Paclitaxel-hyaluronic acid conjugate(Fidia Farmaceutici SpA)(Paclitaxel-hyaluronic acid conjugate(Fidia Farmaceutici SpA)) - 药物靶点：Tubulin_在研适应症：原位癌，膀胱原位癌_专利_临床

概要

基本信息

药物类型

小分子化药

别名

HA-paclitaxel bioconjugate、Hyaluronic acid-paclitaxel、Oncofid P-B

+ [3]

靶点

Tubulin

作用机制

微管蛋白抑制剂、血管生成抑制剂、微管蛋白聚合促进剂

治疗领域

肿瘤泌尿生殖系统疾病

在研适应症

原位癌膀胱原位癌

非在研适应症

间皮瘤非肌层浸润性膀胱肿瘤

原研机构

Fidia Farmaceutici SpA

在研机构

Fidia Farmaceutici SpA

非在研机构-

最高研发阶段临床3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

3

项与 Paclitaxel-hyaluronic acid conjugate(Fidia Farmaceutici SpA) 相关的临床试验

NCT05024773

/ Recruiting临床3期

A Phase III, Single-arm Study to Evaluate the Efficacy and Safety of ONCOFID-P-B (paclitaxel-hyaluronic Acid Conjugate) Administered Intravesically to Patients with BCG-unresponsive Carcinoma in Situ of the Bladder with or Without Ta-T1 Papillary Disease (Orion-BC)

This is a phase III, single-arm, multicenter, international study to assess the efficacy and safety of ONCOFID-P-B following intravesical instillation in adult patients with histologically and cytologically confirmed CIS, with or without concomitant Ta-T1, who are unresponsive to BCG therapy and unwilling or unfit to undergo radical cystectomy.
After providing written informed consent (in presence of an Independent Witness, if applicable), patients will receive an induction therapy consisting of 12 weekly intravesical instillations of ONCOFID-P-B (induction phase). Patients with residual CIS at the end of induction treatment are eligible to enter a re-induction course of therapy (reinduction phase). Patients with stable disease by Investigator assessment defined as neither increased or decreased in extent or severity compared to baseline, are not eligible for re-induction therapy. Patients who achieve a complete resonde (CR) at the end of the induction or re-induction phase enter in the maintenance phase and receive monthly intravesical instillations of ONCOFID-P-B for an additional 12 monsthe or untile recurrence of CIS/HG Ta-T1 or progression to MIBC or extravesical disease. Patients who do not achieve a CR at the end of induction or re-induction phase, will discontinue investigational treatement and are followed up until month 48 from induction or re-induction start, or until a new antitumor therapy is initiated, wichever occurs first.
Tumor response is evaluated by cystoscopy, cytology and biopsy at the end of the induction and re-induction phases and at Safety Follow Up Visit (SFUV). During the maintenance/follow-up period, tumorresponse is evaluated by cystoscopy and cytology every 3 months for up to 24 months from induction or re-induction start, and then every 6 months for an additional 2 years (long-term follow-up). Tumor biopsies are performed in case of of positive cystoscopy and/or cytology. Random biopsies are to be performed at 6, 12 and 18 months after the end of the induction or re-induction phase in responding patients (i.e. at 9, 15 and 21 months after induction or re-induction start.

开始日期2022-12-29

申办/合作机构

Fidia Farmaceutici SpA

NCT04798703

/ Completed临床1期

Phase I Exploratory Study of ONCOFID-P-B™ (PACLITAXEL-HYALURONIC ACID) Administered for 12 Consecutive Weeks Followed by Maintenance Therapy in BCG Unresponsive/ Intolerant Patients With Bladder Carcinoma in Situ (CIS)

Phase I exploratory, open-label, single arm, multicenter study to assess safety, tolerability and antitumor activity of ONCOFID-P-B™ therapy in adult patients with histologically confirmed diagnosis of bladder carcinoma in situ (CIS), who were unresponsive or intolerant to Bacillus Calmette-Guérin (BCG)-therapy.
Patients are initially treated with 12 weekly intravesical instillations of ONCOFID-P-B™ (intensive treatment phase). Patients who achieve a complete response (CR) after the 12 weekly instillations entered the maintenance phase of the study, during which ONCOFID-P-B™ is furtherly administered once a month for 12 months.

