Delving into the Latest Updates on Phaleria macrocarpa extract with Synapse

Overview

Basic Info

Drug Type

Herbal medicine

Synonyms

Phalecarps

Target-

Mechanism

Apoptosis stimulants

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal Diseases

Active Indication

Breast Cancer

Inactive Indication

Metastatic breast cancer

Originator Organization

PT Dexa Medica

Active Organization

PT Dexa Medica

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

ID (13 Sep 2015),

Breast Cancer

Regulation-

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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.

Start Date01 Aug 2011

Sponsor / Collaborator

PT Dexa Medica

NCT01006785 / TerminatedPhase 2

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

Start Date01 Aug 2009

Sponsor / Collaborator

PT Dexa Medica

100 Clinical Results associated with Phaleria macrocarpa extract

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100 Translational Medicine associated with Phaleria macrocarpa extract

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100 Patents (Medical) associated with Phaleria macrocarpa extract

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3

Literatures (Medical) associated with Phaleria macrocarpa extract

01 Jan 2015·Cardiovascular ToxicologyQ4 · MEDICINE

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

Q4 · MEDICINE

Article

Author: 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.

15 Oct 2010·Cancer Biology & TherapyQ3 · MEDICINE

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

Q3 · MEDICINE

Article

Author: Tandrasasmita, Olivia M. ; Baek, Sung Hee ; 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.

01 Jan 2010·Journal of experimental therapeutics & oncology

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

Article

Author: 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 Deals associated with Phaleria macrocarpa extract

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01XX	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Breast Cancer	ID	PT Dexa Medica	13 Sep 2015

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic breast cancer	Phase 2	ID	PT Dexa Medica	01 Aug 2009

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESC2023	Not Applicable	PCSK-9	40	Phaleria macrocarpa extract	hysyjtrjjo(ltivaxedmm) = ferxuvsvch aejltztifr (ciqakeajju )	Negative	14 Apr 2023
				Placebo	hysyjtrjjo(ltivaxedmm) = czgmfugwqq aejltztifr (ciqakeajju )