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.

 

Review paper on the risk of breast cancer in relation to gender, breast development and gonadal function published in JCEM

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The Journal of Clinical Endocrinology & Metabolism has accepted the manuscript “Breast Cancer and Major Deviations of Genetic and Gender-related Structures and Function” by Herjan J.T. Coelingh Bennink, Jan F.M. Egberts, Jan A. Mol, Kit C.B. Roes, Paul J. van Diest for publication. The review reports of the risk of breast cancer (BC) in relation to gender, breast development and gonadal function in eight populations with different genetic conditions. Main three conclusions are: 1) the presence of an Y chromosome protects against the development of BC; 2) Without menstrual cycles, BC hardly occurs with an incidence comparable to males; 3) BC has been reported only once in genetic females with the Mayer-Rokitansky-Küster-Hauser syndrome, who have normal breasts and ovulating ovaries with normal levels of estrogens and progesterone.

For more information, please read the abstract.

 

 

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.

Estetrol has DUAL efficacy in the treatment of
end-stage breast cancer

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The pregnancy estrogen Estetrol (E4) has a DUAL effect when treating heavily-pre-treated women with advanced breast cancer who have no further treatment options. First, E4 has an anti-tumor effect and second, E4 improves wellbeing.

The Dutch biotech company Pantarhei Oncology presents on December 13, 2019 at the San Antonio Breast Cancer Symposium (SABCS) in the USA the results of the first clinical study with High Doses of the fetal estrogen Estetrol (HDE4) in women with advanced end-stage breast cancer. Nine women without further treatment options participated in the study and were treated with 20, 40 or 60 mg E4 per day for 12 weeks. Anti-tumor effects after 12 weeks treatment were confirmed in 5 of 9 women and strong improvement of wellbeing occurred in 7 of 9 patients.

For more information please read the Press Release or the Poster.

Voor meer informatie lees hier het Nederlandstalig persbericht.

 

27th World Congress on Controversies in Obstetrics, Gynecology and Infertility (COGI), November 21-23, 2019, Paris

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On Friday November 22, 2019, Herjan Coelingh Bennink from Pantarhei lectured during the session: Breast cancer epidemic and hormonal replacement: What is the relationship?

The title of this special countercurrent lecture was: Treatment of advanced breast cancer with high dose estrogens.

For more information please read the abstract.

13th European Society of Gynecology (ESG) Congress, October 16-19 2019, Vienna, Austria

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On Thursday October 17, 2019, Herjan Coelingh Bennink of Pantarhei lectured on: “Estetrol for the treatment of advanced breast cancer” in a symposium entitled “Breast cancer: new challenges in diagnosis, pathogenesis and therapy”. The symposium was chaired by Xiangyan Ruan and Kerstin Rhiem.

For more information, please read the abstract.

Pantarhei Bioscience Change of Address

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Beginning of September, Pantarhei Bioscience has moved the office to a new building. The new address is Boulevard 17, 3707 BK Zeist, the Netherlands. For more information, see change-of-address.

Pantarhei Bioscience New Address

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