开始日期2017-05-24

申办/合作机构

Fidia Farmaceutici SpA

NCT04661826

/ Completed临床2期

ONCOFID-P-B (PACLITAXEL-HYALURONIC ACID) in the Intravescical Therapy of Patients With Non-muscle Invasive Cancer of the Bladder. A Phase II Marker Lesion. STUDY

The purpose of the study is to assess, at control visit (V8), the ablative activity of intravesical administration of Oncofid-P-B on a papillary marker tumor on patients suffering from multiple primary and recurrent Ta G1-G2 papillary cancer of the bladder after 6 weeks of weekly study drug administration, through number and percentage of patients with Complete Response.

开始日期2010-05-17

申办/合作机构

Fidia Farmaceutici SpA

100 项与 Paclitaxel-hyaluronic acid conjugate(Fidia Farmaceutici SpA) 相关的临床结果

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100 项与 Paclitaxel-hyaluronic acid conjugate(Fidia Farmaceutici SpA) 相关的转化医学

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100 项与 Paclitaxel-hyaluronic acid conjugate(Fidia Farmaceutici SpA) 相关的专利（医药）

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19

项与 Paclitaxel-hyaluronic acid conjugate(Fidia Farmaceutici SpA) 相关的文献（医药）

2024-04-01·European review for medical and pharmacological sciences

The combination of hyaluronic acid and collagenase in the treatment of skin ulcers: an open, multicenter clinical study assessing safety and tolerability of Bionect Start®.

Article

作者: Pellacani, G ; Moruzzi, M ; Occhionorelli, S ; Latini, C ; Scuderi, N ; Chello, C ; Fino, P

OBJECTIVE:

Several clinical studies have shown that hyaluronic acid collagenase is well-tolerated and very effective in managing chronic venous ulcers. The aim of the present study is to confirm the safety and tolerability of daily application in patients suffering from cutaneous ulcers of different etiologies. The efficacy of the treatment and its impact on patients' quality of life are also assessed.

PATIENTS AND METHODS:

Patients with a clinical diagnosis of skin ulcer with devitalized/fibrinous/slough tissue that could delay the healing process were enrolled in the study. The hyaluronic acid/collagenase ointment was applied topically until wound closure or total debridement of non-viable tissue was achieved, however, with a limit of 30 days. Monitoring was performed weekly, either through outpatient visits or telephone surveys. Assessments included adverse events, local irritation reactions, pain at dressing changes, and wound bed status. Patients were also requested to complete a quality-of-life questionnaire.

RESULTS:

The study involved 96 patients with a mean age of 71 years. The patients suffered mainly from traumatic (21.9%), venous (15.6%), or pressure ulcers (12.5%); in 26% of cases, ulcers had mixed etiology. In approximately 32% of patients, the ulcer had been present for more than 6 months, and 18.1% of subjects had previously undergone surgical wound debridement.

CONCLUSIONS:

Daily application of hyaluronic acid-collagenase achieved the following results: i) absence of adverse events related to the use of the product; ii) significant reduction in the degree of localized irritation and pain at dressing changes; iii) significant support to wound bed preparation; iv) trend towards improvement in the quality of life and health status of the patients.

2022-01-02·Journal of microencapsulation4区 · 医学

Hyaluronic acid-coated and Olaparib-loaded PEI − PLGA nanoparticles for the targeted therapy of triple negative breast cancer

4区 · 医学

Article

作者: Ji, Wenting ; Wang, Kaiping ; Shi, Chen ; Mei, Hao ; Hu, Huiping ; Zhang, Yu ; Wu, Tingting ; He, Zihao

AIM:

To prepare the hyaluronic acid-coated Olaparib-loaded PEI - PLGA nanoparticles (HA-Ola-PPNPs) and investigate their tumour-targeted anticancer effect.

METHODS:

The synthesis of HA-Ola-PPNPs was verified by DLS, TEM and SEM, followed was measured its cytotoxicity using CCK-8 assay. Confocal microscopy was used to observe the cellular uptake. Cell apoptosis was analysed by flow cytometry, biological SEM, and TEM. The expression of related proteins within the tumour site was investigated by immunostaining.

RESULTS:

The prepared HA-Ola-PPNPs showed a diameter of ∼160 nm with a negatively charged surface (-16.9 ± 2.7 mV) and sustained drug release behaviour. And the encapsulation efficiency of HA-Ola-PPNPs was 78.63 ± 5.29%. HA-Ola-PPNPs exhibited efficient in vitro and in vivo antitumor activities. HA-Ola-PPNPs induced cell apoptosis by upregulating Bax, Cytochrome C, and Caspase 3, downregulating Bcl-2 in breast cancer-bearing mice.

CONCLUSIONS:

According to the results, the Ola-loaded and HA-coated PEI - PLGA nanoparticles could be considered as a powerful tumour-targeted drug delivery system for TNBC treatment.

