Phaleria macrocarpa extract(Phaleria macrocarpa extract) - 在研适应症：乳腺癌_专利_临床

概要

基本信息

药物类型

中药

别名

Phalecarps

靶点-

作用机制

细胞凋亡刺激剂

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

非在研机构-

最高研发阶段批准上市

首次获批日期

印尼 (2015-09-13),

乳腺癌

最高研发阶段(中国)-

特殊审评-

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关联

2

项与 Phaleria macrocarpa extract 相关的临床试验

NCT01433562 / Completed临床2/3期

Combination of DLBS1425 With Anthracyclin-based Regimen as a Neoadjuvant Therapy in Subjects With Stage II or III Breast Cancer

This is a 2-arm, randomized, double-blind, placebo-controlled study aiming to determine the efficacy and safety of DLBS1425 in combination with anthracyclin-based regimen as a neoadjuvant therapy in subjects with previously untreated stage II or III (operable) breast cancer.
The anthracyclin-based regimen in the study will be either CAF/iv and CEF/iv only. The neoadjuvant anthracyclin-based chemotherapy will be given for 3 cycles. The length of each cycle will be 21-28 days.

开始日期2011-08-01

申办/合作机构

PT Dexa Medica

NCT01006785 / Terminated临床2期

Phase II Clinical Study: A Randomized, Open, and Dose Ranging Study to Evaluate the Efficacy and Safety of DLBS1425 in Subjects With Metastatic / Advanced Breast Cancer

The purposes of this study are :
to investigate the safety and clinical efficacy of sole therapy with DLBS1425 in suppressing disease-(tumour) progression in subjects with advanced/metastatic breast cancer; and
to determine the minimal effective and safe dose of DLBS1425 in the therapy of advanced/metastatic breast cancer

开始日期2009-08-01

申办/合作机构

PT Dexa Medica

100 项与 Phaleria macrocarpa extract 相关的临床结果

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100 项与 Phaleria macrocarpa extract 相关的转化医学

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100 项与 Phaleria macrocarpa extract 相关的专利（医药）

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3

项与 Phaleria macrocarpa extract 相关的文献（医药）

2015-01-01·Cardiovascular Toxicology4区 · 医学

Cardiovascular Effects of Phaleria macrocarpa Extracts Combined with Mainstay FAC Regimen for Breast Cancer

4区 · 医学

Article

作者: Kusnandar Anggadiredja ; Raymond R. Tjandrawinata

DLBS1425 is a bioactive compound extracted from Phaleria macrocarpa, with anti-proliferative, anti-inflammatory and anti-angiogenic properties against cancer cells. The present study was aimed to assess cardiotoxicity of DLBS1425, compared to the mainstay regimen for breast cancer, 5-fluorouracil:doxorubicin:cyclophosphamide (FAC, given at 500/50/500 mg/m(2)). Treatment with FAC regimen at standard dose resulted in very severe toxicity, so mice had no chance to survive for more than 7 days following initial drug treatment. Furthermore, histological examination on the heart revealed severe muscular damage when mice were given the FAC regimen alone (severe toxicity). FAC as chemotherapeutic regimen exerted high toxicity profile to the cardiovascular cells in this experiment. Meanwhile, treatment with DLBS1425 alone up to a dose equivalent to as high as 300 mg three times daily in human had no hazardous consequences on the heart, hematological feature, as well as general safety. In the cardiovascular cells, DLBS1425 in the presence of FAC regimen (one-eight of the initial dose) gave protection to the cardiac muscle cells as well as other hematological features. Taken together, results of the present study suggest that DLBS1425 is safe when used as adjuvant therapy for breast cancer and may be even protective against cardiac cellular damage produced by chemotherapeutic regimen.

2010-10-15·Cancer Biology & Therapy3区 · 医学

Induction of cellular apoptosis in human breast cancer by DLBS1425, aPhaleria macrocarpacompound extract, via down-regulation of PI3-kinase/AKT pathway

3区 · 医学

Article

作者: Baek, Sung Hee ; Tandrasasmita, Olivia M. ; Lee, Jason S. ; Tjandrawinata, Raymond R.

Phaleria macrocarpa, also known as Mahkota dewa, is an Indonesian native plant that has been used as a remedy for many diseases. However, the molecular mechanism of Phaleria macrocarpa is still limited. In this study, we evaluate its molecular mechanism using a bioactivity-guided DLBS1425, an extract of Phaleria macrocarpa on MDA-MB-231 breast cancer cell line. DLBS1425 exhibited inhibition of proliferative, migratory and invasive potential of MDA-MB-231 in a dose-dependent manner, and significantly reduced phosphoinositide-3 (PI3)-kinase/protein kinase B (AKT) signalling by reducing PI3K transcript level and subsequent reduction in AKT phosphorylation. Further, it induced pro-apoptotic genes including BAX, BAD and PUMA and consequently induces cellular death signal by caspase-9 activation, promoting PARP cleavage and DNA fragmentation. Our results suggest that DLBS1425 is a potential anticancer agent which targets genes involved in both cell survival and apoptosis in MDA-MB-231 breast cancer cells.

2010-01-01·Journal of experimental therapeutics & oncology

DLBS1425, a Phaleria macrocarpa (Scheff.) Boerl. extract confers anti proliferative and proapoptosis effects via eicosanoid pathway.

Article

作者: Tjandrawinata, Raymond R ; Arifin, Poppy Firzani ; Tandrasasmita, Olivia M ; Aripin, Asep ; Rahmi, Dina

Phaleria macrocarpa (Scheff.) Boerl. (Thymelaeaceae), an Indonesian native plant, has been used to treat various diseases in Indonesia. DLBS1425, a standardized extract of flesh fruit of Phaleria macrocarpa, is hypothesized to have anti-cancer activities. Anti-proliferative and induction of apoptosis conferred by DLBS1425 on breast cancer cells, MDA-MB-231 and MCF-7 cells were investigated. DLBS1425 showed an inhibition of proliferation in both cell lines. Induction of apoptosis was shown by DNA fragmentation, activation of caspase 9, and regulation of Bax and Bcl-2 at the mRNA level. DLBS1425 downregulated COX-2, cPLA2, and VEGF-C mRNA expressions. DLBS1425 also down-regulated c-fos and HER-2/neu mRNA expression in TPA- or fatty acid-induced MDA-MB-231 cells. These findings demonstrate that DLBS1425 has anti-proliferative, anti-inflammatory, and anti-angiogenic properties, which make it pharmacologically ideal for the prevention and/or treatment of breast cancer.

100 项与 Phaleria macrocarpa extract 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01XX	-

研发状态

批准上市

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适应症	国家/地区	公司	日期
乳腺癌	印尼	PT Dexa Medica	2015-09-13

未上市

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适应症	最高研发状态	国家/地区	公司	日期
转移性乳腺癌	临床2期	印尼	PT Dexa Medica	2009-08-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ESC2023	N/A	PCSK-9	40	Phaleria macrocarpa extract	憲窪觸艱鏇顧醖願顧鹹(製鬱獵製艱齋願壓鏇夢) = 夢築顧鏇艱獵艱範餘夢蓋餘餘觸網觸艱壓醖獵 (餘獵選齋壓鏇積鬱艱蓋 )	不佳	2023-04-14
				Placebo	憲窪觸艱鏇顧醖願顧鹹(製鬱獵製艱齋願壓鏇夢) = 鬱築壓廠顧艱簾鹽簾構蓋餘餘觸網觸艱壓醖獵 (餘獵選齋壓鏇積鬱艱蓋 )