Efficacy of Daily IV Administration of Dornase Alfa Up to 14 Days Post Subarachnoid Hemorrhage on Functional Independence At 6 Months: a PROBE Multicenter Open-label Randomized Controlled Trial

Subarachnoid hemorrhage due to aneurysm rupture (SAH) results in high mortality, while survivors frequently suffer reduced quality of life and even loss of autonomy, particularly in the active population. A significant proportion of this morbidity and mortality is linked to the occurrence of delayed cerebral ischemia (DCI), defined as a new focal neurological deficit or reduced level of consciousness unrelated to the treatment of the aneurysm or a concomitant condition.
DCI mainly occurs between days 4 and 14 after SAH, with an estimated incidence of 30%, and is significantly associated with an unfavorable functional prognosis at 3 months. Currently, the only treatment for post-SAH DCI is to prevent or reverse the onset of vasospasm, with limited efficacy, for example through nimodipine administration or hemodynamic optimization. However, according to existing data, vasospasm is not the only cause of DCI, as it may occur elsewhere than in the arterial territory affected by vasospasm, or even in the absence of any vasospasm at all. Recent reviews of the literature highlight the role of microvascular thrombo-inflammation in the pathophysiology of DCI.
This phenomenon begins as soon as SAH occurs, with the appearance of multiple microvascular obstructions responsible for ischemia of downstream territories and loss of distal autoregulatory capacity. Among the effectors of thrombo-inflammation, the NETose phenomenon (production of NETs - Neutrophil Extracellular Traps or extracellular DNA network) has recently been associated with the onset of DCI. Indeed, the concentration of NETs increases in the cerebrospinal fluid (CSF) and blood of SAH patients, and correlates with the severity of the hemorrhage. Furthermore, intravenous or intraperitoneal administration of DNAse in an animal model of SAH has been shown to reduce NET concentration and improve functional prognosis by acting directly on cerebral perfusion through the reduction of micro-thrombosis.
In humans, recombinant DNAse (dornase alfa, Pulmozyme®) has marketing authorization for inhaled administration in cystic fibrosis. The toxicology report accompanying the marketing authorization demonstrates the absence of serious side effects following administration of high IV doses of Pulmozyme® in monkeys and rats. Other studies evaluating IV administration of bovine DNAse at high doses report no complications.
In 1999, a study was published evaluating intravenous (IV) Pulmozyme® in lupus patients, reporting no serious adverse events (SAEs) among the 14 patients receiving the treatment. We are currently conducting a clinical trial of the same molecule in IV administration in patients treated with mechanical thrombectomy and IV thrombolysis for ischemic stroke (NCT04785066).
This study is the first randomized clinical trial to target NETs as effectors of the thrombo-inflammation responsible for post-HSA DCI.

Start Date01 Feb 2025

Sponsor / Collaborator

Fondation Ophtalmologique Adolphe de Rothschild

NCT05880524

/ Not yet recruitingPhase 2IIT

Reduction of SystemiC Inflammation After Ischemic Stroke by Intravenous DNase Administration (ReSCInD)

The goal of this (monocentric, randomised, placebo-controlled single-blinded; phase 2) clinical trial is to test the hypothesis that DNase 1 administration leads to a reduction in systemic immune response measured in patients after acute ischaemic stroke compared to control treatment.
Participants will receive intravenous DNase 1 (500 µg/kg) or placebo (NaCl 0.9%) twice within 24±6 hours after symptom onset (last seen well). Blood samples will be taken at baseline, day 1 and 3. Personal visits will occur on baseline, day 1, 3 and discharge date. A telephone interview will be conducted on day 30±3.

Start Date01 Dec 2024

Sponsor / Collaborator

Ludwig-Maximilians-Universität München

[+2]

NCT04409925

/ CompletedPhase 1IIT

Phase I Pilot Study Investigating the Safety and Feasibility of Inhaled rhDNase1 and Its Impact on Neutrophil Extracellular Traps (NETs) in Non-Ventilated COVID-19 Infected Patients

This is a pilot study to investigate the safety and feasibility of rhDNase1 and its impact on neutrophil extracellular traps (NETs) in COVID-19 infected patients.

