Latest news with #pharmacokinetics
Globe and Mail
5 days ago
- Business
- Globe and Mail
AstraZeneca's AZD4144 Study Completion: Key Insights for Investors
AstraZeneca ((AZN)), Parexel International ((PRXL)), AstraZeneca plc ((GB:AZN)), AstraZeneca ((DE:ZEGA)), AstraZeneca plc US ((AZNCF)) announced an update on their ongoing clinical study. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. AstraZeneca, in collaboration with Parexel International, recently completed a Phase I clinical study titled An Open-label, Randomised, 2-arm, 3-period, 6-treatment Single-dose, Crossover Study Comparing the Pharmacokinetics of 2 Different Formulations of AZD4144, and Effect of Food and Omeprazole on the Pharmacokinetics of AZD4144 in Healthy Participants. The study aimed to evaluate the pharmacokinetics of two formulations of AZD4144 and the impact of food and omeprazole on its absorption in healthy individuals. The study tested two formulations of AZD4144, an investigational drug, in tablet and oral solution forms. It also assessed the effect of omeprazole, a commonly used medication for reducing stomach acid, on AZD4144's pharmacokinetics. This open-label, randomized, crossover study involved two arms with different treatment sequences. Participants received single doses of AZD4144 under various conditions, including fasted and fed states, and in combination with omeprazole. The primary goal was to understand how these factors influence the drug's absorption and processing in the body. The study commenced on April 23, 2025, and was completed by July 22, 2025. These dates are crucial as they mark the timeline of the study's execution and data collection, which can affect the timing of subsequent phases and regulatory submissions. This update could influence AstraZeneca's stock performance by providing insights into the drug's development progress. Positive results might boost investor confidence, while any setbacks could have the opposite effect. The study's completion also positions AstraZeneca competitively within the pharmaceutical industry as it advances its pipeline. The study is now completed, with further details available on the ClinicalTrials portal.
Globe and Mail
5 days ago
- Business
- Globe and Mail
AstraZeneca's Latest Study: Evaluating Ceralasertib's Impact on Cancer Drug Pharmacokinetics
AstraZeneca ((AZN)), Parexel International ((PRXL)), AstraZeneca plc ((GB:AZN)), AstraZeneca ((DE:ZEGA)), AstraZeneca plc US ((AZNCF)) announced an update on their ongoing clinical study. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. AstraZeneca, in collaboration with Parexel International, is conducting a Phase I clinical study titled 'A Phase I, Open-label, Fixed-sequence Study to Evaluate the Effect of Ceralasertib on Pharmacokinetics of Drug X, Drug Y and Drug Z in Participants With Advanced Solid Tumours.' The study aims to assess how ceralasertib affects the pharmacokinetics of three other drugs in patients with advanced solid tumors, potentially offering new insights into cancer treatment. The intervention involves administering ceralasertib, alongside Drugs X, Y, and Z. Ceralasertib is given twice daily over a week, with single doses of the other drugs administered on specific days to evaluate interactions. This open-label study follows a single-group assignment model with no masking, focusing on treatment as its primary purpose. It includes multiple visits and wash-out periods to ensure accurate results. The study began on May 21, 2025, with the latest update submitted on July 22, 2025. These dates are crucial for tracking the study's progress and ensuring transparency. For investors, this study could influence AstraZeneca's stock performance by potentially expanding its oncology portfolio. The collaboration with Parexel highlights a strategic partnership that could enhance research capabilities, impacting investor sentiment positively. Competitors in the oncology sector may also be closely monitoring these developments. The study is currently recruiting, with further details available on the ClinicalTrials portal.
