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Last update 23 Jan 2025

Dexrazoxane Hydrochloride

Last update 23 Jan 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Topotect, Totect, dexrazoxane

+ [13]

Target

Top II

Mechanism

Top II inhibitors(Topoisomerase II inhibitors)

Therapeutic Areas

Other Diseases

Active Indication

Extravasation of Diagnostic and Therapeutic MaterialsCytoprotective Agent

Inactive Indication

BronchitisCardiomyopathiesHemorrhage+ [1]

Originator Organization

Clinigen Ltd.

Active Organization

CNX Therapeutics Ltd.

Kissei Pharmaceutical Co., Ltd.

Nanjing Hairun Pharmaceutical Co Ltd.

Inactive Organization

Valerio Therapeutics SA

Pfizer Inc.

Clinigen Ltd.

Drug Highest PhaseApproved

First Approval Date

US (26 May 1995),

CardiomyopathiesMetastatic breast cancer

RegulationOrphan Drug (US), Accelerated Approval (US)

Structure/Sequence

Molecular FormulaC11H17ClN4O4

InChIKeyBIFMNMPSIYHKDN-FJXQXJEOSA-N

CAS Registry149003-01-0

View All Structures (2)

Clinical Trials associated with Dexrazoxane Hydrochloride

NCT06647953

/ Not yet recruitingPhase 3IIT

Prospective Treatment of Types I, II and III Pleuropulmonary Blastoma (PPB)

This phase III trial tests how well surgery plus chemotherapy compared to surgery alone works in treating patients with type I pleuropulmonary blastoma (PPB), and tests how well surgery plus standard chemotherapy with the addition of topotecan works compared to surgery plus standard chemotherapy alone in treating patients with type II and III PPB.
Historically, most children with type I PPB had surgery and approximately 40% of children with type I PPB received chemotherapy following their surgery, usually for 22-42 weeks. There has not been a consistent standard for which children with type I PPB receive chemotherapy after surgery. For patients whose tumor has been removed completely with surgery, observation without chemotherapy may work as well as giving chemotherapy after surgery in preventing a return of the PPB tumor.
The standard chemotherapy for patients with types II or III PPB in the United States is four cycles of IVADo (ifosfamide, vincristine, dactinomycin, and doxorubicin) followed by 8 cycles of IVA (ifosfamide, vincristine and dactinomycin). Ifosfamide is in a class of medications called alkylating agents. It works by slowing or stopping the growth of tumor cells in the body. Vincristine is in a class of medications called vinca alkaloids. It works by stopping tumor cells from growing and dividing and may kill them. Dactinomycin is a type of antibiotic that is only used in cancer chemotherapy (antineoplastic antibiotic). It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill tumor cells. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill tumor cells. It also blocks a certain enzyme needed for cell division and DNA repair. Topotecan is in a class of medications called topoisomerase I inhibitors. It works by interfering with tumor cell DNA which kills them. Giving topotecan in addition to standard IVADo and IVA chemotherapy regimens may shrink the cancer as well as or better than the standard therapy or could decrease the chance the tumor spreads while causing fewer side effects.

Start Date17 Mar 2025

Sponsor / Collaborator

The Children's Oncology Group Foundation, Inc.

NCT06220032

/ RecruitingPhase 3IIT

ANTICIPATE: Prevention of ANThracycline-Induced Cardiac Dysfunction by Dexrazoxane In PATients With diffusE Large B-cell Lymphoma: a Phase III National Multicenter Prospective Randomized Open-label Trial

