Liposome Encapsulated Botulinum Toxin A(Buddhist Tzu Chi General Hospital)(Liposome Encapsulated Botulinum Toxin A(Buddhist Tzu Chi General Hospital))

概要

基本信息

药物类型

毒素、脂质体药物

别名

Lipotoxin

靶点

SNAP25

作用方式

抑制剂

作用机制

SNAP25 抑制剂(突触相关蛋白25 抑制剂)

治疗领域

泌尿生殖系统疾病其他疾病

在研适应症-

非在研适应症

间质性膀胱炎膀胱过度活动症综合征

原研机构

财团法人佛教慈济综合医院

在研机构-

非在研机构

财团法人佛教慈济综合医院

权益机构-

最高研发阶段无进展临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

2

项与 Liposome Encapsulated Botulinum Toxin A(Buddhist Tzu Chi General Hospital) 相关的临床试验

NCT02247557

/ Completed临床2期IIT

Intravesical Instillation of Liposome Encapsulated Botulinum Toxin A (Lipotoxin) in Treatment of Interstitial Cystitis - a Randomized, Double-blind, Placebo-controlled, Prospective Study

To evaluate the efficacy and safety of intravesical instillation of Lipotoxin for the treatment of IC/BPS

开始日期2014-09-01

申办/合作机构

财团法人佛教慈济综合医院

NCT01167257

/ Completed临床2期IIT

Comparative Study of the Efficacy and Safety of Liposome Encapsulated Botulinum Toxin-A (Lipotoxin) Versus Normal Saline Instillation in Treatment of Patients With Refractory Overactive Bladder Syndrome

Overactive bladder (OAB) is a bothered symptom syndrome. Traditional medication for OAB is antimuscarinic agent. However, adverse events such as dry mouth, constipation, blurred vision, and dizziness may prohibit patient to take this drug for OAB. Intravesical botulinum toxin A (BoNT-A) is a novel treatment however, BoNT-A can cause acute urinary retention and large postvoid residual. In this grant we will evaluate liquid liposome delivery of BoNT-A (Liposome encapsulated BoNT-A) into the bladder without the need for cystoscopic-guided needle injection for refractory OAB.

开始日期2010-05-01

申办/合作机构

财团法人佛教慈济综合医院

100 项与 Liposome Encapsulated Botulinum Toxin A(Buddhist Tzu Chi General Hospital) 相关的临床结果

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100 项与 Liposome Encapsulated Botulinum Toxin A(Buddhist Tzu Chi General Hospital) 相关的转化医学

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100 项与 Liposome Encapsulated Botulinum Toxin A(Buddhist Tzu Chi General Hospital) 相关的专利（医药）

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7

项与 Liposome Encapsulated Botulinum Toxin A(Buddhist Tzu Chi General Hospital) 相关的文献（医药）

2017-08-01·The Journal of urology1区 · 医学

A Prospective, Multicenter, Double-Blind, Randomized Trial of Bladder Instillation of Liposome Formulation OnabotulinumtoxinA for Interstitial Cystitis/Bladder Pain Syndrome

1区 · 医学

Article

作者: Chuang, Yao-Chi ; Kuo, Hann-Chorng

PURPOSE:

Intravesical instillation of liposomal formulated botulinum toxin A (lipotoxin) has shown therapeutic effects as treatment of refractory overactive bladder without needle injections. We assessed lipotoxin to treat refractory interstitial cystitis/bladder pain syndrome.

MATERIALS AND METHODS:

This 2-center, double-blind, randomized, placebo controlled, physician initiated study enrolled patients with refractory interstitial cystitis/bladder pain syndrome. A total of 31 patients were assigned to intravesical instillation of lipotoxin (onabotulinumtoxinA 200 U with 80 mg sphingomyelin), 28 were assigned to onabotulinumtoxinA 200 U in normal saline and 31 were assigned to normal saline alone. The primary end point was the average change in O'Leary-Sant symptom scores, including ICSI (Interstitial Cystitis Symptom Index) and ICPI (Interstitial Cystitis Problem Index) between baseline and 4 weeks after treatment. Other end points included the average changes in a 3-day voiding diary, a visual analog scale for pain and a global response assessment of patient satisfaction.

RESULTS:

Improvements in the pain scale and O'Leary-Sant symptom scores occurred in all 3 groups by 4 weeks after treatment. Lipotoxin instillation was associated with a statistically significant decrease in O'Leary-Sant symptom scores (mean ± SD 7.38 ± 8.75), ICSI (4.00 ± 4.28), ICPI (3.35 ± 5.11) and the visual analog scale pain scale (1.64 ± 2.52), and an increase in the global response assessment (1.35 ± 1.28). However, there was no difference in improvement among the 3 groups. No significant adverse events were found in any group.

CONCLUSIONS:

Lipotoxin failed to demonstrate a positive proof of concept compared to onabotulinumtoxinA or placebo. However, a single intravesical instillation of lipotoxin was associated with decreased interstitial cystitis/bladder pain syndrome symptoms compared to baseline in patients with moderate to severe interstitial cystitis/bladder pain syndrome. The effect was likely due to a significant placebo effect.

