FIH

Intravacc announces positive data of first in human intranasal OMV based vaccine for SARS-CoV-2

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星期二, 三月 26, 2024
Conference, Immunoglobulin A, Female, Aes, FIH, SARS-CoV-2, Volunteering, Trial of the century, Male, OMV, Vaccination, Safety, Vaccine, Immunoglobulin G, Administration

The phase I clinical trial, which was conducted in Australia, assessed the tolerability, safety and immunogenicity of the Avacc 10® vaccine.

Key Points: 
  • The phase I clinical trial, which was conducted in Australia, assessed the tolerability, safety and immunogenicity of the Avacc 10® vaccine.
  • In a randomized, double-blinded, placebo and OMV controlled study, 36 healthy 18-55 year-old, male and female volunteers, received two intranasal doses, 3 weeks apart.
  • Dr. Dinja Oosterhoff, Intravacc’s VP of Research & Development, stated:
    “This FIH intranasal vaccine study marks a significant milestone for Intravacc’s flagship OMV based vaccine platform.
  • Now Intravacc is also developing an intranasal vaccine for Gonorrhea targeting the FIH in Q4 2025.

Curadev's Differentiated Next Generation STING Agonist CRD3874-SI

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星期四, 二月 15, 2024
Pharmacology, Therapeutic index, CDN, Nucleic acid metabolism, PI, FIH, Society, Patient, Poster, Immunotherapy, Human, Mouse, Pharmaceutical industry

BOSTON and NOIDA, India, Feb. 15, 2024 /PRNewswire/ -- Curadev is excited to introduce CRD3874, a first-in-class allosteric small molecule STING agonist, with distinct pharmacological properties that distinguish it from agents that bind to STING's cGAMP site.

Key Points: 
  • BOSTON and NOIDA, India, Feb. 15, 2024 /PRNewswire/ -- Curadev is excited to introduce CRD3874, a first-in-class allosteric small molecule STING agonist, with distinct pharmacological properties that distinguish it from agents that bind to STING's cGAMP site.
  • An intravenous formulation of this lead asset (CRD3874-SI) recently received approval from the US FDA for use in first-in-human studies in patients with advanced solid cancers.
  • These features of CRD3874-SI predict a high therapeutic index in humans and support clinical investigation of this agent in cancer patients.
  • The poster was co-authored by Dr. Ciara Kelly , MD, Memorial Sloan Kettering Cancer Center, who is the PI for the FIH study ( NCT06021626 ).

Benitec Biopharma Releases Second Quarter 2024 Financial Results and Provides Operational Update

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星期二, 二月 13, 2024
Form 10-Q, Natural history, Research, Oropharyngeal dysphagia, Oculopharyngeal muscular dystrophy, Data monitoring committee, Dysphagia, FIH, Safety, Patient, Protocol, Disorder, DSMB, Pharmaceutical industry

HAYWARD, Calif., Feb. 13, 2024 (GLOBE NEWSWIRE) -- Benitec Biopharma Inc. (NASDAQ: BNTC) (“Benitec” or “Company”), a clinical-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on its proprietary “Silence and Replace” DNA-directed RNA interference (“ddRNAi”) platform, today announced financial results for its second fiscal quarter ended December 31, 2023. The Company has filed its quarterly report on Form 10-Q with the U.S. Securities and Exchange Commission.

Key Points: 
  • HAYWARD, Calif., Feb. 13, 2024 (GLOBE NEWSWIRE) -- Benitec Biopharma Inc. (NASDAQ: BNTC) (“Benitec” or “Company”), a clinical-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on its proprietary “Silence and Replace” DNA-directed RNA interference (“ddRNAi”) platform, today announced financial results for its second fiscal quarter ended December 31, 2023.
  • Following the DSMB recommendation, a second subject has been scheduled to receive BB-301 in February 2024.
  • Total Expenses for the quarter ended December 31, 2023, were $6.9 million compared to $5.6 million for the quarter ended December 31, 2022.
  • The loss from operations for the quarter ended December 31, 2023, was $6.9 million compared to a loss of $5.6 million for the quarter ended December 31, 2022.

IAMA Therapeutics Announces First Subject Dosed in Phase 1 Study of IAMA-6 for the Treatment of Autism and Epilepsy

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星期二, 一月 23, 2024
Health, Neurology, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, IAMA, Spectrum, Myenteric plexus, Epilepsy, NKCC1, DSM-IV codes, FIH, SAD, Therapy, Pharmaceutical industry

IAMA-6, IAMA’s lead program, is being evaluated for the treatment of autism and epilepsy in a Phase 1 first-in-human (FIH), randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study.

