A Phase I/II safety and efficacy study of Vibrio alginolyticus collagenase in patients with Peyronie’s Disease A Phase I single ascending dose with a Phase II expansion, safety, tolerability, efficacy, pharmacokinetics and immunogenicity study

Start Date22 Apr 2025

Sponsor / Collaborator

Fidia Farmaceutici SpA

NCT06245603

/ RecruitingNot ApplicableIIT

A Study to Evaluate Efficacy and Safety of Hydeal Cyst® Intravesical Instillations in Patients Treated With Intravesical Chemotherapy or Immunotherapy in Non-muscle Invasive Bladder Cancer

Prior to performing any study specific procedure (including screening procedures to determine eligibility), a signed consent form will be obtained for each subject. Patients will be enrolled in the study only if they meet all the inclusion criteria and none of the exclusion criteria.
Prior to perform any study specific procedure (including screening procedures to determine eligibility), a signed informed consent form will be obtained for each subject. The informed consent form will describe the purpose of the study, the procedures to be followed, and the risk and benefits of participation. The investigator will conduct the informed consent discussion and will check that the subject comprehends the information provided and will answers any questions about the study. Consent will be voluntary and free from coercion. The investigator that will conduct the consent discussion will also sign the informed consent form. A copy of the informed consent form will be given to the subject and the fact that the subject has been consented to the study will be documented in the subject's record. When all the inclusion and exclusion criteria have been addressed and the eligibility of the subject confirmed, the subject may be enrolled in the study.
The following activities and/or assessments will be performed during screening, prior the treatment period start: demographic, medications related to the disease or symptoms and cancer history data collection; Urine-colture; randomization; Questionnaires QoL e IPSS.
BCG or MMC will be started within 1-2 weeks from randomization (within 4-6 weeks after TURB).
BCG or MMC will be administered once a week by intravesical instillation: BCG will be abministered for 6 weeks and MMC for 8 weeks. (induction cycles) Before instillations a physical examination will be performed and symptoms evaluated: changes from baseline and abnormalities will be recorded in patient notes.
IPSS questionnaire and QoL questionaire will be administered to the patient at week 1, 4 and 6/8 (6 for BCG and 8 for MMC) of treatment.
48 hours after post BCG or MMC intravesical instillation, patients of Arm A will undergo Hydeal Cyst intravesical instillation.
BCG patiens will received 6 Hydeal Cyst intravesical instillation; MMC patiens will received 8 Hydeal Cyst intravesical instillation.
After 2 weeks from BCG or MMC instillation end, IPSS e QoL questionaires will be administered and a control urino-colture will be executed.
After 6 and 18 weeks from instillation therapy end, a control visit will be made.
A physical examination will be performed and symptoms evaluated: changes from baseline and abnormalities will be recorded in patient notes.
Control cystoscopy and urino-colture will be executed (as for clinical practice) and IPSS and quality of life evaluated.

Start Date20 Dec 2024

Sponsor / Collaborator

Istituto Oncologico Veneto

[+1]

CTIS2023-507332-20-00

/ RecruitingPhase 1/2

A Phase I/II study of Vibrio alginolyticus collagenase in patients with Dupuytren contracture. A Phase I single ascending dose with a Phase II expansion, safety, tolerability, efficacy, pharmacokinetics and immunogenicity study

Start Date18 Dec 2024

Sponsor / Collaborator

Fidia Farmaceutici SpA

100 Clinical Results associated with Fidia Farmaceutici SpA

0 Patents (Medical) associated with Fidia Farmaceutici SpA

Literatures (Medical) associated with Fidia Farmaceutici SpA

01 May 2017·ARCHIVES OF PHYSICAL MEDICINE AND REHABILITATION

Effectiveness of 3 Weekly Injections Compared With 5 Weekly Injections of Intra-Articular Sodium Hyaluronate on Pain Relief of Knee Osteoarthritis or 3 Weekly Injections of Other Hyaluronan Products: A Systematic Review and Meta-Analysis

Review

Author: Modi, Simple ; Kulinets, Irina ; Stitik, Todd P ; Issac, Sony M ; Nasir, Saad

OBJECTIVE:

To investigate whether the number of hyaluronic acid (HA) injections in a sodium hyaluronate (Hyalgan) course of therapy alters effectiveness in reducing knee osteoarthritis (OA) pain.

