POLARIS

AriBio Receives IND Approval from China’s NMPA for POLARIS-AD, a Phase 3 Trial for the Treatment of Early Alzheimer’s Disease

Retrieved on: 
tisdag, maj 14, 2024
Biotechnology, Neurology, Health, Pharmaceutical, Clinical Trials, Patient, CSF, Plasma, Investigational New Drug, NMPA, POLARIS, Polaris, Apoptosis, Mini–Mental State Examination, Clinical trial, Geriatric Depression Scale, IND, Disease, Safety, GDS, ClinicalTrials.gov, Biomarker, Attention, Cerebrospinal fluid, PDE5, CDE, Pharmaceutical industry

The Phase 3 clinical trial will enroll early AD patients at up to 20 clinical trial centers in China with consistent eligibility criteria compared to other countries that are also enrolling patients.

Key Points: 
  • The Phase 3 clinical trial will enroll early AD patients at up to 20 clinical trial centers in China with consistent eligibility criteria compared to other countries that are also enrolling patients.
  • With the inclusion of China, a significant player in the global pharmaceutical market, in the Phase 3 clinical trial development of AR1001, AriBio continues to expand its reach and impact in the fight against Alzheimer's disease.
  • AR1001 is a phosphodiesterase-5 (PDE5) inhibitor being developed as an investigational oral agent for the treatment of Alzheimer’s disease.
  • AR1001-ADP3-US01 ( NCT05531526 ) is a Phase 3 double-blind, randomized, placebo-controlled, multi-center trial evaluating the efficacy and safety of AR1001 in patients with early Alzheimer’s disease.

AriBio Receives EMA Phase 3 Clinical Trial Authorisation for AR1001 in Treatment of Alzheimer’s Disease (POLARIS-AD)

Retrieved on: 
måndag, april 29, 2024
Science, Neurology, Biotechnology, Research, Pharmaceutical, Health, FDA, Clinical Trials, Clinical trial, Safety, Food, Plasma, Mirodenafil, Patient, POLARIS, EMA, GDS, CSF, MHRA, Biomarker, European Medicines Agency, Pharmaceutical industry

AriBio Co., Ltd. (AriBio) announced authorisation from the European Medicines Agency (EMA) for POLARIS-AD (AR1001-ADP3-US01), a global, phase 3, early Alzheimer’s disease clinical trial.

Key Points: 
  • AriBio Co., Ltd. (AriBio) announced authorisation from the European Medicines Agency (EMA) for POLARIS-AD (AR1001-ADP3-US01), a global, phase 3, early Alzheimer’s disease clinical trial.
  • EMA now aligns with the U.S. Food and Drug Administration (FDA) and UK Medicines and Healthcare Products Regulatory Agency (MHRA) on the Clinical Trial Authorisation of POLARIS-AD.
  • The final decision from EMA was completed on April 24th with clinical trial approvals in the following member states: Czech Republic, Denmark, France, Germany, Italy, Spain and The Netherlands.
  • Currently, 1,150 participants are expected to be randomized into the Phase 3 clinical trial across 200 sites globally.

Encoded Therapeutics Announces UK CTA Approval for Dravet Syndrome Gene Therapy Candidate ETX101

Retrieved on: 
måndag, februari 26, 2024
Children, Neurology, Genetics, Clinical Trials, Health Technology, Biotechnology, General Health, Pharmaceutical, Consumer, Health, Royal Hospital, Central nervous system, Health care, Therapy, CNS, POLARIS, MHRA, Dravet syndrome, IND, AAV, CTA, Medication, Pharmaceutical industry

Dravet syndrome is the most common developmental and epileptic encephalopathy and is characterized by a spectrum of clinical symptoms, including treatment-resistant seizures and neurodevelopmental stagnation.

Key Points: 
  • Dravet syndrome is the most common developmental and epileptic encephalopathy and is characterized by a spectrum of clinical symptoms, including treatment-resistant seizures and neurodevelopmental stagnation.
  • The UK CTA for EXPEDITION is part of a global regulatory strategy established by Encoded for clinical development of ETX101, which also includes regulatory clearance for an investigational new drug (IND) application in the United States and approval under the Clinical Trial Approval (CTA) scheme in Australia.
  • “This CTA marks the third regulatory approval for ETX101 as we advance our global clinical development program, POLARIS, to bring this potential one-time AAV gene regulation therapy to people affected by SCN1A+ Dravet syndrome around the world,” said Sal Rico, M.D., Ph.D., Chief Medical Officer of Encoded.
  • EXPEDITION represents a significant stride forward in our collective pursuit of new treatments that can truly make a difference in the lives of people affected by Dravet syndrome."

MHRA Issues Notice of Acceptance for POLARIS-AD, a Phase 3 Early Alzheimer’s Disease Trial Sponsored by AriBio Co., Ltd.

