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Last update 08 May 2025

Amifostine

Last update 08 May 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Amifostine (USP), Amifostine anhydrous, Amifostine hydrate

+ [20]

Target

TNSALP

Action

modulators

Mechanism

TNSALP modulators(Alkaline phosphatase, tissue-nonspecific isozyme modulators)

Therapeutic Areas

Hemic and Lymphatic DiseasesMouth and Tooth DiseasesOther Diseases

Active Indication

Cytoprotective AgentNeutropeniaXerostomia

Inactive Indication

Acute Myeloid LeukemiaAcute Radiation SyndromeChemotherapy-induced damage+ [10]

Originator Organization

MedImmune LLC

Active Organization

Links Medical Products, Inc.

Meiluo Pharmaceutical Co. Ltd.

Original BioMedicals Co., Ltd.

Inactive Organization

MedImmune LLC

Cosette Pharmaceuticals, Inc.

Schering-Plough Corp.

License Organization

CNX Therapeutics Ltd.

Clinigen Ltd.

Drug Highest PhaseApproved

First Approval Date

United States (08 Dec 1995),

Chemotherapy-induced damage

RegulationOrphan Drug (United States), Accelerated Approval (United States)

Structure/Sequence

Molecular FormulaC5H21N2O6PS

InChIKeyTXQPXJKRNHJWAX-UHFFFAOYSA-N

CAS Registry112901-68-5

Clinical Trials associated with Amifostine

NCT03702985

/ Unknown statusPhase 2IIT

A Phase II Trial of Capecitabine and Irinotecan With or Without Amifostine in Neoadjuvant Chemoradiotherapy in Locally Advanced Rectal Cancer

The study evaluates the addition of Amifostine to capecitabine and irinotecan in neoadjuvant chemoradiation(CRT) in locally advanced rectal cancer. Half of participants will receive capecitabine and along with neoadjuvant radiotherapy, followed by a cycle of XELIRI, while the others will receive capecitabine and irinotecan added by amifostine during CRT, followed by a cycle of XELIRI. All participants will be scheduled to receive surgery 6-8 weeks after the completion of CRT. Then it will depends which regimens the patient would receive according to his or her pathological results.

Start Date28 May 2018

Sponsor / Collaborator

Fudan University

NCT03474861

/ Unknown statusPhase 1

A Combination Study to Evaluate the Safety and Efficacy of an Anticancer Medication (A01) With Immune Cells (IC01) in Subjects With Advanced Gastrointestinal Cancer

This is an open-label study to evaluate the safety and efficacy of an anticancer medication (A01) combined with immune cells (IC01) in subjects with advanced Gastrointestinal cancer.

Start Date01 Apr 2018

Sponsor / Collaborator

Hangzhou Converd Co., Ltd.

[+1]

NCT03472352

/ Unknown statusPhase 1

A Combination Study to Evaluate the Safety and Efficacy of an Anti-cancer Medication (A01) With Immune Cells (IC01) in Subjects With Advanced Solid Tumors

This is an open-label study to evaluate the safety and efficacy of an anticancer medication (A01) with immune cells (IC01) in subjects with advanced solid tumors.

Start Date01 Apr 2018

Sponsor / Collaborator

Hangzhou Converd Co., Ltd.

100 Clinical Results associated with Amifostine

100 Translational Medicine associated with Amifostine

100 Patents (Medical) associated with Amifostine

1,864

Literatures (Medical) associated with Amifostine

01 Jun 2025·Microbial Pathogenesis

Probing the multitargeted potency of FDA-approved Amifostine against MRSA and control comparison with sulfamethoxazole to establish alternative medications

Article

Author: Alenazy, Rawaf ; Alotaibi, Bader S ; Alamri, Ahlam Saleh ; Alqahtani, Mohammed ; Alkhorayef, Nada ; Almufarriji, Fawaz M ; Alnomasy, Sultan F