Patients treated for DLBCL are at high risk of developing AICD. This adverse event is characterized by irreversible damage to the heart muscle with a loss of cardiomyocytes and subsequent decline in cardiac pumping capacity. Thereby patients treated for this malignancy are at double the risk of developing symptomatic heart failure / cardiomyopathy when compared to the general population. This corresponds to a cumulative incidence of 5-10% within 5-years after receiving R-CHOP. In the elderly, an incidence of 26% has been reported after 8-years of follow-up. Among patients who die in complete remission, heart failure has been described to be one of the most important causes of death. ANTICIPATE aims to evaluate if dexrazoxane can prevent AICD in DLBCL patients and identify those at highest risk of AICD. Of all patients treated with anthracyclines in a first-line setting, DLBCL patients were chosen for this trial for two primary reasons. Firstly, these patients have a favourable oncological prognosis with a 5-year relative survival in the Netherlands of 64-78% in those aged 18-74 years increasing the importance of preventing long-term toxicity. Secondly, the cumulative anthracycline dose used for the treatment of DLBCL is higher than the dose used in breast cancer. The cumulative anthracycline dose is the most important risk factor for AICD known.

Start Date15 Aug 2024

Sponsor / Collaborator

Hemato-Oncologie voor Volwassenen Nederland

[+1]

NCT06262438

/ RecruitingPhase 2IIT

A Phase II, Single Arm, Open Label, Study on the Safety, Efficacy, Pharmacokinetics & Pharmacodynamics of Quizartinib + Chemotherapy and as Single-agent After High Dose Therapy in Newly Diagnosed Pediatric FLT3-ITD+ and NPM1wt AML Patients

The CHIP-AML22 Master protocol has the overall aim of increasing the cure rate in newly diagnosed pediatric de novo AML patients, while avoiding unnecessary toxicity. The linked Quizartinib trial (CHIP-AML22/Quizartinib) is a phase II, single arm, open label, study on the safety, efficacy, pharmacokinetics and pharmacodynamics of quizartinib in combination with chemotherapy and as single-agent after high dose therapy in newly diagnosed pediatric AML patients with a FLT3-ITD mutation and NPM1 wild-type.

Start Date06 Feb 2024

Sponsor / Collaborator

Princess Maxima Centre For Pediatric Oncology

[+1]

100 Clinical Results associated with Dexrazoxane Hydrochloride

100 Translational Medicine associated with Dexrazoxane Hydrochloride

100 Patents (Medical) associated with Dexrazoxane Hydrochloride

869

Literatures (Medical) associated with Dexrazoxane Hydrochloride

01 Feb 2025·Cardiology Clinics

Cardiotoxicity of Anthracyclines

Review

Author: Asnani, Aarti ; Hoeger, Christopher W ; Balough, Elizabeth ; Ariza, Abul ; Hoeger, Christopher W.

Anthracycline chemotherapy is associated with cardiotoxicity, predominantly manifesting as left ventricular systolic dysfunction within the first year of treatment. Early detection is possible through biomarkers and cardiovascular imaging before clinical symptoms develop. Comprehensive cardiovascular risk assessment is essential for all patients prior to anthracycline therapy to stratify their risk of cardiotoxicity. Preventive measures, including cardiovascular risk optimization, as well as anthracycline dose adjustments, the use of liposomal anthracyclines, and dexrazoxane in high-risk patients, are crucial to mitigate the risk of cardiotoxicity. Long-term follow-up and cardiovascular risk optimization are critical for cancer survivors to optimize cardiovascular outcomes.

01 Jan 2025·Annals of Hepatology

Lipocalin-2 silencing alleviates sepsis-induced liver injury through inhibition of ferroptosis

Article

Author: Li, Yuping ; Li, Lu ; Du, Ruoli ; Li, Zhenghong ; Yun, Qi ; Gao, Qin ; Ye, Hongwei ; Zhang, Yuming

