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© 2022
Positive results of E4 co-treatment with androgen deprivation therapy for advanced prostate cancer has been published in European Urology Open Science
/in News, PublicationsPositive results of E4 co-treatment with androgen deprivation therapy for advanced prostate cancer has been published in European Urology Open Science
Pantarhei Oncology proudly announces that its paper ‘Estetrol Cotreatment of Androgen Deprivation Therapy in Infiltrating or Metastatic, Castration-sensitive Prostate Cancer: A Randomized, Double-blind, Phase II Trial (PCombi)’ has been published in the journal European Urology Open Science after comprehensive review. This journal is an international peer-reviewed, scientific, open access journal in the field of urology.
The research paper reports the results of the PCombi study, a phase II, double-blind, randomised, placebo-controlled, multi-centre study in males recently diagnosed with locally advanced or metastatic prostate cancer, who started ADT treatment with an LHRH agonist. The ADT-treated patients were co-treated for 24-weeks with 40 mg E4 or placebo. The high dose E4 treatment was well-tolerated and no treatment-related cardiovascular adverse events were observed. Patient treated with E4 reported fewer complaints of estrogen deficiency symptoms and better quality of life than patients who received placebo. With E4, 6% of the patients reported hot flushes compared to 55% of patients treated with placebo. Total and free testosterone, prostate-specific antigen (PSA), and follicle-stimulating hormone (FSH) were suppressed more rapid and profound, suggesting enhanced disease control by E4. In addition, bone turnover was substantially reduced in the E4-treated patient implicating a bone-sparing effect. The study results have now been published in European Urology Open Science (EUROS).
FDA geeft goedkeuring voor anticonceptiepil met E4
/in NewsFDA geeft goedkeuring voor anticonceptiepil met E4
Zeist, 20 april 2021 – Pantarhei Bioscience maakt bekend dat de Amerikaanse Food & Drug Administration (FDA) goedkeuring heeft gegeven voor de nieuwe anticonceptiepil Estelle® van Mithra Pharmaceuticals. Deze anticonceptiepil bevat het door Pantarhei Bioscience ontwikkelde oestrogeen Estetrol (E4). Eind maart had het adviescomité (CHMP) van het Europees Geneesmiddelenagentschap (EMA) reeds een positieve opinie gegeven voor Estelle®.
Voor meer informatie lees hier het Nederlandstalig Persbericht.
Positief advies EMA voor anticonceptiepil met E4
/in NewsPositief advies EMA voor anticonceptiepil met E4
In navolging van eerdere goedkeuring door gezondheidsinstantie van Canada
Zeist, 31 maart 2021 – Pantarhei Bioscience maakt bekend dat het Comité voor Geneesmiddelen voor Menselijk Gebruik (CHMP) van het Europees Geneesmiddelenagentschap (EMA) een positieve opinie heeft afgegeven voor de nieuwe anticonceptiepil Estelle® van Mithra Pharmaceuticals met het door Pantarhei Bioscience ontwikkelde oestrogeen Estetrol (E4). Goedkeuring voor de Europese markt door de Europese Commissie wordt tegen het einde van het tweede kwartaal van 2021 verwacht.
Voor meer informatie lees hier het Nederlandstalig Persbericht.
Positive advice of the EMA for contraceptive pill with Estetrol after earlier approval by Health Canada
Zeist, 31 March 2021 – Pantarhei Bioscience announces that the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) has published a positive opinion for a novel combined oral contraceptive (OC) containing 15 mg estetrol (E4) and 3 mg drospirenone (DRSP), developed by Pantarhei Bioscience and Mithra Pharmaceuticals. Subject to approval by the European Commission, the marketing authorization valid for all European Union Member States is expected to be granted by the end of the second quarter 2021. The product will be marketed in Europe by the Hungarian company Gedeon Richter under the brand name Drovelis®.
For more information please read the Press Release.