QOD

Larimar Therapeutics Reports Positive Top-line Data from Phase 2 Dose Exploration Study from 25 mg and 50 mg Cohorts of Nomlabofusp in Patients with Friedreich’s Ataxia

Retrieved on: 
Monday, February 12, 2024
Pharmacology, QOD, FDA, BLA, Skin, Safety, Therapy, Pharmacokinetics, Webcast, Patient, OLE, FXN, Disease, Tissue, FA, Pharmaceutical industry

Participants in the 25 mg (n=13) and 50 mg (n=15) cohorts were randomized 2:1 to receive subcutaneous injections of nomlabofusp or placebo.

Key Points: 
  • Participants in the 25 mg (n=13) and 50 mg (n=15) cohorts were randomized 2:1 to receive subcutaneous injections of nomlabofusp or placebo.
  • Further dose expansion in the OLE will be considered based on safety, pharmacokinetics, and tissue FXN levels from the 25 mg dose of nomlabofusp.
  • All treated patients demonstrated increases in FXN levels in skin cells and the majority of patients also demonstrated increases in FXN levels in buccal cells.
  • Median baseline tissue FXN levels in skin cells were 3.70 pg/µg and 2.12 pg/µg for the 25 mg and 50 mg cohorts, respectively, and in buccal cells were 1.78 pg/µg and 1.61 pg/µg for the 25 mg and 50 mg cohorts, respectively.

Primmune Therapeutics Presents Clinical Data from Phase 1 Study Evaluating PRTX007 in Healthy Volunteers at the 2023 American Association for the Study of Liver Diseases (AASLD) Annual Meeting

Retrieved on: 
Friday, November 10, 2023
Biotechnology, Infectious Diseases, Health, Pharmaceutical, Clinical Trials, Greater Mauritania, Hepatology, Safety, Annual general meeting, Therapy, Aes, Hepatitis B virus, Headache, AASLD, SAD, IL-6, Patient, HBV, QOD, TLR7, Pharmacokinetics, Liver, Messenger, Half-life, Șaeș, NK, Vaccine

The data presented highlight the suitability of PRTX007 for investigation as a combination therapy for curative treatment of chronic hepatitis B virus (HBV) infection.

Key Points: 
  • The data presented highlight the suitability of PRTX007 for investigation as a combination therapy for curative treatment of chronic hepatitis B virus (HBV) infection.
  • Data show that PRTX007 demonstrated a favorable safety profile in all of the analyzed cohorts with no serious adverse events (SAEs) observed.
  • “We are encouraged by the results of this Phase 1 study which demonstrate the safety and tolerability of PRTX007 administration in healthy volunteers.
  • CD8+ T cells and NK cell activation (CD38+ markers) increased markedly from pretreatment to end of dosing in all HVs.

Live from ASH 2023 | Results from Chinese Studies of Olverembatinib Presented in Oral Report at the ASH Annual Meeting for the Sixth Consecutive Year, Including Data Showing Promising Efficacy in Patients with TKI-Resistant and/or Intolerant CML-CP

Retrieved on: 
Wednesday, December 13, 2023
Hydroxycarbamide, Research, Intolerance, Dasatinib, HHT, Aes, Incidence, ASH, Risk, NMPA, TKI, Eastern Cooperative Oncology Group, Hematology, Disease, Hospital, Patient, Nilotinib, QOD, Pacific Time Zone, BCR, Pacific Ocean, CHB, Prognosis, Natural product, ECOG, Cancer, CML, Death, R, Hepatitis, Society, Notifiable disease, BAT, HIV disease progression rates, Pharmaceutical industry, Nursing, EFS

This is the sixth consecutive year in which study results on olverembatinib have been selected for Oral Presentations at the ASH Annual Meeting.

Key Points: 
  • This is the sixth consecutive year in which study results on olverembatinib have been selected for Oral Presentations at the ASH Annual Meeting.
  • After reaching EFS, patients in the BAT arm were allowed to cross-over to the olverembatinib arm for continued treatment.
  • Patients: As of October 17, 2023, a total of 144 patients were enrolled, of whom 96 patients received olverembatinib and 48 received BAT.
  • In addition, the olverembatinib arm has shown a higher cumulative response rate and longer duration of responses.

It’s Official: Studies Find Worker’s Comp Patients Fare Worse After Spine Surgery Than Other Patients

Retrieved on: 
Wednesday, September 6, 2023
Surgery, Health, Professional Services, Health Insurance, Human Resources, Spine, Smoker, Depression, Journal of Neurosurgery, Anxiety, Life, Quality of life, ACDF, Research, Brain, Patient, Harvard University, Pain, Back pain, Mevalonate pathway, Overweight, Decompression, Trauma, Mental health, HMT, Conference, QOD, Injury, Pharmaceutical industry, Medical device, Nursing

Two studies in the peer-reviewed Journal of Neurosurgery: Spine confirm what has long been suspected: worker’s compensation (WC) patients undergoing lumbar spine surgery fare worse post-surgery than other patients undergoing the same procedures.

Key Points: 
  • Two studies in the peer-reviewed Journal of Neurosurgery: Spine confirm what has long been suspected: worker’s compensation (WC) patients undergoing lumbar spine surgery fare worse post-surgery than other patients undergoing the same procedures.
  • One-year postoperative improvements, return-to-work rates and satisfaction were all significantly lower for workers’ compensation compared with non-workers compensation patients, even though workers’ compensation patients had fewer comorbidities and were younger.
  • It also found that worker’s compensation patients were significantly more likely to experience greater pain and residual disability, as well as a delayed return to work, than other patients.
  • Vx® Therapy equips patients to resume their normal activities of daily living sooner and with minimal disruption.

Ascentage Pharma Presents Updated Results from Multiple Clinical Studies at American Society of Clinical Oncology Annual Conference

Retrieved on: 
Friday, May 26, 2023
TKI, CXCR4, PD, Cohort, SDH, Arrhythmia, Patient, AST, Landing slot, Thrombocytopenia, Fatigue, Disease, ALK, GIST, Male, PRS, Diarrhea, Arm, Pharmacokinetics, Mutation, Vomiting, ALT, Leukopenia, PR, Safety, Neutropenia, AE, Pulmonary embolism, Dehydration, Aes, DLT, DDI, Multimedia, NSCLC, MTTR, Immunotherapy, CBR, Anemia, CR, FAK, Pembrolizumab, ORR, Joint effusion, Electrolyte, Armed Forces Health Longitudinal Technology Application, PK, Rituximab, PM, Phosphorylation, IO, DCR, TLS, Weight loss, Trae tha Truth, Septic shock, WM, Thrombosis, Kidney, Nausea, AM, Recurrence, SD, QOD, Female, Powder metallurgy, Pharmaceutical industry, Nursing, PBMC

As of December 9, 2022, 130 patients were enrolled and treated with APG-2449 at doses ranging from 900 to1,500 mg.

Key Points: 
  • As of December 9, 2022, 130 patients were enrolled and treated with APG-2449 at doses ranging from 900 to1,500 mg.
  • Meanwhile, patients with higher pFAK expression in tumor tissues at baseline tended to achieve better clinical responses than those with lower pFAK expression after APG-2449 treatment.
  • Efficacy Results: The median duration of treatment in the 20 patients with SDH-deficient GIST was 7.8 (1.81-42.3) months.
  • Conclusions: Alrizomadlin combined with pembrolizumab is well tolerated and demonstrates clinical efficacy in patients with cutaneous melanoma that had progressed on PD-1/PD-L1 immunotherapy.

Primmune Therapeutics Presents New Clinical Data from Phase 1 Study Evaluating PRTX007 in Healthy Volunteers at the 2023 American Association for Cancer Research (AACR) Annual Meeting

Retrieved on: 
Tuesday, April 18, 2023
Research, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, Oncology, Greater Mauritania, TLR7, AACR, AE, Aes, Pharmacokinetics, IL-6, SAD, NK, Patient, MAD, Entrepreneurship, American Association for Cancer Research, Therapy, Headache, QOD, Vaccine, Pharmaceutical industry

In addition to assessing the clinical safety and tolerability of PRTX007, the study was designed to evaluate the pharmacokinetics of PRTX007 and identify the specific active dosing range for use in future cancer studies.

Key Points: 
  • In addition to assessing the clinical safety and tolerability of PRTX007, the study was designed to evaluate the pharmacokinetics of PRTX007 and identify the specific active dosing range for use in future cancer studies.
  • There were no systemic increases in proinflammatory factors observed for any dose range in the Phase 1 study.
  • Both the clinical characteristics and unique pattern of immune induction by PRTX007 support its use in combination with immune checkpoint inhibitors.
  • Primmune plans to conduct a future study evaluating PRTX007 in combination with a checkpoint inhibitor across the active doses identified in the Phase 1 study for the potential treatment of solid tumors.

Primmune Therapeutics Presents Data from Phase 1 Study Evaluating PRTX007 in Healthy Volunteers at the 2022 American Association for Cancer Research (AACR) Annual Meeting

Retrieved on: 
Friday, April 8, 2022
Biotechnology, Infectious Diseases, Health, Clinical Trials, Oncology, Therapy, SAD, QOD, Pharmacokinetics, Adult, AACR, MAD, American Association, Cancer, Entrepreneurship, Safety, AES, TLR7, American Association for Cancer Research, Patient, Pharmaceutical industry

The study is a single-center, prospective, randomized, double-blind, placebo-controlled study with 9 single-ascending dose (SAD) cohorts and 4 multiple-ascending dose (MAD) cohorts where PRTX007 is administered orally to adult healthy volunteers.

Key Points: 
  • The study is a single-center, prospective, randomized, double-blind, placebo-controlled study with 9 single-ascending dose (SAD) cohorts and 4 multiple-ascending dose (MAD) cohorts where PRTX007 is administered orally to adult healthy volunteers.
  • In addition to assessing the safety, tolerability and pharmacokinetics of PRTX007, the study is designed to evaluate pharmacodynamic responses relevant to dose selection for patients with cancer.
  • In addition, every other day (QOD) dosing demonstrated stable systemic immune induction without evidence of counter-regulation.
  • Both the clinical characteristics and unique pattern of immune induction by PRTX007 support its use in combination with immune checkpoint inhibitors.

ASH 2021 | Ascentage Pharma to Present Three Studies of Olverembatinib (HQP1351), a Novel Drug Candidate for the Treatment of Drug-Resistant Leukemia, in Abstracts Including One Oral Report at ASH Annual Meeting

Retrieved on: 
Friday, November 5, 2021
MSD, NDA, Population, Progression-free survival, Biotechnology, Degenerative disease, IAP, Treatment, Dana–Farber Cancer Institute, Cancer, Efficacy, QOD, Therapy, Mayo Clinic, Diagnosis, TKI, BCR, Stock exchange, PFS, Mahr, PK, Leukopenia, Motherboard, Hepatitis, California Department of Alcohol and Drug Programs, Thrombocytopenia, Male, Patient, Center for Drug Evaluation and Research, D-project, Center, FTD, MMR, Mutation, Multimedia, Trae tha Truth, Anemia, CML, Apoptosis, AstraZeneca, OS, ODD, Priority review, Infection, MD Anderson Cancer Center, BCR-ABL, CDE, 2021 Essex County Council election, Unity Biotechnology, BTD, CHR, Pharmaceutical industry, Medical imaging, Health insurance, Fine chemical

Olverembatinib was orally administered once every other day (QOD)in 28-day cycles and at 11 dose cohorts ranging from 1 to 60 mg.

Key Points: 
  • Olverembatinib was orally administered once every other day (QOD)in 28-day cycles and at 11 dose cohorts ranging from 1 to 60 mg.
  • - From October 26, 2016, through February 2, 2021 (data cut-off date), 101 patients with CML-CP (n=86) or CML-AP (n=15) were enrolled and treated with olverembatinib.
  • In all, 84 (83.2%) patients received 2 prior lines of TKI-therapies, and 63 (62.4%) harbored the T315I mutation.
  • Ascentage Pharma (6855.HK) is a globally focused biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B, and age-related diseases.