Surgical Prophylaxis: Assessing Decolonization Efficacy of Polyhexanide Versus Mupirocin and Chlorhexidine in Decolonizing Staphylococcus Aureus Preoperatively in Elective Spine Surgery (SPADE): A Pilot Randomized Controlled Trial

This pilot randomized controlled trial evaluates the feasibility, tolerability, and preliminary efficacy of a decolonization regimen using polyhexanide in reducing Staphylococcus aureus colonization in the preoperative phase of elective spine surgery, compared to the standard mupirocin and chlorhexidine regimen. The trial involves 24 participants randomized into two groups: one receiving polyhexanide and the other receiving mupirocin and chlorhexidine. The primary outcome is the randomization rate, with secondary outcomes including other feasibility outcomes, tolerability, and efficacy measures such as the reduction in S. aureus colony-forming units (CFUs) and changes in the nasal and skin microbiome composition.

Start Date18 Nov 2024

Sponsor / Collaborator-

NCT06213649 / RecruitingPhase 3IIT

Parasitic Ulcer Treatment Trial

The Parasitic Ulcer Treatment Trial (PUTT) is a multi-center, parallel-group, randomized clinical trial. The purpose of this study is to determine whether including topical corticosteroids in a regimen for acanthamoeba keratitis (AK) will improve vision. Patients presenting to all enrollment centers with evidence of acanthamoeba keratitis will be eligible for the trial if there is evidence of ocular inflammation after 4 weeks of anti-amoebic therapy. Those who agree to participate will be randomized to one of two treatment groups:
* Group 1: Topical corticosteroid
* Group 2: Topical placebo

Start Date01 Jul 2024

Sponsor / Collaborator

The University of California, San Francisco

[+14]

NCT06338163 / Not yet recruitingPhase 4IIT

Polihexanide SSIs Measures Bundle (PSMB) During Enhanced Recovery After Major Digestive Surgery

This is a randomized controlled, prospective, multicenter superiority trial with two parallel treatment groups and single blinding (local investigators performing postoperative follow up will be blinded for group allocation), with prospective enrollment planned from July 2024 to June 2025 in 20 Italian surgical centers. All patients undergoing elective major gastro-intestinal (GI) tract surgery (upper GI, HPB, & lower GI) will be included in a prospective database after written informed consent. A total of 2,000 patients is expected based on a mean of 100 cases per center.

Start Date01 Jul 2024

Sponsor / Collaborator-

100 Clinical Results associated with Polihexanide

100 Translational Medicine associated with Polihexanide

100 Patents (Medical) associated with Polihexanide

938

Literatures (Medical) associated with Polihexanide

01 Jan 2025·CARBOHYDRATE POLYMERS

Polyhexamethylene biguanidine coated silver nanoparticles embedded into chitosan thiourea/PVA nanofibers as wound healing mats: In vitro and in vivo studies

Article

Author: Motasadizadeh, Hamidreza ; Dinarvand, Rassoul ; Maghsoudian, Samane ; Fatahi, Yousef ; Azad, Kimia ; Shaabani, Alireza ; Mahmoudieh, Mahsa ; Nematollahi, Saeed ; Nouri, Zeinab ; Samadi, Nasrin

Burn injuries are prone to infection, leading to significant public health concerns and economic implications. There is a growing demand to develop innovative wound dressings with antibacterial activity. In this study, silver nanoparticles coated with polyhexamethylene biguanidine (Ag/PHMBG) were embedded into chitosan thiourea (CST) nanofibers as a novel multifunctional wound healing mat for treating second-degree burn wounds. Structural, mechanical, and biological properties of nanofibers were investigated using FE-SEM, XRD, ATR-FTIR, and In vitro degradation. The animal study was performed to investigate the suitability of the polymeric mats as a wound healing/dressing system. FE-SEM analysis revealed that the average diameter of the obtained uniform and bead-less Ag/PHMBG-loaded CST nanofibers was around 75 nm. CST-based nanofibers with 3 wt% Ag/PHMBG (PCT3) demonstrated notable antimicrobial efficacy against both S. aureus and P. aeruginosa, achieving 95 % growth inhibition within 3 days while exhibiting no cytotoxic effects on normal fibroblast cells. In addition, CST nanofibers have good breathability with a water vapor transmittance rate of 2.9 ± 0.41-4.4 ± 0.47 kg/m². d. The animal studies showed that the wound healing and tissue regeneration process by PCT3 nanofibers were faster than the other groups. In conclusion, CST-based nanofibers are a potentially promising substitute for conventional wound dressings in clinical applications.