Start Date25 Dec 2020

Sponsor / Collaborator

Centre universitaire de santé McGill

[+3]

100 Clinical Results associated with Dornase Alfa

100 Translational Medicine associated with Dornase Alfa

100 Patents (Medical) associated with Dornase Alfa

1,919

Literatures (Medical) associated with Dornase Alfa

01 Mar 2025·CELL AND TISSUE BANKING

Advances in preparation of acellular human dermis for tissue banking and transplantation

Article

Author: Barrera, Valentina ; Randles, Michael ; Stern, Irit ; Rooney, Paul

Abstract:

Non-healing wounds cost the National Health Service over £5.6 billion annually in wound management. Skin allografts are used to treat non-healing wounds, ulcers and burns, offering the best protection against infection. In order to allow host cells to repopulate and to avoid immunogenicity, cell components are removed through decellularisation. Decellularisation of human dermis has so far been performed in NHS Blood and Transplant using a combination of two enzymes (RNase T1 and the recombinant human DNase Pulmozyme)®. This study aims at validating a new method to remove DNA from donated dermis via the use of a single enzyme, Benzonase, known for its effectiveness of DNA digestion. Skin samples were decellularised by removing the epidermis, lysing of dermal cells, removal of cellular fragments by a detergent wash and removal of nucleic acids by a nuclease incubation with either Benzonase or Pulmozyme + RNase T1. DNA quantification with PicoGreen, as well as histology on wax-embedded biopsies, stained with DAPI and haemotoxylin and eosin, were performed. In vitro toxicity test on human osteosarcoma immortalised cells and skin fibroblasts, and biomechanical (tensile) testing, were also performed. The effectiveness of DNA digestion with the new methodology was comparable to previous procedure. Mean DNA removal percentage following decellularisation with Pulmozyme + RNase was 99.9% (3.83 ng/mg). Mean DNA removal percentage with Benzonase was 99.8% (9.97 ng/mg). Histology staining showed complete decellularisation following either method. Benzonase was proven to be non-toxic to both cell lines used, and a one-way Anova test showed no significant difference in neither stress nor strain between acellular dermal matrix decellularised with either Benzonase or Pulmozyme + RNase T1. Benzonase was able to effectively decellularise dermis after prior removal of epidermis. It performed just as well as the combination of Pulmozyme + RNase T1, but represents significant advantages in terms of cost effectiveness, procurement and storage; Benzonase has been successfully used in the decellularisation of other tissues, thus would be better for Tissue Banking use. Switching to this combined DNase/RNase can have far-reaching consequences in the production of acellular human dermal matrix by NHSBT and in the treatment of patients requiring it.

01 Feb 2025·JOURNAL OF PHARMACY TECHNOLOGY

Combination Dornase and Alteplase for Intra-abdominal Drain, Abscess, and Hematoma Clearance: A Retrospective Case Series

Article

Author: Nordbeck, Sarah ; Schultz, Michelle ; Patel, Jasmine ; Olsen, Megumi

Background::

Since the advent of the MIST2 trial, the combined instillation of dornase and alteplase has become an effective nonsurgical treatment option for empyema and pleural fluid collection. Percutaneous drainage of abdominal abscesses and fluid collections, rather than open surgical treatment, also has become commonplace. The are several case reports and studies on the use of fibrinolytics to drain abdominal fluid collections but no literature reporting use of both alteplase and dornase for abdominal administration.

Objective::

We present a case series from an academic medical center where dornase therapy was added to fibrinolytic therapy to treat intra-abdominal fluid collections, hematoma, and abdominal drainage catheters with low output.

Methods::

This is an institutional review board-approved retrospective case series of 13 patients who underwent combination use of alteplase and dornase via intra-abdominal route. The primary objective was to assess for increased drain output, reduction in size of the fluid collection, and adverse events.

Results::

Many patients had improved drain output after dornase-alteplase therapy. One patient had significant bleeding complications.

Conclusions::

All patients were discharged alive from the hospital. Clinical success was difficult to define due to variable goals of therapy. Further data are needed to establish the safety and efficacy of this practice, especially compared with intra-abdominal alteplase alone. Patients in our series generally received larger doses of alteplase than in prior studies due to use of dosing modeled on the MIST2 trial. Based on the limited experience of our study, we recommend holding therapeutic anticoagulation during the administration of intra-abdominal dornase-alteplase.

