OARSI

Pacira BioSciences Announces PCRX-201 Granted Regenerative Medicine Advance Therapy (RMAT) Designation for the Treatment of Osteoarthritis of the Knee

Retrieved on: 
Wednesday, March 13, 2024
Knee, Congress, Biologics license application, Patient, ATMP, Research, World Congress, OARSI, European Medicines Agency, WOMAC, Osteoarthritis Research Society International, KOOS, Drug development, Safety, Pain, Vasopressin receptor 2, DVD-Audio, Food, Osteoarthritis, FDA, BLA, Pharmaceutical industry

TAMPA, Fla., March 13, 2024 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to PCRX-201 (enekinragene inzadenovec), the company’s novel, intra-articular helper-dependent adenovirus (HDAd) gene therapy product candidate that codes for interleukin-1 receptor antagonist (IL-1Ra), for the treatment of osteoarthritis of the knee.

Key Points: 
  • PCRX-201 was well tolerated, with efficacy observed through at least 52 weeks at all doses and cohorts.
  • Preliminary 36-week data were presented at the Osteoarthritis Research Society International (OARSI) 2023 World Congress, the premier annual international forum in osteoarthritis research and treatment.
  • The 52-week data have been accepted for presentation at OARSI 2024 taking place in Vienna, Austria in April 2024 and the company expects to present 104-week efficacy and safety data later this year.
  • PCRX-201 was also granted Advanced Therapy Medicinal Products (ATMP) designation by the European Medicines Agency in May 2023.

Xalud Therapeutics Presents Clinical Data on XT-150 in Knee Osteoarthritis at the 2023 Osteoarthritis Research Society International World Congress

Retrieved on: 
Monday, March 20, 2023
Gait analysis, DNA, Plasmid, Orthopaedic Research Society, Journal of Orthopaedic Research, Osteoarthritis, ROM, Gait, Interleukin, Preferred walking speed, Ageing, MBA, Inflammation, Fritz Köberle, Walking, Homeostasis, OA, Congress, Patient, Immune system, OARSI, World Congress, Therapy, Arnold, Osteoarthritis Research Society International, Shipbuilding, Pharmaceutical industry, Medical imaging

NEW YORK, March 20, 2023 (GLOBE NEWSWIRE) -- Xalud Therapeutics, a clinical-stage biotechnology company developing novel non-viral gene therapies to treat pathologic inflammation, today announced pooled gait data from a world-renowned gait laboratory in Adelaide, Australia, which served as a study site for two studies of lead candidate XT-150 in patients with knee osteoarthritis (OA). XT-150 is a locally injectable plasmid DNA (pDNA)-delivered gene therapy expressing IL-10v, a proprietary modified version of interleukin-10 (IL-10), which Xalud is evaluating across a broad range of chronic inflammatory diseases in clinical and preclinical studies.

Key Points: 
  • The results demonstrate a positive signal supporting the use of XT-150 as a potential effective treatment in knee OA with the goal of improving joint function.
  • The data were presented in a poster presentation titled “Functional improvements in knee kinematics during walking gait over six months following treatment with XT-150: pooled results from two clinical trials” at the 2023 Osteoarthritis Research Society International (OARSI) World Congress.
  • We believe that this supplements the body’s own IL-10 activity and may restore immune system homeostasis in chronic inflammatory diseases such as knee OA.
  • Xalud has included gait analysis as part of its multi-study development program to provide functional assessment in addition to patient reported outcomes.

New data by AKL Therapeutics suggests investigational oral osteoarthritis drug APPA may have a promising senotherapeutic effect with potential in other diseases of ageing

Retrieved on: 
Monday, March 20, 2023
Immortalised cell line, COPD, Osteoarthritis, Osteoporosis, Disease, Arthropathy, Woman, Cartilage, Research, APPA, Biomedical Research, Inflammation, Cell, Chronic obstructive pulmonary disease, AKL, Pain, Degenerative disease, Knee, Cellular senescence, Patent, Patient, Senescence, Parkinson's disease, Joint, OARSI, Alzheimer's disease, World Congress, Therapy, Notifiable disease, Osteoarthritis Research Society International, Frailty, Pharmaceutical industry, OA

STEVENAGE, England, March 20, 2023 /PRNewswire/ -- New data* presented at the 2023 Osteoarthritis Research Society International (OARSI) World Congress in Denver, Colorado (March 17th-20th) suggest that AKL Therapeutics' investigational oral osteoarthritis (OA) drug APPA** may have a dual effect on senescence1 – a process in which cells stop dividing as a natural consequence of ageing.2 Senescence plays a major role in the development of many age-related diseases, including osteoarthritis (OA).3

Key Points: 
  • STEVENAGE, England, March 20, 2023 /PRNewswire/ -- New data* presented at the 2023 Osteoarthritis Research Society International (OARSI) World Congress in Denver, Colorado (March 17th-20th) suggest that AKL Therapeutics' investigational oral osteoarthritis (OA) drug APPA** may have a dual effect on senescence1 – a process in which cells stop dividing as a natural consequence of ageing.2 Senescence plays a major role in the development of many age-related diseases, including osteoarthritis (OA).3
    The study, using a human chondrocyte (cartilage-forming) cell line, was carried out at the Institute of Biomedical Research of A Coruña (INIBIC) in Spain.1 It found that APPA appears to not only reduce the number of harmful senescent cells which build up in the cartilage causing inflammation (a 'senolytic' effect), but could also potentially reverse the senescence process so cells can function normally again (a 'senomorphic' effect).1,4
    Alan Reynolds, Chief Scientific Officer at AKL Therapeutics, says: "These latest findings raise the tantalising possibility that APPA could modify the progression of debilitating OA for patients by eliminating or delaying the adverse effects of cellular senescence and the process of ageing.3
    "Frailty and mobility issues have a significant impact as we age, often leading to people living many years in pain and ill health.5,6 If we can reduce senescence, which contributes to joint damage in OA7 and is involved in many other age-related diseases, we can hopefully help improve peoples' healthspan, so they age in better physical and mental health.
  • "8
    As we age, dysfunctional senescent cells – often dubbed "zombie" cells – build up in the body while secreting harmful chemicals which cause inflammation and damage surrounding tissue – a process known as senescence.2 They have become one of the most promising targets for healthy ageing research as senescence is now known to play a major role in the development of many age-related diseases, including OA, Chronic Obstructive Pulmonary Disease (COPD), Alzheimer's Disease, Parkinson's Disease, osteoporosis, and diabetes.9
    Developing a new class of drugs called senotherapeutics to eliminate or delay the damaging effects of this cellular senescence is a new frontier in medicine.10 Senotherapeutics have the potential to increase healthspan by delaying the worse effects of ageing, which would reduce the burden of age-related diseases and could save healthcare systems billions every year.11
    David Miles, Chief Executive Officer at AKL Therapeutics, says: "With a unique mechanism of action,12-15 APPA is the only oral drug that targets the multiple signalling pathways in bone, cartilage and inflammation involved in OA, delivering pain relief to multiple joints.
  • With this latest data now showing that APPA has a potential senomorphic effect, we've recently filed a patent application and will look to carry out further studies on other senescence-related diseases to investigate its potential as a senotherapeutic."
  • APPA is an oral, patented, fixed-dose combination of two synthetically produced, synergistic, secondary metabolites of plant origin.16,17Previous human clinical trials have shown that APPA has a good safety profile, is well-tolerated and reduces pain in OA.18,19 Importantly, it has been shown to reduce levels of cartilage-damaging enzymes and levels of bone destruction.13-15 The Phase 2a trial found that those with more severe disease benefited most from APPA with a statistically significant improvement in pain vs placebo.18
    There are currently no effective and well tolerated oral therapies that provide long-term pain relief or reduce the progression of OA, a common, debilitating, degenerative disease of the joints involving the cartilage, bone, and its surrounding tissues.22 OA is the most common joint disease worldwide, affecting an estimated 10% of men and 18% of women over 60 years of age.23 Globally, the prevalent cases of OA increased by 113.25%, from 247.51 million in 1990 to 527.81 million in 2019, with OA of the knee contributing most to the overall burden.24

New data by AKL Therapeutics suggests investigational oral osteoarthritis drug APPA may have a promising senotherapeutic effect with potential in other diseases of ageing

Retrieved on: 
Monday, March 20, 2023
Immortalised cell line, COPD, Osteoarthritis, Osteoporosis, Disease, Arthropathy, Woman, Cartilage, Research, APPA, Biomedical Research, Inflammation, Cell, Chronic obstructive pulmonary disease, AKL, Pain, Degenerative disease, Knee, Cellular senescence, Patent, Patient, Senescence, Parkinson's disease, Joint, OARSI, Alzheimer's disease, World Congress, Therapy, Notifiable disease, Osteoarthritis Research Society International, Frailty, Pharmaceutical industry, OA

STEVENAGE, England, March 20, 2023 /PRNewswire/ -- New data* presented at the 2023 Osteoarthritis Research Society International (OARSI) World Congress in Denver, Colorado (March 17th-20th) suggest that AKL Therapeutics' investigational oral osteoarthritis (OA) drug APPA** may have a dual effect on senescence1 – a process in which cells stop dividing as a natural consequence of ageing.2 Senescence plays a major role in the development of many age-related diseases, including osteoarthritis (OA).3

