Post by Deleted on Jun 8, 2018 15:32:42 GMT
Hello to everyone.
On the clinical trials of mod-4023:
Adult Subjects:
clinicaltrials.gov/ct2/show/NCT01909479?term=mod
Estimated Study Completion Date : September 2018
Data from the presentation:
investor.opko.com/static-files/c784bb37-d955-4145-b68c-d1486c6c9696
Correspondence and communication with FDA indicated that:
There is a path for submission whereby FDA would assess the totality of the data-all relevant efficacy and safety data in adults and pediatric patients.
The number of patients to be included in the safety database seems sufficient
The design of the bioequivalence study for the change from vial to pen formulation is generally acceptable.
Conclusion: opko still have to do a bridge study to put the hGH-CTP in a pen device.
In Russia:
www.grls.rosminzdrav.ru/CiPermitionReg.aspx?PermYear=0&DateBeg=&DateEnd=&DateInc=&NumInc=&RegNm=&Statement=&Protocol=CP-4-005&Qualifier=&ProtoNum=&idCIStatementCh=&CiPhase=&RangeOfApp=&Torg=&LFDos=&Producer=OIIKO+Биологикс+Лтд.+(OPKO+Biologics+Ltd.)&Recearcher=&sponsorCountry=&MedBaseCount=&CiType=&PatientCount=&OrgDocOut=2&Status=&NotInReg=0&All=0&PageSize=8&order=date_perm&orderType=desc&pagenum=1
Estimated Study Completion Date : 31/12/2019
Prepubertal Children:
Phase 2:
clinicaltrials.gov/ct2/show/NCT02500316?term=opko&recrs=ad&rank=5
Estimated Study Completion Date : December 2021
Following the first year final analysis, in the open-label extension study, the patients were re-randomised to the same 3 MOD-4023 treatments for a second year. As previously reported, the height velocities over the first year indicated good growth across the MOD-4023 treatments (10.44, 10.96, and 11.93 cm/year) that was similar to hGH (12.46 cm/year).
The same pattern was reported for height SDS over the first year (1.14, 1.23, and 1.45 cm/year), compared with hGH (1.54 cm/year). All 3 doses of MOD-4023 demonstrated promising growth at year 2 (extension phase, 7.73, 7.67, and 8.74 cm/year), while the 2 higher doses of MOD-4023 resulted in better growth in comparison with the lower dose of MOD-4023 (0.25 mg/kg per week), and in line with reported age- and GHD severity-matched historical controls (7.5 cm/year).
In Russia:
www.grls.rosminzdrav.ru/CiPermitionReg.aspx?PermYear=0&DateBeg=&DateEnd=&DateInc=&NumInc=&RegNm=&Statement=&Protocol=&Qualifier=&ProtoNum=&idCIStatementCh=&CiPhase=&RangeOfApp=&Torg=&LFDos=mod-4023&Producer=&Recearcher=&sponsorCountry=&MedBaseCount=&CiType=&PatientCount=&OrgDocOut=2&Status=&NotInReg=0&All=0&PageSize=8&order=date_perm&orderType=desc&pagenum=1
Estimated Study Completion Date : 31/07/2018
Phase 3:
Japan:
www.clinicaltrials.jp/user/cteDetail_e.jsp
2018/5/17 application date
JapicCTI-No. JapicCTI-183963
Russia:
www.grls.rosminzdrav.ru/CiPermitionReg.aspx?PermYear=0&DateBeg=&DateEnd=&DateInc=&NumInc=&RegNm=&Statement=&Protocol=CP-4-006&Qualifier=&ProtoNum=&idCIStatementCh=&CiPhase=&RangeOfApp=&Torg=&LFDos=&Producer=&Recearcher=&sponsorCountry=&MedBaseCount=&CiType=&PatientCount=&OrgDocOut=2&Status=&NotInReg=0&All=0&PageSize=8&order=date_perm&orderType=desc&pagenum=1
Estimated Enrollment : 40 participants
Estimated Study Completion Date : 31/09/2019
Europe:
www.clinicaltrialsregister.eu/ctr-search/search?query=%09Somatrogon
Trial protocol: GB (Ongoing) DE (Ongoing) BG (Ongoing) ES (Ongoing) GR (Ongoing)
Thanks.