Methicillin-Resistant Staphylococcus aureus (MRSA) is a multidrug-resistant bacterial strain causing infections from mild skin conditions to life-threatening sepsis. It is classified into healthcare-associated (HA-MRSA) and community-associated (CA-MRSA), with significant healthcare and economic burdens. The rising prevalence and resistance to existing antibiotics highlight the urgent need for improved infection control, antibiotic stewardship, and research into multitargeted therapies to combat resistance and ensure effective treatment options. In this study, we performed a multitargeted docking study followed by pose filtering with MM/GBSA of an FDA-approved drug library. We identified Amifostine as a multitargeted inhibitor of transferases and hydrolases proteins involved in MRSA with docking scores ranging from -11.040 to -7.559 kcal/mol. We compared it with Sulfamethoxazole with docking scores -4.851 to -2.868 kcal/mol, which is an approved compound against MRSA, and found Amifostine a far better drug for MRSA instead just for its use to protect the kidneys of patients getting chemotherapy for the treatment of ovarian cancer. We also performed Interaction Fingerprints, pharmacokinetics, 5ns WaterMap and 100ns MD Simulation in water. We compared the results and extended the study with binding free energy and total energy of each MD simulation trajectory computations and found that Amifostine is a far better drug than Sulfamethoxazole-however, experimental validation is needed before its human use.

21 Apr 2025·Anatolian journal of cardiology

Protective Effect of Amifostine on Radiotherapy-Applied Cardiovascular Tissue.

Article

Author: Taylan, Gökay ; Aydoğdu, Nurettin ; Yalta, Tülin ; Yürüt Çaloğlu, Vuslat ; Aktoz, Meryem ; Çaloğlu, Murat ; Yalta, Kenan

BACKGROUNDThe present study evaluates the protective effect of amifostine (AMI) on acute toxicity in large vessels and the heart in rats with radiotherapy (RT) applied to the thorax.METHODSTwenty-one Wistar albino rats were randomly assigned to 3 groups: Alone RT (n = 7), amifostine plus RT (AMI+RT, n = 7), and control (n = 7) groups. The rats in the RT and AMI+RT groups received a single dose of 20 Gy radiation to the entire thorax. Prior to irradiation, AMI was administered intraperitoneally at a dose of 200 mg/kg, 30 minutes before the procedure. Five days after irradiation, the levels of p53, CD68, and COX in the vascular tissue (aorta) were measured, along with the levels of malondialdehyde (MDA) and glutathione (GSH) in the aortic and heart tissues.RESULTSThe results showed that the level of MDA significantly increased after irradiation, but GSH levels did not change (P < .001 and P = 0.138). Malondialdehyde levels were significantly reduced by AMI, and GSH levels increased (P = .031 and P = .007). When comparing the control group with AMI + RT, MDA and glutathione levels were similar (P = .314 and P = .136). Histopathological evaluation revealed increased cellular inflammation (P = .002) and vascular damage (P = .015) in aortic tissue after thoracic RT irradiation, but no difference in terms of myofibrosis (P = .901) in heart tissue.CONCLUSIONAMI has a radioprotective and antioxidant effect against RT-induced cardiovascular toxicity.

04 Mar 2025·International Journal of Radiation Biology

Screening model in Caenorhabditis elegans for radioprotective natural products

Article

Author: Ma, Baiping ; Zhang, Jie ; Song, Juan ; Wu, Shuang ; Liu, Si ; Yao, Lan ; Yang, Wenxi ; Chen, Xiaojuan ; Li, Zhihui ; Liang, Haizhen