Key Points: 
  • STEVENAGE, England, March 20, 2023 /PRNewswire/ -- New data* presented at the 2023 Osteoarthritis Research Society International (OARSI) World Congress in Denver, Colorado (March 17th-20th) suggest that AKL Therapeutics' investigational oral osteoarthritis (OA) drug APPA** may have a dual effect on senescence1 – a process in which cells stop dividing as a natural consequence of ageing.2 Senescence plays a major role in the development of many age-related diseases, including osteoarthritis (OA).3
    The study, using a human chondrocyte (cartilage-forming) cell line, was carried out at the Institute of Biomedical Research of A Coruña (INIBIC) in Spain.1 It found that APPA appears to not only reduce the number of harmful senescent cells which build up in the cartilage causing inflammation (a 'senolytic' effect), but could also potentially reverse the senescence process so cells can function normally again (a 'senomorphic' effect).1,4
    Alan Reynolds, Chief Scientific Officer at AKL Therapeutics, says: "These latest findings raise the tantalising possibility that APPA could modify the progression of debilitating OA for patients by eliminating or delaying the adverse effects of cellular senescence and the process of ageing.3
    "Frailty and mobility issues have a significant impact as we age, often leading to people living many years in pain and ill health.5,6 If we can reduce senescence, which contributes to joint damage in OA7 and is involved in many other age-related diseases, we can hopefully help improve peoples' healthspan, so they age in better physical and mental health.
  • "8
    As we age, dysfunctional senescent cells – often dubbed "zombie" cells – build up in the body while secreting harmful chemicals which cause inflammation and damage surrounding tissue – a process known as senescence.2 They have become one of the most promising targets for healthy ageing research as senescence is now known to play a major role in the development of many age-related diseases, including OA, Chronic Obstructive Pulmonary Disease (COPD), Alzheimer's Disease, Parkinson's Disease, osteoporosis, and diabetes.9
    Developing a new class of drugs called senotherapeutics to eliminate or delay the damaging effects of this cellular senescence is a new frontier in medicine.10 Senotherapeutics have the potential to increase healthspan by delaying the worse effects of ageing, which would reduce the burden of age-related diseases and could save healthcare systems billions every year.11
    David Miles, Chief Executive Officer at AKL Therapeutics, says: "With a unique mechanism of action,12-15 APPA is the only oral drug that targets the multiple signalling pathways in bone, cartilage and inflammation involved in OA, delivering pain relief to multiple joints.
  • With this latest data now showing that APPA has a potential senomorphic effect, we've recently filed a patent application and will look to carry out further studies on other senescence-related diseases to investigate its potential as a senotherapeutic."
  • APPA is an oral, patented, fixed-dose combination of two synthetically produced, synergistic, secondary metabolites of plant origin.16,17 Previous human clinical trials have shown that APPA has a good safety profile, is well-tolerated and reduces pain in OA.18,19 Importantly, it has been shown to reduce levels of cartilage-damaging enzymes and levels of bone destruction.13-15 The Phase 2a trial found that those with more severe disease benefited most from APPA with a statistically significant improvement in pain vs placebo.18
    There are currently no effective and well tolerated oral therapies that provide long-term pain relief or reduce the progression of OA, a common, debilitating, degenerative disease of the joints involving the cartilage, bone, and its surrounding tissues.22 OA is the most common joint disease worldwide, affecting an estimated 10% of men and 18% of women over 60 years of age.23 Globally, the prevalent cases of OA increased by 113.25%, from 247.51 million in 1990 to 527.81 million in 2019, with OA of the knee contributing most to the overall burden.24

ConcertAI's TeraRecon Inks Distribution Deals with Seven AI Developers Alongside EU Launch of Eureka Clinical AI Platform at #ECR23

Retrieved on: 
Monday, February 27, 2023
Cardiology, Coronary artery disease, Neuro, Doctor of Philosophy, Traumatic brain injury, Workflow, ECR, OARSI, Partnership, Biomarker, Intuition, EMR, Algorithm, Radiology, HL7, Neurology, MRI, PACS, AI, Dementia, Multiple sclerosis, LAA, Skeleton, Osteoarthritis, Perfusion, KL, CE, Lung cancer, Fracture, Biometrics, Medical device, Medical imaging, Epilepsy, EU

CAMBRIDGE, Mass., Feb. 27, 2023 /PRNewswire/ -- ConcertAI's TeraRecon, advanced visualization and AI Clinical SaaS category leader, has announced its Eureka Clinical AI platform is now available to European healthcare providers. The company initiated distribution agreements with seven leading CE-marked AI software developers —Cercare Medical, Combinostics, Coreline Soft, Imaging Biometrics (CE pending), Infervision, Radiobotics, and Riverain Technologies. Eureka Clinical AI is now one of the leading unified solutions for clinical AI algorithms in Europe, providing clinical and diagnostic benefits across radiology, neurology, oncology, pulmonology, and cardiology.

Key Points: 
  • The leading open Clinical AI platform allows users to develop and deploy their own AI algorithms and leverage third-party AI algorithms within existing clinical workflows.
  • CAMBRIDGE, Mass., Feb. 27, 2023 /PRNewswire/ -- ConcertAI's TeraRecon, advanced visualization and AI Clinical SaaS category leader, has announced its Eureka Clinical AI platform is now available to European healthcare providers.
  • Eureka Clinical AI is now one of the leading unified solutions for clinical AI algorithms in Europe, providing clinical and diagnostic benefits across radiology, neurology, oncology, pulmonology, and cardiology.
  • While the Eureka Clinical AI platform is centered around clinical users, we also understand the need to quickly and easily onboard partners and vendor-agnostic algorithms.