Delving into the Latest Updates on Paclitaxel-hyaluronic acid conjugate(Fidia Farmaceutici SpA) with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

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

+ [3]

Target

Tubulin

Action

inhibitors

Mechanism

Tubulin inhibitors, Angiogenesis inhibitors, Tubulin polymerisation promoters

Therapeutic Areas

NeoplasmsUrogenital Diseases

Active Indication

Carcinoma in SituCarcinoma in situ of bladder

Inactive Indication

MesotheliomaNon-Muscle Invasive Bladder Neoplasms

Originator Organization

Fidia Farmaceutici SpA

Active Organization

Fidia Farmaceutici SpA

Inactive Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

Login to view timeline

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.

Start Date29 Dec 2022

Sponsor / Collaborator

Fidia Farmaceutici SpA

NCT04798703

/ CompletedPhase 1

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.

Start Date24 May 2017

Sponsor / Collaborator

Fidia Farmaceutici SpA

NCT04661826

/ CompletedPhase 2

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.

Start Date17 May 2010

Sponsor / Collaborator

Fidia Farmaceutici SpA

100 Clinical Results associated with Paclitaxel-hyaluronic acid conjugate(Fidia Farmaceutici SpA)

Login to view more data

100 Translational Medicine associated with Paclitaxel-hyaluronic acid conjugate(Fidia Farmaceutici SpA)

Login to view more data

100 Patents (Medical) associated with Paclitaxel-hyaluronic acid conjugate(Fidia Farmaceutici SpA)

Login to view more data

9

Literatures (Medical) associated with Paclitaxel-hyaluronic acid conjugate(Fidia Farmaceutici SpA)

01 Jan 2022·Urologic Oncology: Seminars and Original InvestigationsQ3 · MEDICINE

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

Q3 · MEDICINE

Article

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

PURPOSEThis 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 METHODSThis 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.RESULTSAt 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).CONCLUSIONSOncofid-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.

01 Jul 2011·Cancer Chemotherapy and PharmacologyQ4 · MEDICINE

Hyaluronic acid–paclitaxel: effects of intraperitoneal administration against CD44(+) human ovarian cancer xenografts

Q4 · MEDICINE

Article

Author: Gian Franco Zannoni ; Andrea Fattorossi ; Cristiano Ferlini ; Alessandra Battaglia ; Davide Renier ; Ilaria De Stefano ; Daniela Gallo ; Silvia Baroni ; Daniele Travaglia ; Giovanni Scambia ; Maria Grazia Prisco

PURPOSEHyaluronan (HA)-receptors (mainly CD44 and RHAMM) are overexpressed in a wide variety of cancers including ovarian tumors, and HA-bioconjugates have been developed to enhance selective entry of cytotoxic drugs into HA receptor-expressing cancerous cells. Here, we evaluated the potential application of a new HA-paclitaxel bioconjugate, ONCOFID-P, for intraperitoneal (IP) treatment of ovarian cancer.METHODSIn vitro cytotoxic effect of ONCOFID-P was first assessed on CD44(+) OVCAR-3 and SKOV-3 human ovarian cancer cell lines. Studies were performed in female Balb/c athymic mice IP implanted with OVCAR-3 or SKOV-3 and treated with IP ONCOFID-P, and IP and intravenous (IV) free paclitaxel, at their maximum tolerated dose (MTD 168, 80 and 80 mg/kg, total dose, respectively). The potential detrimental effect of the IP ONCOFID-P and IP free paclitaxel on hematopoiesis was also assessed on peripheral blood, bone marrow and spleen.RESULTSResults show that ONCOFID-P cytotoxicity against both OVCAR-3 and SKOV-3 cell lines was somewhat less effective than free paclitaxel. Conversely, in in vivo experiments, IP treatment with ONCOFID-P was overall more effective than IV and IP free paclitaxel in inhibiting intra-abdominal tumor dissemination, abrogating ascites, prolonging survival and curing mice. ONCOFID-P and IP free paclitaxel were equivalent in terms of myelotoxicity, although the former was administered at a two-fold higher dose.CONCLUSIONSPresent data strongly support the development of ONCOFID-P for locoregional treatment of ovarian cancer.