DATA SOURCES:

Electronic databases, including PubMed and Embase, were searched from January 1980 until November 2015.

STUDY SELECTION:

We included clinical studies that evaluated the effectiveness of a course of 3 or 5 weekly intra-articular injections of Hyalgan to treat knee OA pain. We also included clinical studies evaluating the effectiveness of a 3-week course of other Food and Drug Administration-approved HA treatments of knee OA pain. Twenty-four studies were identified, comprising 2168 study participants in 30 treated cohorts.

DATA EXTRACTION:

We determined effect sizes for selected studies by extracting knee OA pain scores before and after HA or control treatments. Meta-regressions were implemented to determine whether the number of weekly injections in a course of Hyalgan therapy modified outcomes.

DATA SYNTHESIS:

The pooled estimate for relief from baseline pain was -31.4 (SE, 5.46; 95% confidence interval [CI], -45.5 to -17.4) with a 3-week course of Hyalgan and -32.2 (SE, 5.25; 95% CI, -45.6 to -18.7) with a 5-week course of Hyalgan. Findings from the meta-analysis indicate relief of knee OA pain with a 3-week course of Hyalgan is similar to that with a 5-week course of Hyalgan (P=.916). The pooled estimate for relief from baseline pain with a 3-week course of other HA products was -29.4 (SE, 4.98; 95% CI, -42.2 to -16.6), also indicating pain relief with a 3-week course of Hyalgan is similar to that with a 3-week course of other HA products (P=.696).

CONCLUSIONS:

There was no statistical difference between reduction in knee OA pain with a 3-week course of Hyalgan compared with reduction in knee OA pain with a 5-week course of Hyalgan or a 3-week course of other HA products. These findings demonstrate that comparable knee OA pain relief is achieved with a 3-week course of Hyalgan and the 2 control groups.

31 Oct 2015·Current drug targetsQ4 · MEDICINE

Hyaluronic Acid as a Protein Polymeric Carrier: An Overview and a Report on Human Growth Hormone

Q4 · MEDICINE

Review

Author: Christian Cuppari ; Antonio Rosato ; Michele Caputo ; Monica Campisi ; Oddone Schiavon ; Gianfranco Pasut ; Anna Mero

Hyaluronic acid (HA) is a natural polysaccharide primarily present in the vitreous humor and in cartilages where it plays a key structural role in organizing the cartilage extracellular matrix. HA is used in a wide range of applications including treatment of arthritis (as a viscosupplementation agent for joints) and in a variety of cosmetic injectable products. Its safety profile is thus well established. Thanks to its high biocompatibility and targeting properties, HA has also been investigated for use as a carrier of anticancer drugs and, recently, also of proteins. Its role in the last case is a particularly challenging one as dedicated coupling chemistries are required to preserve the protein's conformation and activity. This study focuses on the state of the art on protein HAylation. New data from our laboratory on the local delivery of specific biologics to joints will also be outlined.

01 Mar 2011·Current bioactive compounds

ONCOFID™-P a Hyaluronic Acid Paclitaxel Conjugate for the Treatment of Refractory Bladder Cancer and Peritoneal Carcinosis

Author: Renier, Davide ; Campisi, Monica

A review.Hyaluronan receptors (CD44, RHAMM) are over-expressed in a wide variety of cancers including bladder and ovarian tumors.Based on this rationale, a hyaluronic acid paclitaxel conjugate, ONCOFID-P, was developed for the treatment of refractory bladder cancer and peritoneal carcinosis.ONCOFID-P has demonstrated improved in vitro and in vivo efficacy in hyaluronan receptor-pos. tumor models and a favorable toxicity profile in rodents.It has been investigated in 15 patients with refractory bladder cancer by intravesical instillation, showing promising antitumor efficacy with 60 % of treated patients achieving a complete response.As a consequence, phase II studies with ONCOFID-P are ongoing in six European countries.In addition, phase I studies have been initiated investigating the maximum tolerated dose (MTD) and the safety profile of ONCOFID-P following IP infusion in patients affected by i.p. carcinosis in ovarian, breast, stomach, bladder and colon cancer.

