FIH

Monopar Therapeutics Reports First Quarter 2023 Financial Results and Recent Developments

Retrieved on: 
Thursday, May 11, 2023
Therapy, Life, Radionuclide, Hair loss, National University of Singapore, National university, VOICE, LVEF, Receptor (biochemistry), Bone marrow, Cancer, Clinical trial, Quality of life, PET, G&A, Cardiotoxicity, Patient, Investment, ASTS, Doxorubicin, FIH, Pancreatic tumor, Breast cancer, Fine chemical, Medical imaging, Pharmaceutical industry, Extrusion, Video game, Validation (drug manufacture)

WILMETTE, Ill., May 11, 2023 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical­stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today announced first quarter 2023 financial results and summarized recent developments.

Key Points: 
  • WILMETTE, Ill., May 11, 2023 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical­stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today announced first quarter 2023 financial results and summarized recent developments.
  • Results for the First Quarter Ended March 31, 2023, Compared to the First Quarter Ended March 31, 2022
    Cash, cash equivalents and short­term investments as of March 31, 2023, were $11.7 million.
  • R&D expenses for the first quarter of 2023 were $1,653,000 compared to $1,678,000 for the first quarter of 2022.
  • G&A expenses for the first quarter of 2023 were $872,000 compared to $779,000 for the first quarter of 2022.

RQM+™ Acquires Libra Medical

Retrieved on: 
Wednesday, May 10, 2023
Biotechnology, Health, Clinical Trials, Medical Devices, Partnership, University, Boston Scientific, AMS, Massachusetts Institute of Technology, Acquisition, Chemical engineering, FIH, Medtech, St. Jude Medical, Pharmaceutical industry, RQM

RQM+, the world’s leading MedTech service provider, today announced the acquisition of Libra Medical, a full-service contract research organization (CRO) that specializes in early-stage clinical trials.

Key Points: 
  • RQM+, the world’s leading MedTech service provider, today announced the acquisition of Libra Medical, a full-service contract research organization (CRO) that specializes in early-stage clinical trials.
  • Founded in 2007, Libra Medical provides regulatory affairs, clinical operations and quality assurance services to companies that develop complex medical devices and diagnostics products.
  • We are honored to have Dr. Tay, the founder of Libra Medical, join RQM+ to continue the strong relationships she has established with the early-stage MedTech community and the FDA.”
    With more than 20 years of MedTech expertise, Libra Medical CEO Sew-Wah Tay was the vice president of regulatory and clinical affairs at American Medical Systems (AMS).
  • She also served in leadership roles at multiple MedTech startups, St. Jude Medical and Boston Scientific.

Myrtelle to Host Symposium on Gene Therapies Targeting Oligodendrocytes and Implications in Brain Function and Disease States at the American Society of Gene and Cell Therapy 26th Annual Meeting in Los Angeles on Friday, May 19, 2023

Retrieved on: 
Wednesday, May 10, 2023
Health, Genetics, Clinical Trials, Research, Science, Biotechnology, CD, Learning, Neuron, Canavan disease, Inc., University, Gene, Senior, Boonshoft School of Medicine, Clinical trial, Neuroscience, Brain, Cell, Multiple sclerosis, DSM-IV codes, Associate, Assistant, Cerebral cortex, Chromosome 11, Wright, Rita Raave, Leukodystrophy, Neurology, FIH, Patient, Society, Vaccine, Canavan, Myrtelle Canavan, Medicine

The symposium will highlight historical and emerging views of oligodendrocytes in normal brain function and a growing array of disease states, including leukodystrophies and disorders of myelin production such as multiple sclerosis.

Key Points: 
  • The symposium will highlight historical and emerging views of oligodendrocytes in normal brain function and a growing array of disease states, including leukodystrophies and disorders of myelin production such as multiple sclerosis.
  • Oligodendrocytes perform numerous key functions in the brain - including the production of myelin, the insulating material that enables proper neuronal function – and are now appreciated as having roles in a range of diseases.
  • Myrtelle is developing a unique toolkit, including a proprietary class of recombinant adeno-associated virus (rAAV) vectors that directly target these cells.
  • “Given the intractable nature of many neurological diseases, these cells represent important brain components worthy of interrogation in the quest for novel interventions, including gene therapies.