On the clinical trials of mod-4023:
Adult Subjects:
clinicaltrials.gov/ct2/show/NCT01909479?term=mod
Estimated Study Completion Date : September 2018
Data from the presentation:
investor.opko.com/static-files/c784bb37-d955-4145-b68c-d1486c6c9696
Correspondence and communication with FDA indicated that:
There is a path for submission whereby FDA would assess the totality of the data-all relevant efficacy and safety data in adults and pediatric patients.
The number of patients to be included in the safety database seems sufficient
The design of the bioequivalence study for the change from vial to pen formulation is generally acceptable.
Conclusion: opko still have to do a bridge study to put the hGH-CTP in a pen device.
In Russia:
www.grls.rosminzdrav.ru/CiPermitionReg.aspx?PermYear=0&DateBeg=&DateEnd=&DateInc=&NumInc=&RegNm=&Statement=&Protocol=CP-4-005&Qualifier=&ProtoNum=&idCIStatementCh=&CiPhase=&RangeOfApp=&Torg=&LFDos=&Producer=OIIKO+Биологикс+Лтд.+(OPKO+Biologics+Ltd.)&Recearcher=&sponsorCountry=&MedBaseCount=&CiType=&PatientCount=&OrgDocOut=2&Status=&NotInReg=0&All=0&PageSize=8&order=date_perm&orderType=desc&pagenum=1
Estimated Study Completion Date : 31/12/2019
Prepubertal Children:
Phase 2:
clinicaltrials.gov/ct2/show/NCT02500316?term=opko&recrs=ad&rank=5
Estimated Study Completion Date : December 2021
Following the first year final analysis, in the open-label extension study, the patients were re-randomised to the same 3 MOD-4023 treatments for a second year. As previously reported, the height velocities over the first year indicated good growth across the MOD-4023 treatments (10.44, 10.96, and 11.93 cm/year) that was similar to hGH (12.46 cm/year).
The same pattern was reported for height SDS over the first year (1.14, 1.23, and 1.45 cm/year), compared with hGH (1.54 cm/year). All 3 doses of MOD-4023 demonstrated promising growth at year 2 (extension phase, 7.73, 7.67, and 8.74 cm/year), while the 2 higher doses of MOD-4023 resulted in better growth in comparison with the lower dose of MOD-4023 (0.25 mg/kg per week), and in line with reported age- and GHD severity-matched historical controls (7.5 cm/year).
In Russia:
www.grls.rosminzdrav.ru/CiPermitionReg.aspx?PermYear=0&DateBeg=&DateEnd=&DateInc=&NumInc=&RegNm=&Statement=&Protocol=&Qualifier=&ProtoNum=&idCIStatementCh=&CiPhase=&RangeOfApp=&Torg=&LFDos=mod-4023&Producer=&Recearcher=&sponsorCountry=&MedBaseCount=&CiType=&PatientCount=&OrgDocOut=2&Status=&NotInReg=0&All=0&PageSize=8&order=date_perm&orderType=desc&pagenum=1
Estimated Study Completion Date : 31/07/2018
Phase 3:
Japan:
www.clinicaltrials.jp/user/cteDetail_e.jsp
2018/5/17 application date
JapicCTI-No. JapicCTI-183963
Russia:
www.grls.rosminzdrav.ru/CiPermitionReg.aspx?PermYear=0&DateBeg=&DateEnd=&DateInc=&NumInc=&RegNm=&Statement=&Protocol=CP-4-006&Qualifier=&ProtoNum=&idCIStatementCh=&CiPhase=&RangeOfApp=&Torg=&LFDos=&Producer=&Recearcher=&sponsorCountry=&MedBaseCount=&CiType=&PatientCount=&OrgDocOut=2&Status=&NotInReg=0&All=0&PageSize=8&order=date_perm&orderType=desc&pagenum=1
Estimated Enrollment : 40 participants
Estimated Study Completion Date : 31/09/2019
Europe:
www.clinicaltrialsregister.eu/ctr-search/search?query=%09Somatrogon
Trial protocol: GB (Ongoing) DE (Ongoing) BG (Ongoing) ES (Ongoing) GR (Ongoing)
Thanks.