Tolerability

Vaxcyte Completes Enrollment of Phase 2 Study Evaluating VAX-24 for the Prevention of Invasive Pneumococcal Disease (IPD) in Infants

Retrieved on: 
Monday, March 4, 2024
SAN, Immunization, PCV, Serology, Life, Vaccine, Safety, Meningitis, Genetically modified bacteria, IPD, Tolerability, Infant, Disease, Streptococcus pneumoniae, Fungal infection

SAN CARLOS, Calif., March 04, 2024 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced the completion of enrollment in its Phase 2 study evaluating VAX-24, a broad-spectrum, carrier-sparing 24-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD), in healthy infants. Vaxcyte expects to announce topline safety, tolerability and immunogenicity data from the Phase 2 study primary three-dose immunization series by the end of the first quarter of 2025, followed by topline data from the booster dose by the end of 2025.

Key Points: 
  • Vaxcyte expects to announce topline safety, tolerability and immunogenicity data from the Phase 2 study primary three-dose immunization series by the end of the first quarter of 2025, followed by topline data from the booster dose by the end of 2025.
  • “Completing enrollment of the VAX-24 study with more than 800 healthy infants demonstrates yet another significant milestone in the development of our VAX-24 and VAX-31 PCV candidates,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte.
  • “We believe VAX-24 has a potential best-in-class profile for this vital population and is designed to cover more serotypes than any infant pneumococcal vaccine on-market or in U.S. clinics today.
  • “Given the significant burden of disease in young children, there remains a need for broader-spectrum vaccines like VAX-24 and VAX-31, our next-generation 31-valent PCV candidate, that are designed to provide greater protection than the current standard-of-care.”

Vaxcyte Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, February 27, 2024
Licensure, Investment, Growth, Exercise, Tolerability, Immunization, Host, Trial of the century, Ageing, PCV20, PCV, P-value, Safety, BLA, Success, Phase 10, Genetically modified bacteria, Net, G&A, CMC, SAN, Research and development, ID, OPA, Conference, The Lancet, Biologics license application, Breakthrough therapy, Advisory Committee, PCV15, POC, FDA, End, Food, Breakthrough, Element, Fireside chats, Administration, IPD

-- Significant Progress in Establishing Global Commercial Manufacturing Capacity for Vaxcyte's PCV Candidates, Including Expanded Collaboration with Lonza --

Key Points: 
  • ET / 1:30 p.m. PT --
    SAN CARLOS, Calif., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.
  • Additionally, as part of ongoing Chemistry, Manufacturing and Controls (CMC)-focused discussions, Vaxcyte received encouraging input from the FDA regarding the VAX-24 adult licensure requirements.
  • The six-month safety data from both studies showed safety and tolerability results for VAX-24 similar to PCV20 at all doses studied.
  • Vaxcyte will host a conference call and webcast to discuss this announcement today, February 27, 2024, at 4:30 p.m.

BioCryst Presents New Real-world Data Showing Rapid, Substantial and Sustained HAE Attack Rate Reductions After Beginning ORLADEYO® (berotralstat) Treatment

Retrieved on: 
Friday, February 23, 2024
Incidence, AAAAI, Pharmacy, Attack, Expert network, Tranexamic acid, Prior, Effectiveness, Pharmacist, Washington Convention Center, University, Conditional sentence, Day, Lanadelumab, Safety, Androgen, HAE, History, Hereditary angioedema, Tolerability, Monitoring, Internal medicine, Walter, BioCryst Pharmaceuticals, Medicine, Disease, Ageing, Observational study, Poster, American Academy, Pharmaceutical industry

“These additional analyses of real-world use of ORLADEYO show that any person living with HAE has the potential to experience a rapid, substantial and sustained reduction in their monthly attack rate with ORLADEYO.

Key Points: 
  • “These additional analyses of real-world use of ORLADEYO show that any person living with HAE has the potential to experience a rapid, substantial and sustained reduction in their monthly attack rate with ORLADEYO.
  • These analyses present the overall attack rate progression and attack rate progression stratified by severity (i.e., number of attacks at baseline), prior prophylaxis and C1-INH level and function.
  • These findings further demonstrate that ORLADEYO can help maintain disease control in patients with lower baseline attack rates and further reduce attack rates in patients with more active disease.
  • Berotralstat Prophylaxis Reduces HAE Attack Rates Regardless of Baseline Attacks: Real-World Outcomes; Poster #012; Friday, February 23, 3:15-4:15 p.m.