01 Jan 2025·CARBOHYDRATE POLYMERS

Injectable Salecan/hyaluronic acid-based hydrogels with antibacterial, rapid self-healing, pH-responsive and controllable drug release capability for infected wound repair

Article

Author: Wang, Donghui ; Xie, Weidong ; Wang, Pu ; Yip, Ryan Chak Sang ; Chen, Hao ; Zhang, Qinling ; Wang, Shuxin

Designing materials for wound dressings with superior therapeutic benefits, self-healing and injectable characteristics is important in clinical practice. Herein, a new self-healing injectable hydrogel was prepared via thermal treatment and dynamic Schiff base reaction by mixing oxidized hyaluronic acid (OHA) and hydrazided Salecan (Sal-ADH). The versatility of the wound dressing was confirmed by studying the inherent rheological properties, high swelling rate, sustained-release behavior of the drug, pH/hyaluronidase-dependent biodegradation, in vitro antimicrobial as well as in vivo wound healing performance. The presence of the antimicrobial drug polyhexamethylene biguanide (PHMB) conferred good antimicrobial properties to the Sal-ADH/OHA/PHMB (SOP) hydrogel, which could effectively prevent wound infection (the width of the inhibition circle of SOP-0.20 hydrogel was 4.97 mm, 5.93 mm for Staphylococcus aureus and Escherichia coli, respectively). The findings suggested that SOP hydrogel exhibited remarkable self-healing and injectability properties, as well as excellent hemostasis and biocompatibility. In vivo experiments indicated that the application of SOP hydrogels would obviously accelerate wound healing and attenuate the inflammatory response while increasing collagen deposition and angiogenesis. Altogether, antibacterial SOP hydrogels with moderate mechanical properties, pH-responsive release, excellent injectability, exceptional self-healing ability and anti-inflammatory effects could expand potential applications of injectable hydrogels in the biomedical field.

01 Nov 2024·INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES

Alginate and chitosan-based polyamide 56 modified nanofiber membrane for highly effective capture of Escherichia coli: Antibacterial and cytotoxicity studies

Article

Author: Ng, I-Son ; Le, Quang-Vinh ; Chiu, Chen-Yaw ; Wang, Chi-Yun ; Chen, Kuei-Hsiang ; Liu, Bing-Lan ; Chang, Yu-Kaung ; Wen, Hsin-Yu ; Srinophakun, Penjit

In recent years, microbial fermentation has become a sustainable alternative to traditional petrochemical processes for producing biomass nylon 56 (i.e., PA56). This study is centered on creating a highly efficient antibacterial nanofiber membrane using bio-nylon 56 as the main material. The membrane was fabricated via a multi-step process involving sodium alginate, chitosan, and poly(hexamethylene biguanide) (PHMB). The PA56 nanofiber was chemically modified by sequential coupling with alginate (AG) and chitosan (CS), introducing a significant number of functional groups (-COOH and -NH₂). This process resulted in the formation of PA56-AG and PA56-AG-CS nanofibers. Further modification with PHMB led to obtaining the PA56-AG-PHMB and PA56-AG-CS-PHMB antibacterial nanofiber membranes. The optimal preparation conditions for these membranes were determined, including the pH and concentration of AG, the molecular weight, pH, and concentration of CS, and the pH and concentration of PHMB. The PA56-based membranes demonstrated nearly 100 % antibacterial efficiency within a short time. However, the PA56-AG-PHMB membrane exhibited faster antibacterial rates and higher efficiency in repeated use compared to the PA56-AG-CS-PHMB membrane. The two-step coupling reaction in the preparation of PA56-AG-CS-PHMB may have reduced its surface accessibility to E. coli cells, resulting in slower bacterial attachment. Furthermore, the PA56-related membranes showed excellent biocompatibility, with a 100 % cell survival rate. Despite some limitations in reusability, biomass nylon PA56 stands out as an environmentally friendly material derived from renewable resources through microbial fermentation. It offers significant sustainability advantages over traditional petroleum-based nylons, as evidenced by the favorable cytotoxicity test results.