2015-10-02·Expert opinion on emerging drugs2区 · 医学

Emerging drugs for overactive bladder

2区 · 医学

Review

作者: Khullar, Vik ; Karmarkar, Roopali

INTRODUCTION:

Overactive bladder (OAB) is a common problem which can have disastrous effects on the quality of life of the sufferer. There are established treatments for the problem but they have significant adverse effects. Better drugs and new treatment modalities are necessary to deal with OAB.

AREA COVERED:

Antimuscarinics, mirabegron and intravesical injection of botulinum toxin A are established treatments for OAB. Sacral neuromodulation is more invasive but has been successful in treating OAB. Phase II and III trials are in progress for newer β3-agonists and various combinations of antimuscarinics, β3-agonists and antidiuretics. Targeted secretion inhibitors (TSI) can increase efficacy and reduce adverse effects. Liposome integrated botulinum toxin A has an advantage of effective administration by intravesical instillation. Both medicines are in Phase II trials. Many other drugs which have promising results are discussed.

EXPERT OPINION:

Newer antimuscarinics have better tolerability. Long-term data for mirabegron has shown that it is more effective in severe OAB. Combination drugs may prove to be more effective with less adverse effects. Emerging treatments with TSI, lipotoxin and gene therapy appear promising.

2014-06-01·European urology1区 · 医学

Pilot Study of Liposome-encapsulated OnabotulinumtoxinA for Patients with Overactive Bladder: A Single-center Study

1区 · 医学

Article

作者: Kuo, Hann-Chorng ; Chuang, Yao-Chi ; Chancellor, Michael B ; Birder, Lori A ; Liu, Hsin-Tzu

BACKGROUND:

Intradetrusor onabotulinumtoxinA (BoNT-A) injection benefits overactive bladder (OAB) patients, but increased postvoid residual (PVR) urine volume and urinary tract infection (UTI) remain risks. Intravesical instillation of liposomal BoNT-A instead of injection could prevent such adverse events.

OBJECTIVE:

To evaluate instillation of liquid liposomal BoNT-A (Lipotoxin) for the treatment of OAB and to determine its mechanism of action.

DESIGN, SETTING, AND PARTICIPANTS:

A double-blind randomized parallel controlled pilot trial in 24 OAB patients at a single tertiary center.

INTERVENTION:

Patients were randomly assigned to intravesical instillation of Lipotoxin containing 80 mg liposomes and 200 U BoNT-A or normal saline (N/S). Patients were retreated with Lipotoxin 1 mo later if they failed the first treatment.

OUTCOME MEASUREMENT AND STATISTICAL ANALYSIS:

Voiding diaries, OAB symptom scores, urodynamic studies, and adverse events were monitored. The primary end point was change of total urinary frequency per 3 d at 1 mo after treatment. Immunohistochemistry and Western blotting for synaptic vesicle glycoprotein 2A (SV2A) and synaptosomal-associated protein, 25 kDa (SNAP25) were performed at baseline and 3 mo after treatment. The Wilcoxon rank sum test and Wilcoxon signed rank test were used for statistical analysis.

RESULTS AND LIMITATIONS:

At 1 mo after treatment, the change of urinary frequency per 3 d significantly improved in the Lipotoxin group (n=12; median: -6.50; interquartile range [IQR]: -18.3 to -0.25; p=0.008) but not in the N/S group. (n=12.0; IQR: -7.75 to 8.0; p=0.792). Urgency episodes also showed a significant decrease in the Lipotoxin group (-12.0; IQR: -20.3 to -2.75; p=0.012) but not in the N/S group (-1.0; IQR: -11.0 to 2.5; p=0.196). SV2A and SNAP25 were expressed in urothelial cells and suburothelial tissues. However, the protein expression did not significantly differ between responders and nonresponders at 3 mo after treatment.

CONCLUSIONS:

Intravesical Lipotoxin instillation effectively reduced frequency episodes 1 mo after treatment in OAB patients without any increase in PVR or risk of UTI.

PATIENT SUMMARY:

We demonstrated that intravesical Lipotoxin instillation reduced frequency episodes at 1 mo in overactive bladder patients. This procedure is safe, without an increase in postvoid residual or the risk of urinary tract infection.

100 项与 Liposome Encapsulated Botulinum Toxin A(Buddhist Tzu Chi General Hospital) 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
间质性膀胱炎	临床2期	中国台湾	财团法人佛教慈济综合医院	2014-09-01
膀胱过度活动症综合征	临床2期	中国台湾	财团法人佛教慈济综合医院	2010-05-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01167257 (CTgov)	临床2期	膀胱过度活动症综合征	62	Liposome encapsulated botulinum toxin A (Experimental Arm)	構簾襯夢鏇窪壓憲壓網(積願鑰襯鹽淵鑰願窪觸) = 範窪積遞網鑰築構鬱築窪夢選繭獵鬱鹽網觸獵 (獵蓋鹽蓋鹽衊鬱簾壓觸, 遞獵鹹選鏇遞積襯衊蓋 ~ 鬱衊襯選選夢選醖鹹鬱) 更多	-	2014-09-22
				Normal saline instillation (Control Arm)	構簾襯夢鏇窪壓憲壓網(積願鑰襯鹽淵鑰願窪觸) = 淵淵艱齋衊簾壓鹽範繭窪夢選繭獵鬱鹽網觸獵 (獵蓋鹽蓋鹽衊鬱簾壓觸, 淵遞艱簾廠顧襯餘糧範 ~ 壓艱膚蓋遞齋鑰廠夢夢) 更多