Delving into the Latest Updates on Darinaparsin with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Darinaparsin (JAN/USAN), DMAs(III)G, SGLU

+ [11]

Target

Reactive oxygen species

Action

stimulants, inhibitors

Mechanism

Reactive oxygen species stimulants, Apoptosis stimulants, Cell division inhibitors

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [1]

Active Indication

Peripheral T-Cell Lymphoma

Inactive Indication

Advanced cancerAdvanced Hepatocellular CarcinomaAdvanced Malignant Solid Neoplasm+ [7]

Originator Organization

Solasia Pharma KK

Active Organization

Solasia Pharma KK

Nippon Kayaku Co., Ltd.

Inactive Organization

Alaunos Therapeutics, Inc.

Meiji Seika Pharma Co., Ltd.

License Organization

Solasia Pharma KK

HB Human BioSience SAS

Nippon Kayaku Co., Ltd.

+ [2]

Drug Highest PhaseApproved

First Approval Date

Japan (20 Jun 2022),

Peripheral T-Cell Lymphoma

RegulationOrphan Drug (United States), Orphan Drug (European Union)

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Structure/Sequence

Molecular FormulaC12H22AsN3O6S

InChIKeyJGDXFQORBMPJGR-YUMQZZPRSA-N

CAS Registry69819-86-9

Procalcitonin gamma subfamily A, 10 (PCDHGA10) is a member of the procalcitonin gamma gene cluster, which is associated with neuronal synapse development. However, there are lack of studies on the role and potential prognostic value of PCDHGA10 in lung squamous cell carcinoma (LUSC). We analyzed the RNAseq data of PCDHGA10 to compare their expression differences. Then survival analysis, tumor microenvironment (TME) analysis, and mutation analysis were carried out. Additionally, we performed gene ontology (GO) and kyoto gene encyclopedia (KEGG) enrichment analyses to explore potential signal pathways. PCDHGA10 protein expression was evaluated using immunohistochemistry (IHC) on tissue microarrays (HLugS180Su02). By microarray analysis and database analysis, we found that PCDHGA10 was significantly highly expressed in LUSC. Sufferers with elevated PCDHGA10 levels exhibited a worse prognosis, according to the survival analysis. The PCDHGA10 mutation was also linked to LUSC patient prognosis. Besides, PCDHGA10 was closely related to tumor immune cell infiltration and immune checkpoints. In conclusion, PCDHGA10 is expected to become a new molecular marker for LUSC.

02 Jan 2024·Leukemia & lymphoma

Efficacy of darinaparsin for EBV-associated B-cell lymphoma in a heavily treated elderly patient with angioimmunoblastic T-cell lymphoma: a case report

Article

Author: Uehara, Atsushi ; Oura, Mitsuaki ; Matsue, Kosei ; Ikeda, Daisuke ; Takeuchi, Masami ; Tabata, Rikako ; Narita, Kentaro

Click to increase image sizeClick to decrease image size AcknowledgementsThe authors would like to thank Kengo Takeuchi for the pathological diagnosis and Yasuhito Suehara for performing droplet digital PCR. The authors also thank Editage (www.editage.jp) for providing English language editing services.Author contributionsD.I. and K.M. interpreted the data, provided patient care, and wrote the manuscript. M.O., A.U., R.T., K.N., and M.T. provided patient care.Consent formThe patient provided written informed consent.Disclosure statementThe authors report there are no competing interests to declare.Additional informationFundingThis research did not receive any specific grants from funding agencies in the public, commercial, or not-for-profit sectors.

12 Sep 2023·Blood advances

Darinaparsin in patients with relapsed or refractory peripheral T-cell lymphoma: results of an Asian phase 2 study

Article

Author: Nagahama, Fumiko ; Kwong, Yok-Lam ; Terui, Yasuhito ; Tobinai, Kensei ; Uchida, Toshiki ; Yamamoto, Kazuhito ; Sonehara, Yusuke ; Nagai, Hirokazu ; Yoon, Dok-Hyun ; Tien, Hwei-Fang ; Ando, Kiyoshi ; Izutsu, Koji ; Negoro, Eiju ; Fukuhara, Noriko ; Suehiro, Youko ; Nakajima, Hideaki ; Kang, Hye Jin ; Kim, Won-Seog ; Ko, Po-Shen

Abstract:

Darinaparsin is a novel organic arsenical compound of dimethylated arsenic conjugated to glutathione, with antitumor activity and a mechanism of action markedly different from other available agents. This phase 2, nonrandomized, single-arm, open-label study evaluated the efficacy and safety of intravenous darinaparsin (300 mg/m2 over 1 hour, once daily for 5 consecutive days, per 21-day cycle) and its pharmacokinetics at multiple doses in 65 Asian patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The primary end point was the overall response rate (ORR). The ORR based on central assessment was 19.3% (90% confidence interval, 11.2-29.9), which was significantly higher than the predefined threshold of 10% (P = .024). The ORR was 16.2% in patients with PTCL–not otherwise specified and 29.4% in patients with angioimmunoblastic T-cell lymphoma. Tumor size decreased in 62.3% of patients. Treatment-emergent adverse events (TEAEs) were observed in 98.5% of patients. Grade ≥3 TEAEs with an incidence rate of ≥5% included anemia (15.4%), thrombocytopenia (13.8%), neutropenia (12.3%), leukopenia (9.2%), lymphopenia (9.2%), and hypertension (6.2%). Darinaparsin is effective and well tolerated, with TEAEs that were clinically acceptable and manageable with symptomatic treatment and dose reductions. This trial was registered at www.clinicaltrials.gov as #NCT02653976.

2

News (Medical) associated with Darinaparsin

05 Jul 2022

·www.prnewswire.com

Brand Institute Partners on Brand Name Development for Treatment of Relapsed or Refractor Peripheral T-Cell Lymphoma Now Approved by Ministry of Health, Labour and Welfare (Japan)

MIAMI, July 5, 2022 /PRNewswire/ -- Brand Institute is proud to announce its work with Solasia Pharma K.K. ("Solasia") in developing the brand name DARVIAS®. DARVIAS®, an organoarsenic compound with anticancer activity, is a novel mitochondrial-targeted agent being developed for the treatment of various hematologic and solid tumors. DARVIAS® provokes cell cycle arrest and apoptosis through disruption of mitochondrial functions and increased production of reactive oxygen species in tumor cells. DARVIAS® is expected to exert an anticancer effect by inducing cell cycle arrest and apoptosis. DARVIAS® has been approved for relapsed or refractory Peripheral T-Cell Lymphoma by Japan's Ministry of Health, Labour and Welfare (MHLW). Japan is the first country in the world where DARVIAS® has been approved. DARVIAS® has been granted orphan drug designation in the US and EU. "The entire Brand Institute and Drug Safety Institute team congratulates Solasia on the MHLW approval of the DARVIAS injection," said Brand Institute's Chairman and C.E.O., James L. Dettore. About Brand Institute and our wholly owned regulatory subsidiary, Drug Safety Institute Brand Institute is the global leader in pharmaceutical and healthcare-related name development, with a portfolio of over 3,800 marketed healthcare brand names, 1,200 USAN/INN nonproprietary names for 1,100 clients. The company partners on over 75% of pharmaceutical brand and nonproprietary name approvals globally every year with healthcare manufacturers. Drug Safety Institute is composed of former naming regulatory officials from global government health agencies, including Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada (HC), American Medical Association (AMA), and the World Health Organization (WHO). These regulatory experts co-authored the name review guidelines while with their respective agencies, with many responsible for ultimately approving (or rejecting) brand name applications. Now working for a private company, these professionals provide Brand Institute's clients with industry-leading guidance pertaining to drug name safety (i.e., preventing medication errors), packaging, and labeling. Contact: James Dettore Chairman & C.E.O. [email protected] SOURCE Brand Institute, Inc.

Orphan Drug

26 Oct 2021

·www.businesswire.com

Solasia and Nippon Kayaku Announce License Agreement in Japan for New Drug Candidate DARINAPARSIN (SP-02)

TOKYO--(BUSINESS WIRE)--Solasia Pharma K.K. (TOKYO: 4597, Headquarters: Tokyo, Japan, President & CEO: Yoshihiro Arai, hereinafter “Solasia”) and Nippon Kayaku Co., Ltd. (TOKYO: 4272, Headquarters: Tokyo, Japan, President: Atsuhiro Wakumoto) today jointly announced the conclusion of a license agreement for marketing rights to darinaparsin (generic name, development code: SP-02) in Japan (hereinafter “this agreement”). Darinaparsin is a drug candidate under development by Solasia for relapsed or refractory peripheral T-cell lymphoma (PTCL). Solasia filed a new drug application with the Ministry of Health, Labour and Welfare in June 2021 and expects to launch after obtaining approval from the agency in 2022. Mr. Kazuto Koizumi, Managing Director and Head of Pharmaceuticals Group of Nippon Kayaku, commented as follows: “Solasia is a specialty pharmaceutical company that excels in development of innovative medicines in the field of oncology in Japan and other Asian countries. Through the early launch of darinaparsin developed by Solasia, we expect to provide a new treatment option for PTCL, and contribute to patients and their family suffering from the disease, as well as to healthcare professionals.” Mr. Yoshihiro Arai, President and CEO of Solasia, commented as follows: “Nippon Kayaku is one of Japan's leading pharmaceutical companies with strengths in the field of oncology. We are very pleased to have this opportunity to deliver darinaparsin to nationwide medical institutions providing cancer treatment by utilizing Nippon Kayaku’s extensive experience in oncology and strong sales network, and contribute to the treatment of PTCL.” Based on this agreement, Solasia and Nippon Kayaku will make further efforts to provide a new treatment option to patient suffering from PTCL, for which no standard treatment has been established to date. ### About Nippon Kayaku Nippon Kayaku was founded in 1916 as the first industrial explosives manufacturer in Japan. We have developed products to meet the needs of the time by utilizing, combining and transforming our core technologies in the company’s main areas, explosives, dyes, pharmaceuticals and resins. Nippon Kayaku has contributed to realizing a sustainable society through its four businesses of Functional Chemicals, Pharmaceuticals, Safety Systems, and Agrochemicals. In the Pharmaceuticals Business, Nippon Kayaku specializes in anticancer drugs and other cancer-related products, handling a range of products from new drugs to biosimilars and generics. It strives to provide trustworthy information crucial for understanding anticancer drugs to medical institutions. Please visit the company website at for more information. About Solasia Please visit the company website at for more information. About darinaparsin (SP-02) Please visit at

License out/inDrug Approval

100 Deals associated with Darinaparsin

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External Link

KEGG	Wiki	ATC	Drug Bank
D08898	-	-	DB06179

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Peripheral T-Cell Lymphoma	Japan	Solasia Pharma KK	20 Jun 2022
Peripheral T-Cell Lymphoma	Japan	Nippon Kayaku Co., Ltd.	20 Jun 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Hepatocellular Carcinoma	Phase 2	United States	Alaunos Therapeutics, Inc.	01 Jan 2007
Bone Marrow Neoplasms	Phase 2	United States	Alaunos Therapeutics, Inc.	01 Dec 2006
Multiple Myeloma	Phase 2	Canada	Alaunos Therapeutics, Inc.	01 Jan 2006
Hepatocellular Carcinoma	Phase 2	-	Meiji Seika Pharma Co., Ltd.	-
T-Cell Lymphoma	Phase 1	-	Alaunos Therapeutics, Inc.	01 Jun 2010
Advanced cancer	Phase 1	United States	Alaunos Therapeutics, Inc.	01 Aug 2007
Advanced Malignant Solid Neoplasm	Phase 1	United States	Alaunos Therapeutics, Inc.	01 May 2005
Anemia, Refractory, With Excess of Blasts	Phase 1	United States	Alaunos Therapeutics, Inc.	01 May 2005
Myeloproliferative Disorders	Phase 1	United States	Alaunos Therapeutics, Inc.	01 May 2005
Recurrent Acute Leukemia	Phase 1	United States	Alaunos Therapeutics, Inc.	01 May 2005

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02653976 (CTgov)	Phase 2	Peripheral T-Cell Lymphoma	67	SP-02L (darinaparsin for injection)	ksueqmvrjy = lxayfhkueo fsqlfuujwl (hayfwjtnqi, barcukwfmt - hphwxbptbk) View more	-	26 Jan 2024
NCT02653976 (Pubmed)	Phase 2	Peripheral T-Cell Lymphoma	65	Darinaparsin	refhpqmxfj(vvxkmubzgp) = yejrzkhevq feqwaaoaph (idzofwooeq, 11.2 - 29.9)	Positive	20 Jan 2023
NCT01689220 \| NCT01435863 (Pubmed \| Jpn J Clin Oncol) Manual	Phase 1	Peripheral T-Cell Lymphoma	23	Darinaparsin	jpsqbpcwuf(lcfvxdkgad) = lymphopenia (9%), neutropenia (9%) and thrombocytopenia (9%) qgadrxubwn (eycnmogzac )	Positive	08 Feb 2021
NCT02653976 (Biospace) Manual	Phase 2	Peripheral T-Cell Lymphoma	-	DARINAPARSIN	prrnkcfghs(bqpesgtxyk) = reach qhdvenooia (jpsunfjbrp ) View more	Positive	15 Jun 2020
NCT00509782 (Pubmed \| Clin Cancer Res)	Phase 1	Solid tumor	47	Darinaparsin	pdtyiaqjvj(oewjmfqicw) = lmdsgyniwn zccwtmurvy (wygvwgvfdp ) View more	-	15 Jul 2009
ASCO2009	Phase 2	Advanced Hepatocellular Carcinoma	15	Darinaparsin	hgjljvqhag(labijgtber) = lcxxlminfm lwbtlmferm (uvuwnphrwh, 93 - 227) View more	Negative	20 May 2009
ASCO2007	Phase 1	Advanced Malignant Solid Neoplasm	34	ZIO-101	aimsdkxaus(vowtrllquh) = transient confusion, and ataxia yorbfufvbr (pdovvinykz ) View more	-	20 Jun 2007
ASCO2007	Phase 1/2	Multiple Myeloma	19	ZIO-101 daily for 5 consecutive d every 4 w	hyrdctjeog(fssfjtlyie) = transient confusion /ataxia kswdzprutp (cwqsblzbdw )	-	20 Jun 2007
Tandem Meetings ASTCT and CIBMTR2007	Phase 1/2	Multiple Myeloma	13	ZIO-101	mismfzpnvg(smbrzgjblr) = mmioollkhm gbeonbnuew (penselibgb, 0.8) View more	Positive	01 Feb 2007
ASCO2006	Phase 1	Hematologic Neoplasms	8	ZIO-101	cpbihlgoiz(xetsspwglw) = itzqdslxzv amnyhryflu (oqrqqgpgze ) View more	-	20 Jun 2006