News (Medical) associated with Polihexanide

30 Sep 2024

·www.prnewswire.com

SIFI announces allowance of patent on polihexanide for Europe and commercial launch of AKANTIOR® in Germany

The company's intellectual property ("IP") covers the formulation and method of use of polihexanide in the treatment of acanthamoeba keratitis and fungal keratitis The patent, already granted in Italy and EurAsian Countries, ensures IP protection until 2040 AKANTIOR® will be commercially available in Germany from Oct. 1st CATANIA, Italy, Sept. 30, 2024 /PRNewswire/ -- SIFI, a leading international ophthalmic company, announced that is has received a Notice of Allowance from the European Patent Office ("EPO") for EP4216966. The newly granted patent, entitled "formulation based on polyhexamethylene biguanide for use in the treatment of acanthamoeba keratitis and/or fungal infections" ("Patent"), relates to the novel formulation of polihexanide in high concentration, its method of manufacturing and administration regimen in the treatment of acanthamoeba keratitis ("AK") and fungal keratitis ("FK"). The Patent was already granted in Italy in 2022 (IT102020000027155) and in Eurasian Countries earlier this year (EA047258). SIFI is seeking global IP protection through additional patent applications, including in USA, Canada, Mexico, South Korea, India, Australia, Japan and China. The Patent grant follows SIFI's findings in the Phase 3 clinical trial, where AKANTIOR® (polihexanide 0.08%) demonstrated an 86% clinical resolution rate in AK, with an average time-to-cure of approximately 4 months. The Patent also covers the novel dosing regimen of 16 drops/day for first 5 days, 8 drops/day for the following 7 days, 6 drops/day for the following 7 days and 4 drops/day until clinical resolution. The proven dosing regimen represents also a major improvement in patients' quality of life, as it allows during the initial and most intensive phase of the treatment daytime-only instillation of a single medicinal product compared to 24 hourly instillations of up to 3 off-label or unlicensed drugs used as best supportive care until now. Following the granting of a marketing authorisation for the treatment of AK by the European Commission in August, SIFI is launching AKANTIOR® in Germany, where the product will be commercially available from Oct. 1st. Additional European markets will follow based on local early access and reimbursement process timelines. "The granting of the European Patent further demonstrates the innovative profile of our asset for rare corneal infectious diseases, that are very severe and difficult to resolve." Fabrizio Chines, Chairman and CEO of SIFI. "The launch of Akantior® in Germany also marks a significant milestone in our corporate development, establishing a direct presence in Europe's largest pharmaceutical market." SIFI's polihexanide received two orphan drug designation ("ODD") from the US Food and Drug Administration for the treatment of AK and FK, and an additional ODD from the European Medicines Agency for the treatment of FK. ABOUT AKANTIOR®: AKANTIOR (polihexanide 0.08%) is the first approved drug for the treatment of AK in the world. It is an anti-amoebic polymer that acts on both the trophozoites and cysts of the protozoan acanthamoeba. It is formulated at a 0.8mg/ml (0.08%) concentration which makes it possible to administer as monotherapy eye drops in single-dose containers. ABOUT AK: AK is an ultra-rare, acute, severe parasitic corneal infection caused by acanthamoeba, a free-living amoeba, although incidence of AK has been rapidly growing in recent years. AK is an ocular emergency and requires urgent treatment to save the eye. It can lead to poor vision, potential blindness, or even eye loss and often requires single or multiple corneal transplants. It affects people of all ages, most of whom are young or middle-aged soft contact lens wearers. Patients report unbearable pain and extreme light sensitivity and can rarely work or lead normal lives until symptoms resolve. ABOUT SIFI: SIFI is a leading international ophthalmic company, headquartered in Italy, featuring an integrated business model, from research & development to manufacturing and commercialization both in pharmaceutical and biomedical sectors. Since our foundation in 1935, our mission is to improve people's lives through meaningful innovation in eye care. SIFI exports to more than 40 Countries worldwide with a direct presence in major European markets, Mexico and, through joint ventures, in China and the United Arab Emirates. More information available at WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultOrphan DrugPhase 3Drug Approval

