CHDR

EQS-News: G.ST Antivirals reports start of Phase II trial and announces appointment of Ronald Bruce Turner as new Chief Medical Officer

Retrieved on: 
Wednesday, April 10, 2024

An expert in the clinical research of respiratory viruses, Dr. Turner will oversee the Company’s current clinical trial and drive further clinical development.

Key Points: 
  • An expert in the clinical research of respiratory viruses, Dr. Turner will oversee the Company’s current clinical trial and drive further clinical development.
  • This study aims to assess the effectiveness of 2-DG in preventing illness from rhinoviruses, reducing infection rates, and easing symptom severity.
  • A total of 128 volunteers will participate, receiving up to four daily intranasal doses of either 2-DG or a placebo.
  • 2-DG is a unique and intriguing therapeutic approach to treating viral infections by blocking the virus’ nutrient access,” commented Ronald Bruce Turner, MD, CMO of G.ST Antivirals.

Algernon Pharmaceuticals to Move Forward with Psychedelic Drug DMT Stroke Research Program as its Lead Asset

Retrieved on: 
Monday, April 1, 2024

Algernon established Algernon NeuroScience (AGN Neuro), a wholly owned subsidiary, to advance the research and development of the DMT stroke program in 2023.

Key Points: 
  • Algernon established Algernon NeuroScience (AGN Neuro), a wholly owned subsidiary, to advance the research and development of the DMT stroke program in 2023.
  • AGN Neuro has completed a feasibility study and has finalized its clinical trial design for a 40 patient Phase 2a DMT Stroke study.
  • The Phase 2a human stroke trial will study an intravenous sub-psychedelic dose of DMT in patients who are hospitalized after having suffered an acute ischemic stroke.
  • “Algernon is a global leader in this important area of research, and we look forward to further advancing the stroke program through our planned Phase 2a DMT Stroke study.”
    Subjects with a confirmed diagnosis of ischemic stroke will be randomized in blinded fashion to receive either DMT or placebo.

Arvinas Announces First-in-Human Dosing of ARV-102, an Investigational PROTAC® Protein Degrader for Neurodegenerative Disease

Retrieved on: 
Tuesday, February 20, 2024

NEW HAVEN, Conn., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced that the first subject was dosed in its Phase 1 clinical trial of ARV-102, the Company’s first oral PROTAC® (PROteolysis-TArgeting Chimera) protein degrader in development to treat neurodegenerative diseases. In preclinical studies, ARV-102 has been shown to cross the blood-brain barrier and degrade leucine-rich repeat kinase 2 (LRRK2), which is a large multidomain scaffolding kinase. Increased activity and expressions of LRRK2 is genetically involved in the pathogenesis of neurological diseases including Parkinson’s disease and progressive supranuclear palsy.

Key Points: 
  • In preclinical studies, ARV-102 has been shown to cross the blood-brain barrier and degrade leucine-rich repeat kinase 2 (LRRK2), which is a large multidomain scaffolding kinase.
  • Increased activity and expressions of LRRK2 is genetically involved in the pathogenesis of neurological diseases including Parkinson’s disease and progressive supranuclear palsy.
  • In non-human primates, orally administered ARV-102 has been shown to reach deep-brain regions and degrade LRRK2 by nearly 90%.
  • The Phase 1 clinical trial of ARV-102 is enrolling healthy volunteers at the Centre for Human Drug Research (CHDR) in Leiden, the Netherlands.

Algernon NeuroScience Announces 40 Patient Phase 2 Psychedelic Drug DMT Stroke Study

Retrieved on: 
Tuesday, August 8, 2023

VANCOUVER, British Columbia, Aug. 08, 2023 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc. (the “Company” or “AGN Pharma”) (CSE: AGN) (FRANKFURT: AGW0) (OTCQB: AGNPF), a Canadian clinical stage pharmaceutical development company, is pleased to announce that its subsidiary Algernon NeuroScience (AGN Neuro), has completed a feasibility study and has finalized its clinical trial design for a 40 patient Phase 2 DMT Stroke study.