Retrieved on: 
söndag, februari 25, 2024
Nursing, Biotechnology, Practice Management, Health, General Health, Pharmaceutical, Neurology, Other Science, Medical Devices, Science, Clinical Trials, EMA, FDA, Food, Mirodenafil, Amyloid, Safety, Biomarker, European Medicines Agency, GDS, POLARIS, Patient, MHRA, CSF, Clinical trial, Plasma, Medication, Pharmaceutical industry

AriBio Co., Ltd. (AriBio) receives Notice of Acceptance for POLARIS-AD, a Phase 3 early Alzheimer’s disease clinical trial from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom (UK).

Key Points: 
  • AriBio Co., Ltd. (AriBio) receives Notice of Acceptance for POLARIS-AD, a Phase 3 early Alzheimer’s disease clinical trial from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom (UK).
  • The MHRA completed their review on the 21 of February and confirmed a favorable ethical opinion, the Company expects to initiate the clinical trial before the end of Q1’2024 in the UK.
  • POLARIS-AD is a double-blind, randomized, placebo-controlled, multi-center registration trial to evaluate the efficacy and safety of AR1001 (Mirodenafil) over 52 weeks of treatment in patients with early Alzheimer’s disease.
  • “Acceptance of the POLARIS-AD clinical study in the UK is another achievement in the development of AR1001.

UTILITY, INC. ANNOUNCES 2023 YEAR-END RESULTS AND INNOVATIONS

Retrieved on: 
onsdag, februari 21, 2024
Growth, App Store (iOS/iPadOS), Crowdsourcing, POLARIS, FedRAMP, TITAN, Communication, Mobile phone

ATLANTA, Feb. 21, 2024 /PRNewswire/ -- Utility, Inc., the leader in innovative, digital systems tailored for frontline professions, announced the close to its 2023 fiscal year, with annual revenues totaling $60 million, a 38 percent increase over 2022. Increased engagement with an expanded range of law enforcement including hospital, university, public school, and airport security agencies, paired with Utility's ongoing investment in new product offerings and international expansion, contributed to the company's performance. Notable 2023 financial insights include:

Key Points: 
  • Increased engagement with an expanded range of law enforcement including hospital, university, public school, and airport security agencies, paired with Utility's ongoing investment in new product offerings and international expansion, contributed to the company's performance.
  • We look forward to the year ahead and continuing to innovate to meet the growing needs of law enforcement agencies around the world."
  • With the technology, law enforcement gains the ability to capture evidence and enhance investigations through the integration of fixed cameras and mobile applications, along with expanded communication and alert capabilities.
  • Further complementing its strong annual financial results, Utility shared fourth quarter insights with the addition of 12 new agencies to the company's client roster including:

Oricell Announces FDA Clearance of IND Application for OriCAR-017, a novel GPRC5D Targeted CAR-T Cell Therapy Utilizing the Company's Proprietary Platform, for the Treatment of Relapsed/Refractory Multiple Myeloma.

Retrieved on: 
måndag, januari 29, 2024
The Lancet, Hope, CMC, Patient, ISS, MRD, Therapy, GPRC5D, ASCO, EMD, CRS, IND, Food, Multiple myeloma, EHA, FDA, Investigational New Drug, BCMA, POLARIS, NMPA, Pharmaceutical industry

OriCAR-017 is a chimeric antigen receptor (CAR) T cell therapy targeting GPRC5D.

Key Points: 
  • OriCAR-017 is a chimeric antigen receptor (CAR) T cell therapy targeting GPRC5D.
  • The therapy leverages Oricell's proprietary platforms including Ori®Ab antibodies, Ori®CAR construct and unique CMC know-how to achieve optimal binding and superior persistence and anti-tumor efficacy out of rejuvenated CAR-T cells.
  • The IND enables Oricell to initiate the clinical development for OriCAR-017 in the US immediately.
  • "The evidenced superior safety, efficacy and durability profile of OriCAR-017 is truly exciting and will significantly benefit multiple myeloma patients on a global scale.

Utility, Inc. Unveils Major Advancements with POLARIS 7.0

Retrieved on: 
onsdag, januari 24, 2024
EOS, Utility, IP, GPS, AI, Mobile app, Volos, Communication, Integration, DOT, Computer-aided dispatch, Notification, ALPR, CAD, TITAN, POLARIS, Mobile phone

ATLANTA, Jan. 24, 2024 /PRNewswire/ -- Utility, Inc., a leader in technology development for frontline professions, is announcing the launch of POLARIS 7.0, the latest version of its cutting-edge cloud-based incident and evidence management platform. POLARIS 7.0 makes a significant leap forward in functionality, seamlessly connecting incident capture, situational awareness, evidence analysis and secure case sharing, all within a robust and unified platform.