27 Aug 2024

·www.pharmaceutical-technology.com

SIFI’s AKANTIOR gains EC approval for acanthamoeba keratitis

An ultra-rare, sight-threatening corneal infection, acanthamoeba keratitis causes intense pain and photophobia. Credit: Jo Panuwat D/Shutterstock. Italian ophthalmic company SIFI has received European Commission (EC) approval for AKANTIOR (polihexanide) to treat acanthamoeba keratitis (AK), a rare and severe corneal infection. The asset is the first therapy approved for AK in Europe. AKANTIOR targets both adults and children aged 12 years and above. Its commercial launch is set to begin in Germany in the fourth quarter of 2024, with subsequent rollouts in France, Italy, Romania, Spain, Türkiye and the UK. The launches are contingent on each country’s regulatory and reimbursement processes. See Also: AstraZeneca may pull plug on UK vaccine manufacturing plans Touchlight to supply GMP dbDNA for UK Zika vaccine study SIFI has also partnered with Avanzanite to introduce AKANTIOR in other European markets. AKANTIOR (polihexanide 0.08%) is an anti-amoebic polymer effective against both the trophozoites and cysts stages of acanthamoeba. It can be used as a monotherapy in the form of single-dose eye drops. The US Food and Drug Administration (FDA) granted orphan drug designation for AKANTIOR. An ultra-rare, sight-threatening corneal infection, AK causes intense pain and photophobia. The infection primarily affects those who wear contact lenses and is caused by the acanthamoeba protozoan. SIFI chairman and CEO Fabrizio Chines stated: “The approval represents an important step towards delivering a new global standard of care for patients with AK and builds on 15 years of research and development. “For the first time in Europe, AK patients have an approved therapy, marking a new era in the treatment of this disease, which may lead to blindness. AKANTIOR is the first and only approved medicine for AK, and our team is committed to developing polihexanide in other corneal infectious diseases, such as fungal keratitis, where we obtained orphan drug designation from the European Medicines Agency and the FDA.”

Drug ApprovalOrphan DrugVaccine

26 Aug 2024

·www.fiercepharma.com

After FDA rejection, Regeneron gains nod in Europe for T-cell engager odronextamab

Regeneron has won approval in Europe for its blood cancer T-cell engager odronextamab five months after the FDA rejected the treatment under its accelerated pathway because of the timeline of its confirmatory trial. Five months after the FDA rejected Regeneron’s bid for accelerated approval of its T-cell engager odronextamab because of the immaturity of its confirmatory trial, the European Union has signed off on the treatment for two types of blood cancers.In winning the nod from the European Commission for relapsed or refractory follicular lymphoma (FL) and for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), Ordspono becomes Regeneron’s first approved bispecific antibody. The endorsement covers patients who have undergone two or more lines of systemic therapy.Separately, the EC also granted a first-time approval to SIFI’s Akantior (polyhexanide), which becomes the first therapy to treat the rare corneal infection acanthamoeba keratitis. The sudden, parasitic disorder can cause blindness and primarily affects those who wear soft contact lenses. The Italian company has received orphan drug designation from the FDA for polyhexanide as a potential treatment for both acanthamoeba keratitis and fungal keratitis. Regeneron’s approval was backed by phase 1 and phase 2 trials that provided remarkable data. In the ELM-2 study, patients with FL showed an 80% overall response rate (ORR), with 73% achieving a complete response (CR). The median duration of response (DoR) for the complete responders was 25 months.In the same study, patients with DLBCL who were CAR-T therapy-naïve had a 52% ORR, with 31% reaching CR and having an 18-month median DoR.Despite the results, the FDA sent Regeneron two complete response letters in March, rejecting the company’s application for accelerated approval because its confirmatory trials for odronextamab were not yet underway. The FDA and Regeneron need to agree to timelines of the trials “prior to resubmission,” the company said.The rejection came as the FDA is wrestling with how to adjudicate accelerated approvals. With the recent failures of some FDA-sanctioned drugs, the approval mechanism has come under scrutiny. A recent study published in the Journal of the American Medical Association showed that 80% of drugs approved under the pathway couldn't demonstrate survival benefits after five years.In April, the FDA's Oncology Center of Excellence chief Richard Pazdur, M.D., addressed the issue.“If we really believe that there are no other therapeutic alternatives, then there will be obviously some degree of flexibility,” Pazdur said. “When we do see, however, that there may be accelerated approval with the same class of drugs with the same diseases and with sponsors previously having most of the confirmatory study accrual already completed at the time of accelerated approval, we have to have a level playing field for all of the pharmaceutical companies.” In the case of odronextamab, there are other new treatments from its drug class on the market in the indications. Over the last 15 months, AbbVie and Genmab’s bispecific antibody Epkinly has gained FDA nods for both FL and DLBCL. Meanwhile, Roche has two T-cell engagers on the market: Columvi earned an FDA nod in DLBCL in June, and Lunsumino was approved by the FDA as a treatment for FL in December of 2022.All the endorsements for the therapies have been for third-line use. In clinical trials, each of the companies, including Regeneron, is combining the T-cell engagers with other medicines in attempt to move them into earlier treatment lines.“Ordspono marks the first approval from our bispecific antibody platform, which we hope will increasingly contribute to our growing portfolio of practice-changing medicines for oncology and other diseases,” George Yancopoulos, M.D., Ph.D., Regeneron’s chief scientific officer, said in a release.