PURPOSEIonizing radiation (IR) could induce damage such as DNA damage and oxidative stress. Natural products, like tea, have been demonstrated potential in mitigating these damages. However, the lack of efficient and rapid screening methods for natural products hinders their widespread application. To address this challenge, this study utilized Caenorhabditis elegans (C. elegans) as an in vivo model to investigate radioprotective natural products.METHODSL1 stage C. elegans were exposed to X-rays or ⁶⁰Co γ-rays at varying dosages (20, 50, and 100 Gy), then the growth, reproduction, and lifespan of the nematodes were observed. Different culture and sample-administered modes were tested. Known radioprotective agents, including Amifostine (WR2721), Lycium barbarum extract (LBE), and Trillium tschonoskii fraction (TTF), served as positive controls to validate the reliability of the model. The radioprotective activity of teas with different fermentation degrees was compared based on this screening model.RESULTSA screening model in C. elegans was established by X-rays at 20 Gy. An appropriate sample-administrated approach was investigated, which involves adding the sample to the nematode growth medium (NGM) agar covered with inactivated Escherichia coli 2 h before irradiation. The known radioprotective agents (WR2721, LBE, and TTF) validated that the model is stable. Our results of the model application revealed that teas with lower fermentation levels, such as green tea and oolong tea, particularly the n-butanol and ethyl acetate fractions from oolong tea, exhibited significant radioprotective activity.CONCLUSIONSThis study presents an effective in vivo approach for the initial screening of radioprotective natural products.

News (Medical) associated with Amifostine

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 - Bissau (+245) Guyana (+592) Haiti (+509) Honduras (+504) Hong Kong (+852) Hungary (+36) Iceland (+354) India (+91) Indonesia (+62) Iran (+98) Iraq (+964) Ireland (+353) Israel (+972) Italy (+39) Jamaica (+1876) Japan (+81) Jordan (+962) Kazakhstan (+7) Kenya (+254) Kiribati (+686) Korea North (+850) Korea South (+82) Kuwait (+965) Kyrgyzstan (+996) Laos (+856) Latvia (+371) Lebanon (+961) Lesotho (+266) Liberia (+231) Libya (+218) Liechtenstein (+417) Lithuania (+370) Luxembourg (+352) Macao (+853) Macedonia (+389) Madagascar (+261) Malawi (+265) Malaysia (+60) Maldives (+960) Mali (+223) Malta (+356) Marshall Islands (+692) Martinique (+596) Mauritania (+222) Mayotte (+269) Mexico (+52) Micronesia (+691) Moldova (+373) Monaco (+377) Mongolia (+976) Montserrat (+1664) Morocco (+212) Mozambique (+258) Myanmar (+95) Namibia (+264) Nauru (+674) Nepal (+977) Netherlands (+31) New Caledonia (+687) New Zealand (+64) Nicaragua (+505) Niger (+227) Nigeria (+234) Niue (+683) Norfolk Islands (+672) Northern Marianas (+670) Norway (+47) Oman (+968) Palau (+680) Panama (+507) Papua New Guinea (+675) Paraguay (+595) Peru (+51) Philippines (+63) Poland (+48) Portugal (+351) Puerto Rico (+1787) Qatar (+974) Reunion (+262) Romania (+40) Russia (+7) Rwanda (+250) San Marino (+378) Sao Tome & Principe (+239) Saudi Arabia (+966) Senegal (+221) Serbia (+381) Seychelles (+248) Sierra Leone (+232) Singapore (+65) Slovak Republic (+421) Slovenia (+386) Solomon Islands (+677) Somalia (+252) South Africa (+27) Spain (+34) Sri Lanka (+94) St. Helena (+290) St. Kitts (+1869) St. Lucia (+1758) Sudan (+249) Suriname (+597) Swaziland (+268) Sweden (+46) Switzerland (+41) Syria (+963) Taiwan (+886) Tajikstan (+7) Thailand (+66) Togo (+228) Tonga (+676) Trinidad & Tobago (+1868) Tunisia (+216) Turkey (+90) Turkmenistan (+7) Turkmenistan (+993) Turks & Caicos Islands (+1649) Tuvalu (+688) Uganda (+256) Ukraine (+380) United Arab Emirates (+971) Uruguay (+598) Uzbekistan (+7) Vanuatu (+678) Vatican City (+379) Venezuela (+58) Vietnam (+84) Virgin Islands - 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

13 Feb 2019

·www.biospace.com

Clinigen Group To Acquire U.S. Rights to Proleukin From Novartis

London-based Clinigen Group pc will now have full rights to Proleukin (aldesleukin, human recombinant interleukin-2). This morning, the U.K.-based pharmaceutical and services company struck a deal with Novartis to acquire the U.S. rights to the metastatic renal cell carcinoma treatment. London-based Clinigen Group pc will have full rights to Proleukin (aldesleukin, human recombinant interleukin-2). This morning, the U.K.-based pharmaceutical and services company struck a deal with Novartis to acquire the U.S. rights to the metastatic renal cell carcinoma treatment. Clinigen signed an agreement with the Swiss pharma giant to acquire the U.S. rights for up to $210 million in cash. The payment consisted of a $120 million upfront payment, a deferred payment of $60 million and future sales-related milestones that could total $30 million. Clinigen already owns the rights to Proleukin outside the US, which it acquired in July 2018. With the deal, Clinigen will be the exclusive global owner of the licensed version of this drug, which is being used in multiple drug studies across different disease areas. The company said Proleukin has the potential to become an integral part of cancer combination therapies. When the company acquired the global rights to Proleukin over the summer, Clinigen said it planned to attempt to revitalize sales of the medicine by working with health care professionals to “ensure its benefit to patients is well understood and by making the medicine available to those who need it through the Group’s global distribution network for both licensed and unlicensed supply.” Shaun Chilton, group chief executive officer at Clinigen, said the U.S. rights to Proleukin will be significant for the whole of the company, not just its Commercial Medicines division. Chilton noted that the acquisition will allow the Clinigen Group to expand its footprint in the U.S. market. “As part of Commercial Medicines, Proleukin is an excellent fit within our oncology and infectious disease medicines as well as diversifying our wider portfolio - it will be the largest product in the portfolio in terms of current sales. The product has significant potential for revitalization, which will provide further breadth and diversity to the portfolio and material increases in revenues,” Chilton said in a statement. In its announcement this morning, Clinigen said Proleukin further diversifies its Commercial Medicines portfolio of niche hospital-only and critical care products. That division also has the U.S. rights to other assets, including Foscavir, Ethyol and Totect. Commercial rights for those three drugs have been licensed to Pfizer (Foscavir) and Cumberland Pharmaceuticals (Ethyol and Totect), Clinigen said. Proleukin generated $60 million in revenue in the United States for the year leading up to June 30, 2018, Clinigen said, citing data from IQVIA. The company said gross profit margin is expected to be similar to other specialty medicines within its Commercial Medicines division. The deal with Novartis follows Clinigen’s September 2018 deals to acquire CSM and iQone Healthcare , which strengthened the company’s position in the European market.

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100 Deals associated with Amifostine

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KEGG	Wiki	ATC	Drug Bank
D00226	Amifostine	V03AF05	DB01143

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Cytoprotective Agent	China	Meiluo Pharmaceutical Co. Ltd.	01 Jan 2001
Neutropenia	Australia	Links Medical Products, Inc.	16 Apr 1998
Xerostomia	Australia	Links Medical Products, Inc.	16 Apr 1998

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Esophagitis	Discovery	United States	MedImmune LLC	01 Nov 2003
Pneumonia	Discovery	United States	MedImmune LLC	01 Nov 2003
Unresectable Lung Non-Small Cell Carcinoma	Discovery	United States	MedImmune LLC	01 Nov 2003
Hodgkin's Lymphoma	Discovery	United States	MedImmune LLC	01 May 2003
Non-Hodgkin Lymphoma	Discovery	United States	MedImmune LLC	01 May 2003
Locally Advanced Head and Neck Squamous Cell Carcinoma	Discovery	United States	MedImmune LLC	01 May 2002
Head and Neck Neoplasms	Discovery	France	Schering-Plough Corp.	01 Mar 2001
Xerostomia	Discovery	United States	Cosette Pharmaceuticals, Inc.	24 Jun 1999