Cognito Therapeutics OVERTURE Clinical Trial in Alzheimer's Disease Published in Frontiers in Neurology

Retrieved on: 
Wednesday, March 6, 2024
Technology, Medical Devices, General Health, Neurology, Science, Consumer, Clinical Trials, Biotechnology, Health, Health Technology, Other Science, Research, Software, Hardware, Pharmaceutical, Data Management, Seniors, Cognito, Caregiver, Amyloid-related imaging abnormalities, Aes, HOPE, Alzheimer's disease, Political moderate, ARIA, Safety, Hope, Therapy, Memory, EEG, Tolerability, Patient, Clinical trial, Atrophy, MRI, Medical imaging

Cognito Therapeutics , a leader in technology-based therapeutic interventions for neurodegenerative diseases, announced today the publication of the OVERTURE study results in Frontiers in Neurology .

Key Points: 
  • Cognito Therapeutics , a leader in technology-based therapeutic interventions for neurodegenerative diseases, announced today the publication of the OVERTURE study results in Frontiers in Neurology .
  • The OVERTURE clinical trial was a randomized, double-blind, sham-controlled clinical trial conducted over a six-month period at 5 US clinical trial sites, involving participants with mild to moderate AD.
  • Participants were randomly assigned 2:1 to receive self-administered daily, one-hour Spectris therapy designed to evoke EEG-verified gamma oscillations or sham treatment.
  • “Publication of OVERTURE clinical trial results is an important step in our commitment to develop our technology-based therapeutic intervention in Alzheimer’s disease,” said Ralph Kern, M.D., MHSc, Chief Medical Officer of Cognito Therapeutics.

BioCryst to Present New ORLADEYO® (berotralstat) Real-world Data at 2024 American Academy of Allergy, Asthma & Immunology Annual Meeting

Retrieved on: 
Monday, February 5, 2024
Abstract, Convention center, AAAAI, Tolerability, Washington Convention Center, Hereditary angioedema, Walter, Poster, Effectiveness, HAE, BioCryst Pharmaceuticals, American Academy, Prior, Pharmacy, Nightclub

The meeting will take place at the Walter E. Washington Convention Center in Washington, D.C., from February 23-26, 2024.

Key Points: 
  • The meeting will take place at the Walter E. Washington Convention Center in Washington, D.C., from February 23-26, 2024.
  • The five abstracts that BioCryst will present are:
    Berotralstat Prophylaxis Reduces HAE Attack Rates Regardless of Baseline Attacks: Real-World Outcomes; Poster #012; Friday, February 23, 3:15-4:15 p.m.
  • ET; Convention Center, Level 2, Hall D
    Consistently Low Hereditary Angioedema Attack Rates with Berotralstat Regardless of Prior Prophylaxis: Real-World Outcomes; Poster #008; Friday, February 23, 3:15-4:15 p.m.
  • ET; Convention Center, Level 2, Hall D
    Real-World Effectiveness of Berotralstat in HAE With and Without C1-Inhibitor Deficiency; Poster #281; Saturday, February 24, 9:45-10:45 a.m.

Vaxcyte Provides Clinical and Regulatory Progress Update on Potential Best-in-Class Pneumococcal Conjugate Vaccine (PCV) Franchise

Retrieved on: 
Thursday, January 4, 2024
Licensure, Food, PCV, End, Breakthrough therapy, FDA, CMC, Ageing, Phase 10, SAN, Pivotal, Biologics license application, Advisory Committee, PCV20, Breakthrough, Data monitoring committee, Immunization, Initiation, IPD, PCV15, Infant, Safety, Tolerability, Genetically modified bacteria, BLA, Vaccine

-- Enrollment in Ongoing VAX-24 Infant Phase 2 Study Continues to Progress; Topline Data from Primary Immunization Series Expected by End of First Quarter of 2025, Followed by Topline Data from Booster Dose by End of 2025 --

Key Points: 
  • Vaxcyte’s carrier-sparing PCV franchise candidates, including VAX-24, a 24-valent PCV proceeding to Phase 3, and VAX-31, the Company’s next-generation 31-valent PCV, are being studied for the prevention of invasive pneumococcal disease (IPD).
  • The VAX-24 Phase 2 infant study continues to enroll participants in the second and final stage of the study.
  • This is a randomized, observer-blind, dose-finding two-stage clinical study evaluating the safety, tolerability and immunogenicity of VAX-24 in healthy infants.
  • Topline safety, tolerability and immunogenicity data from the ongoing adult Phase 1/2 study in the third quarter of 2024.

SciSparc Celebrates Major Breakthrough: Positive Results Show its Treatment has a Remarkable Impact on Alzheimer's Agitation

Retrieved on: 
Wednesday, November 15, 2023
Sophie, Hypotension, Cannabinoid, Alzheimer's disease, Eating, IMCA, Delirium, FDA, Agitation, Dronabinol, Tolerability, MD, CMAI, Central nervous system, Pharmaceutical industry, Medical device, Hospital, Disease, Patient, Safety

Tel-Aviv, Nov. 15, 2023 (GLOBE NEWSWIRE) -- SciSparc Ltd. (NASDAQ: SPRC), a specialty, clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system (the “Company” or “SciSparc”), unveiled positive topline results from its investigator-initiated Phase IIa trial at the Sophie & Abraham Stuchynski Israeli Alzheimer’s Medical Center (IMCA). The trial results indicated that SciSparc’s proprietary SCI-110 provided a safe and effective solution for alleviating agitation in elderly Alzheimer's patients who participated.