Clinical ResultDrug ApprovalOrphan DrugAccelerated ApprovalImmunotherapy

100 Deals associated with Polihexanide

External Link

KEGG	Wiki	ATC	Drug Bank
D08399	Polihexanide	D08AC05	DB12277

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Acanthamoeba Keratitis	EU	SIFI SpA	22 Aug 2024
Acanthamoeba Keratitis	IS	SIFI SpA	22 Aug 2024
Acanthamoeba Keratitis	LI	SIFI SpA	22 Aug 2024
Acanthamoeba Keratitis	NO	SIFI SpA	22 Aug 2024
Disinfectants	-	B. Braun Medical, Inc.	-
Wounds and Injuries	-	B. Braun Medical, Inc.	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03274895 (Pubmed) Manual	Phase 3	Acanthamoeba Keratitis	127	PHMB 0.02%+ propamidine 0.1%	thmgpslguk(qpfgcctgij) = ojwiaidzup tshzaxvuxm (fjuzfvqwkz ) View more	Positive	01 Mar 2024
				PHMB 0.08%+ placebo	thmgpslguk(qpfgcctgij) = xuqhtvnwne tshzaxvuxm (fjuzfvqwkz ) View more
NCT03274895 (The Orphan Drug for Acanthamoeba Keratitis (ODAK) Trial, CTgov)	Phase 3	Acanthamoeba Keratitis	135	placebo+PHMB 0.08% (PHMB 0.08% Plus Placebo)	knaxyfedvd(thkitonzef) = tzirivgome plzmqigmff (ydpvuqgsta, swenjhvxyf - pqeaxclhnv) View more	-	02 Aug 2023
				PHMB 0.02%+Propamidine 0.1% (PHMB 0.02% Plus Propamidine 0.1%)	knaxyfedvd(thkitonzef) = jnszkhdzdr plzmqigmff (ydpvuqgsta, hygrleknxr - fkrywgkzga) View more
NCT03274895 (PRNewswire) Manual	Phase 3	Acanthamoeba Keratitis	135	Placebo+Polihexanide	xsauruysvq(agwcurcvgw) = ukmtzniqui ndqnmfohbi (bqwrcyjlyt ) View more	Non-inferior	13 Oct 2022
				polihexanide+Polihexanide	xsauruysvq(agwcurcvgw) = upnfqdtino ndqnmfohbi (bqwrcyjlyt ) View more
NCT02506257 (CTgov)	Phase 1	Acanthamoeba Keratitis	90	0.04% PHMB (0.04% PHMB)	ajbsmjfnla(caouqcidiu) = wpyaniofko tkqwzknrkm (joukizxtzj, uvrbdxoktp - tfintuetbc) View more	-	23 Nov 2016
				0.06% PHMB (0.06% PHMB)	ajbsmjfnla(caouqcidiu) = yojaveakfl tkqwzknrkm (joukizxtzj, lkqzbmsqhz - rprqzdtldf) View more
ODAK (ARVO2014)	Not Applicable	Acanthamoeba Keratitis	100	Polyhexamethylene biguanide (PHMB)	mqofgmfjyo(enwmmcuqjn) = zpwirwrvcv ezoolbpoyk (frhkivmuqy )	-	01 Apr 2014
				Combination therapy (PHMB and propamidine)	mqofgmfjyo(enwmmcuqjn) = lfllsihypd ezoolbpoyk (frhkivmuqy )
NCT01153620 (Lavasept 2, CTgov)	Phase 4	Wounds and Injuries	61	Lavasept 0.04% (Lavasept 0.04%)	hjsqohejgk(ruirgnmjos) = dtxrscooof ghcnphkvln (vjpdevcdle, mxszjqxowl - pxkmjtyfzc) View more	-	29 Nov 2011
				Ringer's Solution (Ringer's Solution)	hjsqohejgk(ruirgnmjos) = ugwnnuxxcu ghcnphkvln (vjpdevcdle, sfhdviyxmq - ghnygzrivx) View more
AAO2004	Not Applicable	-	43	Polyhexamethylene Biguanide (PHMB)	zkquvdcxwc(mmojsnzzit) = cctgwlgqyf itapcqdiuz (rxykylcryh ) View more	Negative	25 Oct 2004
				Chlorhexidine (CH)	zkquvdcxwc(mmojsnzzit) = kzyhpqfadu itapcqdiuz (rxykylcryh ) View more
ARVO2004	Not Applicable	-	-	PHMB	aajriiyvzz(wurumflsqm) = jwjumdogic tgdpjoobxn (bpavizqejz ) View more	-	01 May 2004
				PHMB	aajriiyvzz(wurumflsqm) = qrmlqvhzgg tgdpjoobxn (bpavizqejz )

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