Key Points: 
  • VANCOUVER, British Columbia, Aug. 08, 2023 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc. (the “Company” or “AGN Pharma”) (CSE: AGN) (FRANKFURT: AGW0) (OTCQB: AGNPF), a Canadian clinical stage pharmaceutical development company, is pleased to announce that its subsidiary Algernon NeuroScience (AGN Neuro), has completed a feasibility study and has finalized its clinical trial design for a 40 patient Phase 2 DMT Stroke study.
  • The Phase 2 human stroke trial will study an intravenous sub-psychedelic dose of DMT in patients who are hospitalized after having suffered an acute ischemic stroke.
  • Algernon consultant Dr. Rick Strassman, DMT research pioneer and author of the books DMT: The Spirit Molecule and The Psychedelic Handbook commented: “I am encouraged by the results of Algernon’s Phase 1 study in which a prolonged infusion of DMT achieved the desired pharmacokinetics.
  • “We are investigating DMT as a potential new therapeutic treatment that could have a positive impact on ischemic stroke patients worldwide.”

Vaxxinity Announces UB-312 Successfully Met Primary Objectives of Phase 1 Clinical Trial in Parkinson’s Disease

Retrieved on: 
Thursday, June 22, 2023

CAPE CANAVERAL, Fla., June 22, 2023 (GLOBE NEWSWIRE) --  Vaxxinity, Inc. (Nasdaq: VAXX), a U.S. company pioneering the development of a new class of medicines today announced positive results from Part B of its Phase 1 clinical trial of UB-312, an investigational vaccine for Parkinson’s disease (PD), demonstrating UB-312 was well-tolerated and induced anti-alpha-synuclein (aSyn) antibody responses in participants with early PD, meeting the primary objectives of the trial.

Key Points: 
  • Results are consistent with conclusions from Phase 1 Part A and preclinical studies, and support advancement of UB-312 into further clinical development.
  • “These positive Phase 1 results demonstrate several important features necessary for an immunotherapy against Parkinson’s disease and other synucleinopathies to be successful, and represent a further proof-of-principle for Vaxxinity’s platform in chronic disease,” said Mei Mei Hu, CEO of Vaxxinity.
  • “UB-312 was observed to safely break immune tolerance, inducing antibodies against toxic aggregated forms of alpha-synuclein.
  • Together these results support the further development of UB-312 in a Phase 2 clinical trial.

Delix Therapeutics Appoints Aaron Koenig, MD as Chief Medical Officer

Retrieved on: 
Monday, June 12, 2023

BOSTON, June 12, 2023 /PRNewswire/ -- Delix Therapeutics (the "Company"), a neuroscience company developing novel neuroplasticity-promoting therapeutics for psychiatric and neurological conditions, today announced the appointment of Dr. Aaron Koenig as Chief Medical Officer. Dr. Koenig will oversee Delix's clinical development programs, team build-out, and broader development strategy as the company advances its psychoplastogen platform of novel disease-modifying therapeutics for serious psychiatric, neurological, and neurodegenerative disorders.

Key Points: 
  • BOSTON, June 12, 2023 /PRNewswire/ -- Delix Therapeutics (the "Company"), a neuroscience company developing novel neuroplasticity-promoting therapeutics for psychiatric and neurological conditions, today announced the appointment of Dr. Aaron Koenig as Chief Medical Officer.
  • Dr. Koenig joins the company from Sage Therapeutics, where he served most recently as Vice President of Early Medical Science and helped design and oversee clinical-stage programs, including compounds targeting a range of neuropsychiatric and neurodegenerative and disorders.
  • "As Delix navigates its phase I trial for the novel compound DLX-001, Dr. Koenig's experience in early clinical development will be crucial to advancing our novel neuroplasticity-promoting therapeutics," said Delix Therapeutics Head of Research & Development Dr. Eliseo Salinas.
  • A non-hallucinogenic psychoplastogen, DLX-001 is the first of several psychoplastogens in the Delix platform to be approved for human trials.