INTRODUCTION AND OBJECTIVESLiver plays a key role in sepsis, a systemic inflammatory response syndrome caused by infection. Ferroptosis is involved in sepsis-induced liver injury. We aimed to assess the changes in ferroptosis in cecal ligation and puncture (CLP)-induced septic mice, and determine the role of lipocalin-2 (LCN2) in liver ferroptosis.MATERIALS AND METHODSCLP was used to induce sepsis in mice. The morphological changes in liver tissues and mitochondrial structure were observed using hematoxylin and eosin staining and transmission electron microscopy. The levels of serum alanine transaminase, aspartate aminotransferase, superoxide dismutase, and malondialdehyde were detected using the corresponding kits. The changes of reactive oxygen species level in liver tissues were detected using dihydroethidium as a fluorescence probe. LCN2, cysteine-glutamate reverse transport system, and dihydroorotate dehydrogenase protein levels in the liver were detected by western blotting. The ferroptosis inhibitor ferrostatin-1 (Fer-1), iron chelator dexrazoxane (DXZ), iron-dextran, and LCN2 knockdown studies were performed to determine role of ferroptosis and LCN2 in liver injury during sepsis.RESULTSFerroptosis levels increased in the liver tissues of CLP-induced septic mice. Both Fer-1 and DXZ suppressed ferroptosis and attenuated liver injury following sepsis challenge, whereas iron-dextran increased ferroptosis and liver injury in mice with sepsis. LCN2 knockdown suppressed ferroptosis and reduced oxidative stress in the liver.CONCLUSIONSFerroptosis inhibition attenuates septic liver injury. LCN2 knockdown alleviates sepsis-induced liver injury by inhibiting ferroptosis and reducing oxidative stress.

01 Jan 2025·Journal of Natural Medicines

Preventive effect of imperatorin against doxorubicin-induced cardiotoxicity through suppression of NLRP3 inflammasome activation

Article

Author: Li, Tingting ; Zhang, Hao ; Xie, Mengdie ; Tang, Xilan ; Xiong, Yinhua ; Bao, Huiyun ; Ding, Xiaoyun ; Qiu, Yumei ; Wang, Hu ; Huang, Si

Cardiotoxicity is one of the major obstacles to anthracycline chemotherapy. Anthracycline cardiotoxicity is closely associated with inflammation. Imperatorin (IMP), a furocoumarin ingredient extracted from Angelica dahurica, might have potential activity in preventing anthracycline cardiotoxicity due to its anti-cancer, anti-inflammatory, anti-oxidant, cardioprotective properties. This study aims to reveal the effect of IMP on doxorubicin (DOX)-induced cardiotoxicity and its underlying mechanism. We established a rat model of DOX-induced cardiotoxicity by intraperitoneal injection with DOX (1.25 mg/kg twice weekly for 6 weeks), and found that both IMP (25 mg/kg and 12.5 mg/kg) and dexrazoxane 12.5 mg/kg relieved DOX-induced reductions in heart weight, change in cardiac histopathology, and elevated serum levels of LDH, AST and CK-MB. Moreover, DOX upregulated mRNA levels of NLRP3, CASP1, GSDMD, ASC, IL-1β and IL-18, elevated protein expressions of NLRP3, ASC, GSDMD-FL, GSDMD-N, pro‑caspase‑1, caspase‑1 p20, pro‑IL‑1β and IL‑1β in heart tissues, as well as increased serum levels of pro-inflammatory cytokines including IL-1β and IL-18, however both of IMP and dexrazoxane suppressed these alterations. In addition, we carried out neonatal rat cardiomyocytes experiments to confirm the results of the in vivo study. Consistently, pretreatment with IMP 25 µg/mL relieved DOX (1 μg/mL)-induced cardiomyocytes injury, including decreased cell viability and reduced supernatant LDH. IMP inhibited DOX-induced activation of NLRP3 inflammasome in cardiomyocytes. In conclusion, IMP had a protective effect against DOX-induced cardiotoxicity via repressing the activation of NLRP3 inflammasome. These findings suggest that IMP may be a promising alternative or adjunctive drug for the prevention of anthracycline cardiotoxicity.