01 Feb 2025·JOURNAL OF CONTROLLED RELEASE

Nano-alkaline ion-excited NETs ablative eye drops promote ocular surface recovery

Article

Author: Zou, Xi ; Zhang, Lichen ; Sun, Zhuo ; Zhang, Jun ; Xi, Kun ; Deng, Guohua ; Li, Ziang ; Liu, Zhinan ; Zhu, Lin ; Sun, Shanshan

Neutrophil extracellular traps (NETs) promote neovascularization during the acute phase after ocular chemical injury, while the local inflammatory acidic environment delays post-injury repair. Currently, the mechanism of NETs promoting neovascularization has not been fully elucidated, and there is a lack of therapeutic strategies to effectively improve the local microenvironment for corneal repair. In this study, we validated the NETs-M2-angiogenic pathway after injury. Using transcriptomics sequencing and liquid-phase microarray assays, the intrinsic immune cascade mechanism of NETs inducing macrophage M2 polarization and releasing VEGF via PI3K/AKT was identified. Based on this pathology and the physiological need to improve the local inflammatory acidic environment and promote corneal repair, we organically integrated the alkaline ion-rich bioglass with the highly transmissive and highly adhesive filipin protein, and constructed NETs ablative gel eye drops (DMS) that can release DNase I and alkaline ions in a sustained manner. The eye drops restricted the inflammatory interaction of NETs with macrophages from the source, adhered to the corneal surface and continuously released alkaline ions to improve the local acidic inflammatory environment, providing a favorable immune microenvironment for corneal recovery. We established a cell co-culture system and a corneal alkali burn model to further validate the role of DMS in modulating the intrinsic immune cascade of neovascularization for corneal repair and the related mechanisms. In conclusion, based on the biological mechanism of NETs-M2-VEGF after corneal chemical injury, the present study designed eye drops for dual regulation of intrinsic immunity and the inflammatory acid environment, which not only further supplemented and improved the pathophysiological mechanism of corneal neovascularization after chemical injury, but also provided a new way of thinking about corneal regeneration after injury.

News (Medical) associated with Dornase Alfa

23 Dec 2024

·www.prnewswire.com

Protalix BioTherapeutics Issues 2025 Letter to Stockholders

CARMIEL, Israel, Dec. 23, 2024 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE-American: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell based protein expression system, today announced the following letter from its President and Chief Executive Officer, Dror Bashan, to its stockholders. December 23, 2024 Dear Protalix Stockholders, As we conclude 2024, I am filled with a sense of accomplishment as well as excitement for the year ahead. This past year, Protalix has achieved significant milestones that position our company for long-term growth. The success we have achieved this year is a direct result of our team's hard work and dedication. We're proud to share these accomplishments with you. Our commercial partner, Chiesi Global Rare Diseases, is playing a pivotal role in our journey, and we continue to collaborate with Chiesi in its efforts. Most recently, the European Medicine Agency (EMA) validated Chiesi's Variation Submission for pegunigalsidase alfa to label a less frequent dosing regimen (every four weeks) for patients with Fabry disease in the European Union. This submission exemplifies Protalix's and Chiesi's mutual commitment to reducing the treatment burden faced by patients with Fabry disease. We have made important progress on our pipeline programs over the past year. We completed a phase I First-in-Human clinical trial evaluating PRX 115, our recombinant PEGylated uricase (urate oxidase) in development for the potential treatment of uncontrolled gout. Results from the trial demonstrate the potential of PRX-115 to be a safe and effective uric-acid lowering treatment with a potential wide dosing interval. We were proud to present this data to the medical community at the American College of Rheumatology (ACR) Convergence 2024 conference in November and are looking forward to advancing PRX-115 into a phase II clinical trial in patients with uncontrolled gout in the second half of 2025. We are also excited to have fine-tuned our R&D strategy moving forward, leveraging our ProCellEx platform and other capabilities in prioritized renal rare diseases. Our expert R&D team continues to evaluate plant-based drug delivery systems that may allow protective delivery of different modalities. The team is laser focused on these efforts, and we are eager to share more pipeline developments throughout the coming year. We are satisfied with the growth in our sales to Chiesi of Elfabrio®, Elelyso® to Pfizer Inc. and Uplyso® to Brazil which makes up our three revenue streams. We look forward to continuing growth of our sales in the coming years. Finally, by employing financial discipline over the last few years, we were able to repay in full all of our outstanding convertible notes, making us a debt-free company. We are proud of this achievement, and our strong balance sheet enables us to support ongoing operations. Our community continues to face the challenges of military activity in Israel. The suffering experienced by people in all sectors of these conflicts is heart-breaking. Despite the impact of these events on our colleagues and community, on both a personal and professional level, we have successfully maintained full, uninterrupted operations throughout the conflict. The continued dedication of our employees is a source of pride and we look forward to more peaceful times. Looking ahead, the future of Protalix is exciting. I am confident in our ability to deliver innovative solutions to improve the lives of patients in need. I want to express my sincere gratitude to our dedicated employees, our supportive Board of Directors and our valued shareholders. Your collective efforts and belief in our mission are instrumental in driving our progress. We sincerely thank you. Truly yours, Dror Bashan, President & Chief Executive Officer About Protalix BioTherapeutics, Inc. Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx. It is the first company to gain U.S. Food and Drug Administration (FDA) approval of a protein produced through plant cell-based in suspension expression system. This unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights to taliglucerase alfa for the treatment of Gaucher disease, Protalix's first product manufactured through ProCellEx, excluding in Brazil, where Protalix retains full rights. Protalix's second product, Elfabrio®, was approved by both the FDA and the European Medicines Agency in May 2023. Protalix has partnered with Chiesi Farmaceutici S.p.A. for the global development and commercialization of Elfabrio. Protalix's development pipeline consists of proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: PRX–115, a plant cell-expressed recombinant PEGylated uricase for the treatment of uncontrolled gout; PRX–119, a plant cell-expressed long action DNase I for the treatment of NETs-related diseases; and others. Forward-Looking Statements To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. The terms "expect," "anticipate," "believe," "estimate," "project," "may," "plan," "will," "would," "should" and "intend," and other words or phrases of similar import are intended to identify forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk and the final results of a clinical trial may be different than the preliminary findings for the clinical trial. Factors that might cause material differences include, among others: risks related to the commercialization of Elfabrio® (pegunigalsidase alfa-iwxj), our approved product for the treatment of adult patients with Fabry disease; risks relating to Elfabrio's market acceptance, competition, reimbursement and regulatory actions, including as a result of the boxed warning contained in the FDA approval received for the product; the possible disruption of our operations due to the war declared by Israel's security cabinet against the Hamas terrorist organization located in the Gaza Strip, the military campaign against the Hezbollah and other terrorist activities and armed conflict, including as a result of the disruption of the operations of certain regulatory authorities and of certain of our suppliers, collaborative partners, licensees, clinical trial sites, distributors and customers, and the risk that the current hostilities will result in a greater regional conflict; risks related to the regulatory approval and commercial success of our other product and product candidates, if approved; risks related to our expectations with respect to the potential commercial value of our products and product candidates; failure or delay in the commencement or completion of our preclinical studies and clinical trials, which may be caused by several factors, including: slower than expected rates of patient recruitment; unforeseen safety issues; determination of dosing issues; lack of effectiveness during clinical trials; inability to satisfactorily demonstrate non-inferiority to approved therapies; inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; inability to monitor patients adequately during or after treatment; and/or lack of sufficient funding to finance our clinical trials; delays in the approval or potential rejection of any applications we file with the FDA, EMA or other health regulatory authorities for our other product candidates, and other risks relating to the review process; risks associated with global conditions and developments such as supply chain challenges, the inflationary environment and tight labor market, and instability in the banking industry, which may adversely impact our business, operations and ability to raise additional financing if and as required and on terms acceptable to us; risks related to any transactions we may effect in the public or private equity markets to raise capital to finance future research and development activities, general and administrative expenses and working capital; risks relating to our evaluation and pursuit of strategic partnerships; the risk that the results of our clinical trials will not support the applicable claims of safety or efficacy and that our product candidates will not have the desired effects or will be associated with undesirable side effects or other unexpected characteristics; risks relating to our ability to manage our relationship with our collaborators, distributors or partners, including, but not limited to, Pfizer Inc., or Pfizer, and Chiesi Farmaceutici S.p.A.; risks related to the amount and sufficiency of our cash and cash equivalents; risks relating to changes to interim, topline or preliminary data from clinical trials that we announce or publish; risks relating to the compliance by Fundação Oswaldo Cruz, an arm of the Brazilian Ministry of Health, with its purchase obligations under our supply and technology transfer agreement, which may have a material adverse effect on us and may also result in the termination of such agreement; risk of significant lawsuits, including stockholder litigation, which is common in the life sciences sector; our dependence on performance by third-party providers of services and supplies, including without limitation, clinical trial services; the inherent risks and uncertainties in developing drug platforms and products of the type we are developing; the impact of development of competing therapies and/or technologies by other companies; risks related to our supply of drug products to Pfizer; potential product liability risks, and risks of securing adequate levels of related insurance coverage; the possibility of infringing a third-party's patents or other intellectual property rights and the uncertainty of obtaining patents covering our products and processes and successfully enforcing our intellectual property rights against third-parties; and risks relating to changes in healthcare laws, rules and regulations in the United States or elsewhere; and other factors described in our filings with the U.S. Securities and Exchange Commission. The statements in this press release are valid only as of the date hereof and we disclaim any obligation to update this information, except as may be required by law. Investor Contact Mike Moyer, Managing Director LifeSci Advisors +1-617-308-4306 [email protected] Logo - SOURCE Protalix BioTherapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1Drug ApprovalPhase 2

16 Dec 2024

·www.accesswire.com

Xenetic Biosciences, Inc. Extends Research Agreement with the University of Virginia for the Advancement of its DNase-Based Oncology Platform

Company continuing to advance DNase-based oncology program towards clinical proof-of-concept studies in multiple indications FRAMINGHAM, MA / ACCESSWIRE / December 16, 2024 / Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing hard to treat cancers, today announced it has extended its previously announced Research Funding Agreement (the "Agreement") with the University of Virginia ("UVA") to advance the development of its systemic DNase program through 2025. Xenetic's DNase-based oncology platform is designed to target neutrophil extracellular traps (NETs), which are weblike structures composed of extracellular chromatin coated with histones and other proteins. In cancer, NETs are expelled by activated neutrophils into the tumor microenvironment (TME) and blood, thereby promoting cancer spread, local and systemic immunosuppression, as well as cancer-associated thrombosis. Reduction of NETs burden via application of Xenetic's proprietary recombinant human DNase I has been shown to improve efficacy of immunotherapy, adoptive cell therapy and chemotherapy in preclinical animal models."Allan Tsung, MD, and the team at UVA continue to be valued partners and we are pleased with the progress under the Agreement in evaluating the potential addition of DNase to available treatment options in areas of significant unmet need. The preclinical and translational data that UVA has accumulated under the initial Scope of Work to the Agreement further strengthens the scientific rationale for investigating combinations of DNase I with immunotherapies and chemotherapies. In the next phase of this partnership, UVA will continue to investigate combinations of DNase I with immunotherapies in models of primary and metastatic colorectal cancer. As a surgical oncologist and scientist, Dr. Tsung is internationally recognized for leading substantial research on the role of NETs in tumor growth, metastasis, and resistance to existing cancer therapies and we look forward to leveraging that expertise as we advance our technology toward the clinic," commented Reid P. Bissonnette, Ph.D., Executive Consultant for Translational Research and Development of Xenetic.Under the terms of the Agreement, in addition to advancing Xenetic's existing intellectual property, Xenetic has an option to acquire an exclusive license to any new intellectual property arising from the DNase research program. Allan Tsung, MD, a member of the Company's Scientific Advisory Board and Chair of the Department of Surgery at the UVA School of Medicine, will continue to oversee the research conducted under the Agreement. Xenetic is working toward its planned first-in-human study to evaluate DNase combined with immune checkpoint inhibitors or chemotherapy.About Xenetic BiosciencesXenetic Biosciences, Inc. is a biopharmaceutical company focused on advancing innovative immune-oncology technologies addressing hard to treat cancers. The Company's DNase I platform is designed to improve outcomes of existing treatments, including immunotherapies, by targeting neutrophil extracellular traps (NETs), which are involved in cancer progression. Xenetic is currently focused on advancing its systemic DNase program into the clinic as an adjunctive therapy for pancreatic carcinoma, colorectal cancer and locally advanced or metastatic solid tumors.For more information, please visit the Company's website at www.xeneticbio.com and connect on X, LinkedIn, and Facebook.Forward-Looking StatementsThis press release contains forward-looking statements that we intend to be subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," "remain," "focus", "confidence in", "potential", "making", and other words of similar meaning, including, but not limited to: all statements regarding the collaboration agreement with UVA, including regarding the next phase of the partnership with UVA where UVA will continue to investigate combinations of DNase I with immunotherapies in models of primary and metastatic colorectal cancer and our plans to continue to leverage the knowledge and expertise of the team at UVA to potentially expand and broaden the utility of our proprietary platform technology; and expectations regarding our DNase-based oncology platform, including statements regarding: advancing DNase-based oncology program towards clinical proof-of-concept studies in multiple indications; focusing on advancing innovative immuno-oncology technologies addressing hard to treat oncology indications; advancing the development of the Company's program on the combination of systemic DNase and CAR T-cell therapies; the DNase platform improving outcomes of existing treatments, including immunotherapies, by targeting neutrophil extracellular traps (NETs), which are involved in cancer progression; and our focus on advancing our systemic DNase program into the clinic as an adjunctive therapy for pancreatic carcinoma, colorectal cancer and locally advanced or metastatic solid tumors. All forward-looking statements contained herein are based on current expectations and are subject to a number of risks and uncertainties. Many factors could cause our actual activities, performance, achievements, or results to differ materially from the activities and results anticipated in forward-looking statements. Important factors that could cause actual activities, performance, achievements, or results to differ materially from such plans, estimates or expectations include, among others, (1) failure to achieve the expected outcomes and realize the anticipated benefits from our collaboration agreements, including the agreement with UVA; (2) unexpected costs, charges or expenses resulting from our manufacturing and collaboration agreements, including the agreement with UVA; (3) unexpected costs, charges or expenses resulting from the licensing of the DNase platform; (4) uncertainty of the expected financial performance of the Company following the licensing of the DNase platform; (5) failure to realize the anticipated potential of the DNase or PolyXen technologies; (6) the ability of the Company to obtain funding and implement its business strategy; and (7) other risk factors as detailed from time to time in the Company's reports filed with the SEC, including its annual report on Form 10-K, periodic quarterly reports on Form 10-Q, current reports on Form 8-K and other documents filed with the SEC. The foregoing list of important factors is not exclusive. In addition, forward-looking statements may also be adversely affected by general market factors, general economic and business conditions, including potential adverse effects of public health issues, such as the COVID-19 outbreak, and geopolitical events, such as the conflicts in Ukraine and in the Middle East, on economic activity, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new product candidates and indications, manufacturing issues that may arise, patent positions, litigation and shareholder activism, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and the Company does not undertake any obligation to update forward-looking statements, except as required by law.Contact:JTC Team, LLCJenene Thomas(908) 824-0775[email protected]SOURCE: Xenetic Biosciences, Inc.

