifanib
- 抑制受体酪胺酸激酶（RTK）、血管内皮生长因子（VEGF）和血小板衍生生长因子（PDGF）
- 目前处于第三期临床试验。
- 适应症
肝细胞癌
Sorafenib
- 抑制Raf激酶、PDGF（血小板衍生生长因子）、VEGF受体2和3激酶，以及c-Kit（干细胞因子受体）
- 于2005年12月20日首次获得FDA批准。
- 适应症
2005年：晚期肾细胞癌
2007年：无法切除的肝细胞癌
2013年：转移性分化型甲状腺癌(Metastatic Differentiated Thyroid Cancer)
Midostaurin
- 抑制蛋白激酶Cα、VEGFR2、KIT、PDGFR以及野生型/突变型FLT3酪胺酸激酶。
- 于2017年4月28日获得FDA批准。
- 适应症
2017年：FLT3突变型急性骨髓性白血病(AML)及系统性肥大细胞增多症(Systemic Mastocytosis)
Clinical Study Design 临床试验之规划
Phase I 临床试验预计于 2024 Q2进行
三家台湾医院
实体肿瘤病患
预计收30~40名临床受试者
Adaptive 3+3
预计一次疗程为六个月
预计一周注射药物一次
专利
取得美国、台湾地区、南韩、中国、欧洲，总计17个地区。
- United States
- Taiwan
- Korea
- China
- Europe