News (Medical) associated with Fidia Farmaceutici SpA

27 Jul 2021

·www.vccircle.com

Sanofi India to sell nutraceuticals’ biz to Kedaara backed Universal Nutriscience

Sanofi India Ltd, local unit of the French drugmaker, on Wednesday said it has received board approval to sell its nutraceuticals business to Universal Nutriscience Pvt Ltd for Rs 587 crore ($78.9 million). As part of the transaction, 16 nutraceutical brands in the portfolio will be transferred to Universal Nutriscience, said Sanofi India in a statement. Universal Nutriscience is a strategic partnership between homegrown private equity firm Kedaara Capital and nutraceuticals firm Universal Medicare. "Following a strategic review of its portfolio, the company believes that the potential of the Nutraceuticals range would be maximised in an organisation, which can provide deep category understanding and continuous innovation required to win in this specialised area," said Rajaram Narayanan, managing director of Sanofi India. All employees who are associated with Sanofi India's nutraceuticals business will also be transitioned to Universal Nutriscience, he added. The deal is expected to be completed within the next three months. "We are committed to building a focused nutraceuticals business backed by three decades of experience in R&D and manufacturing to provide end-to-end scientifically backed products and services," said Nishant Sharma, investment chief and managing partner, Kedaara Capital. Sanofi has built its India business via multiple acquisitions. It 2009, it acquired vaccine maker Shantha Biotech and later in 2011, it bought the over-the-counter business of Mumbai-based Universal Medicare Ltd for its branded nutraceuticals formulations. A February 2021 media report by Pharma Intelligence said that globally Sanofi is looking to offload 150 over-the-counter brands as part of a radical overhaul of its consumer healthcare operation. In March, Sanofi sold an integrated portfolio of its anti-inflammatory drugs to Italian drug maker Fidia Farmaceutici. At that point, the drugmaker said that the “transaction continues Sanofi’s ongoing strategic transformation by simplifying its portfolio and streamlining to enhance profitability”. The new head of business Julie Van Ongevalle has unveiled a wide-ranging turnaround plan with the goal of transforming Sanofi into an OTC market leader, the report added. In late 2019, Sanofi announced the sale of a manufacturing unit in Gujarat’s Ankleshwar to Advent International-backed Zentiva Pvt Ltd for Rs 261.7 crore (about $36.53 million) in a slump sale.

AcquisitionVaccine

24 Mar 2021

·www.pharmaceutical-technology.com

Sanofi to divest anti-inflammatory drug portfolio to Fidia Farmaceutici

Sanofi has concluded an agreement to sell its anti-inflammatory drugs portfolio to Italian company Fidia Farmaceutici to streamline established products. The latest deal continues the company’s strategic transformation by simplifying its portfolio. Sanofi General Medicines executive vice-president Olivier Charmeil said: “Established Products is an important growth driver for Sanofi. However, we are re-focusing our efforts as part of the company’s overall strategic transformation in order to pioneer new opportunities that will drive strong health outcomes for the millions of lives we touch. “Upon completion of appropriate regulatory processes, today’s agreement with Fidia Farmaceutici will ensure patients will have continued access to these seven brands while also allowing for us to further optimise our operating model through our play-to-win strategy.” The divestment covers registrations, trademarks and related commercial rights of seven products, including four corticosteroids and one non-steroidal anti-inflammatory drug, across Europe and emergent markets. Sanofi noted that the products are currently used for treating a wide range of conditions in several therapeutic areas. Fidia Farmaceutici president and CEO Carlo Pizzocaro said: “The acquisition confirms our will, despite the tough challenge created by Covid-19, to continue investing in core pharmaceutical business as part of our international growth, not only thanks to consolidation in the areas in which we are leaders but also through more solid positioning as a result of entering different therapeutic areas.” The companies will not divulge the commercial terms of the agreement. In January, Sanofi signed an agreement to acquire clinical-stage biopharmaceutical company Kymab for an upfront cash payment of about $1.1bn.

CollaborateAcquisition

100 Deals associated with Fidia Farmaceutici SpA

100 Translational Medicine associated with Fidia Farmaceutici SpA

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Pipeline

Pipeline Snapshot as of 06 Feb 2026

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Discovery

Preclinical

Phase 3

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Paclitaxel-hyaluronic acid conjugate(Fidia Farmaceutici SpA) ( Tubulin )	Carcinoma in Situ More	Phase 3
FID-337	Osteoarthritis More	Preclinical
FID-338	Osteoarthritis More	Preclinical
FID-145 ( MMP3 )	Osteoarthritis More	Discovery
Siagoside	Stroke More	Discontinued

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