Pantarhei Oncology receives positive advice from the FDA to initiate Phase III development of estetrol for prostate cancer treatment

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Pantarhei Oncology receives positive advice from the FDA to initiate Phase III development of estetrol for prostate cancer treatment

After having achieved proof-of-concept in human for estetrol (E4) as a potential combination treatment with androgen deprivation therapy (ADT) of advanced prostate cancer, Pantarhei submitted a Pre-Investigational New Drug Application (Pre-IND) to the US Food & Drug Administration (FDA) for guidance on the further development with this new combination treatment.

In a positive meeting with the FDA, the company has reached an agreement on their development plans including a proposal for a Phase III clinical study. Based on this outcome, the PCombi project (E4 for prostate cancer patients) is now ready to start Phase III, the final stage of development to bring the product to the market.

The next study will be a pivotal phase III, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of estetrol as co-treatment with ADT in patients with advanced prostate cancer. Main objectives are to evaluate E4 treatment for the prevention of estrogen deficiency symptoms caused by the ADT (such as hot flushes and bone loss) and for its additional anti-tumor effects.

The company is currently looking for a strategical or financial partner for further financing the development of this project.

 

 

Interview met Herjan Coelingh Bennink en Iman Schultz in BiotechNEWS & Life Sciences

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Estetrol voldoet aan hooggespannen verwachtingen.

Goedkeuring voor het gebruik van het unieke natuurlijke zwangerschapsoestrogeen estetrol (E4) in een anticonceptiepil. Canada was recent de eerste, EMA en FDA volgden. Het zijn mijlpalen in het bestaan van Pantarhei Bioscience die het oestrogeen ontwikkelde. Maar het E4 toepassingsgebied is veel breder: binnen Pantarhei Oncology wordt het nu ook ingezet bij de behandeling van gevorderde borst- en prostaatkanker. Het ‘brein’ achter E4, gynaecoloog en reproductief endocrinoloog em. Prof. Dr. Herjan J.T. Coelingh Bennink (President en Founder) en Dr. Iman Schultz, Director R&D, vertellen.

Lees hier het interview met Herjan Coelingh Bennink en Iman Schultz in BiotechNEWS & Life Sciences.

 

 

European Commission approves new oral contraceptive containing E4

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European Commission approves new oral contraceptive containing E4
Dutch pill previously approved in the USA and Canada

Zeist, the Netherlands, 21 May 2021 – Pantarhei Bioscience announced today that the European Commission has approved the new oral contraceptive Estelle®. This contraceptive pill contains Estetrol (E4), an estrogen developed by Pantarhei Bioscience since 2000. At the end of March, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) already gave a positive opinion for Estelle®.

For more information, please read the Press Release.

 

Goedkeuring Europese Commissie voor anticonceptiepil met E4
Nederlandse pil eerder al goedgekeurd in de VS en Canada

Zeist, 21 mei 2021 – Pantarhei Bioscience maakt bekend dat de Europese Commissie goedkeuring heeft gegeven voor de nieuwe anticonceptiepil Estelle® met daarin 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 deze pil.

Voor meer informatie lees hier het Nederlandstalig Persbericht.

 

Positive results of E4 co-treatment with androgen deprivation therapy for advanced prostate cancer has been published in European Urology Open Science

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Positive 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

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FDA 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

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Positief 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.

 

 

Dutch BioTech Pantarhei Bioscience’s success with new drug in Canada.

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Approval by Health Canada of a new oral contraceptive with the “forgotten” estrogen Estetrol 

Zeist, 22 March 2021 – Pantarhei Bioscience announces that Canada is the first country in the world to have approved the natural pregnancy estrogen Estetrol (E4) for use in the oral contraceptive Estelle®. The development of this new pill represents a joint effort between Pantarhei Bioscience and Mithra Pharmaceuticals in Belgium.

For more information please read the Press Release.

 

Het Nederlandse Pantarhei Bioscience behaalt succes met geneesmiddel in Canada

Canadese goedkeuring primeur voor anticonceptiepil met ‘vergeten’ hormoon E4 

Zeist, 16 maart 2021 – Pantarhei Bioscience maakt bekend dat Canada als eerste land ter wereld goedkeuring heeft gegeven voor het gebruik van het natuurlijke zwangerschapsoestrogeen estetrol (E4) in de anticonceptiepil Estelle®, onder het handelsmerk Nextstellis®. Het is het eerste en enige orale anticonceptiemiddel op basis van het unieke oestrogeen Estetrol (E4), ontwikkeld door Pantarhei Bioscience en Mithra Pharmaceuticals.

Voor meer informatie lees hier het Nederlandstalig Persbericht.

 

 

Research paper on positive results treatment for advanced breast cancer with the fetal estrogen estetrol (E4) has been accepted for publication in the Journal of Cancer Research and Clinical Oncology

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Pantarhei Oncology proudly announces that its paper ‘Tumor Suppression, Dose Limiting Toxicity and Wellbeing with the Fetal Estrogen Estetrol (E4) in patients with advanced breast cancer’ has been accepted for publication in the Journal of Cancer Research and Clinical Oncology after comprehensive review. The Journal of Cancer Research and Clinical Oncology is an international peer-reviewed scientific journal in the field of oncology.

The research paper states that treating postmenopausal women diagnosed with advanced breast cancer can be treated safely with high doses of E4. All 12 patients enrolled had progressive, heavily pre-treated advanced breast cancer. No treatment-related serious adverse events  or doses of limiting toxicity (DLTs) occurred during the first 4 weeks of E4 treatment allowing further investigation of all three doses. Five of nine patients completing 12 weeks of E4 treatment showed objective anti-tumor effects and six of nine patients reported improved wellbeing.

Schmidt_et_al-2020-Journal_of_Cancer_Research_and_Clinical_Oncology

Last patient out in the phase II PCombi study with Estetrol in patients with prostate cancer

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On May 14, 2020, the last patient has had his last study visit for the phase IIa clinical study of Pantarhei assessing the efficacy and safety of the fetal estrogen estetrol (E4) in prostate cancer patients. The study, the PCombi study, is a double-blind, randomised, placebo-controlled, multi-centre study in patients treated with hormone therapy, an luteinising hormone-releasing hormone (LHRH) agonist, for their prostate cancer.

The main objectives of this study are to evaluate the additional effect of E4 on testosterone suppression by the LHRH agonist as well as the prevention and treatment of hypoestrogenic side effects (e.g. hot flushes) due to the concomitant suppression of estrogens.

First results are expected to be available by beginning of August this year.

 

Pantarhei appoints Iman Schultz as new Director of Research & Development

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Per 1st of January 2020, Iman Schultz has joined Pantarhei as Director R&D. Iman will be responsible for the pre-clinical and clinical development of Pantarhei, including the coordination, analysis and scientific support of Pantarhei’s projects.

Yvette Zimmerman, CEO of Pantarhei states: “With the start of Iman, the company brings in 10 years of R&D experience in the field of biotechnology and drug development for oncological treatments, which will strengthen the company during further development of the projects.” Iman holds a PhD in Translation Oncology. Prior to joining Pantarhei he has been involved in oncology drug development as research scientist and project manager R&D at InteRNA Technologies BV, the Netherlands. In addition, Iman has valuable experience in the management of intellectual property (IP) support and securing financial support for different drug development companies.

 

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