Miami Herald
08-07-2025
- Business
- Miami Herald
Xenetic Biosciences, Inc. Announces Update from Collaboration Partner of First Patient Dosed in Exploratory Clinical Study of DNase I in Combination with FOLFIRINOX for the First Line Treatment of Unresectable, Locally Advanced or Metastatic Pancreatic Cancer
Investigator initiated exploratory clinical study being conducted in Israel pursuant to agreement with collaboration partner, PeriNess Company evaluating systemic recombinant human DNase I (DNase I) in combination with chemotherapy and immunotherapy platforms for the treatment of pancreatic carcinoma, colorectal cancer and other locally advanced or metastatic solid tumors FRAMINGHAM, MA / ACCESS Newswire / July 8, 2025 / Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing difficult to treat cancers, today announced that its collaboration partner, PeriNess Ltd. (PeriNess), has informed the Company that Bnei Zion Medical Center has commenced patient dosing in an exploratory clinical study of systemic DNase I in combination with FOLFIRINOX for the first line treatment of unresectable, locally advanced or metastatic pancreatic cancer. Dr. Abed Agbabrya, head of Oncology at the Bnei Zion Hospital, will act as the principal investigator and all work will be conducted at The Fund for Medical Research, Development of Infrastructure and Health services - Bnei Zion Medical Center in Israel. Dr. Dmitry Genkin, Xenetic Chairman stated, "We are very pleased with the update provided by PeriNess and for the start of patient dosing in this exploratory study. We remain committed to advancing our systemic recombinant human DNase I technology into the clinical stage. The ability of DNase I to degrade neutrophil extracellular traps (NETs) in the pancreatic cancer tumor microenvironment holds promise to improve clinical responses in a critically underserved patient population. We look forward to further exploring the full potential of DNase I." PeriNess has informed the Company that the exploratory study is evaluating the safety, biomarker response, pharmacokinetics (PK) and clinical activity of DNase I in combination with first line regimen of FOLFIRINOX chemotherapy in patients with locally advanced or metastatic pancreatic cancer. All patients will receive intravenous infusions of DNase I on Days 1 and 8 of consecutive 14-day cycles. Safety will be continuously evaluated until the end of the study. DNase I pharmacokinetics will be evaluated on Days 1 and 2 of the first FOLFIRINOX cycle and Days 1 and 2 of the third FOLFIRINOX cycle. Neutrophil extracellular traps biomarkers will be evaluated on Day 1 of the first FOLFIRINOX cycle and every 4 weeks thereafter. Clinical activity will be evaluated by the Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Progression-Free Survival (PFS). As previously announced, in December 2024, Xenetic entered into a Clinical Trial Services Agreement with PeriNess, under which 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 Xenetic Biosciences Xenetic Biosciences, Inc. is a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing difficult to treat cancers. The Company's DNase technology is designed to improve outcomes of existing treatments, including immunotherapies, by targeting neutrophil extracellular traps (NETs), which are involved in the progression of many human cancers. Xenetic is currently focused on advancing its systemic DNase I 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 and connect on X, LinkedIn, and Facebook. Forward-Looking Statements This 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", "look forward", "holds", and other words of similar meaning, including, but not limited to, all statements regarding expectations with respect to the investigator initiated exploratory study being conducted by Bnei Zion Medical Center evaluating the safety, biomarker response, PK and clinical activity of DNase I in combination with first line regimen of FOLFIRINOX chemotherapy in patients with locally advanced or metastatic pancreatic cancer, including the first patient dosing under the exploratory study; all statements regarding expectations with respect to our collaboration with PeriNess; and all statements regarding expectations for our DNase I-based oncology platform, including statements regarding: DNase holding promise to improve clinical responses in a critically underserved patient population, our expectations regarding exploring the full potential of DNase I, our focus on advancing innovative immune-oncology technologies addressing difficult to treat cancers, the DNase I technology improving outcomes of existing treatments, including immunotherapies, by targeting neutrophil extracellular traps (NETs), which are involved in the progression of many human cancers, and our focus on advancing our systemic DNase I 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) the relevance of, or our ability to utilize, the data from the investigator initiated exploratory study, if any, (2)) unexpected costs, charges or expenses resulting from our manufacturing and collaboration agreements, including the Clinical Trial Services Agreement with PeriNess; (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 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 and geopolitical events, such as the conflicts in the Ukraine and 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) 824-0775xbio@ SOURCE: Xenetic Biosciences, Inc.
