나눔터
공지사항
의학정보
복지정책
환우회소식
회비 및 후원금 납부내역
헌팅턴병 메뉴얼
HOME > 나눔터 > 의학정보

작성자
huntington [작성일 : 2016-09-23 15:48:40 ]   
제목 Teva 제약회사에서 진행중인 임상시험 소식을 전해드립니다.

신경보호효과 개선을 위한 약(Pridopidine)으로 현재 2임상시험 중에 있으며 헌팅턴병 증상을 늦추는 효과를 보인다고 합니다.


아직은 임상시험 단계인 약이며 추가 임상시험 단계등의 결과나오면 소식전해드리겠습니다.





Trial finds Teva drug could slow Huntington's disease

 

http://www.globes.co.il/en/article-teva-pridopidine-could-slow-huntingtons-d

isease-1001153229

 

Globes Correspondent 09/19/2016

 

 

 

Teva Pharmaceutical Industries Ltd. <http://www.tevapharm.com/>  today

announced what could be a major breakthrough in the treatment of

Huntington's Disease (HD) with positive results from its exploratory Phase

II PRIDE-HD study. The trial found a statistically significant impact on the

endpoint of the progression of Huntington Disease at 52 weeks following

treatment with Pridopidine at certain doses versus placebo. The effect of

Pridopidine was further evident in a sub-population of patients with early

stage HD, an effect first observed at 26 weeks.

 

 

 

"Slowing down the progression of this disease has proven to be impossible

until now. These findings give us a reason to believe we may be finally

making progress in slowing deterioration of disease," said Spyros

Papapetropoulos, Teva's VP Clinical Development, Neurodegenerative Diseases.

 

 

 

 

This was a 52-week, dose-ranging trial of Pridopidine twice daily versus

placebo, in the treatment of Huntington disease (HD). The study was directed

at measuring improvement in motor function and the effect on HD progression.

An unusually high placebo effect, extending beyond that expected from

previous studies, limited the ability to determine treatment effects on

assessments of HD motor scores. Evidence of symptomatic impact, however, was

seen in the early stage HD patient sub-population, with improvement in Total

Motor Score (TMS) and dystonia observed at 26 and 52 weeks in this patient

sub-set (stage 1 HD) at specific doses.

 

 

 

The discovery of Pridopidine's previously unknown mode of action as a potent

agonist of the Sigma 1 Receptor (S1R) resulted in a change in PRIDE-HD study

design, from a 26-week study focused on symptoms, to a 52-week study focused

on exploring pridopidine's potential impact on disease progression, as

measured by Total Functional Capacity (TFC).

 

 

 

"I am encouraged by these results, which provide us with clear insights into

the approach to be taken in Phase III development", said Michael Hayden,

President of Teva Global R&D and Chief Scientific Officer. "My obvious hope

is that this will provide the HD community with a medicine capable of

slowing down the progression of this devastating disease."

 

 

 

"These study results are very important for the HD community and for the

continued development of pridopidine. Firstly, pridopidine's safety profile

has been confirmed and extended. Secondly, we now have a clearer idea of the

dosages to study in Phase 3. Lastly, we have some of the most encouraging

evidence to date about an intervention which may slow the inexorable

functional decline of HD," said Karl Kieburtz, M.D., M.P.H., Director of the

Clinical & Translational Science Institute at the University of Rochester

Medical Center.

 

 

 

The results seen in this exploratory study will need to be confirmed in a

Phase III program that will be developed in collaboration with relevant

regulatory agencies.

 

 

 

Pridopidine is an investigational, oral small molecule being developed for

the treatment of HD that exerts its effect as an agonist of S1R. S1R plays a

key role in neuroprotection through increased production of brain-derived

neurotrophic factor (BDNF). Levels of BDNF are decreased in HD and other

neurodegenerative disorders including Parkinson's disease, Alzheimer's

disease and ALS.

 

================================

 

 

 

Huntington Study Group PRIDE HD Study Information:

http://huntingtonstudygroup.org/current-clinical-trials/pride-hd-study/

 

.       No information available yet on enrolling for the Phase 3 study.

 

.       No facilities in Florida participated in the Phase II study:

https://clinicaltrials.gov/ct2/show/study/NCT02006472?show_locs=Y#locn

 

[ 새글 | 답글 | 수정 | 삭제 ] [ 목록 ]
[ 총게시물 : 120 | page : 6 ]
[ 정렬조건 : 등록일 | 조회  ]
순번 제목 조회 파일 등록일 작성자
60   Ionis와 Roche의 최신의 huntingtin-제거 연구에 관한 HDSA의 Q & A 424 21/12/29 운영자  
59   헌팅턴병 신약 허가절차를 빠르게 하기 위한 새로운 협력 414 21/12/20 운영자  
58   처음엔 돌리, 이제는 아기 돼지가; 새로운 헌팅턴병 Knock-in 돼지 모델... 380 19/05/13 운영자  
57   Enroll-HD에 HDBuzz 등록 338 19/04/07 운영자  
56   Huntington의 질병 치료 회의 2020 - 2일차입니다 380 20/01/29 운영자  
55   Huntington의 질병 치료 회의 2020 - 1일차입니다. 361 20/01/20 운영자  
54   새로운 분자가 실험실 모델에서 Huntington의 질병 변이를 역전 시킬 수... 596 22/01/11 운영자  
53   COVID-19는 Huntington 질병 가족 및 HD 연구에 어떤 의미가 있습니까? 515 22/01/04 운영자  
52   젊음의 샘: HTT 단백질은 젊은 상태를 유지함으로써 뉴런을 회복시킵니 546 22/02/26 운영자  
51   HD Young Adult Study는 눈에 띄는 변화가 있는 증상이 없는 지점을 정 591 22/02/20 운영자  
50   다른 세포 유형을 뉴런으로 변환하는 것 612 22/02/12 운영자  
49   HD 및 히스타민: 스트레스 받는 뇌 대화를 잠재우기 위해 혼성 수용체를... 566 22/02/02 운영자  
48   유전자 편집 기술인 CRISPR을 경계해야 합니다. 361 19/07/23 운영자  
47   팀으로서 같이 작업합니다. 뇌 발달의 변화는 일부 뇌 부위가 게을러질 313 19/12/23 운영자  
46   유전자가 불안정 할 때 : HD에서 체세포의 불안정성의 표적 384 19/11/15 운영자  
45   Signal 연구의 슬픈 소식 : pepinemab은 헌팅턴병 증상에 영향을 주지 398 19/10/02 운영자  
44   다른 신경질환에 대한 치료약물이 헌팅턴 병 환자에게도 효과가 있을 수... 395 19/08/01 운영자  
43   Huntington Study Group (HSG) 2020 연례 컨퍼런스 : 헌팅턴 질병의 주 360 20/03/11 운영자  
42   Huntington Study Group (HSG) 2020 연례 컨퍼런스 : 헌팅턴 질병의 주 381 20/03/11 운영자  
41   HD 치료 설계를 위한 DNA 복구의 어두운면을 밝히다 362 19/09/08 운영자  

1 2 3 4 5 6 [ 새글 | 처음목록 | 목록 ]  
단체명 : 헌팅턴병 환우회   주소 : 서울시 종로구 연건동 서울대학교병원  

Copyrightⓒ by huntington.co.kr All rights reserved.    webmaster  개인정보 취급방침