2022-01-01·Urologic oncology3区 · 医学

Oncofid-P-B: a novel treatment for BCG unresponsive carcinoma in situ (CIS) of the bladder: Results of a prospective European Multicentre study at 15 months from treatment start

3区 · 医学

Article

作者: Carlos, Llorente ; De Cobelli, Ottavio ; Santoro, Armando ; Lazzeri, Massimo ; Duran-Merino, Ramon ; Colombo, Piergiuseppe ; Guazzoni, Giorgio ; Hurle, Rodolfo ; Trapani, Ettore Di ; Nohales, Gloria

PURPOSE:

This study reports the safety and efficacy of Oncofid^-P-B, a novel compound under development by Fidia Farmaceutici S.p.A. with specific binding to CD44 receptor, in patients with CIS unresponsive or intolerant to BCG.

MATERIALS AND METHODS:

This is a phase 1 open-label, single arm, multicenter European study to assess safety, tolerability and efficacy of Oncofid-P-B administered in 20 patients with CIS ± Ta-T1, unresponsive or intolerant to BCG, unwilling or unfit for cystectomy. Oncofid-P-B was administered by intravesical instillation for 12 consecutive weeks (intensive phase) followed, in CR patients, by 12 monthly instillations (maintenance phase). The primary objective was the overall safety profile. Secondary objectives included: i) any evidence of antitumor activity, ii) patient's compliance, iii) systemic absorption. The CR was defined as a negative cystoscopy, negative biopsy of the urothelium and negative cytology.

RESULTS:

At the end of the intensive phase, 15 of the 20 enrolled patients (75%), achieved the CR. Patients still in CR after 3, 6, 9 and 12 months of maintenance phase were 13 (65%), 12 (60%), 9 (45%) and 8 (40%), respectively. Only seven (5 mild and 2 moderate) drug-related AEs were reported in three patients. No drug related serious AEs and no drug related withdrawals have been reported. In all plasma samples, the drug concentratiosn was below the LLOQ (1ng/ml).

CONCLUSIONS:

Oncofid-P-B is very safe, well tolerated and highly effective (75% CR) when administered weekly for up to 12 consecutive weeks (75% CR), with 40% CR still after 15 months from treatment start.

100 项与 Paclitaxel-hyaluronic acid conjugate(Fidia Farmaceutici SpA) 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
原位癌	临床3期	美国	Fidia Farmaceutici SpA	2022-12-29
原位癌	临床3期	法国	Fidia Farmaceutici SpA	2022-12-29
原位癌	临床3期	意大利	Fidia Farmaceutici SpA	2022-12-29
原位癌	临床3期	波兰	Fidia Farmaceutici SpA	2022-12-29
原位癌	临床3期	西班牙	Fidia Farmaceutici SpA	2022-12-29
膀胱原位癌	临床3期	美国	Fidia Farmaceutici SpA	2022-12-29
膀胱原位癌	临床3期	法国	Fidia Farmaceutici SpA	2022-12-29
膀胱原位癌	临床3期	意大利	Fidia Farmaceutici SpA	2022-12-29
膀胱原位癌	临床3期	波兰	Fidia Farmaceutici SpA	2022-12-29
膀胱原位癌	临床3期	西班牙	Fidia Farmaceutici SpA	2022-12-29

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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


NCT05024773 (Orion-BC study, ASCO_GU2025)	临床3期	膀胱原位癌 CD44	63	Oncofid-P-B 600 mg	鹹襯鑰廠繭網蓋獵鹽鹽(膚鏇鏇憲觸膚鏇夢積壓) = 製齋齋鹹壓築顧鬱鹽憲顧願膚齋窪齋範願願襯 (糧範遞憲餘網選廠蓋鬱 )	积极	2025-02-13
PD12-01 (AUA2020)	临床1期	膀胱原位癌	20	Oncofid-P-B	憲製襯蓋衊夢廠網鹹淵(繭願願簾選醖壓構窪獵) = Seven G1-G2 drug-related adverse events (AEs) were reported in only three patients over 298 instillations 糧夢構築醖蓋鏇鏇網築 (衊範醖製壓鏇鏇鏇衊齋 )	积极	2020-04-01
ASCO_GU2020	临床1期	原位癌	20	Oncofid-P-B	衊觸膚觸繭觸獵襯膚獵(艱繭夢艱遞鬱積積鹹範) = 艱襯艱選繭餘積壓鑰鏇醖構鏇膚鹽膚鑰憲糧獵 (範齋網鬱艱獵鑰製獵遞 )	积极	2020-02-19