ImmunotherapyLicense out/inCell Therapy

05 Dec 2024

·www.accesswire.com

Xenetic Biosciences, Inc. Enters into Clinical Trial Services Agreement with PeriNess Ltd. to Accelerate Development of DNase I Oncology Program

Collaboration utilizes PeriNess' expertise in clinical development of human recombinant DNase and bolsters efforts towards clinical proof-of-concept studies in multiple indications FRAMINGHAM, MA / ACCESSWIRE / December 5, 2024 / Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing hard to treat cancers, today announced it has entered into a Clinical Trial Services Agreement (the "Agreement") with the Israel-based biotechnology company PeriNess Ltd. ("PeriNess") to advance the Company's development program for its systemic DNase I candidate in combination with chemotherapy and immunotherapy platforms for the treatment of pancreatic carcinoma, colorectal cancer and other locally advanced or metastatic solid tumors toward exploratory clinical studies."We are pleased to be working with PeriNess, and to have the opportunity to leverage their experience for the development of Xenetic's intravenous DNase I candidate through preclinical and early-stage clinical programs. We are excited to take this step forward on the path to the clinic and look forward to investigating our systemic DNase I candidate, XBIO-015, as an adjunctive treatment," commented James Parslow, Interim Chief Executive Officer and Chief Financial Officer of Xenetic."We are thrilled to enter this strategic Clinical Trial Services Agreement with Xenetic and further advance the development of their systemic DNase I platform. We believe this collaboration is a great example of where we can put substantial synergies from our projects toward accelerating the clinical development of a highly promising DNase I program for patients in need of new therapies," commented Michal Ben Attar, Chief Executive Officer of PeriNess.A large body of published preclinical data highlights the pivotal role of Neutrophil Extracellular Traps (NETs) in modulating cancer chemotherapy and immunotherapy efficacy and provides a strong rationale for incorporating DNase I as an adjunctive treatment to improve therapeutic responses in patients with pancreatic and colorectal cancers receiving chemotherapy and immunotherapy.Under the terms of the Agreement, PeriNess will lead in the regulatory approval, operational execution and management of potential exploratory, investigator initiated studies of recombinant DNase as an adjunctive treatment in patients with pancreatic carcinoma and other locally advanced or metastatic solid tumors receiving chemotherapy and immunotherapy in Israeli medical centers.About PeriNess Ltd.PeriNess, a pioneering privately held Israeli company, is at the forefront of developing innovative solutions for male infertility. The company is developing a novel drug based on DNase I, which has shown potential to improve sperm quality and increase the chances of conception. PeriNess preclinical studies have shown that Neutrophil Extracellular Traps (NETs) in the blood is the deleterious factor triggering sperm damage and have confirmed that DNase treatment reduces levels of NETs in the blood, prevents sperm cell damage and improves sperm quality. With the recent completion of its Phase 1 clinical trial in Israel, PeriNess is now advancing DNase I to Phase 2 clinical trials, aiming to bring a groundbreaking new treatment to millions of couples struggling with infertility.About Xenetic BiosciencesXenetic Biosciences, Inc. is a biopharmaceutical company focused on advancing innovative immune-oncology technologies addressing hard to treat cancers. The Company's DNase I platform is designed to improve outcomes of existing treatments, including immunotherapies, by targeting neutrophil extracellular traps (NETs), which are involved in cancer progression. Xenetic is currently focused on advancing its systemic DNase program into the clinic as an adjunctive therapy for pancreatic carcinoma , colorectal cancer and locally advanced or metastatic solid tumors.For more information, please visit the Company's website at www.xeneticbio.com and connect on X, LinkedIn, and Facebook.Forward-Looking StatementsThis press release contains forward-looking statements that we intend to be subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including, but not limited to, statements regarding: the Agreement with PeriNess, including that such collaboration will bolster efforts towards clinical proof-of-concept studies in multiple indications and advance the Company's development program for its systemic DNase I candidate in combination with chemotherapy and immunotherapy platforms for the treatment of pancreatic carcinoma, colorectal cancer and other locally advanced or metastatic solid tumors toward exploratory clinical studies, statements regarding the role of PeriNess under the Agreement, statements regarding the opportunity to leverage PeriNess's experience for the development of intravenous DNase I candidate through preclinical and early-stage clinical programs, and statements regarding our excitement to take this step forward on the path to the clinic and investigating our systemic DNase I candidate, XBIO-015, as an adjunctive treatment, as well as all statements regarding expectations for our DNase-base oncology platform, including our focus on advancing our systemic DNase program into the clinic as an adjunctive therapy for pancreatic carcinoma and locally advanced or metastatic solid tumors. Any forward-looking statements contained herein are based on current expectations and are subject to a number of risks and uncertainties. Many factors could cause our actual activities, performance, achievements, or results to differ materially from the activities and results anticipated in forward-looking statements. Important factors that could cause actual activities, performance, achievements, or results to differ materially from such plans, estimates or expectations include, among others, (1) unexpected costs, charges or expenses resulting from our manufacturing and collaboration agreements, including the Agreement with PeriNess; (2) unexpected costs, charges or expenses resulting from the licensing of the DNase platform; (3) uncertainty of the expected financial performance of the Company following the licensing of the DNase platform; (4) failure to realize the anticipated potential of the DNase, XCART or PolyXen technologies; (5) the ability of the Company to obtain funding and implement its business strategy; and (6) other risk factors as detailed from time to time in the Company's reports filed with the SEC, including its annual report on Form 10-K, periodic quarterly reports on Form 10-Q, current reports on Form 8-K and other documents filed with the SEC. The foregoing list of important factors is not exclusive. In addition, forward-looking statements may also be adversely affected by general market factors, general economic and business conditions, including potential adverse effects of public health issues, such as the COVID-19 outbreak, and geopolitical events, such as the conflicts in the Ukraine and in the Middle East, on economic activity, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new product candidates and indications, manufacturing issues that may arise, patent positions, litigation and shareholder activism, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and the Company does not undertake any obligation to update forward-looking statements, except as required by law.Contact:JTC Team, LLCJenene Thomas(908) 824-0775[email protected]SOURCE: Xenetic Biosciences, Inc.

Phase 1ImmunotherapyPhase 2

100 Deals associated with Dornase Alfa

External Link

KEGG	Wiki	ATC	Drug Bank
D03896	Dornase Alfa	R05CB13	DB00003

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Cystic Fibrosis	US	Genentech, Inc.	30 Dec 1993

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Empyema, Pleural	Phase 3	IT	Hoffmann-La Roche, Inc.	01 Oct 2007
Pleural Effusion	Phase 3	IT	Hoffmann-La Roche, Inc.	01 Oct 2007
Graft vs Host Disease	Phase 2	US	Genentech, Inc.	01 Apr 2016
Dry Eye Syndromes	Phase 2	US	Genentech, Inc.	01 Jul 2014
Asthma	Phase 2	US	The Feinstein Institutes for Medical Research	01 Aug 2012
Sinusitis	Phase 2	US	Genentech, Inc.	01 Dec 2006
Acute asthma	Phase 2	US	Genentech, Inc.	01 Jan 2004

