In this phase 1/2 trial, 4 cohorts of 10 healthy volunteers received escalating doses of ciraparantag (100 to 300mg) or placebo (8:2 ratio) approximately 4h after a single subcutaneous dose of enoxaparin, 1.5mg/kg. Safety, pharmacokinetic and pharmacodynamic effects were assessed.

RESULTS:

Complete reversal of enoxaparin anticoagulation, measured by a reduction of whole blood clotting time, was observed in all subjects who received a single ciraparantag dose ranging from 100mg to 300mg. The anticoagulation reversal occurred rapidly after bolus injection and persisted for the duration of the study. At 12h and 24h, the differences in whole blood clotting time in the treated group compared to placebo were no longer significant, consistent with the decline in enoxaparin concentrations and anticoagulation effects. No procoagulant signals were detected as measured by D-dimer, F1.2, and tissue factor pathway inhibitor levels. Ciraparantag was well tolerated with only transient, minor side effects.

CONCLUSION:

Ciraparantag reverses the whole blood clotting time induced by enoxaparin in a dose related manner and produces no procoagulant signal or deleterious adverse events in doses up to 300mg.

2015-07-01·International journal of toxicology4区 · 医学

Nonclinical Safety Assessment of PER977

4区 · 医学

Article

作者: Laulicht, Bryan ; Bakhru, Sasha ; Gad, Shayne C. ; Sullivan, Dexter W. ; Steiner, Solomon

A new molecular entity, PER977 (di-arginine piperazine), is in clinical development as an anticoagulant reversal agent for new oral anticoagulants and heparins. The good laboratory practices (GLP)-compliant studies were conducted to evaluate the toxicity of PER977 and its primary metabolite, 1,4-bis(3-aminopropyl)piperazine (BAP). PER977 and BAP were negative for systemic toxicity in dogs and rats. PER977 was rapidly eliminated from the blood with little to no accumulation. PER977 was negative for genotoxicity and did not alter neurological, respiratory, or cardiovascular function. Maximum tolerated doses for PER977 were 40 (rat) and 35 mg/kg (dog), and greater than 80 mg/kg (rat) for BAP. The no observable adverse effect level (NOAEL) for 14-day intravenous exposure to both rats and dogs was 20 mg/kg/d. For BAP, the NOAELs for 14-day intravenous exposure to rats and dogs were 5 and 20 mg/kg, respectively. Based on these results, a safe and conservative dose level of 19.4 mg/d was used for the PER977 first in human study.

2015-06-01·American heart journal2区 · 医学

Novel oral anticoagulants and reversal agents: Considerations for clinical development

2区 · 医学

Article

作者: Reilly, Paul A ; Krucoff, Mitchell W ; Berkowitz, Scott D ; Sager, Philip T ; Hoffman, Maureane ; Weitz, Jeffrey I ; Curnutte, John T ; Stockbridge, Norman ; Kowey, Peter R ; Sarich, Troy C ; Levy, Jerrold H ; Kaminskas, Edvardas ; Singer, Daniel E ; Gibson, C Michael ; Mintz, Paul D ; Seltzer, Jonathan H ; Costin', James

This white paper provides a summary of presentations and discussions that were held at an Anticoagulant-Induced Bleeding and Reversal Agents Think Tank co-sponsored by the Cardiac Safety Research Consortium and the US Food and Drug Administration (FDA) at the FDA's White Oak Headquarters on April 22, 2014. Attention focused on a development pathway for reversal agents for the novel oral anticoagulants (NOACs). This is important because anticoagulation is still widely underused for stroke prevention in patients with atrial fibrillation. Undertreatment persists, although NOACs, in general, overcome some of the difficulties associated with anticoagulation provided by vitamin K antagonists. One reason for the lack of a wider uptake is the absence of NOAC reversal agents. As there are neither widely accepted academic and industry standards nor a definitive regulatory policy on the development of such reversal agents, this meeting provided a forum for leaders in the fields of cardiovascular clinical trials and cardiovascular safety to discuss the issues and develop recommendations. Attendees included representatives from pharmaceutical companies; regulatory agencies; end point adjudication specialist groups; contract research organizations; and active, academically based physicians. There was wide and solid consensus that NOACs overall offer improvements in convenience, efficacy, and safety compared with warfarin, even without reversal agents. Still, it was broadly accepted that it would be helpful to have reversal agents available for clinicians to use. Because it is not feasible to do definitive outcomes studies demonstrating a reversal agent's clinical benefits, it was felt that these agents could be approved for use in life-threatening bleeding situations if the molecules were well characterized preclinically, their pharmacodynamic and pharmacokinetic profiles were well understood, and showed no harmful adverse events in early human testing. There was also consensus that after such approval, efforts should be made to augment the available clinical information until such time as there is a body of evidence to demonstrate real-world clinical outcomes with the reversal agents. No recommendations were made for more generalized use of these agents in the setting of non-life-threatening situations. This article reflects the views of the authors and should not be construed to represent FDA's views or policies.

项与 Perosphere, Inc. 相关的新闻（医药）

2024-09-25

·Business Wire

Perosphere Technologies to Deliver Oral Presentation & Posters on Point-of-Care Coagulometer at ADLM International CPOCT Symposium

DANBURY, Conn.--( BUSINESS WIRE )--Perosphere (Perosphere Technologies Inc.), a private medical technologies company focused on developing next-generation coagulation diagnostics, today announced its participation on the agenda of the 29th ADLM International Critical & Point of Care Testing (CPOCT) Symposium, held September 25-27, 2024 in San Diego, CA. Perosphere CEO Dr. Sasha Bakhru will deliver an oral presentation highlighting the accuracy and effectiveness of measuring the Whole Blood Clotting Time (WBCT) with the company’s novel point-of-care coagulometer, Perosphere ClotChek™, for patients on direct oral anticoagulants (DOACs) compared to normal, non-medicated individuals. An additional featured poster describes the in vitro validation of Perosphere ClotChek. “We are thankful to ADLM for convening this symposium to highlight the latest innovations in critical and point-of-care testing,” said Sasha Bakhru, PhD, CEO of Perosphere. “We are proud to present data on our novel point-of-care coagulometer, Perosphere ClotChek, that can address a significant unmet need as designed with sensitivity for patients on DOACs at risk for bleeding.” The details of the presentations are as follows: Oral Presentation Selected as one of the top research abstracts at the symposium, Dr. Bakhru will highlight results from a study characterizing the response of the Perosphere ClotChek coagulometer to DOAC-induced anticoagulation in whole blood samples from DOAC patients at peak anticoagulation and at minimal anticoagulation, with comparison to ClotChek results in normal, non-medicated subjects. Oral Poster Presentation Title: Clinical Performance of a Novel Point-of-Care Coagulometer for the DOACs Presenter: Sasha Bakhru, PhD, CEO, Perosphere Presentation Date: September 26, 2024 Presentation Time: 3:15 - 3:30 pm Dr. Bakhru will detail the observed sensitivity of Perosphere ClotChek WBCT versus other comparator measures, as well as strong linear correlation for clotting time versus drug concentration, and high precision of the instrument. Scientific Posters on Display Perosphere will feature two posters among the 32 total on display at the conference, including the oral presentation poster and a poster describing the evaluation of the point-of-care coagulometer for accuracy, linearity, and precision utilizing venous whole blood and liquid quality controls. Poster Title: Accuracy and Precision Evaluation of a Novel Point-of-Care Coagulometer for the DOACs Author: Dardan Osmani, MS, MBA, Director of Technical Operations, Perosphere Together, the data to be presented at the ADLM International CPOCT Symposium serves to illustrate that Perosphere ClotChek, a novel point-of-care coagulometer, demonstrates encouraging performance in accurately and precisely measuring the pharmacodynamic effects of DOACs, delivering results within 3-8 minutes and requiring only a single drop of fresh whole blood from a venous blood draw. For more information about the 29 th ADLM International CPOCT Symposium, visit https://www.myadlm.org/meetings-and-events/international-cpoct-symposium . About Perosphere Technologies Perosphere Technologies is changing the way decisions are made at the point of care in hospitals and outpatient clinics for patients at risk for bleeding. A private medical technologies company, Perosphere is focused on development and commercialization of Perosphere ClotChek TM , a novel PoC (point-of-care) Coagulometer, which quickly informs diagnosis, treatment, and prevention decisions through precision data, made immediately accessible to all. This novel PoC diagnostic instrument effectively and swiftly measures Whole Blood Clotting Times (WBCT) with a high degree of sensitivity appropriate for several drug classes, including the Direct Oral Anticoagulants (DOACs). Perosphere ClotChek serves to help establish a new standard of care for patients on anticoagulant therapies or at risk for bleeding, and has the potential to improve efficiency, provide significant cost savings, and support better patient outcomes. Perosphere ClotChek is CE Marked in the European Union and has not been subject to a FDA pre-market approval nor 510(k) cleared in the United States. For further information, contact us at info@perospheretech.com or +1 (475) 218-4600. www.perospheretech.com

2024-07-25

·Business Wire

Perosphere Technologies and CoRRect Medical Sign Distribution Agreement for Point-of-Care Coagulometer in Germany

DANBURY, Conn.--( BUSINESS WIRE )--Perosphere (Perosphere Technologies Inc.), a private medical technologies company focused on developing next-generation coagulation diagnostics, today announced that it has signed an agreement with CoRRect Medical GmbH, a leading medical device distributor, for the exclusive distribution of Perosphere’s Point-of-Care (PoC) Coagulometer in Germany. With this agreement, Perosphere’s PoC Coagulometer will become available for the first time to hospitals and healthcare professionals in Germany, where annual anticoagulant prescription rates per 100,000 persons increased by 135.8% between 2005 and 2016. 1 The PoC Coagulometer is a novel pharmacodynamic, reagent-free diagnostic instrument for use at the point of care, i.e., bedside to deliver rapid diagnosis of coagulation status and direct informed treatment decision-making in hospital settings and outpatient clinics supporting medical management of patients on anticoagulant therapies, including the Direct Oral Anticoagulants (DOACs). “We are eager to partner with CoRRect Medical to introduce Perosphere’s PoC Coagulometer in Germany, addressing the unmet medical need in coagulation testing and management to help improve patient outcomes and reduce associated costs,” said Daryl Mootoo, Chief Operating Officer of Perosphere. “CoRRect Medical has outstanding expertise in understanding the needs of healthcare professionals to provide solutions that can integrate seamlessly into practice.” CoRRect Medical specializes in the commercialization and distribution of high-quality and innovative medical devices for cardiology, vascular surgery, and cardiac surgery in Germany and across Europe. CoRRect Medical operates under Uniphar Medtech, a European medical device distributor with a presence across 21 markets. Within the Uniphar Medtech family of businesses, Perosphere also has an exclusive agreement with M3 Medical for the distribution of the PoC Coagulometer in Ireland. “We are inspired by Perosphere’s medical innovation and proud to be entrusted as its exclusive partner to bring this point-of-care, DOAC-sensitive coagulation testing device to the health system in Germany,” said Michael Braun, Chief Executive Officer of CoRRect Medical. Mr. Braun added, “The PoC Coagulometer will fill a critical diagnostic void for healthcare professionals and help improve care outcomes for patients.” About Perosphere Technologies Perosphere Technologies is changing the way decisions are made at the point-of-care in hospitals and outpatient clinics for patients at risk for bleeding. A private medical technologies company, Perosphere is focused on development and commercialization of the novel PoC (point-of-care) Coagulometer, which quickly informs diagnosis, treatment, and prevention decisions through precision data, made immediately accessible to all. It is the only PoC diagnostic instrument that effectively and swiftly tests clotting times across drug classes, including the Direct Oral Anticoagulants (DOACs). The PoC Coagulometer serves to help establish a new standard of care for patients on anticoagulant therapies or at risk for bleeding, and has the potential to improve efficiency, provide significant cost savings, and support better patient outcomes. The PoC Coagulometer has a CE Mark in the European Union and is not FDA-cleared in the United States. For further information, contact us at info@perospheretech.com or +1 (475) 218-4600. www.perospheretech.com About CoRRect Medical GmbH CoRRect Medical GmbH specializes in the commercialization and distribution of high-quality and innovative medical devices for cardiology, vascular surgery and cardiac surgery using minimally invasive procedures. CoRRect Medical GmbH’s commitment to innovative technologies brings medical progress to patients, saving their lives and increasing their quality of life. Our aim is to find new products which help patients in case of illness and offer treating physicians procedural optimization. The CoRRect Medical team has been introducing new innovative technologies into Germany, Switzerland and the EU over the last 30 years. For more information, visit https://correctmedical.com/en/home-en/ . 1 Guelker, J. et al. Increasing use of anticoagulants in Germany and its impact on hospitalization for gastrointestinal bleeding. Thrombosis Research , 181, 2019, 135-140. https://doi.org/10.1016/j.thromres.2019.07.009 .

诊断试剂

2023-09-19

·BioSpace

Perosphere Technologies Awarded Federal Grants for Point-of-Care Coagulometer

NHLBI/NIH and ACME POCT/NIH Award Prestigious Grants to Perosphere Technologies to Enhance Novel Broad-Spectrum Point-of-Care Coagulometer DANBURY, Conn.--(BUSINESS WIRE)-- Perosphere Technologies (Perosphere Technologies Inc.), a private medical technologies company focused on developing coagulation diagnostics, has today announced the receipt of two prestigious federal grants: a Direct Phase II Small Business Innovation Research (SBIR) grant from the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), and a subaward through an Atlanta Center for Microsystems Engineered Point-of-Care Technologies (ACME POCT) Center Grant, funded by the National Institute of Biomedical Imaging and Bioengineering (NIBIB/NIH). The grants, totaling over $2MM, will fund the further development and commercialization of a novel point-of-care (PoC) coagulometer, known as the Perosphere Technologies POC Coagulometer. “We are very honored to receive these grants from NIH and ACME POCT, as they will present a unique opportunity to further expand our groundbreaking point-of-care coagulation diagnostics technology,” said Dr. Stefan Zappe, Principal Investigator and Chief Technology Officer at Perosphere Technologies. “Perosphere Technologies aims to revolutionize coagulation testing by providing healthcare professionals with accurate and timely results.” “The potential applications of the Perosphere Technologies PoC Coagulometer will greatly expand thanks to these grant awards, accelerating our understanding of disease mechanisms and therapeutic approaches,” said Dr. Sasha Bakhru, CEO of Perosphere Technologies. “We are proud of the work and research that have gone into creating this device. By providing physicians with the tools to make faster, better-informed treatment decisions, our technology has strong potential to significantly enhance patient care.” The device’s portability and versatility make it well-suited for emergency room and emergency vehicle use, as well as for routine care in inpatient and outpatient settings including hospitals, clinics, surgical suites, doctor’s offices, and pharmacies. About Perosphere Technologies Perosphere Technologies is changing the way decisions are made for patients at risk for bleeding. A private medical technologies company, Perosphere is focused on development and commercialization of the novel PoC (point-of-care) Coagulometer, which informs diagnosis, treatment, and prevention through precision data, made immediately accessible to all. It is the only point-of-care diagnostic tool that effectively and swiftly tests clotting times across drug classes, including Direct Oral Anticoagulants (DOACs). The fast diagnosis and related appropriate treatment decisions the PoC Coagulometer enables will help establish a new standard of care in hospital emergency departments for patients at risk for bleeding and has the potential to improve efficiency, provide significant cost savings, and better patient outcomes. The PoC Coagulometer has a CE Mark in the EU but is not yet cleared in the US. For further information, contact us at info@perospheretech.com or +1 (475) 218-4600. View source version on businesswire.com: Contacts FOR MORE INFORMATION Laura O’Neill FINN Partners laura.oneill@finnpartners.com +1 402 499 8203 Source: Perosphere Technologies Inc. View this news release online at:

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