News (Medical) associated with Dexrazoxane Hydrochloride

11 Aug 2023

·www.pharmaceutical-technology.com

Clinigen clears out cancer therapies in line with latest growth strategy

Akosua Mireku @AkosuaMireku1 This action follows Clinigen’s January 2023 sale of its kidney cancer treatment Proleukin (aldesleukin) to Iovance Biotherapeutics. Credit: Volodymyr Maksymchuk via Shutterstock. UK-headquartered Clinigen announced the divestment of global rights for four of its cancer therapies from its portfolio, as per a 10 August press release. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Report. The company gave away the rights of Cardioxane, Savene, Totect and Ethyol (amifostine), as Clinigen shifts its pharmaceutical strategy. The first three drugs use dexrazoxane to treat cardiotoxicity caused by cancer drugs while Ethyol is used to correct the effects of cancer treatment with cisplatin or radiation. Recommended Reports Reports Global Hematological Cancer (Blood Cancer) Therapy Market to 2027 - Comprehensive Overview of Mar... GlobalData Reports Hypopharyngeal Cancer Drugs in Development by Stages, Target, MoA, RoA, Molecule Type and Key Pla... GlobalData View all Companies Intelligence Iovance Biotherapeutics Inc Clinigen Inc CNX Therapeutics Ltd Drug Safety Navigator, LLC Lamda Laboratories SA View all Clinigen announced that the four drugs will join CNX Therapeutics’ pharmaceutical portfolio. Based in the UK, CNX Therapeutics commercialises and distributes pharmaceuticals in 40 countries globally. According to its website, the biotech is “seeking to expand its product portfolio in Europe and selected global markets.” This action follows Clinigen’s January 2023 sale of its kidney cancer treatment Proleukin (aldesleukin) to Iovance Biotherapeutics . This deal included an upfront payment of £166.7m ($211.8m), a milestone-based payment of £41.7m ($53m) upon first approval of lifileucel in advanced melanoma, and double-digit Proleukin global sales royalties from Iovance to Clinigen. Proleukin uses interleukin-2 to induce T cell-mediated tumour regression in advanced melanoma. CNX is developing lifileucel as a cell therapy for various cancers. The US Food and Drug Administration accepted a biologics licence application (BLA) for lifileucel in May 2023. In a press release , Clinigen CEO Jerome Charton said: “These medicines have been integral to Clinigen, but as we refocus our efforts, it is crucial to align our offerings with our core strategy and I’m delighted that CNX Therapeutics will be acquiring these brands.” Clinigen’s recent divestments follow others to strengthen its existing capabilities. Last year, the company acquired Drug Safety Navigator to improve its pharmacovigilance capabilities. It also expanded its US site due to reported growth in demand for its clinical supplies management services. This included the opening of new satellite sites in North Dakota and Pennsylvania. This year, Clinigen also sold its innovative contract development business Lamda Laboratories to Germany-based Adragos Pharma. Before this divestment, Lamda acted as Clinigen’s sole development centre. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. By GlobalData Submit Country Code UK (+44) USA (+1) Algeria (+213) Andorra (+376) Angola (+244) Anguilla (+1264) Antigua & Barbuda (+1268) Argentina (+54) Armenia (+374) Aruba (+297) Australia (+61) Austria (+43) Azerbaijan (+994) Bahamas (+1242) Bahrain (+973) Bangladesh (+880) Barbados (+1246) Belarus (+375) Belgium (+32) Belize (+501) Benin (+229) Bermuda (+1441) Bhutan (+975) Bolivia (+591) Bosnia Herzegovina (+387) Botswana (+267) Brazil (+55) Brunei (+673) Bulgaria (+359) Burkina Faso (+226) Burundi (+257) Cambodia (+855) Cameroon (+237) Canada (+1) Cape Verde Islands (+238) Cayman Islands (+1345) Central African Republic (+236) Chile (+56) China (+86) Colombia (+57) Comoros (+269) Congo (+242) Cook Islands (+682) Costa Rica (+506) Croatia (+385) Cuba (+53) Cyprus North (+90392) Cyprus South (+357) Czech Republic (+42) Denmark (+45) Djibouti (+253) Dominica (+1809) Dominican Republic (+1809) Ecuador (+593) Egypt (+20) El Salvador (+503) Equatorial Guinea (+240) Eritrea (+291) Estonia (+372) Ethiopia (+251) Falkland Islands (+500) Faroe Islands (+298) Fiji (+679) Finland (+358) France (+33) French Guiana (+594) French Polynesia (+689) Gabon (+241) Gambia (+220) Georgia (+7880) Germany (+49) Ghana (+233) Gibraltar (+350) Greece (+30) Greenland (+299) Grenada (+1473) Guadeloupe (+590) Guam (+671) Guatemala (+502) Guinea (+224) Guinea - 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British (+1284) Virgin Islands - US (+1340) Wallis & Futuna (+681) Yemen (North)(+969) Yemen (South)(+967) Zambia (+260) Zimbabwe (+263) Country UK USA Afghanistan Åland Islands Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos Islands Colombia Comoros Congo Democratic Republic of the Congo Cook Islands Costa Rica Côte d"Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati North Korea South Korea Kuwait Kyrgyzstan Lao Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macao Macedonia, The Former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Northern Mariana Islands Norway Oman Pakistan Palau Palestinian Territory Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Réunion Romania Russian Federation Rwanda Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Pierre and Miquelon Saint Vincent and The Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and The South Sandwich Islands Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates US Minor Outlying Islands Uruguay Uzbekistan Vanuatu Venezuela Vietnam British Virgin Islands US Virgin Islands Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Kosovo By downloading this case study, you acknowledge that GlobalData may share your information with GlobalData and that your personal data will be used as described in their Privacy Policy Submit Visit our Privacy Policy for more information about our services, how GlobalData may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Report.

