Oncopeptides presenterar nya data från fas 1/2-studien ANCHOR

Oncopeptides ansöker om villkorat godkännade av melflufen

Melflufen is a novel peptide-drug conjugate that rapidly delivers a cytotoxic payload into tumor cells. It has emerged as a potential new multiple myeloma treatment, particularly for late-stage forms of the disease. Here we describe the rationale and design of OCEAN (NCT03151811), a randomized, head … 2020-11-19 Data From Oncopeptides Melflufen Clinical Development Program Presented at SOHO 2019 Annual Meeting STOCKHOLM , Sept. 11, 2019 /PRNewswire/ -- Oncopeptides AB (Nasdaq Stockholm: ONCO) announced today that clinical trial data were presented at the Society of Hematologic Oncology (SOHO) 2019 Annual Meeting in Houston, TX , USA. STOCKHOLM - October 1, 2020 - Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) announced today that the open-label Expanded Access Program, sEAPort, for eligible U.S. patients, is formally open.Melflufen (INN melphalan flufenamide), is currently being evaluated in several clinical studies as a treatment for patients with triple-class refractory multiple myeloma. Det är en viktig milstolpe för Oncopeptides och ett stort steg på vägen att göra melflufen tillgänglig för patienter med multipelt myelom, som är i desperat behov av nya behandlingsmöjligheter”, säger Marty J Duvall, VD för Oncopeptides.

Godkännandet omfattar behandling av blodcancerformen multipelt myelom, där patienter genomgått åtminstone fyra behandlingslinjer.

ONCOPEPTIDES: "VÄLDIGT LOVANDE" DELRESULTAT

About Oncopeptides Oncopeptides is a pharmaceutical company focused on the development of targeted therapies for difficult-to-treat hematological diseases. The lead product candidate melflufen, is a first in class peptide-drug conjugate that targets aminopeptidases and releases alkylating agents into tumor cells. Welcome to the Oncopeptides clinical development program. and efficacy of melphalan flufenamide (also referred to as melflufen in clinical development) in 7 Jan 2021 Melflufen is an anticancer drug under development by Oncopeptides AB. It is a peptidase enhanced cytotoxic that exerts a targeted delivery of 14 May 2020 STOCKHOLM — May 14, 2020 — Oncopeptides AB (Nasdaq Stockholm: ONCO) announces today that data from the pivotal phase 2 study 1 Oct 2020 Oncopeptides has launched their United States Expanded Access Program with melflufen (also called Melphalan Flufenamide) for relapsed or Oncopeptides seeks European marketing approval for melflufen to treat r/r multiple myeloma.

Oncopeptides startar ett Expanded Access Program i USA

Global Clinical Lead Melflufen at Oncopeptides AB. Oncopeptides ABKarolinska Institutet.

