Bone disease

Century Therapeutics Presents New Preclinical Data Highlighting iPSC-derived Cell Therapy Platform Technology at the 2024 American Association for Cancer Research (AACR) Annual Meeting

Retrieved on: 
Monday, April 8, 2024
Computational biology, Malignancy, Canadian Aviation Regulations, Gene editing, Bone disease, Cell, Hook effect, CXCR4, Enfortumab vedotin, Synthetic biology, Patient, Neoplasm, Epitope, Differentiable function, Ink, PBMC, Protein engineering, HLA, Science, Cytotoxicity, AACR, Phenotype, Therapy, IPSC, Skin, Inflammation, Prognosis, Carcinogenesis, Rejection, CD22, VHH, Poster, NK, Century, Autoimmunity, Bone marrow, Engineering, CD19, Vaccine

PHILADELPHIA, April 08, 2024 (GLOBE NEWSWIRE) -- Century Therapeutics (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology and autoimmune and inflammatory disease, today announced that preclinical data from the Company’s iPSC-derived cell therapy platform was presented at the AACR Annual Meeting 2024.

Key Points: 
  • PHILADELPHIA, April 08, 2024 (GLOBE NEWSWIRE) -- Century Therapeutics (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology and autoimmune and inflammatory disease, today announced that preclinical data from the Company’s iPSC-derived cell therapy platform was presented at the AACR Annual Meeting 2024.
  • This novel CAR was engineered and tested in iPSC-derived gamma-delta T cells, showing in vitro tumor cell cytotoxicity.
  • These findings support the continued examination of a CD19xCD22 bispecific CAR for off-the-shelf allogeneic cell therapy to expand patient access beyond CD19 CAR-T cell therapies.
  • In these preclinical studies, Century identified novel single-domain antibodies (VHH) that bind to multiple epitopes on the NECTIN4 extracellular domain.

Entera Bio Announces Key Regulatory Milestone for Oral PTH(1-34) Peptide (EB613) Phase 3 Program: FDA Ruling on Qualifying BMD as a Surrogate Endpoint for Osteoporosis Drugs is Expected Within 10 Months

Retrieved on: 
Tuesday, March 26, 2024
Fracture, SABRE, Bone disease, Hip, Risk, Patient, Quality of life, BMD, Woman, Society, Osteoporosis, Ecosystem, PTH, FDA, Ageing, Food

The proposed registrational Phase 3 study for EB613, Entera’s lead clinical candidate, which is a first-in-class PTH(1-34) daily tablet treatment for osteoporosis is designed to meet the quantitative BMD thresholds proposed by SABRE.

Key Points: 
  • The proposed registrational Phase 3 study for EB613, Entera’s lead clinical candidate, which is a first-in-class PTH(1-34) daily tablet treatment for osteoporosis is designed to meet the quantitative BMD thresholds proposed by SABRE.
  • In November 2023 we issued a press release echoing ASBMR’s announcement that SABRE had submitted its final qualification package to FDA for the replacement of fracture as a regulatory endpoint.
  • Today we are thrilled to echo ASBMR’s announcement that FDA has set a concrete timetable to issue its ruling.
  • Fractures, particularly of the hip, are considered the most serious consequence of osteoporosis, which predominantly affects postmenopausal women and older men.

NextCure Provides Business Update and Reports Full Year 2023 Financial Results

Retrieved on: 
Thursday, March 21, 2024
Research, Toxicity, Bone disease, Agreement, Osteogenesis imperfecta, DAR, AML, Risk, Patient, MMAE, Mouse, OI, Public expenditure, Plaque, Apolipoprotein E, PRS, IND, ARIA, GMP, Osteoporosis, CRC, Workforce, Use, ADC, Osteoarthritis, FDA, GLP, Pharmaceutical industry

We plan to present the data of the CRC patients at a scientific conference within the second quarter of 2024.

Key Points: 
  • We plan to present the data of the CRC patients at a scientific conference within the second quarter of 2024.
  • Selected our first antibody drug conjugate (ADC) candidate of a potential of three from our collaboration with LegoChem Biosciences, Inc. (LegoChem).
  • Under the terms of the Agreement, both parties equally share the costs of developing the molecules and profits on commercialized products.
  • Implemented a restructuring plan to reduce operating costs and better align our workforce with the needs of our business.

Nanox Announces AI Software Increases Identification of Patients with Vertebral Compression Fractures, an early sign of Osteoporosis, Up to Six-Fold

Retrieved on: 
Tuesday, March 12, 2024
Syndrome, Health, National Health Service, ROI, Congress, LTD, Rheumatology, Bone disease, Data analysis, Risk, Patient, Fracture, VCF, NHS, Abdomen, Hospital, Research, AI, University, Systematic review, Treatment, Spine, FLS, Family, FDA, Vertebral compression fracture, University of Oxford, Medical device

PETACH TIKVA, Israel, March 12, 2024 (GLOBE NEWSWIRE) -- NANO-X IMAGING LTD ("Nanox" or the "Company," Nasdaq: NNOX), an innovative medical imaging technology company, and its deep-learning medical imaging analytics subsidiary, Nanox AI Ltd. (Nanox.AI), today announced that early findings from the AI-enabled Detection of OsteoPorosis for Treatment (ADOPT) study, which uses a Nanox.AI artificial intelligence solution, HealthVCF, to review routine CT scans, have identified up to six times more patients with vertebral compression fracture than the national average at National Health Services (NHS) hospitals in the UK, which include University of Oxford and other healthcare centers.

Key Points: 
  • Thus far in the study, the Nanox.AI algorithm has identified over 2,400 patients with VCF from routine CT scans that were not known to the NHS’s hospitals, and have since been flagged for follow-up assessments.
  • “Leveraging AI-powered population health solutions presents an effective and efficient avenue for early identification of patients at very high risk of fractures, facilitating timely intervention and care.
  • As such, there have been efforts to introduce FLS into public health systems.
  • The next-generation HealthOST received FDA 510(K) clearance in April 2022.

Sandoz receives FDA approval for first and only denosumab biosimilars

Retrieved on: 
Tuesday, March 5, 2024
Bone fracture, Fracture, Woman, Hypocalcemia, Osteoporosis, Bone disease, Hypercalcaemia, FDA, Quality of life, Food, Cancer, Denosumab, Metastasis, Risk, Breast, Safety, Mitigation, Novartis, REMS, Benign tumor, Disease, Patent, Patient, Medicine, Multiple myeloma, Ageing, Dietary supplement

Keren Haruvi, President Sandoz North America, said: "Sandoz has achieved the first FDA approval for biosimilars to denosumab, a medicine that can address primary and secondary bone loss, such as osteoporosis, as well as cancer-related skeletal events, which are disease states that can profoundly reduce quality of life for patients.

Key Points: 
  • Keren Haruvi, President Sandoz North America, said: "Sandoz has achieved the first FDA approval for biosimilars to denosumab, a medicine that can address primary and secondary bone loss, such as osteoporosis, as well as cancer-related skeletal events, which are disease states that can profoundly reduce quality of life for patients.
  • I am proud that Sandoz continues to pioneer access to these life-changing medicines for the patients who need them most."
  • Wyost® and Jubbonti® have the same dosage form, route of administration, dosing regimen and presentation as the respective reference medicines.
  • Given ongoing patent litigation around these products, Sandoz will not comment on anticipated launch timing or other launch details at this time.

Teva Announces Approval of a Generic Version of Forteo® (teriparatide injection), in the U.S.

Retrieved on: 
Friday, November 17, 2023
FDA, Pharmaceutical, Health, Medicine, Vomiting, Digoxin, Osteoporosis, Woman, Urine, Antares, NYSE, Bone disease, Calcium, Spine, Prednisone, Constipation, Allergy, History, IQVIA, Patient, Arthralgia, Medication, TEVA, Fracture, Muscle weakness, System, Blood, Tongue, Vitamin, Bone tumor, Nausea, Kidney, Pain, Swelling, Osteosarcoma, Skin, Rat, TASE, Injection, Face, Blood pressure, Generic drug, Dietary supplement, Pharmaceutical industry, Vaccine, Birth control, Injection moulding, Medical imaging, Poultry farming, Phosphorus, Teriparatide, Teva

Teva Pharmaceuticals Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced today the approval of a generic version of Forteo®1, in the United States.

Key Points: 
  • Teva Pharmaceuticals Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced today the approval of a generic version of Forteo®1, in the United States.
  • Currently, 1 in 12 generic prescriptions dispensed in the U.S. is filled with a Teva generic product.
  • Teva’s generic equivalent of Forteo® (teriparatide injection) utilizes the Antares Pharma, Inc. multi-dose pen device.
  • Teriparatide injection can lessen the chance of broken bones (fractures) in the spine and other bones in postmenopausal women with osteoporosis.

Preclinical Data Demonstrate Anti-Siglec-15 Treatment Reduced Bone Loss and Enhanced Bone Quality in Mice with Moderate-to-Severe Osteogenesis Imperfecta (OI)

Retrieved on: 
Tuesday, October 17, 2023
Hospital for Special Surgery, Male, Cortex, Spectroscopy, Female, BMD, Bone, Bone disease, Osteogenesis imperfecta, Society, Mab, Hospital, American Society for Bone and Mineral Research, Osteoporosis, Cancer, Fracture, Osteoclast, Calvarial doughnut lesions-bone fragility syndrome, Mouse, S15, Porosity, Life, OI, Patient, Medical imaging, Birth control

These results support development of NC605 as a potential highly effective treatment for osteogenesis imperfecta, a rare disease in which bones easily fracture.

Key Points: 
  • These results support development of NC605 as a potential highly effective treatment for osteogenesis imperfecta, a rare disease in which bones easily fracture.
  • Osteogenesis imperfecta is a rare disorder that results in high bone turnover, abnormal bone formation, bone fragility and recurrent fractures.
  • There is no cure for OI and current anti-resorptive treatments increase bone mineral density (BMD) primarily by inhibiting bone loss; however, these agents also inhibit bone formation.
  • Unlike anti-resorptive therapies, NC605 enhances osteoblast recruitment, resulting in overall enhanced bone quality.

Amolyt Pharma Announces Data on Prevalence of Bone Disease in Patients with Hypoparathyroidism and Favorable Bone Effects of Eneboparatide at the American Society for Bone and Mineral Research (ASBMR) 2023 Annual Meeting

Retrieved on: 
Monday, October 16, 2023
Annual general meeting, Calcium, Hypoparathyroidism, McMaster University, Bone fracture, Bone disease, Society, American Society for Bone and Mineral Research, PTHR1, Homeostasis, Fracture, Phase 3, Osteoporosis, Medicine, DXA, Patient, PMF, Metabolic bone disease, Woman, Osteopenia, Quality of life, Medical imaging, Dietary supplement

LYON, France, and CAMBRDIGE, Mass., Oct. 16, 2023 (GLOBE NEWSWIRE) -- Amolyt Pharma, a global company specialized in developing therapeutic peptides for rare endocrine and related diseases, today announced data from two posters that were presented at the American Society for Bone and Mineral Research (ASBMR) 2023 Annual Meeting, which is being held October 13-16, 2023, in Vancouver, BC, Canada. The data include a prospective analysis of bone disease in patients with hypoparathyroidism from the Canadian National Hypoparathyroidism Registry with evidence of significant bone disease burden in postmenopausal females (PMF). In addition, data from both pre-clinical and clinical studies of eneboparatide continue to demonstrate its ability to restore balanced bone turnover, preserving bone integrity, while maintaining calcium homeostasis and normalizing urinary calcium.

Key Points: 
  • The data include a prospective analysis of bone disease in patients with hypoparathyroidism from the Canadian National Hypoparathyroidism Registry with evidence of significant bone disease burden in postmenopausal females (PMF).
  • In addition, data from both pre-clinical and clinical studies of eneboparatide continue to demonstrate its ability to restore balanced bone turnover, preserving bone integrity, while maintaining calcium homeostasis and normalizing urinary calcium.
  • “We’re very pleased to have a strong presence at this year’s ASBMR Annual Meeting.
  • These data increase our understanding of the relationship between hypoparathyroidism and bone strength.

AM-Pharma Announces Positive Clinical Data From Phase 1b Study Evaluating Ilofotase Alfa in Hypophosphatasia Patients

Retrieved on: 
Wednesday, October 11, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Bone disease, Vancouver Convention Centre, Pharmacokinetics, Doctor of Philosophy, Biomarker, MD, Society, Data, DSM-IV codes, PLP, Safety, University, ALPL, Disease, Arthropathy, Patient, HPP, PDT, Enzyme, Pyrophosphate, Hypophosphatasia, American Society for Bone and Mineral Research, Muscle weakness, Enzyme replacement therapy, Pharmaceutical industry

AM-Pharma B.V. today announced positive clinical results from the Phase 1b study evaluating the company’s proprietary recombinant alkaline phosphatase, ilofotase alfa, as potential enzyme replacement therapy in adult hypophosphatasia (HPP) patients.

Key Points: 
  • AM-Pharma B.V. today announced positive clinical results from the Phase 1b study evaluating the company’s proprietary recombinant alkaline phosphatase, ilofotase alfa, as potential enzyme replacement therapy in adult hypophosphatasia (HPP) patients.
  • Patients were followed for 10 days after dosing to evaluate changes in the biochemical fingerprint of HPP, safety and tolerability.
  • In addition, ilofotase alfa was well-tolerated with pharmacokinetics consistent with observations from previous clinical studies.
  • "The encouraging early results confirming dose-dependent reductions of PLP and PPi levels upon treatment with ilofotase alfa underline the compound's therapeutic potential in that indication and I'm looking forward to evaluating ilofotase alfa in next stage clinical studies."

Peer-Reviewed Publication of Positive Preclinical Data of SiSaf’s SIS-ADO2 siRNA Program to Treat Rare Genetic Bone Disorder Osteopetrosis

Retrieved on: 
Monday, September 18, 2023
Human, AL, Osteopetrosis, University, RNA, Bone disease, Autosome, Nucleic acid, Messenger, Small RNA, University of L'Aquila, Bone, House, American Society for Bone and Mineral Research, Patient, Annual general meeting, Mouse, Silicon, LNP (newspaper), FDA, Phenotype, IND, Society, Safety, Pharmaceutical industry, Medical imaging, Vaccine

These results could have significant translational impact on bone disease therapies and open the path to human trials of SiSaf’s potentially curative treatment for Osteopetrosis ADO2.

Key Points: 
  • These results could have significant translational impact on bone disease therapies and open the path to human trials of SiSaf’s potentially curative treatment for Osteopetrosis ADO2.
  • There are currently no approved treatments for this debilitating disease and no other treatments currently in clinical trials.
  • SIS-101-ADO, SiSaf’s lead in house program, is an ADO2-specific siRNA specifically designed against the human CLCN7G215R mRNA formulated with the company’s sshLNP.
  • In addition, due to the serious manifestations of this rare skeletal disorder in children, the FDA granted SIS-101-ADO Rare Pediatric Disease Designation for the treatment of Autosomal Dominant Osteopetrosis.