Business Wire
29-05-2025
- Health
- Business Wire
Drug Farm Reports Data on Safety and Pharmacokinetics from Phase 1 First-in-Human Trial of DF-003 in Healthy Volunteers
ALBANY, N.Y. & SHANGHAI--(BUSINESS WIRE)--Drug Farm, a private biotechnology company utilizing genetics and artificial intelligence technologies to discover and develop innovative, immune-modulating therapies, today announced positive results from a recently completed Phase 1 study (NCT05997641) of DF-003 in healthy volunteers. The data were presented at the American Society for Clinical Pharmacology & Therapeutics (ASCPT) meeting in Washington, DC. DF-003 is a first-in-class, immune-modulating alpha-kinase 1 (ALPK1) inhibitor that targets the root cause of the rare genetic disease, ROSAH syndrome. This randomized, placebo-controlled, double-blinded study evaluated the safety, tolerability and pharmacokinetics of DF-003 in forty-eight healthy volunteers. In the first portion of the trial, single ascending doses were orally administered in five cohorts (randomized 3:1; DF-003: placebo) ranging from 3 mg up to 150 mg. In the second portion of the trial, 50 mg of DF-003 was orally administered daily for fourteen consecutive days in one cohort (randomized 3:1; DF-003: placebo) in eight healthy volunteers. The primary objective of the study was to evaluate the safety and tolerability of DF-003, as well as its pharmacokinetic properties. Key Results Safety: DF-003 was safe at all doses tested with no serious adverse events described. Rates of treatment emergent adverse events (TEAEs) were similar between active and placebo-treated participants, and no TEAEs required dose modification or interruption. Pharmacokinetics: The pharmacokinetic profile of DF-003 was largely dose proportional and the data support additional clinical trials as a once-daily, orally administered drug. 'We are happy to share the results from our Phase 1 study that demonstrate the excellent safety of DF-003,' said Neil Solomons, MD, Head, Clinical Development at Drug Farm. 'We are also pleased that the pharmacokinetic profile of DF-003 leads to trough concentrations in blood that are consistent with efficacy in preclinical models of ROSAH syndrome and cardio-renal disease. The dose ranges explored in this Phase 1 trial will be used in our upcoming proof of concept trials in ROSAH syndrome and cardio-renal disease patient populations.' 'This is a major inflection point for Drug Farm in our quest to advance DF-003, a first-in-class, immune-modulating drug that precision targets the disease-causing mutations of ROSAH syndrome, as well as the excessive activation of the ALPK1 pathway found in cardio-renal disease,' said Henri Lichenstein, PhD, Chief Executive Officer at Drug Farm. 'There are no approved drugs for ROSAH syndrome, and we are excited about the potential of DF-003 to save sight and to ameliorate other debilitating inflammatory symptoms associated with this disease.' About DF-003 DF-003 is a proprietary, first-in-class drug developed by Drug Farm that inhibits the activity of ALPK1 and variants of ALPK1 which cause ROSAH syndrome. DF-003 has therapeutic potential for ROSAH syndrome and cardio-renal disease as the drug has shown efficacy in preclinical models of these disease indications. DF-003 has completed a Phase 1 clinical trial (NCT05997641) in normal healthy volunteers and is now accruing patients with ROSAH syndrome in a Phase 1b trial (NCT06395285). About ROSAH Syndrome ROSAH (retinal dystrophy, optic nerve edema, splenomegaly, anhidrosis and headache) syndrome is a rare, autosomal dominant autoinflammatory genetic disease named according to the characteristic symptoms exhibited by affected patients (1, 2). Disease-causing mutations in ALPK1 lead to ROSAH syndrome. The most common presenting symptom is a progressive decline in visual acuity that typically begins before 20 years of age, with ophthalmologic examination often revealing optic disc elevation, uveitis, and retinal nerve degeneration (2, 3). Most ROSAH patients also exhibit inflammatory features such as non-infectious low-grade fevers, arthralgia, headaches, and persistently elevated levels of inflammatory cytokines including tumor necrosis factor-α (TNFα), interleukin-6 (IL-6), and IL-1β (3). 1. Tantravahi SK, et al. An inherited disorder with splenomegaly, cytopenias, and vision loss. Am J Med Genet A. 2012;158(3):475-81. 2. Williams LB, et al. ALPK1 missense pathogenic variant in five families leads to ROSAH syndrome, an ocular multisystem autosomal dominant disorder. Genet Med. 2019;21(9):2103-15. 3. Kozycki CT, et al. Gain-of-function mutations in ALPK1 cause an NF-κB-mediated autoinflammatory disease: functional assessment, clinical phenotyping and disease course of patients with ROSAH syndrome. Ann Rheum Dis. 2022;81(10):1453-64. About Drug Farm Drug Farm is a private biotechnology Company developing innovative treatments targeting innate immunity for hepatitis B, heart and kidney diseases, and ROSAH (retinal dystrophy, optic nerve edema, splenomegaly, anhidrosis and headache) syndrome. Drug Farm's unique IDInVivo platform combines breakthrough technologies in genetics and AI to discover new treatments. IDInVivo technology allows the direct assessment of gene targets in living animals with intact immune systems. Using the IDInVivo platform, Drug Farm has identified novel innate immunity pathways and targets and is now rapidly advancing multiple first-in-class drug candidates into clinical development. For more information please visit:
Associated Press
12-05-2025
- Business
- Associated Press
Circle Pharma to Present Trials in Progress Poster on CID-078, a First-in-Class Cyclin A/B Inhibitor, at the ASCO 2025 Annual Meeting
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--May 12, 2025-- Circle Pharma, a clinical-stage biopharmaceutical company advancing macrocycle therapeutics for difficult-to-treat cancers, today announced that its Trials in Progress abstract has been selected for poster presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 30 to June 3 in Chicago. The poster will showcase the design and ongoing progress of its Phase 1 study of CID-078 (NCT06577987), a first-in-class, oral macrocycle cyclin A/B RxL inhibitor. The abstract will be featured in a Poster Session focused on Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology, under the New Targets and New Technologies (non-IO) subtrack. Poster Presentation Details: Abstract Title:A phase 1 study to evaluate the safety, pharmacokinetics, and efficacy of the first-in-class cyclin A/B RxL inhibitor CID-078, an orally bioavailable, cell-permeable macrocycle First Author: Nehal Lakhani, MD, PhD, The START Center for Cancer Research, Grand Rapids, MI Abstract Number: TPS3175 Poster Board Number: 481a Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology Date & Time: June 2, 2025, from 1:30 PM – 4:30 PM CDT 'CID-078 exemplifies Circle Pharma's commitment to advancing new treatments for patients with cancer,' said Michael C. Cox, PharmD, MHSc, BCOP, SVP, and head of early development of Circle Pharma. 'CID-078 has shown strong single-agent activity in tumor models with dysregulated cell cycle pathways, where activity has been linked to specific molecular features such as RB1 mutations and high E2F pathway scores. We believe CID-078 has the potential to be a new treatment option for patients with solid tumors such as small-cell lung cancer or triple-negative breast cancer which are known to harbor these alterations, or solid tumors harboring an RB mutation identified through comprehensive genomic profiling. We are encouraged by the progress of the CID-078 phase 1 study, and we're excited to share early clinical insights at ASCO 2025.' Contributing Authors: William McKean, Ildefonso Rodriguez Rivera, Antonio Giordano, Timothy Yap, Afshin Dowlati, Vivek Subbiah, Judy Wang, Manali Bhave, Kyaw Thein, Jinshu Fang, Eric Connor, Li-Fen Liu, Peadar Cremin, Lukas Makris, Li-Pen Tsao, Lisa Kopp, Michael Cox, and Shivaani Kummar. About CID-078, Circle Pharma's Cyclin A/B RxL Inhibitor Program CID-078 is an orally bioavailable macrocycle with dual cyclin A and B RxL inhibitory activity that selectively targets tumor cells with oncogenic alterations that cause cell cycle dysregulation. In biochemical and cellular studies, Circle Pharma's cyclin A/B RxL inhibitors have been shown to potently and selectively disrupt the protein-to-protein interaction between cyclins A and B and their key substrates and modulators, including E2F (a substrate of cyclin A) and Myt1 (a modulator of cyclin B). Preclinical studies have demonstrated the ability of these cyclin A/B RxL inhibitors to cause single-agent tumor regressions in multiple in vivo models. A multi-center phase 1 clinical trial ( NCT06577987 ) is currently enrolling patients. About Circle Pharma, Inc. South San Francisco-based Circle Pharma is a clinical-stage biopharmaceutical company harnessing the power of macrocycles to develop therapies for cancer and other serious illnesses. The company's proprietary MXMO™ platform overcomes key challenges in macrocycle drug development, enabling the creation of intrinsically cell-permeable and orally bioavailable therapies for historically undruggable targets. Circle Pharma's pipeline is focused on targeting cyclins, key regulators of the cell cycle that drive many cancers. Its lead program, CID-078, a cyclin A/B-RxL inhibitor, is in a Phase 1 clinical trial (NCT06577987) for patients with advanced solid tumors. To learn more about Circle Pharma, please visit View source version on CONTACT: Media Contact: Roslyn Patterson Phone:650.825.4099 Email:[email protected] KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA ILLINOIS INDUSTRY KEYWORD: ONCOLOGY PROFESSIONAL SERVICES HEALTH VENTURE CAPITAL CLINICAL TRIALS PHARMACEUTICAL BIOTECHNOLOGY SOURCE: Circle Pharma Copyright Business Wire 2025. PUB: 05/12/2025 07:05 AM/DISC: 05/12/2025 07:05 AM