Key Points: 
  • IAMA-6, IAMA’s lead program, is being evaluated for the treatment of autism and epilepsy in a Phase 1 first-in-human (FIH), randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study.
  • “We are proud to announce the commencement of the first-in-human trial aimed at establishing a safe dose range for the continued clinical development of our lead program, IAMA-6,” stated Andrea P. Malizia, CEO of IAMA Therapeutics.
  • This significant milestone brings us one step closer to fulfilling our commitment to address the unmet medical needs in this patient population."
  • Initial interim data from this study is expected in June 2024.

RIVERMARK MEDICAL ANNOUNCES COMPLETION OF EXPANDED INDICATION STUDY FOR THE FLOSTENT™ SYSTEM

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星期一, 一月 8, 2024
Urine, Entrepreneurship, Urinary retention, Risk, Rivermark of Santa Clara, Advocate Aurora Health, Urology, DRS, Trial of the century, Prostate, FIH, Patient, Diagnosis, BPH

MILWAUKEE, Jan. 8, 2024 /PRNewswire/ -- Rivermark Medical, a company dedicated to developing a novel therapeutic device for benign prostatic hyperplasia (BPH), announced today the successful completion of its RAPID-UR study, an extended indication study that evaluated the use of the Company's FloStent System in patients suffering urinary retention due to BPH. The pilot study included 11 patients, and procedures were performed by Drs. Ingrid Perscky and Ruben Urena at the Pacifica Salud Costa del Este Hospital in Panama City, Panama.

Key Points: 
  • Ingrid Perscky and Ruben Urena at the Pacifica Salud Costa del Este Hospital in Panama City, Panama.
  • Urinary retention (UR) refers to a patient's inability to pass urine, often requiring placement of a temporary indwelling catheter for relief.
  • We are confident this expanded application of the FloStent System will address this critical unmet need."
  • Clinical data from the RAPID-I FIH study, along with results from the expanded indication study, RAPID-UR, will be presented at upcoming Urology congresses.

Zymeworks Outlines Strategic Priorities and Outlook for 2024 and 2025

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星期四, 一月 4, 2024
HER2, Biotechnology, Autoimmunity, FDA, Spacecraft, GEA, File, Publishing, Inflammation, Society, Cancer, Russell 3000 Index, Conference, IND, BTC, Prevalence, Jazz Pharmaceuticals, GPC3, Webcast, Patient, Senior, Environment, NASDAQ Biotechnology Index, BeiGene, Trial of the century, Standard of care, FIH, Publication, ADC, NBI, BLA, Pharmaceutical industry

Beyond ZW191, we are planning additional IND filings and FIH studies for ZW220 (NaPi2b) and ZW251 (GPC3) to commence in 2025.

Key Points: 
  • Beyond ZW191, we are planning additional IND filings and FIH studies for ZW220 (NaPi2b) and ZW251 (GPC3) to commence in 2025.
  • “Our strong financial position allows us to be opportunistic in evaluating additional R&D opportunities and pursuing potential strategic partnerships and collaborations.
  • We expect to submit INDs for ZW171 and ZW191 in 2024, and INDs for ZW220 and ZW251 in 2025.
  • An R&D Day to highlight our progress and future R&D strategy will be held in the fourth quarter of 2024.

Arvinas and Pfizer Announce Interim Data from Phase 1b Trial of Vepdegestrant in Combination with Palbociclib (IBRANCE®) and Plans to Expand Vepdegestrant Development Program

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星期二, 十二月 5, 2023
CBR, Patient, Febrile neutropenia, ESR1, Breast Cancer Research, HER2, Neoplasm, Infection, Breast cancer, Fulvestrant, PFE, Colorectal cancer, Cyclin-dependent kinase 4, Chimera, Neutropenia, Melanoma, Sarah Cannon Research Institute, DNA, Incidence, Research, CDK4, ARVN, Abstract, FIH, Proteolysis, Face, Webcast, CDK, Safety, PFS, Circulating tumor DNA, Pharmaceutical industry

NEW HAVEN, Conn. and NEW YORK, Dec. 05, 2023 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) today announced clinical data for vepdegestrant (ARV-471), a novel oral PROteolysis TArgeting Chimera (PROTAC®) estrogen receptor (ER) degrader, in combination with palbociclib (IBRANCE®). Interim results from the Phase 1b combination cohort demonstrate encouraging clinical activity in heavily pre-treated patients with a median of four lines of therapy across disease settings with locally advanced or metastatic ER positive/human epidermal growth factor 2 (HER2) negative (ER+/HER2-) breast cancer. These data will be presented in a spotlight presentation at the 2023 San Antonio Breast Cancer Symposium (SABCS).