Microbot Medical Initiates Preparations for First-In-Human (FIH) Cases in Brazil for the LIBERTY® Robotic System

Retrieved on: 
Monday, May 8, 2023
FIH, Clinical trial, University, Patient, Medical device

HINGHAM, Mass., May 08, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), the developer of the LIBERTY Robotic system, the first fully disposable endovascular robotic system, announced that it has initiated preparations for potential First-In-Human cases in Brazil, by engaging with distinguished publisher and lecturer interventional radiologist Prof. Francisco Cesar Carnevale.

Key Points: 
  • HINGHAM, Mass., May 08, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), the developer of the LIBERTY Robotic system, the first fully disposable endovascular robotic system, announced that it has initiated preparations for potential First-In-Human cases in Brazil, by engaging with distinguished publisher and lecturer interventional radiologist Prof. Francisco Cesar Carnevale.
  • The engagement with Prof. Carnevale, from the prestigious University of Sao Paulo Medical School Hospital, is expected to support the Company's intention to conduct a FIH clinical trial in Brazil as part of its ongoing clinical and regulatory efforts.
  • “Following the successful usage of the LIBERTY system in over 100 pre-clinical catheterization procedures, and the value the Key Opinion Leaders that have performed those cases see in the LIBERTY system, the engagement with Prof. Carnevale to perform the first clinical cases represents a major step as we aim to continue our efforts toward regulatory approvals and commercialization,” commented Harel Gadot, Chairman, CEO and President.
  • “Parallel to working in our main target markets for our innovative robotic system, like the US and Europe, we are constantly seeking additional collaboration and key opinion leaders, who wish to benefit their patients and the healthcare provider in their respective markets.”
    The potential clinical cases are expected to commence upon completion of the verification & validation process of the LIBERTY Robotic system, as well as obtaining the necessary regulatory approvals to perform those cases.

Xeltis presents excellent six-month first-in-human data from aXess hemodialysis vascular graft trial at Vascular Access Society Congress

Retrieved on: 
Friday, April 28, 2023
University of Insubria, Infection, Kidney disease, Surgeon, University, Chronic kidney disease, Congress, Patient, Risk, FIH, CKD, Vascular surgery, Fistula, Medical imaging, Birth control, Pharmaceutical industry, EU

aXess graft demonstrated excellent patency, low rates of infection and re-intervention

Key Points: 
  • aXess graft demonstrated excellent patency, low rates of infection and re-intervention
    EINDHOVEN, The Netherlands – 28 April 2023, Xeltis, a developer of transformative implants that enable the natural creation of living and long-lasting vessels and valves, today presents highly-encouraging six-month data from its first-in-human (FIH) aXess vascular graft trial ( NCT04898153 ) at the 13th Congress of the Vascular Access Society in Porto, Portugal.
  • aXess is a vascular access graft for patients with chronic kidney disease (CKD) requiring hemodialysis.
  • In six-month data from the FIH trial, the aXess graft demonstrated high patency rates (80% primary patency, 95% primary assisted patency, 100% secondary patency).
  • The full data will be presented by Matteo Tozzi, Professor of Vascular Surgery, University of Insubria, Italy, in a presentation entitled: aXess Vascular Graft – FIH trial 6-month outcomes today at 09:05 WEST.

TransCode Therapeutics Announces IRB Approval for FDA Cleared First-In-Human Clinical Trial

Retrieved on: 
Thursday, April 27, 2023
Triple-negative breast cancer, Glioblastoma, Human, Therapy, Clinical trial, Cancer, Pharmacokinetics, Transcoding, Breast, RNA, Someren-Eind, Investigational New Drug, Animal, Patient, IRB, Skin, Metastasis, FIH, Liver, FDA, Recurrence, Safety, TTX, Dana, Pharmaceutical industry, Medical imaging, Operation

The planned clinical trial is to evaluate delivery of TransCode’s lead therapeutic candidate, TTX-MC138, to metastatic lesions in up to 12 cancer patients with advanced solid tumors.