AcquisitionLicense out/in

10 Aug 2023

·www.biospace.com

Clinigen divests global rights to four cancer support therapies to CNX Therapeutics

Clinigendivests global rights to four cancer support therapies to CNX Therapeutics Clinigen Limited (‘Clinigen’), the global pharmaceutical services company, has completed the divestment of four cancer supportive care products from its established brands portfolio to CNX Therapeutics, a speciality pharmaceutical company with a focus on improving access to medicines that are critical to the well-being of patients. Under the terms of the agreement, (the financial terms for which are not being disclosed), Clinigen will divest four medicines; Cardioxane®, Savene®, Totect® and Ethyol®, all of which help mitigate the side effects patients may experience when treated with other cancer therapies. Cardioxane®, used in adults with advanced or metastatic breast cancer to prevent long-term harmful effects on the heart caused by treatment with certain anthracyclines. Savene®, used to treat anthracycline extravasation in adults, a rare condition that can impact cancer patients. Totect®, used for the treatment of anthracycline extravasation as well as for preventing cardiomyopathy associated with doxorubicin in women with metastatic breast cancer. Ethyol®, used to reduce the cumulative renal toxicity of cisplatin in patients with advanced ovarian cancer and for reduction of the toxic effects of radiation on normal oral tissues in patients with head and neck cancer. The divestment is the next step for Clinigen in its strategy of increasing focus on those areas of the pharmaceutical services market where it has a growing and sustainable competitive advantage, increasing its exposure to high value, niche services and divesting units and products which no longer support that goal. Earlier this year Clinigen agreed the sale of Proleukin® to Iovance Biotherapeutics, and later divested Lamda Laboratories SA, its European-based innovative contract development business, to Adragos Pharma GmbH. In late 2022, Clinigen acquired Drug Safety Navigator (‘DSN’), a specialist pharmacovigilance service provider based in the US, adding vital pharmacovigilance capabilities to its pharmaceutical services offering. Jerome Charton,Chief Executive Officer at Clinigen commented, “This divestment marks another milestone in Clinigen’s continued strategic evolution towards providing high-value services to the pharmaceutical and biotech sectors. These medicines have been integral to Clinigen, but as we refocus our efforts, it is crucial to align our offerings with our core strategy and I’m delighted that CNX Therapeutics will be acquiring these brands.” CNX Therapeutics’ CEO, Guy Clark said, “The addition of these products to the CNX portfolio strengthens our position as a provider of critically-important hospital injectable products, and demonstrates our commitment to improving the lives of patients by ensuring the supply of essential medicines. We recognise the great value of these products to prescribers and patients, and are very pleased to partner with Clinigen to transition this important portfolio of products and to ensure ongoing continuity of supply.” Greenhill & Co are acting as financial advisor to Clinigen. – Ends – Contact details: Consilium Strategic Communications Jessica Hodgson / Susan Stuart / Melissa Gardiner Tel: +44 (0) 20 3709 5700Clinigen@consilium-comms.com Notes to Editors About Clinigen Clinigen is a global, specialist pharmaceutical services company focused on providing ethical access to medicines. Its mission is to deliver the right medicine to the right patient at the right time. The Group supports pharmaceutical and biotech companies across the medical product lifecycle, from clinical through to commercial and operates from sites in North America, Europe, Africa and the Asia Pacific. Clinigen has more than 1,200 employees across five continents in 15 countries, and provides access in more than 120 countries every year. For more information on Clinigen, please visit: About CNX Therapeutics CNX Therapeutics is a speciality pharmaceutical company committed to improving the lives of patients by providing access to essential medicines. They commercialise and distribute a portfolio of pharmaceuticals for neurological, psychiatric and hospital emergencies in 40 countries worldwide, both directly and through strategic partnerships. CNX Therapeutics’ vision is to become a recognised partner of choice through their commercial excellence, patient focus and presence across Europe. They aim to have a pioneering and industry-leading approach to their Environment, Social and Governance (ESG) goals, which forms a key element of the organisation’s mission and objectives. For more information on CNX Therapeutics, please visit:

AcquisitionRadiation Therapy

09 Feb 2019

·www.fda.gov

Olaratumab (LARTRUVO)

On October 19, 2016, the U.S. Food and Drug Administration granted accelerated approval to olaratumab (LARTRUVO, Eli Lilly and Company) for the treatment of patients with soft tissue sarcoma (STS) not amenable to curative treatment with radiotherapy or surgery and with a histologic subtype for which an anthracycline-containing regimen is appropriate. Approval was based on data from a randomized, active-controlled, clinical trial involving 133 patients with metastatic STS. Patients were required to have STS not amenable to curative treatment with surgery or radiotherapy, and a histologic type of sarcoma for which an anthracycline-containing regimen was appropriate, but had not been administered. Patients were randomized (1:1) to receive the combination of olaratumab plus doxorubicin or doxorubicin as a single agent. Olaratumab was administered at 15 mg/kg as an intravenous (IV) infusion on days 1 and 8 of each 21-day cycle. All patients received doxorubicin 75 mg/m2 as an IV infusion on day 1 of each 21-day cycle for maximum of eight cycles and were permitted to receive dexrazoxane on cycles 5 to 8. Single-agent olaratumab was offered to patients in the doxorubicin alone arm at the time of disease progression. Sixty-six patients were randomized to the combination treatment and 67 to doxorubicin alone. Sixty-five percent of patients had no prior chemotherapy (excluding adjuvant and neoadjuvant therapy), 38% had leiomyosarcoma, 1.5% had synovial sarcoma, and 61% had other histologies (over 25 different STS histologies). All patients had metastatic disease and were enrolled in the United States. Patients who received the combination treatment had a statistically significant improvement in overall survival (OS) compared to those receiving doxorubicin alone. Patients receiving the combination treatment had a median OS of 26.5 months (95% CI: 20.9, 31.7) compared to 14.7 months (95% CI: 9.2, 17.1) for those receiving doxorubicin alone (HR=0.52 [95% CI: 0.34, 0.79]). The median progression-free survival (independent review) was 8.2 months (95% CI: 5.5, 9.8) for patients who received the combination treatment and 4.4 months (95% CI: 3.1, 7.4) for those receiving doxorubicin alone (HR=0.74 [95% CI: 0.46, 1.19]). The overall response rate (independent review) was 18% (95% CI: 9.8, 29.6) in the combination arm and 8% (95% CI: 2.5, 16.6) in the doxorubicin alone arm. The most common (greater than or equal to 20%) side effects of treatment with olaratumab are nausea, fatigue, neutropenia, musculoskeletal pain, mucositis, alopecia, vomiting, diarrhea, decreased appetite, abdominal pain, neuropathy, and headache. Infusion-related reactions were seen in 13% of patients. The recommended dose and schedule of olaratumab is 15 mg/kg administered as an IV infusion over 60 minutes on days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity. For the first eight cycles, olaratumab is administered with doxorubicin. FDA granted olaratumab fast track and breakthrough therapy designation, priority review status, and accelerated approval for this indication. As a condition of the accelerated approval, Eli Lilly and Company is required to conduct a randomized, controlled trial to verify and further describe the clinical benefit of olaratumab given with doxorubicin in patients with STS. Olaratumab also received orphan drug designation. A description of these expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics, available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf. Content current as of: 10/20/2016 10/20/2016 Resources for Information | Approved Drugs Oncology (Cancer)/Hematologic Malignancies Approval Notifications Ongoing | Cancer Accelerated Approvals Verified Clinical Benefit | Cancer Accelerated Approvals Withdrawn | Cancer Accelerated Approvals Other | Cancer Accelerated Approvals Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description Oncology (Cancer)/Hematologic Malignancies Approval Notifications Ongoing | Cancer Accelerated Approvals Verified Clinical Benefit | Cancer Accelerated Approvals Withdrawn | Cancer Accelerated Approvals Other | Cancer Accelerated Approvals Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description

