DNL.L (Mkap €25 M) Attraktive Medikamente vor der Zulassung (Seite 74)
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Antwort auf Beitrag Nr.: 61.968.062 von zubi1955 am 20.11.19 09:08:37Sehr schön, hoffentlich kommen in den nächsten Tagen/Wochen die weiteren News. Dann hätte dich das lange Warten gelohnt.
Antwort auf Beitrag Nr.: 61.967.909 von zubi1955 am 20.11.19 08:56:09
Guter Start mit 0.355 £
Es geht doch 😀
Grüsse aus der Schweiz
Zubi
Guter Start mit 0.355 £
Es geht doch 😀
Grüsse aus der Schweiz
Zubi
Diurnal Group PLC Successful outcome of testosterone clinical study
Successful outcome of oral testosterone clinical study
Primary efficacy endpoint met with DITEST(TM) in 24-patient study
Potential to be the first effective oral native testosterone treatment in a $4.8bn global market
Diurnal's third product in clinical development; another significant step towards building a global endocrinology franchise
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces positive headline results from the Company's DITEST(TM) (native oral testosterone formulation) Phase I proof-of-concept clinical trial. This study, which confirms the positive findings in the Company's successful in vivo pre-clinical studies, evaluated the pharmacokinetics, safety and tolerability of DITEST(TM) in the target patient group of 24 adult men with primary or secondary hypogonadism(1) .
The estimated $4.8 billion market in US and Europe for testosterone-based products for the treatment of hypogonadism is dominated by topically-available products, which have compliance and safety issues, while key issues with the use of alternative, oral modified testosterone products (testosterone undecanoate) has been the variability in absorption and the requirement for a high-fat meal to achieve therapeutic testosterone levels. The DITEST study was designed to compare both of these properties to an existing testosterone undecanoate therapy in hypogonadism patients.
The primary endpoint of the trial compared the rate and extent of absorption of testosterone from a single dose of DITEST(TM) 120mg with a single dose of testosterone undecanoate 80mg in the fed state in hypogonadal men. In this respect, DITEST(TM) was shown to achieve testosterone levels within the healthy young male adult normal range after oral administration, with levels that were less variable than testosterone undecanoate.
Secondary endpoints demonstrated that there was no impact on the rate and extent of absorption of testosterone from DITEST(TM) 200mg whether taken with either food or in the fasted state, representing a major difference with testosterone undecanoate. The safety and tolerability of two different doses of DITEST(TM) were also assessed in the study: there were no serious adverse events in the DITEST(TM) arm of the study, and levels of the potent testosterone derived androgen, dihydrotestosterone (DHT), were lower than with testosterone undecanoate.
Professor John Newell-Price, University of Sheffield and Lead Investigator on the study, commented:
"Currently available topical formulations of native testosterone have significant compliance and potential safety issues while, to date, attempts to create oral preparations of modified testosterone have resulted in products with considerable pharmacokinetic variability and a requirement to be taken with a high-fat meal. For hypogonadal men, there is an unmet need for an effective and convenient oral testosterone replacement therapy. I am strongly encouraged by these study results, which demonstrate that the DITEST(TM) formulation has the potential to address these needs."
Martin Whitaker, CEO of Diurnal, added:
"The positive outcome of this trial is another meaningful step towards achieving Diurnal's vision of becoming one of the world's leading endocrinology speciality pharma companies. We are excited by the potential of DITEST(TM) to address a significant unmet patient need for hypogonadal men, which affects over 60 million men globally(2) . DITEST(TM) is our next pipeline product in the clinic after our lead programmes, Alkindi(R) and Chronocort(R) . We look forward to engaging with regulators in the US and Europe to progress DITEST(TM) to late stage clinical trials, and to discussing these positive trial data with potential development and commercialisation partners."
Successful outcome of oral testosterone clinical study
Primary efficacy endpoint met with DITEST(TM) in 24-patient study
Potential to be the first effective oral native testosterone treatment in a $4.8bn global market
Diurnal's third product in clinical development; another significant step towards building a global endocrinology franchise
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces positive headline results from the Company's DITEST(TM) (native oral testosterone formulation) Phase I proof-of-concept clinical trial. This study, which confirms the positive findings in the Company's successful in vivo pre-clinical studies, evaluated the pharmacokinetics, safety and tolerability of DITEST(TM) in the target patient group of 24 adult men with primary or secondary hypogonadism(1) .