I veckans avsnitt gästas vi av Oncopeptides vd Jakob Oncopeptides is a global biotech company focused on the development of by the U.S. FDA for PEPAXTO (melphalan flufenamide, also known as melflufen), 08:00 Stockholm - 31 mars 2021 - Oncopeptides AB (Nasdaq Stockholm; PEPAXTO (melfalan flufenamid, även kallat melflufen), villkorat godkännande i Aktieägarna i Oncopeptides AB (publ), org. nr 556596-6438, ("Oncopeptides" eller "Bolaget") kallas härmed till extra bolagsstämma i Tändstickspalatset, Västra {{ $select.selected.num + '. ' +$select.selected.name }}. {{ eCtrl.event.layout.chapters.title || 'Select chapter' }}. {{ chapter.num }}. {{ chapter.name }} The U.S. FDA has granted priority review for Oncopeptides´ New Drug Application seeking accelerated approval of melflufen in combination with dexamethasone for treatment of adult patients with multiple myeloma whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent and one anti-CD-38 monoclonal antibody, i.e., triple-class refractory multiple myeloma patients.
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Läkemedlet Melflufen (INN melfalan flufenamid) utvärderas för närvarande i flera kliniska studier som behandling av patienter med trippelklassrefraktärt Oncopeptides vd Marty J Duvall uppger att bolaget står redo för en lansering av melflufen i USA vid behandling av en form av HORIZON (OP-106): Melflufen plus dexamethasone in relapsed/refractory multiple myeloma (RRMM) refractory to pomalidomide and/or an anti- Oncopeptides har informerat den Europeiska läkemedelsmyndigheten EMA att de avser ansöka om villkorat marknadsgodkännande för melflufen. Det framgår Forskningsbolaget Oncopeptides har enligt ett pressmeddelande lämnat in en ansökan till EMA om villkorat godkännande för melflufen i EU. Data från Oncopeptides kliniska studier, HORIZON och ANCHOR, där melflufen utvärderas i RRMM, har accepterats för presentation vid AACR årsmöte. "Vi tror att melflufen kan komma att möta ett växande medicinskt behov hos patienter i Europa med relapserande refraktärt multipelt myelom ( 1, mar, ONCOPEPTIDES: SEB HÖJER RIKTKURSEN TILL 210 KR (184). 1, mar, ONCOPEPTIDES: FDA GER MELFLUFEN VILLKORAT GODKÄNNANDE Relapsed refractory multiple myeloma and melflufen – clinical Overview of US launch of melflufen – Marty J Duvall, CEO Oncopeptides. ONCOPEPTIDES: KOMMER ANSÖKA GODKÄNNANDE USA FÖR MELFLUFEN (OMS) STOCKHOLM (Nyhetsbyrån Direkt) Oncopeptides har påbörjat Johan Aschan.

Oncopeptides has one U.S. FDA approved product, PEPAXTO® (melphalan flufenamide), known during clinical development as melflufen. PEPAXTO is approved for patients with triple-class refractory Melphalan flufenamide is an investigational drug. Its safety and efficacy have not been established and it has not been approved by any regulatory authority. Oncopeptides, maker of PEPAXTO expects to have the intravenous drug to be available to physicians and patients within two weeks. Melflufen is the very first anti-cancer peptide-drug conjugate to be approved by the FDA, representing a new way to tackle multiple myeloma and cancer in general. Melphalan flufenamide is a peptidase enhanced cytotoxic (PEnC) that exerts a targeted delivery of melphalan in cells with high expression of aminopeptidases, such as aminopeptidase N, which has been described as over-expressed in human malignancies. Aminopeptidase N plays a functional role in malignant angiogenesis.
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Stockholm Saturday, April 17, 2021, 17:00 Hrs [IST]. Oncopeptides Melphalan flufenamide is a peptide drug conjugate prodrug, developed by Oncopeptides, for the treatment of multiple myeloma and amyloid light-chain 2 days ago "We believe that melflufen may address a growing medical need in patients with relapsed refractory multiple myeloma in Europe. In order to help Melphalan flufenamide, sold under the brand name Pepaxto, is an anticancer medication used "The novel alkylating prodrug melflufen (J1) inhibits angiogenesis in vitro and in vivo". Biochemical Oncopeptides AB. 1 March 2 Oncopeptides AB. Melflufen plus dexamethasone in relapsed and refractory multiple myeloma (O-12-M1): a multicentre, international, open-label, phase 1-2 26 Feb 2021 PEPAXTO® (melphalan flufenamide, also known as melflufen) is the first anticancer peptide-drug conjugate for patients with relapsed or 27 Sep 2020 Keywords: melflufen; melphalan flufenamide; peptide–drug assistance with this manuscript, which was funded by Oncopeptides AB. Conflicts 16 Sep 2019 Oncopeptides remains on track to submit an NDA in 1Q20 for melflufen to treat multiple myeloma, as the latest data from a pivotal Phase II study 23 May 2019 Approval Submission On The HORIZON For Oncopeptides' Melflufen refractory multiple myeloma can support NDA; Oncopeptides aims for 1 Sep 2020 STOCKHOLM, Seden I August 29, 2020 I Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) today announces that the US Food and Drug 24 May 2019 Oncopeptides AB has initiated the preparation for submitting a New Drug Application for accelerated approval of melflufen for the treatment of 26 Mar 2020 Oncopeptides AB remains on track for an NDA filing in the second quarter for its peptide-drug conjugate, melflufen, in relapsed refractory 31 Aug 2020 It is an important milestone for Oncopeptides, and a major step in making melflufen available for patients with multiple myeloma, who 17 Jun 2015 Oncopeptides has presented results from an ongoing study of melflufen with dexamethasone in patients with relapsed and relapsed refractory 14 May 2020 The aim is to market melflufen for the treatment of relapsed multiple myeloma patients that fail to respond to three different classes of drugs, and 9 Dec 2020 This study was sponsored by Oncopeptides AB, which also provided support for manuscript editorial assistance.

Oncopeptides. Accessed October 19, 2020. https://oncopeptides.se/en/section/our-clinical-trials/ 2. Safety and efficacy of melflufen and dexamethasone in relapsed and/or relapsed-refractory multiple myeloma patients. ClinicalTrials.gov Identifier: NCT01897714.
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Melflufen (melfalan flufenamid) är ett nytt peptidlänkat läkemedel mot cancer som snabbt levererar ett cellgift till tumörceller. Melflufen är i sen klinisk utvecklingsfas för möjlig behandling av patienter med relapserande och refraktärt multipelt myelom (RRMM). Om Oncopeptides Oncopeptides är ett läkemedelsföretag med inriktning på utveckling av riktade terapier för svårbehandlade hematologiska sjukdomar. Bolaget fokuserar på utvecklingen av produktkandidaten melflufen, ett nytt peptidlänkat cancerläkemedel som snabbt levererar ett alkylerande cellgift till tumörceller. 2 dagar sedan · Läkemedelsbolaget Oncopeptides har lämnat in en ansökan om villkorat marknadsgodkännande för melflufen i EU vid behandling av en form av blodcancerformen multipelt myelom. Det framgår av ett pressmeddelande. About Oncopeptides Oncopeptides is a pharmaceutical company focused on the development of targeted therapies for difficult-to-treat hematological diseases.

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The … STOCKHOLM — April 16, 2021 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today announces that the Company has submitted an application to the European Medicines Agency, EMA, for conditional marketing authorization of melflufen (melphalan flufenamide) in the EU, based on the STOCKHOLM — May 14, 2020 — Oncopeptides AB (Nasdaq Stockholm: ONCO) announces today that data from the pivotal phase 2 study HORIZON, and additional clinical and preclinical data that further evaluate the therapeutic peptide-drug conjugate platform, have been accepted by the European Hematology Association (EHA). The abstracts are now published online. Melflufen (melphalan … 2021-02-27 2020-05-15 1 day ago It is an important milestone for Oncopeptides, and a major step in making melflufen available for patients with multiple myeloma, who desperately need new treatment options,” says Marty J Duvall, CEO of Oncopeptides.

About Oncopeptides Oncopeptides is a pharmaceutical company focused on the development of targeted therapies for difficult-to-treat hematological diseases. The lead product candidate melflufen, is a first in class peptide-drug conjugate that targets aminopeptidases and releases alkylating agents into … 2020-04-06 2020-09-04 Oncopeptides Announces New Clinical and Preclinical Melflufen Data at the Upcoming European Hematology Association Meeting PRESS RELEASE PR Newswire May. 14, 2020, 03:13 PM Melphalan flufenamide, sold under the brand name Pepaxto, is an anticancer medication used to treat multiple myeloma.. The most common adverse reactions include fatigue, nausea, diarrhea, pyrexia and respiratory tract infection.