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

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

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

 

 

 

European Commission approves new oral contraceptive containing E4

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.

 

 

 

 

Pantarhei Oncology reports breakthrough in prostate cancer treatment

Pantarhei Oncology reports breakthrough in prostate cancer treatment

Zeist, 11 May 2021 – The leading scientific journal European Urology Open Science (EUROS) has reported the results of a new treatment of advanced prostate cancer developed by Pantarhei Oncology, a biotech company located in Zeist, the Netherlands. Pantarhei Oncology has demonstrated, that by combining the standard of care androgen deprivation therapy (ADT) with the natural estrogen Estetrol (E4), side effects of ADT are significantly reduced and additional long term anti-tumor effects are expected.

For more information, please read the Press Release or the article

 

Pantarhei Oncology rapporteert doorbraak in prostaatkanker behandeling  

Zeist, 11 mei 2021 – Het toonaangevende wetenschappelijke tijdschrift European Urology Open Science (EUROS) heeft de resultaten van een door Pantarhei Oncology ontwikkeld nieuw geneesmiddel voor de behandeling van patiënten met gevorderde prostaatkanker gepubliceerd. De combinatie van de standaard hormoon therapie, bekend als ADT, met het natuurlijke oestrogeen Estetrol (E4), vertoont aanzienlijk minder bijwerkingen en heeft sterkere anti-tumor effecten.

Voor meer informatie lees hier het Nederlandstalig Persbericht  of het artikel

 

 

 

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

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

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

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

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

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

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.