ISA Pharmaceuticals to Present Pre-clinical Data on its Protective SLP Therapy Against SARS-CoV-2 at the CIMT Annual Meeting

Retrieved on: 
Thursday, April 27, 2023

ISA106, a SARS-CoV-2 immunotherapeutic, consists of multiple SLPs derived from the S, N and M proteins, carefully designed for optimal immunogenicity, administration and manufacturability.

Key Points: 
  • ISA106, a SARS-CoV-2 immunotherapeutic, consists of multiple SLPs derived from the S, N and M proteins, carefully designed for optimal immunogenicity, administration and manufacturability.
  • These are demonstrable ex vivo in peripheral blood mononuclear cells (PBMCs) from convalescent donors who recovered from SARS-CoV-2 infection.
  • The data support further development of ISA106 for the protection of immunocompromised people for whom currently approved SARS-CoV-2 vaccines are insufficiently protective."
  • If you would like to meet with ISA Pharmaceuticals at the above event, please contact us at [email protected] .

ISA Pharmaceuticals to Present Pre-clinical Data on its Protective SLP Therapy Against SARS-CoV-2 at the CIMT Annual Meeting

Retrieved on: 
Thursday, April 27, 2023

ISA106, a SARS-CoV-2 immunotherapeutic, consists of multiple SLPs derived from the S, N and M proteins, carefully designed for optimal immunogenicity, administration and manufacturability.

Key Points: 
  • ISA106, a SARS-CoV-2 immunotherapeutic, consists of multiple SLPs derived from the S, N and M proteins, carefully designed for optimal immunogenicity, administration and manufacturability.
  • These are demonstrable ex vivo in peripheral blood mononuclear cells (PBMCs) from convalescent donors who recovered from SARS-CoV-2 infection.
  • The data support further development of ISA106 for the protection of immunocompromised people for whom currently approved SARS-CoV-2 vaccines are insufficiently protective."
  • If you would like to meet with ISA Pharmaceuticals at the above event, please contact us at [email protected] .

Algernon NeuroScience Provides Update on Phase 1 DMT Clinical Study, Drug Found Safe to Proceed to Next Phase

Retrieved on: 
Thursday, February 16, 2023

The trial is being conducted at the Centre for Human Drug Research (“CHDR”) in Leiden, Netherlands.

Key Points: 
  • The trial is being conducted at the Centre for Human Drug Research (“CHDR”) in Leiden, Netherlands.
  • In addition, several pharmacodynamic measures believed to be associated with neuroplasticity, including both measurements of biochemical markers and electroencephalographic readings, will be recorded.
  • There will be up to 60 healthy volunteers enrolled in total, which will include both psychedelic experienced and psychedelic naïve subjects.
  • “Although DMT has been previously investigated in humans, we are breaking new ground in this study in terms of both the length of the infusion and the frequency of exposure.”

AIM ImmunoTech Reports Positive Safety, Tolerability and Biological Activity Data for Intranasal Ampligen® (Rintatolimod) in Healthy Subjects

Retrieved on: 
Thursday, December 8, 2022

OCALA, Fla., Dec. 08, 2022 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus, today reported that data were recently presented by Lisanne C.A. Smidt - Centre for Human Drug Research (CHDR), Leiden, the Netherlands in a poster titled, “Safety, tolerability and biological activity of repeated intranasal administration of TLR3 agonist Ampligen (Poly I:Poly C12U) in healthy subjects,” at the British Society for Immunology Congress 2022 . The data showed positive safety, tolerability and biological activity of a 13-day dosing regimen conducted in Q2 2021 for intranasal Ampligen® (rintatolimod) in healthy subjects.

Key Points: 
  • Smidt - Centre for Human Drug Research (CHDR), Leiden, the Netherlands in a poster titled, “Safety, tolerability and biological activity of repeated intranasal administration of TLR3 agonist Ampligen (Poly I:Poly C12U) in healthy subjects,” at the British Society for Immunology Congress 2022 .
  • The data showed positive safety, tolerability and biological activity of a 13-day dosing regimen conducted in Q2 2021 for intranasal Ampligen® (rintatolimod) in healthy subjects.
  • Intranasal administration of Ampligen could induce an innate mucosal immune response, thereby inhibiting respiratory viruses at the point of entry.
  • Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA.