ANCOVA

AB Science provides a summary of the live webcast held on March 4, 2024 giving an update on AB Science development

Retrieved on: 
Thursday, March 7, 2024
Bias, Lung compliance, NON, SCIENCE, Tracheotomy, Acute myeloid leukemia, Mast cell activation syndrome, BTK, Alzheimer's disease, ANCOVA, Azacitidine, Missionary, B cell, Riluzole, CHMP, Guideline, NOD, Sickle cell disease, ALZ, Tablet, MECOM, AML, SCD, Biomarker, DSM-IV codes, Survival, Science, Prostate cancer, Oxygen, EMA, Docetaxel, Health Canada, ISM, FDA, Masitinib, Euronext, Cell, Chromosome abnormality, OS, UPDATE, Multiple sclerosis, COVID-19, Patient, Disease, Itch, RHU, CAFS, Failure, Depression, Pharmaceutical industry

SUMMARY OF THE WEBCAST HELD ON MARCH 4, 2024 PROVIDING AN UPDATE ON AB SCIENCE DEVELOPMENT

Key Points: 
  • SUMMARY OF THE WEBCAST HELD ON MARCH 4, 2024 PROVIDING AN UPDATE ON AB SCIENCE DEVELOPMENT
    AB Science SA (Euronext - FR0010557264 - AB) is providing a summary of the live webcast held on March 4, 2024, giving an update on AB Science development.
  • Regarding Health Canada, a Notice of Deficiency-Withdrawal (NOD/w) has been issued and AB Science intends to submit a Request for Reconsideration.
  • Based on the supporting arguments and counterarguments outlined above, AB Science intends to submit a Request for Reconsideration.
  • AB Science will be free to continue the development of masitinib in SCD based on phase 2 data with biomarkers.

AB Science announces that Health Canada has issued a Notice of Non-Compliance-Withdrawal (NON/w) for masitinib in ALS

Retrieved on: 
Monday, February 26, 2024
Bias, PFS, EMA, Function, ALS, Health Canada, ANCOVA, Progression-free survival, JTR, OS, Observation, Tracheotomy, Patient, Clinical trial, CIR, Drug, Science, CAFS, Rated R, Pharmaceutical industry

Health Canada stated that a Request for Reconsideration can be filed within 30 days of receiving the NON/w.

Key Points: 
  • Health Canada stated that a Request for Reconsideration can be filed within 30 days of receiving the NON/w.
  • The reconsideration process will re-examine, with new assessors, the decision based on information that was included in the original submission.
  • AB Science provided a methodologically justified new claim “patients with ALS prior to any loss of function”, where CAFS and Overall Survival (OS) are significantly improved.
  • Based on the supporting arguments and counterarguments outlined above, AB Science intends to submit a Request for Reconsideration.

Travere Therapeutics Announces Confirmatory Data from the Phase 3 PROTECT Study of FILSPARI® Demonstrating Long-Term Kidney Function Preservation in IgA Nephropathy; Narrowly Missing eGFR Total Slope Endpoint versus Active Control, Irbesartan

Retrieved on: 
Thursday, September 21, 2023
Medicine, Kidney failure, International, Heart Protection Study, CMA, Jay Traver, European Medicines Agency, Clinical trial, EGFR, European Directive on Traditional Herbal Medicinal Products, CSL Vifor, Immunoglobulin A, Dialysis, Committee, EMA, Proteinuria, Conditional, Nephrology, ANCOVA, Shanda, Publication, Patient, Division, Risk, Irbesartan, Kidney transplantation, Webcast, Committee for Medicinal Products for Human Use, FDA, Therapy, PROTECT, Kidney disease, Safety, CHMP, Hydraulic machinery, Medical device, Pharmaceutical industry, EU, IgA nephropathy

This outcome is incredibly important for IgAN patients, who face the risk of progression to kidney failure in their lifetime.

Key Points: 
  • This outcome is incredibly important for IgAN patients, who face the risk of progression to kidney failure in their lifetime.
  • “Since our accelerated approval, we’ve continued to hear inspiring stories of the impact this medicine is having on people living with IgAN.
  • While eGFR total slope narrowly missed statistical significance, the overall evidence from PROTECT suggests potential long-term benefit of FILSPARI as a foundational treatment for patients with IgAN.
  • Following the live webcast, an archived version of the call will be available for 30 days on the Company’s website.

Ligand’s Partner Travere Therapeutics Announces Confirmatory Data from the Phase 3 PROTECT Study of FILSPARI® Demonstrating Long-Term Kidney Function Preservation in IgA Nephropathy; Narrowly Missing eGFR Total Slope Endpoint versus Active Control

Retrieved on: 
Thursday, September 21, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, Kidney failure, Heart Protection Study, CMA, Jay Traver, European Medicines Agency, EGFR, European Directive on Traditional Herbal Medicinal Products, CSL Vifor, Medicine, Committee, EMA, Proteinuria, Conditional, Shanda, ANCOVA, Publication, Patient, Risk, Irbesartan, Committee for Medicinal Products for Human Use, FDA, Therapy, PROTECT, Kidney disease, Safety, CHMP, Hydraulic machinery, Pharmaceutical industry, EU, IgA nephropathy

This outcome is incredibly important for IgAN patients, who face the risk of progression to kidney failure in their lifetime.

Key Points: 
  • This outcome is incredibly important for IgAN patients, who face the risk of progression to kidney failure in their lifetime.
  • We’re proud of the high bar we’ve set in delivering the only head-to-head study in IgAN, which compares FILSPARI against maximally tolerated dose of irbesartan.
  • Since our accelerated approval, we’ve continued to hear inspiring stories of the impact this medicine is having on people living with IgAN.
  • While eGFR total slope narrowly missed statistical significance, the overall evidence from PROTECT suggest potential long-term benefit of FILSPARI as a foundational treatment for patients with IgAN.

Altamira Therapeutics Reports Additional Significant Efficacy Outcomes from Bentrio Clinical Trial in Seasonal Allergic Rhinitis

Retrieved on: 
Thursday, September 14, 2023
Therapy, Rhinorrhea, SAR, Marketing, Allergic rhinitis, Pollen, Sleep, ANCOVA, Seawater, Patient, Sneeze, MITES, Nasal spray, NASAR, FDA, Nasal congestion, Safety, Allergen, The Rheumatoid Arthritis Quality of Life Questionnaire, Pharmaceutical industry, Dietary supplement

Altamira Therapeutics Ltd. (Nasdaq:CYTO), a company dedicated to developing therapeutics that address important unmet medical needs, today announced further positive and statistically significant efficacy data from the randomized controlled NASAR clinical trial, which evaluated their Bentrio nasal spray in seasonal allergic rhinitis (SAR).

Key Points: 
  • Altamira Therapeutics Ltd. (Nasdaq:CYTO), a company dedicated to developing therapeutics that address important unmet medical needs, today announced further positive and statistically significant efficacy data from the randomized controlled NASAR clinical trial, which evaluated their Bentrio nasal spray in seasonal allergic rhinitis (SAR).
  • The reduction in nasal symptoms conferred by Bentrio was 2.4 times larger than with saline nasal spray and clinically relevant.
  • Additional data, which have become subsequently available from the NASAR trial, confirm and reinforce the body of evidence demonstrating Bentrio’s efficacy in SAR management.
  • Further, the read-out from the NASAR trial suggest that Bentrio helps reduce the need for relief medication (cetirizine nasal spray).

Altamira Therapeutics Provides Business Update and First Half 2023 Financial Results

Retrieved on: 
Tuesday, September 12, 2023
KRAS, Nanoparticle, Rhinitis, Marketing, Synovitis, Heqet, Allergic rhinitis, RNA, MBA, Doctor of Philosophy, Preprint, Patent, Patient, NF-κB, MITES, AVS, DNMT3B, Rheumatoid arthritis, Joint capsule, Therapy, Myocardial infarction, Research, Small RNA, Regeneration, Sneeze, Washington University School of Law, Neoplasm, Nasal spray, FDA, Vertigo, IND, Safety, Volunteering, SAR, Altamira, Cell, IP, Immunotherapy, Messenger, NASAR, Nasal congestion, CHF, Osteoarthritis Research Society International, Rhinorrhea, Q&A, SARS-CoV-2, Infection, Clinical trial, Pollen, Inflammation, ANCOVA, OTC, Mouse, Washington University School of Medicine, Vaccine, Pharmaceutical industry, Cryptocurrency, BPPV, St. Louis

Company hosts 1H 2023 Financial Results and Business Update call today at 8 a.m.

Key Points: 
  • Company hosts 1H 2023 Financial Results and Business Update call today at 8 a.m.
  • ET
    Altamira Therapeutics Ltd. (NASDAQ:CYTO) ("Altamira" or the "Company"), a company dedicated to addressing unmet medical needs, today provided a business update and reported its first half 2023 financial results.
  • Net loss for the first half of 2023 was CHF 5.4 million compared with CHF 8.2 million for the first half of 2022.
  • ET to discuss its business update and first half 2023 results.

Altamira Therapeutics Announces Publication of Positive Results from Clinical Trial with Bentrio in House Dust Mite Allergy in Leading Peer Reviewed Journal

Retrieved on: 
Monday, July 17, 2023
Therapy, HDM, Clinical trial, Altamira, Allergic rhinitis, History, ANCOVA, PAR, Patient, Pharmaceutical industry, Medical imaging

Altamira Therapeutics Ltd. ("Altamira" or the "Company") (Nasdaq: CYTO), a company dedicated to developing therapeutics that address important unmet medical needs, today announced the publication of the detailed results from its clinical trial with Bentrio® nasal spray in house dust mite (“HDM”) allergic rhinitis.

Key Points: 
  • Altamira Therapeutics Ltd. ("Altamira" or the "Company") (Nasdaq: CYTO), a company dedicated to developing therapeutics that address important unmet medical needs, today announced the publication of the detailed results from its clinical trial with Bentrio® nasal spray in house dust mite (“HDM”) allergic rhinitis.
  • The peer-reviewed article was published in Clinical and Translational Allergy, one of the leading journals in the field of allergology.
  • The primary endpoint was the change in the Total Nasal Symptom Score (TNSS; determined in 20-minute intervals) from baseline.
  • “Also, in both studies Bentrio exhibited a lasting protective effect for several hours, reflecting its long nasal residence time.

Ligand’s Partner Viking Therapeutics Announces Positive Top-Line Results from Phase 2b VOYAGE Study of VK2809 in Patients with Biopsy-Confirmed Non-Alcoholic Steatohepatitis (NASH)

Retrieved on: 
Tuesday, May 16, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, Data set, NASH, Diarrhea, Triglyceride, Lipid, History, Vomiting, Plasma, DSM-IV codes, MRI, SAE, ANCOVA, Patient, Analysis of covariance, Risk, Nausea, NAFLD, Apolipoprotein B, Safety, Biopsy, Pharmaceutical industry

The high response rates observed in this study suggest improved probabilities of histologic benefit, as has been demonstrated in published clinical studies.

Key Points: 
  • The high response rates observed in this study suggest improved probabilities of histologic benefit, as has been demonstrated in published clinical studies.
  • These results align well with those reported from our prior 12-week NAFLD study, but in a more severe population and at lower doses.
  • The majority (94%) of treatment related adverse events among patients receiving VK2809 were reported as mild or moderate.
  • Rates of nausea, diarrhea, stool frequency, and vomiting were similar among VK2809-treated patients compared to placebo.

Viking Therapeutics Announces Positive Top-Line Results from Phase 2b VOYAGE Study of VK2809 in Patients with Biopsy-Confirmed Non-Alcoholic Steatohepatitis (NASH)

Retrieved on: 
Tuesday, May 16, 2023
Data set, NASH, Diarrhea, Triglyceride, Overalls, Lipid, History, Vomiting, Plasma, DSM-IV codes, MRI, SAE, ANCOVA, Patient, Analysis of covariance, Risk, Nausea, NAFLD, Apolipoprotein B, Safety, Biopsy, Pharmaceutical industry

"The high response rates observed in this study suggest improved probabilities of histologic benefit, as has been demonstrated in published clinical studies.

Key Points: 
  • "The high response rates observed in this study suggest improved probabilities of histologic benefit, as has been demonstrated in published clinical studies.
  • These results align well with those reported from our prior 12-week NAFLD study, but in a more severe population and at lower doses.
  • The majority (94%) of treatment related adverse events among patients receiving VK2809 were reported as mild or moderate.
  • Rates of nausea, diarrhea, stool frequency, and vomiting were similar among VK2809-treated patients compared to placebo.

Altamira Therapeutics Provides Update on Clinical Trials with Bentrio

Retrieved on: 
Tuesday, January 24, 2023
Nasal congestion, Virus, Particle-size distribution, Safety, Rhinitis, ANCOVA, Sudden death, COVID-19, Sneeze, Rhinorrhea, Allergen, Therapy, Omicron, Degenerative disease, CT, SAR, Research, Allergic rhinitis, Patient, Nasal mucosa, PCR, Incidence, NASAR, Severe acute respiratory syndrome coronavirus 2, Nasal spray, Pharmaceutical industry

The treatment effect of 1.55 points in favor of Bentrio was statistically significant in the ANCOVA model (LSmeans; p = 0.015; 95% confidence interval -2.78 to -0.32).

Key Points: 
  • The treatment effect of 1.55 points in favor of Bentrio was statistically significant in the ANCOVA model (LSmeans; p = 0.015; 95% confidence interval -2.78 to -0.32).
  • The interim analysis further showed good tolerability and safety both for Bentrio and the comparator.
  • Participants were randomized at a 1:1 ratio to either receive Bentrio or saline spray via self-administration three times per day, or as needed.
  • “We are very excited about the strong efficacy signals observed with Bentrio at the halfway point of the NASAR seasonal allergic rhinitis trial in Australia,” commented Thomas Meyer, Altamira Therapeutics’ founder, Chairman, and CEO.