バイオマリン社 フェーズ3 2016年4月発表か/BioMarin will provide an update on Phase 3 design and plans in April 2016

バイオマリン社は、10月29日に開かれた2015年第3四半期の決算報告において、vosoritideの向こう6か月のマイルストーンを発表。
標題のとおり、末尾の下線部が今回、初めて明らかになりました。
clinicalTrial.govには、募集要項が、もう少し早い段階で公表されるかもしれませんが、いずれにせよ、フェーズ3の第1群は、15 µg/kgとなる見込みです。
思い返せば、栄護の病状が発覚後、間もなくして見つけた、同社のフェーズ1に関する記事の発表日付は、ちょうど今から約5年前の2010年10月。
時間はかかれど、打ち切りになることなく、着実に進展しています。
BioMarin trasmited new information that is Anticipated Milestones over the Next 6-months in Third Quarter 2015 Financial Results and Company Update on October 29, 2015.
As this subject, an underlined part is new information.
It may be transmited its enrolment through clinicalTrial.gov earlier. Anyway phase 3 starts 15 µg/kg as its Cohort 1.
I will always remember it has past 5 years since first bmn111 news in Oct. 2010.
It takes long time but steps steadily without closing.

(reference)

Vosoritide for achondroplasia:

In June, the Company published results from the Phase 2 study showing a 50 percent or 2.01 cm/year increase in mean annualized growth velocity (speed at which growth in children occurs) in the cohort of 10 patients receiving a 15 µg/kg dose of vosoritide daily for six months compared with their own pre-treatment growth velocity (p-value= 0.01). Based on these results, BioMarin intends to move into Phase 3 study discussions on the next stage of development with health authorities with a dose of 15 micrograms per kilogram daily. In addition, to support further exploration of a dose that may enable “catch-up” growth in the event of delayed treatment, a fourth cohort with 30 micrograms per kilogram daily has recently completed enrollment in the Phase 2 study.  BioMarin will provide an update on Phase 3 design and plans, as well as 12 month results from the Phase 2 study at the R&D Day in April 2016.

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