BioRestorative Therapies Lower Back Candidate Shows Decrease In Pain, Increased Function
BioRestorative Therapies Lower Back Candidate Shows Decrease In Pain, Increased Function
The 10 safety run-in subjects reported no serious adverse events (SAEs).BioRestorative Therapies Inc. (NASDAQ:BRTX) revealed on Wednesday new preliminary 26 to 52 week blinded data from the first 10 patients with chronic lumbar disc disease (cLDD) enrolled in the ongoing Phase 2 trial of BRTX-100.
BioRestorative Therapies Inc. (納斯達克:BRTX) 在週三透露了來自正在進行的BRTX-100第二階段試驗中首批10名慢性腰椎間盤疾病患者（cLDD）新的初步盲法數據，數據時間範圍爲26到52周。
BRTX-100 is a novel cell-based therapeutic engineered to target body areas with little blood flow.
BRTX-100是一種新型電芯治療藥物，旨在針對血液流動較少的身體部位。
A Phase 2 study is evaluating the safety and efficacy of BRTX-100 in treating cLDD. Up to 99 eligible subjects will be enrolled.
第二階段研究正在評估BRTX-100在治療cLDD方面的安全性和有效性。最多將招募99名符合條件的受試者。
The 10 safety run-in subjects reported no serious adverse events (SAEs).
10名安全性預試驗受試者報告沒有嚴重不良事件（SAE）。
There was also no dose (40X106 cells) limiting toxicity at 26 to 52 weeks.
在26到52周時，劑量（40X106電芯）沒有限制毒性。
The company reported blinded clinical data on the secondary efficacy endpoint of at least a 30% decrease in pain measured on the Visual Analog Scale (VAS) and at least a 30% increase in function based on the Oswestry Disability Index (ODI) at week 52.
該公司報告了關於至少在視覺模擬評分（VAS）上疼痛減少30%和基於Oswestry殘疾指數（ODI）功能提高30%的二級有效性終點的盲法臨床數據，數據收集時間爲第52周。
The blinded preliminary efficacy endpoint data demonstrated:
盲法初步有效性終點數據表明：
- At 26 weeks, 70% of subjects (n=10) and 100% of subjects (n=4) at 52 weeks reported a >30% improvement in VAS versus baseline.
- At 12 and 26 weeks, 70% of subjects (n=10) had a >30% improvement in ODI versus baseline.
- At 52 weeks, 100% of subjects (n=4) had a >30% improvement in ODI versus baseline.
- At 26 weeks, 70% of subjects (n=10) reported a >30% decrease in pain (VAS) and a >30% increase in function (ODI).
- 在26周時，70%的受試者（n=10）和52周時100%的受試者（n=4）報告與基線相比VAS改善超過30%。
- 在12周和26周時，70%的受試者（n=10）在ODI上比基線改善超過30%。
- 在52周時，100%的受試者（n=4）在ODI上比基線改善超過30%。
- 在26周時，70%的受試者（n=10）報告疼痛（VAS）減少超過30%，功能（ODI）提高超過30%。
BRTX Price Action: BRTX stock is down 1.22% at $1.62 at last check Wednesday.
BRTX價格動態：BRTX股票在週三最後檢查時下跌1.22%，報$1.62。
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譯文內容由第三人軟體翻譯。
