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

1,779

Literatures (Medical) associated with Dornase Alfa

01 Jun 2025·Biomaterials

Inhalable DNase I@Au hybrid nanoparticles for radiation sensitization and metastasis inhibition by elimination of neutrophil extracellular traps

Article

Author: Chen, Weiyu ; Zhou, Min ; Sun, Yuchao ; He, Jian ; Wang, Kai ; Wang, Yongfang ; Zheng, Yichun

High-dose radiation therapy is a widely used clinical strategy to inhibit tumor growth. However, the rapid generation of excessive reactive oxygen species (ROS) triggers the formation of neutrophil extracellular traps (NETs), which capture free tumor cells in the bloodstream, promoting metastasis. In this study, we developed a hybrid nanoparticle composed of DNase I and gold (DNase I@Au) to enhance radiotherapy efficacy while mitigating metastasis by precisely eliminating NETs. The DNase I@Au nanoparticles, administered via aerosol inhalation, are efficiently delivered to lung tumor tissue, improving radiosensitization and reducing tumor size. Crucially, the nanoparticles could gradually release DNase I, effectively degrading ROS-induced NETs and preventing the interaction of free malignant cells with tumor sites or vasculature, thereby inhibiting metastasis. Therefore, we provide an enzyme and sensitizer co-loaded strategy that offers a promising approach to improve the therapeutic outcome of radiotherapy and reduce the risk of lung cancer metastasis under ROS stimulation.

01 Apr 2025·Journal of Controlled Release

Archaea-inspired deoxyribonuclease I liposomes prevent multiple organ dysfunction in sepsis

Article

Author: Wang, Kaikai ; Lu, Zhongqiu ; Su, Xiayi ; Li, Xinze ; Huang, Zhiwei ; Wu, Fan ; Yu, Dedong

Neutrophil extracellular traps (NETs) and circulating cell-free DNA (cfDNA) are pivotal in driving excessive inflammation and organ damage during sepsis, with their levels correlating positively with sepsis severity in both patients and murine models. Despite the ability of deoxyribonuclease I (DNase I) to degrade NETs and cfDNA, its short half-life and rapid degradation limit its therapeutic effectiveness. To address this challenge, we developed a methyl-branched liposome fused with a red blood cell membrane for the systemic delivery of DNase I (DNase I/Rm-Lipo). The efficacy of DNase I/Rm-Lipo was evaluated in the stimulated immune cells and septic model. The data confirmed that DNase I/Rm-Lipo efficiently removed excess NETs and cfDNA in activated neutrophils. Following injection, DNase I/Rm-Lipo exhibited an extended circulation time, effectively suppressing neutrophil activation and regulating macrophage polarization to mitigate inflammation and prevent organ dysfunction in septic mice. These findings highlight the therapeutic potential of DNase I/Rm-Lipo as a promising candidate for sepsis management by targeting the degradation of NETs and cfDNA.

01 Mar 2025·Hepatology

Neutrophil extracellular traps promote MASH fibrosis by metabolic reprogramming of HSC

Article

Author: Xiong, Qi ; Islam, Mozaffarul ; Tsung, Allan ; Wang, Yu ; Zhou, Xinyu ; Huang, Hai ; Wang, Han ; Xia, Yujia ; He, Jiayi ; Zhang, Hongji ; Kim, Alex

Background and Aims:Metabolic dysfunction–associated steatohepatitis (MASH) fibrosis is a reversible stage of liver disease accompanied by inflammatory cell infiltration. Neutrophils extrude a meshwork of chromatin fibers to establish neutrophil extracellular traps (NETs), which play important roles in inflammatory response regulation. Our previous work demonstrated that NETs promote HCC in MASH. However, it is still unknown if NETs play a role in the molecular mechanisms of liver fibrosis.Approach and Results:Following 12 weeks of Western diet/carbon tetrachloride, MASH fibrosis was identified in C57BL/6 mice with increased NET formation. However, NET depletion using DNase I treatment or mice knocked out for peptidyl arginine deaminase type IV significantly attenuated the development of MASH fibrosis. NETs were demonstrated to induce HSCs activation, proliferation, and migration through augmented mitochondrial and aerobic glycolysis to provide additional bioenergetic and biosynthetic supplies. Metabolomic analysis revealed markedly an altered metabolic profile upon NET stimulation of HSCs that were dependent on arachidonic acid metabolism. Mechanistically, NET stimulation of toll-like receptor 3 induced cyclooxygenase-2 activation and prostaglandin E2 production with subsequent HSC activation and liver fibrosis. Inhibiting cyclooxygenase-2 with celecoxib reduced fibrosis in our MASH model.Conclusions:Our findings implicate NETs playing a critical role in the development of MASH hepatic fibrosis by inducing metabolic reprogramming of HSCs through the toll-like receptor 3/cyclooxygenase-2/cyclooxygenase-2 pathway. Therefore, NET inhibition may represent an attractive treatment target for MASH liver fibrosis.

News (Medical) associated with Dornase Alfa

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

22 Nov 2024

·www.accesswire.com

Xenetic Biosciences, Inc. Releases Virtual Investor "What This Means" Segment

Dr. Reid Bissonnette, Executive Consultant for Translational Research and Development at Xenetic, discusses positive preclinical data recently presented at the Society for Immunotherapy of Cancer (SITC) 39th Annual MeetingWatch the "What This Means" video hereFRAMINGHAM, MA / ACCESSWIRE / November 22, 2024 / Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immune-oncology technologies addressing hard to treat cancers, today announced that announced that Dr. Reid Bissonnette, Executive Consultant for Translational Research and Development at Xenetic participated in a Virtual Investor "What This Means" segment. As part of the segment, Dr. Bissonnette discussed key highlights from the Company's recent positive data demonstrating DNase I significantly improves efficacy of anti-CTLA-4 immune checkpoint blockade in preclinical models of microsatellite stable/mismatch repair proficient (MSS/MMRp) colorectal carcinoma (CRC) which was presented at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting. MSS/MMRp CRC represents approximately 85% of CRC patients, and for which immune checkpoint blockade agents have provided meager benefit.The Virtual Investor "What This Means" segment featuring Xenetic is now available here.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 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 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", and other words of similar meaning, including, but not limited to, all statements regarding expectations for our DNase-base oncology platform, including statements regarding: our growing body of preclinical data evaluating the DNase-based oncology platform across a number of high-value oncology indications, ongoing progress towards first in human clinical study for locally advanced or metastatic solid tumors, our strategic focus on exploratory investigator-initiated studies with institutional partners, including leveraging institutional partnerships to drive our development strategy, our focus on advancing innovative immune-oncology technologies addressing hard to treat cancers, our expectations regarding preclinical data generated to date, our focus on building a growing body of data and further developing our pipeline to build value in the near and long term, our plans regarding presentations of the results of preclinical data, 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 towards Phase 1 clinical development as an adjunctive therapy for the treatment of pancreatic carcinoma and other 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; (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 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.

ImmunotherapyAACR

21 Nov 2024

·www.accesswire.com

Xenetic Biosciences, Inc. Presents Positive Preclinical Data Highlighting the Potential of Co-Administration of DNase I with CAR T Cells in a Murine Model of Melanoma Lung Metastasis

Data presented at the AACR Special Conference in Cancer Research: Tumor-body Interactions: The Roles of Micro- and Macroenvironment in CancerResults bolster Company's rationale for incorporating DNase I as an adjunctive treatment to improve therapeutic responses in patients undergoing CAR T cell therapy FRAMINGHAM, MA / ACCESSWIRE / November 21, 2024 / Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immune-oncology technologies addressing hard to treat cancers, today announced the presentation of preclinical data investigating the potential of co-administration of deoxyribonuclease I (DNase I) with chimeric antigen receptor (CAR) T cells in a syngeneic B16 melanoma murine model of lung metastasis.The poster titled, "The synergistic action of DNase I and CAR T cells enhances the therapeutic efficacy of adoptive immunotherapy in the syngeneic murine metastasis model," was presented on behalf of the Company by Alexey Stepanov, PhD, Institute Investigator at The Scripps Research Institute, at the AACR Special Conference in Cancer Research: Tumor-body Interactions: The Roles of Micro- and Macroenvironment in Cancer, held November 17-20, 2024, in Boston."Xenetic's proprietary DNase-based oncology platform continues to demonstrate encouraging potential across a number of cancer indications and therapy modalities where there remains significant unmet need. CAR T cell therapy is a promising approach for treating various malignancies however, it has so far shown benefit only in hematological cancers, so efficacy in solid tumors remains an important goal. There, its antitumor activity is often hindered by a hostile, immunosuppressive tumor microenvironment (TME), which, in turn, is very often characterized by the presence of tumor-associated cell-free DNA (cfDNA) in the form of neutrophil extracellular traps (NETs). This research underscores the critical role of the NETs in modulating CAR T cell efficacy and the potential of DNase I to improve therapeutic responses for patients as an adjunctive treatment. Highlighted by the results seen with the co-administration of DNase I with murine EGFR-CAR T cells, we believe this approach has the potential to prolong survival compared to treatment with CAR T cell monotherapy," commented Reid Bissonnette, Ph.D., Executive Consultant for Translational Research and Development at Xenetic. "We continue to be encouraged by the data demonstrated to date and look forward to further exploring the translational potential of this combinatorial approach in enhancing cancer treatment."For the preclinical study co-administration of DNase I with CAR T cells was investigated in a syngeneic B16 murine melanoma model of lung metastasis. Bioluminescent imaging of melanoma metastatic processes has shown that a single injection of DNase I (10 mg/kg) together with CAR T cells suppressed B16-EGFR lung metastasis at early stages in comparison to the vehicle control group and extended survival.Key HighlightsCo-administration of single injection of DNase I (10 mg/kg) with murine EGFR-CAR T cells demonstrated to significantly suppress metastatic tumor burden, decreases the number of metastatic foci, and substantially prolongs survival compared to the CAR T cell monotherapy group.Degrading of NETs by DNase I increases the amount of tumor-infiltrating T and CAR T cells and reduces the immunosuppressive effects of the TME.Tumor immune cell infiltrate analysis revealed that the CD8 population of tumor-infiltrating CAR T cells from the DNase I treated group have lower expression of PD-1 and TIM-3 exhaustion markers.Xenetic continues to advance its DNase-based oncology program towards Phase 1 clinical development for the treatment of pancreatic carcinoma and other locally advanced or metastatic solid tumors. Preliminary preclinical studies evaluating the combinations of DNase I with chemotherapy and DNase I with immuno-therapies in colorectal cancer models as well as CAR-T therapy have been completed.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 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 and other locally advanced or metastatic solid tumors.For more information, please visit the Company's website at www.xeneticbio.com and connect on Twitter, 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", and other words of similar meaning, including, but not limited to, all statements regarding expectations for our DNase-based oncology platform, including statements regarding: the potential of co-administration of deoxyribonuclease I (DNase I) with chimeric antigen receptor (CAR) T cells in a syngeneic B16 melanoma murine model of lung metastasis; the DNase-based oncology platform continuing to demonstrate encouraging potential across a number of cancer indications and therapy modalities where there remains significant unmet need; efficacy of CAR T cell therapy in solid tumors remaining an important goal; our belief that this approach has the potential to prolong survival compared to treatment with CAR T cell monotherapy; continuing to be encouraged by the data demonstrated to date and looking forward to further exploring the translational potential of this combinatorial approach in enhancing cancer treatment; our focus on advancing innovative immune-oncology technologies addressing hard to treat cancers; 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 towards Phase 1 clinical development as an adjunctive therapy for the treatment of pancreatic carcinoma and other 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; (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 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.

ImmunotherapyCell TherapyAACR

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.

to view more data

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

Developing

10 top R&D records.

to view more data

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

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ISTH2023	Not Applicable	Thrombosis	63	rt-PA	ofbdoolfdm(fxgmerlhln) = owqdkmsrpa dhbwzbkiyi (qrzmeivmuo )	-	24 Jun 2023
				rt-PA + DNase-1	ofbdoolfdm(fxgmerlhln) = kqyyvrnhpv dhbwzbkiyi (qrzmeivmuo )
MIST-2 (ERS2021)	Not Applicable	Pleural Diseases	30	16mg t-PA and 5mg DNase	lubuoyaapq(frfonbkepa) = dvncpgrpjo dgwrnoyxgl (aaoruttelt, 905 - 2360)	-	05 Sep 2021
NCT02702518 (CTgov)	Phase 1/2	Dry Eye Syndromes \| Graft vs Host Disease	58	rhDNase I (rhDNase I)	qcdcfwxsmd(yzpcuzgsah) = typaipgysl uveggiiyfu (qduecoivbb, edohzusnei - pnodtlbnoe) View more	-	10 Aug 2021
				Vehicle (Vehicle)	qcdcfwxsmd(yzpcuzgsah) = ycvzbrrmga uveggiiyfu (qduecoivbb, auwtfscrrq - xurqmbpnko) View more
NCT02193490 (CTgov)	Phase 1/2	Dry Eye Syndromes	47	DNase (DNase)	(olkwhocbhb) = wwehxumopj kbvaypkvtk (phemsmvflh, ryfozwgcsx - pkovxehufo) View more	-	05 Nov 2019
				Vehicle (Vehicle)	(olkwhocbhb) = phqjikaucd kbvaypkvtk (phemsmvflh, fjflusgyfb - xxkabnjwvo) View more
ERS2018	Not Applicable	Empyema	10	Dornase alfa 2.5 mg	yxcxxtench(vjoamrwcup) = pzzflgvjyp argdxcbjar (bzttppmftv ) View more	-	15 Sep 2018
NCT01356147 (PVAIN, CTgov)	Phase 4	Pneumonia, Ventilator-Associated \| Ventilator associated bacterial pneumonia \| Infectious Lung Disorder	11	Placebo (Sham Placebo)	loiolchdpj(ahlgftkgic) = lxbqbhfbhj mqqcairqcl (kqgbuzkizo, okthsbqqst - pfnerbmogv) View more	-	08 Feb 2017
				Dornase alfa (Dornase Alfa)	loiolchdpj(ahlgftkgic) = wwtjssvngp mqqcairqcl (kqgbuzkizo, lmqfxmrgux - owhjsdczbj) View more
NCT00419380 (CTgov)	Phase 4	Otitis Media	40	dornase alfa (Pulmozyme®) (Dornase Alfa (Pulmozyme®))	nriizuluuj(ziyedyqmeg) = ylefliduae ptutwbcskl (yokktrtlui, xxivpcpire - nffcefxaer) View more	-	27 Mar 2015
				dornase alfa (Pulmozyme®) (Ofloxin)	nriizuluuj(ziyedyqmeg) = ytdtfhtovy ptutwbcskl (yokktrtlui, sbnqogcdtb - tpbbtcyrfa) View more
NCT00416182 (CTgov)	Phase 2	Sinusitis \| Cystic Fibrosis	16	Pulmozyme (dornase alfa) (Pulmozyme)	baitasbovw(ghhtmbwhbu) = pvdsvzqzuy ytkbcjmhxl (pvlaeelyat, fffazzblgu - ugexfrdaac) View more	-	14 Nov 2014
				Placebo (Placebo)	baitasbovw(ghhtmbwhbu) = alsotmbjua ytkbcjmhxl (pvlaeelyat, orefcojtgg - arxctewqhs) View more
NCT01712334 (CTgov)	Phase 4	Cystic Fibrosis	99	dornase alfa [Pulmozyme®] (eRapid Nebulizer)	xoromyjusz(hkqtncdpzr) = xnojetqlnm hzowtxwunf (fgqalhfoyy, pmyyltdump - eaxfjdshzq) View more	-	01 May 2014
				dornase alfa [Pulmozyme®] (Jet Nebulizer)	xoromyjusz(hkqtncdpzr) = ueoozvzhku hzowtxwunf (fgqalhfoyy, ztlsrnohyb - mpqoaksljv) View more
ARVO2014	Not Applicable	Dry Eye Syndromes	-	DNase I eye drops	(enpuzjyqzt) = rsnckdjaos luqkivluoy (kzalilatrw ) View more	-	01 Apr 2014

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