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00601198 (CTgov)	Phase 2	Colorectal Cancer	4	Amifostine	eiseyxwoiw(pgmuxcizmc) = rjqmlukgrs egwjibovrc (xusgzpjlvy, kcdhlpetzc - gmidqztcgm) View more	-	01 Aug 2023
NCT05167370 (CTgov)	Phase 2	Relapsed Solid Neoplasm \| Brain Cancer	2	Amifostine	alzrpfrsty(hxizadgspa) = focxuiowly qaaoxheilo (veymslyqjv, pisolacxgh - kmiikrhfbr) View more	-	25 Jan 2022
NCT01364259 (CTgov)	Phase 3	Hypesthesia \| Trigeminal Neuralgia	17	CyberKnife stereotactic radiosurgery (Placebo)	olkudafxwt(dyefvvhyds) = jdaxvnntay ptnbxezxbt (efuyylnezl, owniloyoaw - dejyunuyko) View more	-	04 Apr 2017
NCT01364259 (CTgov)	Phase 3	Hypesthesia \| Trigeminal Neuralgia	17	Amifostine (Amifostine)	olkudafxwt(dyefvvhyds) = dysponbwgw ptnbxezxbt (efuyylnezl, idememtetw - uuulcmkdju) View more	-	04 Apr 2017
NCT00270790 (CTgov)	Phase 2	Locally Advanced Head and Neck Squamous Cell Carcinoma	21	Radiotherapy+Carboplatin+Taxol+Amifostine	xvyokytrzw(ifsisuhuss) = utgqvonrae cbnprowueq (pcfplexeuo, gjcewafcgx - hjopzrrcnu) View more	-	08 Aug 2016
Tandem Meetings ASTCT and CIBMTR2013	Phase 2	Multiple Myeloma	58	Melphalan 280 mg/m2 + Amifostine	gtykxzqvax(alelrlsslu) = 7% experienced atrial fibrillation or flutter mydgfehnvj (achzqzpryk ) View more	Negative	01 Feb 2013
ASTRO2010	Not Applicable	Head and Neck Neoplasms	50	Amifostine (IMRT)	phopmpflmm(hkzqcwcqee) = brvjdouaji gomoyhultd (bbbuowweti ) View more	Positive	01 Nov 2010
ASTRO2010	Not Applicable	Head and Neck Neoplasms	50	Conventional Radiotherapy with Amifostine	phopmpflmm(hkzqcwcqee) = spivdjulzd gomoyhultd (bbbuowweti )	Positive	01 Nov 2010
NCT00409331 (CTgov)	Phase 2	Squamous Cell Carcinoma of Head and Neck \| Head and Neck Neoplasms	3	Intensity- Modulated Radiation Therapy+Amifostine	dighwxjeom(mnragnuapq) = rtuoszhinr uffyovkatv (gtkqbjondw, jvntqkzccs - bhhwvkulsu) View more	-	18 Jan 2010
NCT00095927 (Pubmed \| Cancer)	Phase 2	Head and Neck Neoplasms	58	Carboplatin/paclitaxel + Amifostine	(otpfzamnih) = ppzbhfwitv smsqjunyiw (iucxstbaoe )	-	01 Oct 2009
ASTRO2007	Not Applicable	Lung Cancer Consolidation	44	Amifostine	sahpilqnbm(kfzrsoqauf) = sikskkyjoq lifahnpvns (gcwwwwjqia ) View more	Positive	01 Nov 2007
ASTRO2007	Not Applicable	Lung Cancer Consolidation	44	Carboplatin+Paclitaxel	(sjcnygszer) = ptmxljnvww oljdialwfr (sejmahnblq ) View more	Positive	01 Nov 2007
ASTRO2007	Not Applicable	Locally Advanced Lung Non-Small Cell Carcinoma	193	Amifostine	(yprwxbstmv) = tgjtqhxbtm xdgpcldako (dgpmvhqtzf ) View more	Negative	01 Nov 2007
ASTRO2007	Not Applicable	Locally Advanced Lung Non-Small Cell Carcinoma	193	Control (no Amifostine)	(yprwxbstmv) = pbylteftyi xdgpcldako (dgpmvhqtzf ) View more	Negative	01 Nov 2007

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