Key Points: 
  • The trial results indicated that SciSparc’s proprietary SCI-110 provided a safe and effective solution for alleviating agitation in elderly Alzheimer's patients who participated.
  • Agitation is a devastating symptom of Alzheimer's Disease (AD), afflicting nearly all patients as the disease progresses, and imposing tremendous suffering and caregiving burdens.
  • The results not only met primary endpoints regarding tolerability and adverse events but also demonstrated SCI-110's potential to alleviate agitation without side effects.
  • Moreover, when measured by the Cohen Mansfield Agitation Inventory (CMAI), our treatment led to a significant 23% reduction in agitation symptoms.

argenx Highlights Data Evaluating VYVGART in Neuromuscular Autoimmune Disease at AANEM and MGFA Scientific Sessions

Retrieved on: 
Wednesday, November 1, 2023
Hives, Headache, Incidence, Alfa Romeo, Erythema, Vaccine, Immunization, Itch, Respiratory tract infection, Infection, Quality of life, Periodic breathing, Bruise, Milk, Infant, Rash, Vaccination, Acetylcholine receptor, Antibody, Risk, Immunoglobulin G, Angioedema, Urinary tract infection, Efgartigimod alfa, Safety, Pain, Pharmaceutical industry, Health care, Birth control, Patient, Life, Tolerability, Neurology

Delay the administration of VYVGART or VYVGART HYTRULO in patients with an active infection until the infection has resolved; monitor for clinical signs and symptoms of infections.

Key Points: 
  • Delay the administration of VYVGART or VYVGART HYTRULO in patients with an active infection until the infection has resolved; monitor for clinical signs and symptoms of infections.
  • If serious infection occurs, administer appropriate treatment and consider withholding treatment with VYVGART or VYVGART HYTRULO until the infection has resolved.
  • Because VYVGART and VYVGART HYTRULO cause a reduction in immunoglobulin G (IgG) levels, vaccination with live-attenuated or live vaccines is not recommended during treatment with VYVGART or VYVGART HYTRULO.
  • If a hypersensitivity reaction occurs during VYVGART or VYVGART HYTRULO administration, discontinue use and institute appropriate supportive measures if needed.

VYNE Therapeutics Announces Positive Data from Phase 1b Trial for Novel BET Inhibitor VYN201 in Patients with Nonsegmental Vitiligo

Retrieved on: 
Monday, October 30, 2023
Vitiligo, Pigment, Boston Medical Group, Pharmacokinetics, Skin, Tolerability, Autoimmune disease, BET, Safety, Initiate, Therapy, Depigmentation, Patient, Pharmaceutical industry, Vaccine

The Phase 1b trial is a 16-week open-label trial assessing the safety, tolerability and pharmacokinetics of once-daily topical VYN201 in 29 patients across three dose cohorts (0.5%, 1.0% and 2.0% strengths).

Key Points: 
  • The Phase 1b trial is a 16-week open-label trial assessing the safety, tolerability and pharmacokinetics of once-daily topical VYN201 in 29 patients across three dose cohorts (0.5%, 1.0% and 2.0% strengths).
  • “We are encouraged by these data from our Phase 1b trial that demonstrate proof-of-concept in nonsegmental vitiligo, which we believe is the first clinical evidence of a BET inhibitor’s effect in autoimmune disease.
  • VYNE management will review the final results from the Phase 1b trial for VYN201.
  • The VYNE team will also discuss the Company’s development plans for VYN201 and its oral BET inhibitor VYN202.

Legend Biotech to Showcase Leadership in Multiple Myeloma Treatment at the ASH 2023 Annual Meeting

Retrieved on: 
Thursday, November 2, 2023
Oncology, Health, Infectious Diseases, Clinical Trials, Pharmaceutical, Biotechnology, Marriott Marquis, Health care, Multiple myeloma, Safety, Quality of life, Quality, Poster, Relapse, Commerce, Investigational New Drug, Cohort, Pharmaceutical industry, Mobile phone, Patient, Tolerability

Cellular Immunotherapies: Early Phase and Investigational Therapies: CAR-T Cell Therapies for Multiple Myeloma and B Cell Lymphomas

Key Points: 
  • Cellular Immunotherapies: Early Phase and Investigational Therapies: CAR-T Cell Therapies for Multiple Myeloma and B Cell Lymphomas
    Session Name: 905.
  • Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster I
    Session Name: 705.
  • Cellular Immunotherapies: Late Phase and Commercially Available Therapies: Poster II
    Session Name: 705.
  • Cellular Immunotherapies: Late Phase and Commercially Available Therapies: Poster III
    Session Name: 902.