The estimated $4.8 billion market in US and Europe for testosterone-based products for the treatment of hypogonadism is dominated by topically-available products, which have compliance and safety issues, while key issues with the use of alternative, oral modified testosterone products (testosterone undecanoate) has been the variability in absorption and the requirement for a high-fat meal to achieve therapeutic testosterone levels. The DITEST study was designed to compare both of these properties to an existing testosterone undecanoate therapy in hypogonadism patients.
The primary endpoint of the trial compared the rate and extent of absorption of testosterone from a single dose of DITEST(TM) 120mg with a single dose of testosterone undecanoate 80mg in the fed state in hypogonadal men. In this respect, DITEST(TM) was shown to achieve testosterone levels within the healthy young male adult normal range after oral administration, with levels that were less variable than testosterone undecanoate.
Secondary endpoints demonstrated that there was no impact on the rate and extent of absorption of testosterone from DITEST(TM) 200mg whether taken with either food or in the fasted state, representing a major difference with testosterone undecanoate. The safety and tolerability of two different doses of DITEST(TM) were also assessed in the study: there were no serious adverse events in the DITEST(TM) arm of the study, and levels of the potent testosterone derived androgen, dihydrotestosterone (DHT), were lower than with testosterone undecanoate.
Professor John Newell-Price, University of Sheffield and Lead Investigator on the study, commented:
"Currently available topical formulations of native testosterone have significant compliance and potential safety issues while, to date, attempts to create oral preparations of modified testosterone have resulted in products with considerable pharmacokinetic variability and a requirement to be taken with a high-fat meal. For hypogonadal men, there is an unmet need for an effective and convenient oral testosterone replacement therapy. I am strongly encouraged by these study results, which demonstrate that the DITEST(TM) formulation has the potential to address these needs."
Martin Whitaker, CEO of Diurnal, added:
"The positive outcome of this trial is another meaningful step towards achieving Diurnal's vision of becoming one of the world's leading endocrinology speciality pharma companies. We are excited by the potential of DITEST(TM) to address a significant unmet patient need for hypogonadal men, which affects over 60 million men globally(2) . DITEST(TM) is our next pipeline product in the clinic after our lead programmes, Alkindi(R) and Chronocort(R) . We look forward to engaging with regulators in the US and Europe to progress DITEST(TM) to late stage clinical trials, and to discussing these positive trial data with potential development and commercialisation partners."
Antwort auf Beitrag Nr.: 61.955.786 von Reinerle am 19.11.19 07:12:34....da kann ich auch die Kohle im Casino versenken hopp oder topp
Ist doch super. Weniger Mitarbeiter weniger Personalkosten. Verstehe den Post nicht
Trading Spotlight
Als ob es bei (kleinen) Biotech‘s um die Mitarbeiter-Anzahl ginge...🙄
Selbst wenn der Laden nur 10 Mitarbeiter hätte, aber Chronocort die US-Zulassung bekäme, würde sich die Aktie vervielfachen...
Selbst wenn der Laden nur 10 Mitarbeiter hätte, aber Chronocort die US-Zulassung bekäme, würde sich die Aktie vervielfachen...
Antwort auf Beitrag Nr.: 61.924.739 von Sugar2000 am 14.11.19 17:51:04unser doener bude um die Ecke hat bald mehr mitarbeiter als DIURNAL
27 Mitarbeiter
ich lach mich schlapp
27 Mitarbeiter
ich lach mich schlapp
Antwort auf Beitrag Nr.: 61.923.428 von kelev_ra am 14.11.19 16:08:29Vorhin gab es einen Umsatz :-)
Handel läuft ganz normal. Aktuell einfach kein Kaufinteresse. Kommt hoffentlich wieder.
Vielleicht wurde der Handel ausgesetzt und eine Übernahme steht im Raum
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