01 Feb 2011·Journal of UrologyQ1 · MEDICINE

Paclitaxel-Hyaluronic Acid for Intravesical Therapy of Bacillus Calmette-Guérin Refractory Carcinoma In Situ of the Bladder: Results of a Phase I Study

Q1 · MEDICINE

Article

Author: Rosato, A. ; Bassi, P.F. ; Volpe, A. ; Franchini, S. ; Palermo, G. ; D'Agostino, D. ; Renier, D. ; Racioppi, M.

PURPOSECarcinoma in situ represents high grade anaplasia of the bladder mucosa. Intravesical immunotherapy with bacillus Calmette-Guérin is the gold standard treatment for patients with carcinoma in situ. Patients with carcinoma in situ refractory to bacillus Calmette-Guérin are candidates for major surgery such as radical cystectomy. We identified the maximum tolerated dose and the recommended dose, and evaluated the safety profile of paclitaxel-hyaluronic acid bioconjugate given by intravesical instillation to patients with carcinoma in situ refractory to bacillus Calmette-Guérin.MATERIALS AND METHODSA total of 16 patients with carcinoma in situ refractory to bacillus Calmette-Guérin were enrolled in a phase I, open label, single institution study. A minimum of 3 eligible patients were included per dose level. Paclitaxel-hyaluronic acid solution (ONCOFID-P-B™) was administered for 6 consecutive weeks. The primary objective was to identify the maximum tolerated dose and the recommended dose. As secondary objectives the safety profile of ONCOFID-P-B, the pharmacokinetic profile after each instillation and the tumor response were also evaluated.RESULTSNo dose limiting toxicity occurred at any drug level evaluated. The plasma levels of the study drug were always below the lower limit of quantification at all tested doses after each instillation. A total of 11 adverse events were reported by 7 patients and 9 (60%) showed complete treatment response.CONCLUSIONSIntravesical instillation of ONCOFID-P-B for carcinoma in situ refractory to bacillus Calmette-Guérin showed minimal toxicity and no systemic absorption in the first human intravesical clinical trial to our knowledge. Finally, satisfactory response rates were observed.

100 Deals associated with Paclitaxel-hyaluronic acid conjugate(Fidia Farmaceutici SpA)

Login to view more data

R&D Status

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Carcinoma in Situ	Phase 3	Italy	Fidia Farmaceutici SpA	29 Dec 2022
Carcinoma in Situ	Phase 3	United States	Fidia Farmaceutici SpA	29 Dec 2022
Carcinoma in Situ	Phase 3	Spain	Fidia Farmaceutici SpA	29 Dec 2022
Carcinoma in Situ	Phase 3	France	Fidia Farmaceutici SpA	29 Dec 2022
Carcinoma in Situ	Phase 3	Poland	Fidia Farmaceutici SpA	29 Dec 2022
Carcinoma in situ of bladder	Phase 3	Poland	Fidia Farmaceutici SpA	29 Dec 2022
Carcinoma in situ of bladder	Phase 3	United States	Fidia Farmaceutici SpA	29 Dec 2022
Carcinoma in situ of bladder	Phase 3	Spain	Fidia Farmaceutici SpA	29 Dec 2022
Carcinoma in situ of bladder	Phase 3	Italy	Fidia Farmaceutici SpA	29 Dec 2022
Carcinoma in situ of bladder	Phase 3	France	Fidia Farmaceutici SpA	29 Dec 2022

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05024773 (Orion-BC study, ASCO_GU2025)	Phase 3	Carcinoma in situ of bladder CD44	63	Oncofid-P-B 600 mg	(tcqykmuabi) = docqkmjftc mfsqukijoj (fehrielhpf )	Positive	13 Feb 2025
PD12-01 (AUA2020)	Phase 1	Carcinoma in situ of bladder	20	Oncofid-P-B	nraysqbltd(jhhyrjdmlm) = Seven G1-G2 drug-related adverse events (AEs) were reported in only three patients over 298 instillations ebooefveay (cgkcquzltl )	Positive	01 Apr 2020
ASCO_GU2020	Phase 1	Carcinoma in Situ	20	Oncofid-P-B	(wxaywwencj) = ijntxwvfic yavfargzoq (wyqvffvzqv )	Positive	19 Feb 2020