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04359654 (Pubmed)	Phase 2	COVID-19 C-reactive protein (CRP) \| lymphocyte counts \| cf-DNA ... View more	39	Dornase alfa + Best Available Care	qbhmxntbuz(maocgtroaz) = awkaopxeas uoapguyebu (lhdvoyghtx ) View more	Positive	16 Jul 2024
				Best Available Care	qbhmxntbuz(maocgtroaz) = xxxbyxhbmf uoapguyebu (lhdvoyghtx ) View more
ISTH2023	Not Applicable	Thrombosis	63	rt-PA	mchhivthjn(cvyowqptfh) = cctnequxgl zygqluwpem (drzpsfiyky )	-	24 Jun 2023
				rt-PA + DNase-1	mchhivthjn(cvyowqptfh) = fpwenegotv zygqluwpem (drzpsfiyky )
MIST-2 (ERS2021)	Not Applicable	Pleural Diseases	30	16mg t-PA and 5mg DNase	qdkndnkuvw(sbefgfhzwt) = bfqckqlzbl hptdsexcmv (bxzuxudefs, 905 - 2360)	-	05 Sep 2021
ERS2021	Not Applicable	-	715	Tigeraza® (dornase alfa)	lpsfinecdr(vusgqdjlhb) = qkzaqgwlxp wvqvmsbqlg (osotrbhlri ) View more	-	05 Sep 2021
NCT02702518 (CTgov)	Phase 1/2	Dry Eye Syndromes \| Graft vs Host Disease	58	rhDNase I (rhDNase I)	ecwayszfrf(zexyhebqqq) = iixfszjpqd otqkxyfvpm (kgfndhrskt, vzbyoriayd - kfcjygkdmp) View more	-	10 Aug 2021
				Vehicle (Vehicle)	ecwayszfrf(zexyhebqqq) = xjucxmsaix otqkxyfvpm (kgfndhrskt, dkugdbhcys - nskcacgrbb) View more
NCT01717742 (CTgov)	Phase 3	Empyema, Pleural	97	tPA (Intervention)	athhnhtyta(ehptelpqcr) = faxwsqyffv apdfnmhhhy (gfjrzdoany, elwixbefyt - yzwmriuecl) View more	-	03 Apr 2020
				tPA (Control)	athhnhtyta(ehptelpqcr) = icsppmnvgg apdfnmhhhy (gfjrzdoany, hbhdyprodd - xnspwdnwdu) View more
NCT02193490 (CTgov)	Phase 1/2	Dry Eye Syndromes	47	DNase (DNase)	dxhbfudhiq(kedheygbad) = sxeofpvcdn ipsnocbnem (byfbxeyddl, jwxxqzqxip - dyrsabdvdm) View more	-	05 Nov 2019
				Vehicle (Vehicle)	dxhbfudhiq(kedheygbad) = ozdzdwatzm ipsnocbnem (byfbxeyddl, nfttecgavy - twusvdddyb) View more
ERS2018	Not Applicable	Empyema	10	Dornase alfa 2.5 mg	ieiubvawdo(vxekwhchxb) = eelxyvsdjy pqmcwajyub (gvymtnebin ) View more	-	15 Sep 2018
NCT01356147 (PVAIN, CTgov)	Phase 4	Pneumonia, Ventilator-Associated \| Ventilator associated bacterial pneumonia \| Infectious Lung Disorder	11	Placebo (Sham Placebo)	yezrbewtfs(tnkruediij) = bthjafwzha hyzeiiayhq (ubjnxkqkmy, zudtiuxubh - zyivsstfgv) View more	-	08 Feb 2017
				Dornase alfa (Dornase Alfa)	yezrbewtfs(tnkruediij) = tmpkqsqdvk hyzeiiayhq (ubjnxkqkmy, pmvhkjrbko - uvfvagxrdf) View more
NCT00419380 (CTgov)	Phase 4	Otitis Media	40	dornase alfa (Pulmozyme®) (Dornase Alfa (Pulmozyme®))	lmmboqwytc(guhzseykpe) = naopgotibm ermrfnegth (kozjbudmuo, kpymzvxdyk - khqyupkpjn) View more	-	27 Mar 2015
				dornase alfa (Pulmozyme®) (Ofloxin)	lmmboqwytc(guhzseykpe) = ucwhvimolj ermrfnegth (kozjbudmuo, cjkmpwxgix - nmywsirqow) View more

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