Accelerated ApprovalOrphan DrugFast TrackBreakthrough TherapyDrug Approval

100 Deals associated with Dexrazoxane Hydrochloride

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KEGG	Wiki	ATC	Drug Bank
D07807	Dexrazoxane Hydrochloride	V03AF02	DB00380

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Extravasation of Diagnostic and Therapeutic Materials	NO	CNX Therapeutics Ltd.	27 Jul 2006
Extravasation of Diagnostic and Therapeutic Materials	EU	CNX Therapeutics Ltd.	27 Jul 2006
Extravasation of Diagnostic and Therapeutic Materials	LI	CNX Therapeutics Ltd.	27 Jul 2006
Extravasation of Diagnostic and Therapeutic Materials	IS	CNX Therapeutics Ltd.	27 Jul 2006
Cytoprotective Agent	CN	Nanjing Hairun Pharmaceutical Co Ltd.	29 May 2006

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Extravasation of Diagnostic and Therapeutic Materials	Phase 2	US	Clinigen Ltd.	06 Sep 2007
Hemorrhage	Phase 2	IT	Valerio Therapeutics SA	01 Apr 2002
Hemorrhage	Phase 2	PL	Valerio Therapeutics SA	01 Apr 2002
Hemorrhage	Phase 2	DE	Valerio Therapeutics SA	01 Apr 2002
Bronchitis	Phase 2	DK	Valerio Therapeutics SA	01 Jun 2001
Hemorrhage	Discovery	NL	Valerio Therapeutics SA	01 Apr 2002
Hemorrhage	Discovery	DK	Valerio Therapeutics SA	01 Apr 2002