Key Points: 
  • These data will be presented in a spotlight presentation at the 2023 San Antonio Breast Cancer Symposium (SABCS).
  • The results from this trial evaluating vepdegestrant in combination with palbociclib help advance our goals of benefitting patients with ER+/HER2- breast cancer.
  • “Collectively, the data presented this year at SABCS for vepdegestrant, especially in combination with palbociclib, show the potential of this investigational innovative therapeutic option.
  • A conference call and webcast will be held with executives from Arvinas and Pfizer to discuss the data presented at SABCS.

IAMA Therapeutics Announces Approval of Clinical Trial Application (CTA) by the Italian Medicines Agency (AIFA) to Initiate a Phase 1 Study of IAMA-6 for the Treatment of Autism and Epilepsy

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星期三, 十二月 20, 2023
Biotechnology, Professional Services, Health, Pharmaceutical, Small Business, Neurology, Other Science, Research, Science, Clinical Trials, Finance, IAMA, Epilepsy, Therapy, NKCC1, Pharmacokinetics, Spectrum, Myenteric plexus, FIH, SAD, Safety, CTA, DSM-IV codes, Pharmaceutical industry

“We are proud to announce the first regulatory clearance for our lead program, IAMA-6, which has been shown to be safe and well-tolerated in preclinical studies,” said Andrea P. Malizia, Chief Executive Officer of IAMA Therapeutics.

Key Points: 
  • “We are proud to announce the first regulatory clearance for our lead program, IAMA-6, which has been shown to be safe and well-tolerated in preclinical studies,” said Andrea P. Malizia, Chief Executive Officer of IAMA Therapeutics.
  • “Children living with central nervous system disorders, including autism and epilepsies, face significant unmet medical needs.
  • The compound is designed to directly target and inhibit NKCC1 and neuronal hyperexcitability.
  • The Company expects to begin dosing healthy adults in the Phase 1 study in January 2024.

Outstanding 12-month first-in-human data from Xeltis’ aXess hemodialysis vascular conduit trial presented at VEITHsymposium 2023

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星期五, 十一月 17, 2023
Kidney disease, Fistula, Patient, FIH, Endothelium, Infection, Dialysis, AVF, AVG, Pharmaceutical industry

The data was presented yesterday by Prof. Dr. Frans Moll at the 50th Annual VEITHsymposium in New York.

Key Points: 
  • The data was presented yesterday by Prof. Dr. Frans Moll at the 50th Annual VEITHsymposium in New York.
  • At 12 months, 100% secondary patency, 78% primary assisted patency and 0% infections were observed in data from 20 patients implanted with the aXess conduit.
  • This performance builds on the very encouraging 6-month data presented in April 2023 at the Vascular Access Society Congress in Porto, Portugal.
  • aXess is a restorative conduit which enables the creation of a new, long-term living vessel for hemodialysis vascular access.

Benitec Biopharma Releases First Quarter 2024 Financial Results and Provides Operational Update

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星期一, 十一月 13, 2023
Natural history, Clinical, REB, Oropharyngeal dysphagia, Dysphagia, Safety, Research, Dispute board, Principal investigator, IND, FIH, FDA, Oculopharyngeal muscular dystrophy, HIV disease progression rates, RNA, Pharmaceutical industry, Nursing, Medical imaging, Health insurance, Cryptocurrency, OPMD, Benitec Biopharma

Dosing with BB-301: 1-day of BB-301 dosing to initiate participation in the Phase 1b/2a single-arm, open-label, sequential, dose-escalation cohort study.

Key Points: 
  • Dosing with BB-301: 1-day of BB-301 dosing to initiate participation in the Phase 1b/2a single-arm, open-label, sequential, dose-escalation cohort study.
  • Total Revenues for the quarter ended September 30, 2023, were $0 compared to $0 for the quarter ended September 30, 2022.
  • Total Expenses for the quarter ended September 30, 2023 were $5.9 million compared to $4.6 million for the quarter ended September 30, 2022.
  • The loss from operations for the quarter ended September 30, 2023, was $5.9 million compared to a loss of $4.6 million for the quarter ended September 30, 2022.