Key Points: 
  • POLARIS 7.0 makes a significant leap forward in functionality, seamlessly connecting incident capture, situational awareness, evidence analysis and secure case sharing, all within a robust and unified platform.
  • Utility's commitment to revolutionary technology continues with the unveiling of POLARIS 7.0, bringing forth enhanced capabilities for observing, collecting, analyzing and sharing digital evidence, from advanced media editing and redaction to comprehensive in-field operational support.
  • Key features of POLARIS 7.0:
    Media Editing and Redaction: Users can now edit and redact media seamlessly, including content from body cameras, in-car video cameras, third-party sources, and citizen-provided evidence.
  • Mobile Application: Utility introduces a mobile application, empowering investigators to work on their cases directly through agency-provided mobile devices.

Latest Data of InnoCare’s Oncology Pipelines Presented at the 65th Annual Meeting of ASH

Retrieved on: 
måndag, december 11, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, HKEX, Rituximab, Lenalidomide, Toxicity, Treatment, Progression-free survival, Lymphoid leukemia, MCL, ASH, Aes, Refractory, Bleeding, Patient, Abstract, PFS, Impact, TLS, POLARIS, MRD, DOR, Pharmacokinetics, OLR, Atrial fibrillation, Medicine, SSE, ORR, Diarrhea, Cancer, Peking Union Medical College, Zhongshan Hospital, Fudan University, CRR, Infrared spectroscopy correlation table, Society, TTR, Relapse, B-cell lymphoma, Hospital, Pharmaceutical industry, Vaccine, Medical imaging, Management, Safety

InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the latest data from InnoCare’s oncology studies were presented at the 65th American Society of Hematology (ASH) Annual Meeting.

Key Points: 
  • InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the latest data from InnoCare’s oncology studies were presented at the 65th American Society of Hematology (ASH) Annual Meeting.
  • The study of orelabrutinib’s regimen in patients with untreated mantle cell lymphoma (MCL) was selected as an oral presentation.
  • The overall response rate (ORR) was 100%, and the complete response rate (CRR) was 76.2%.
  • This retrospective data suggests that orelabrutinib in combination with rituximab has an encouraging anti-tumor activity in MZL, with a favorable safety profile.

AriBio Co., Ltd. Announces Global Expansion of POLARIS-AD, A Phase 3 Early Alzheimer’s Disease Registration Trial

Retrieved on: 
tisdag, november 14, 2023
FDA, Seniors, Neurology, Clinical Trials, Biotechnology, Managed Care, Health, Consumer, Pharmaceutical, Ministry, Safety, Research, European Medicines Agency, MFDS, MMSE, Plasma, MHRA, NMPA, Collection, CSF, EMA, Patient, Cerebrospinal fluid, European, POLARIS, CHMP, Committee, Investigational New Drug, IND, GDS, Biomarker, CTA, Pharmaceutical industry, Food

AriBio Co., Ltd. (AriBio) announces the global expansion of the POLARIS-AD study, a phase 3 early Alzheimer’s disease trial into the European Union, United Kingdom, Korea and China.

Key Points: 
  • AriBio Co., Ltd. (AriBio) announces the global expansion of the POLARIS-AD study, a phase 3 early Alzheimer’s disease trial into the European Union, United Kingdom, Korea and China.
  • The phase 3 study is a double-blind, randomized, placebo-controlled, multi-center registration trial to evaluate the efficacy and safety of AR1001 (mirodenafil dihydrochloride) over 52 weeks of treatment in patients with early Alzheimer’s disease.
  • This global trial by AriBio highlights the regulatory appetite for further research for Alzheimer’s disease and the need for alternative safe and oral therapies compared to the recently FDA approved monoclonal antibodies.
  • AriBio is well positioned and adequately financed to execute on this global expansion”, stated Matthew Choung, Chairman and Chief Executive Officer (CEO) of AriBio.

Greater Sum Ventures Makes Majority Investment in Utility, Inc., a Technology Company for Frontline Professions

Retrieved on: 
måndag, november 13, 2023
Software, Carriers and Services, Mobile, Wireless, Networks, Internet, Hardware, Law Enforcement, Emergency Services, Technology, Homeland Security, Other Technology, Telecommunications, Public Policy, Government, GSV, History, POLARIS, Trust, Documentation, PSG, TITAN, Digital, Partnership, Communication, Growth, Case management, Law enforcement, Financial services, Management, Utility

Entrepreneurial family office and growth equity firm Greater Sum Ventures (GSV) today announced its majority investment in Utility Associates, Inc. (Utility).

Key Points: 
  • Entrepreneurial family office and growth equity firm Greater Sum Ventures (GSV) today announced its majority investment in Utility Associates, Inc. (Utility).
  • Utility is at the forefront of providing innovative, digital systems tailored for frontline professionals such as law enforcement officers and first responders.
  • The funding will provide additional capital to increase Utility’s investment in innovation and help further accelerate its growth.
  • The company meets the ever-increasing demands of frontline professionals and the communities they serve through digital evidence management, in-car video, and advanced body cameras.