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASH2024	Not Applicable	Acute Myeloid Leukemia	-	Dexrazoxane	xujomdsvpx(micigqgsqc) = wwruxelsvv nsqkeutpif (vnbtolpipd ) View more	-	07 Dec 2024
				Non-initiators of Dexrazoxane	xujomdsvpx(micigqgsqc) = vltwipsyxt nsqkeutpif (vnbtolpipd ) View more
ASCO2023	Not Applicable	Neoplasms	142	Anthracycline + Dexrazoxane	(japcryfayz) = fsweuqqnea sazlxejlvj (aktynzvyvj )	Positive	31 May 2023
				Anthracycline only	(japcryfayz) = yepriyhbyv sazlxejlvj (aktynzvyvj ) View more
NCT03786783 (ANBL17P1, CTgov)	Phase 2	High Risk Neuroblastoma \| Ganglioneuroblastoma	42	External Beam Radiation Therapy+Etoposide+Carboplatin+Doxorubicin+Isotretinoin+Sargramostim+Topotecan+Dexrazoxane+Dinutuximab+Cyclophosphamide+Melphalan+Cisplatin+Vincristine+Thiotepa	tjakatdrkr(autsjpykpj) = tccflletuk knssytfpul (pvgukqxjfi, quqqztsdna - evsnyuydyr) View more	-	14 Mar 2023
NCT00980460 (AHEP0731, CTgov)	Phase 3	Hepatoblastoma \| Liver Cancer	236	Therapeutic Conventional Surgery (Very Low-risk Group)	(bhjytcyzty) = yqhjyaqozl bkgyhldvnw (yvuzcmrabk, gtelsxmlhl - rhjbxzsumi) View more	-	28 Dec 2021
				Therapeutic Conventional Surgery+Cisplatin+Vincristine Sulfate+Fluorouracil (Low-risk Group (Regimen T))	(bhjytcyzty) = qmvhnitkrv bkgyhldvnw (yvuzcmrabk, rsksrpoluq - ywgvdmtvao) View more
ESC2021	Not Applicable	acute leukemia	2,375	Dexrazoxane	eeeynjgiso(gratbbsjpa): OR = 1.15 (95% CI, 0.57 - 2.31), P-Value = 0.7 View more	-	29 Jun 2021
				No drug or placebo
NCT01231906 (AEWS1031, CTgov)	Phase 3	Peripheral Primitive Neuroectodermal Tumors \| Ewing Sarcoma	642	Laboratory Biomarker Analysis+Dexrazoxane+Etoposide+Cyclophosphamide+Ifosfamide+doxorubicin hydrochloride+Vincristine Sulfate (Arm A (Combination Chemotherapy))	(deonwqmwhn) = uzufazrkqv jfykuxlhoc (nonlqnnvkk, nejcmvqvpo - etzwvgawzl) View more	-	04 May 2021
				Laboratory Biomarker Analysis+Dexrazoxane+Etoposide+Cyclophosphamide+Ifosfamide+doxorubicin hydrochloride+Topotecan Hydrochloride+Vincristine Sulfate (Arm B (Combination Chemotherapy, Topotecan Hydrochloride))	(deonwqmwhn) = bjhygqcdjz jfykuxlhoc (nonlqnnvkk, qldecihhex - tpephcxmtb) View more
P9404 \| P9425 \| P9426 \| DFCI 95-01 \| P9754 (ASCO2020)	Not Applicable	Neoplasms	173	Dexrazoxane+Doxorubicin	(vpodkqzdky) = haghznbxee saklidpeup (sbwneohbsj, 6.0 - 18.0) View more	Positive	25 May 2020
				Doxorubicin	(vpodkqzdky) = jthvpowftw saklidpeup (sbwneohbsj, 6.0 - 28.2) View more
NCT00038142 (CTgov)	Phase 2	Ewing Sarcoma	46	Dexrazoxane+ImmTher+Cyclophosphamide+Doxorubicin+Vincristine (Arm A: VACdxr With ImmTher)	mwxiepvbjp(hrplndxfui) = lgeuglhphe asrcidjndp (zucholaivj, wscmvxvtsl - wxujvqdgxm) View more	-	29 Jan 2020
				Dexrazoxane+Cyclophosphamide+Doxorubicin+Vincristine (Arm B: VACdxr)	mwxiepvbjp(hrplndxfui) = ojakoruibb asrcidjndp (zucholaivj, cpzoapnazi - tssmpefezg) View more
NCT00928200 (CTgov)	Phase 1	Food Hypersensitivity \| Recurrent Adult Acute Lymphoblastic Leukemia \| refractory acute lymphoid leukemia in relapse	1	Dexrazoxane+doxorubicin+Hydrocortisone+Erwinase+dexamethasone+Methotrexate+Vincristine+Cytarabine	ebmxfnhnbs(grnrxykzqc) = eycpguetye hdejgktqru (wkwrltyram, hxavwerkho - nszefaaizx) View more	-	19 Feb 2019
PROSPERO (ASCO2018)	Not Applicable	Breast Cancer Adjuvant	1,545	Dexrazoxane	guzlpmzuyh(kqffxzmfmm): RR = 0.262 (95% CI, 0.169 - 0.407) View more	Positive	01 Jun 2018
				Anthracycline-based chemotherapy

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