Key Points: 
  • The planned clinical trial is to evaluate delivery of TransCode’s lead therapeutic candidate, TTX-MC138, to metastatic lesions in up to 12 cancer patients with advanced solid tumors.
  • “We are very pleased to have received IRB Approval for our FIH clinical trial,” said TransCode’s Chief Executive Officer and co-founder, Michael Dudley.
  • “We are pleased that the FDA and IRB have completed their reviews of the Phase 0 clinical trial application and authorized commencement of the trial,” said Susan Duggan, TransCode’s Senior Vice President of Operations.
  • “The FDA authorization and IRB approval to initiate this trial mark the development of TransCode Therapeutics into a clinical-stage oncology company.“

Reviva Pharmaceuticals to Host Key Opinion Leader Event on Brilaroxazine (RP5063) in Phase 3 Clinical Trials for Schizophrenia

Retrieved on: 
Tuesday, April 25, 2023
Molecule, PD, Pharmacogenomics, Drug, Patient, Environment, Neurology, Clinical, BCPP, University, CSO, Allodynia, Parexel, DSM-IV codes, Capsaicin, Magnetic resonance, MRS, RP5063, UV, NGF, FIH, CSF, Serotonin, ChromeOS, Safety, Public key certificate, FCCP, Research, Neurodegenerative disease, KOL, Central nervous system, Drug development, Doctor of Pharmacy, UT, PET, CNS, Bipolar disorder, AD, APEX, Pharmacology, Pharmaceutical industry, Schizophrenia, Psychopharmacology, Depression, Psychiatry, Pharmacy

He will look at brilaroxazine, a next-generation serotonin-dopamine modulator, and its potential as a treatment solution for schizophrenia.

Key Points: 
  • He will look at brilaroxazine, a next-generation serotonin-dopamine modulator, and its potential as a treatment solution for schizophrenia.
  • The Reviva leadership team will provide an overview of the efficacy and safety data generated in the clinical trials completed to date and an update on ongoing RECOVER Phase 3 trial evaluating brilaroxazine in patients with acute schizophrenia.
  • Brilaroxazine is a new chemical entity with broad therapeutic potential in neuropsychiatric and inflammatory conditions arising from underlying dysfunction in serotonin and dopamine signaling.
  • Dr. Ereshefsky’s unique perspective as a clinical scientist (clinical psychiatric pharmacist and psychopharmacologist) helps to guide drug development from preclinical to late Phase.

Myrtelle Announces Positive 6-month Post-Treatment Data in Patients in Its First-in-Human Clinical Study of rAAV-Olig001-ASPA Gene Therapy in Canavan Disease

Retrieved on: 
Wednesday, April 19, 2023
Health, Genetics, Clinical Trials, Research, Science, Biotechnology, CD, Gross, Canavan disease, Inc., Natural history, Boonshoft School of Medicine, In vivo magnetic resonance spectroscopy, OH, Clinical trial, Mutation, Neuroscience, Brain, ASPA, Cerebrospinal fluid, Language, Assistant, NAA, Chromosome 11, MRI, MRS, Magnetic resonance imaging, Metabolism, MD, Patient, Wright, N-Acetylaspartic acid, Preyasi Raave, Annual general meeting, Neurology, White matter, CSF, FIH, Medical imaging, Medicine

In several domains, the observed improvement in treated patients are in contrast to the observed deterioration in untreated age-matched CD patients within Myrtelle’s natural history data set.

Key Points: 
  • In several domains, the observed improvement in treated patients are in contrast to the observed deterioration in untreated age-matched CD patients within Myrtelle’s natural history data set.
  • In CD, normal brain development is impaired due to a mutation in the ASPA gene that encodes the enzyme Aspartoacylase (ASPA).
  • The oligodendrocyte-targeting rAAV vector-based gene therapy is intended to restore ASPA function and hence the metabolism of NAA and brain development in patients with CD.
  • In addition, volumetric MRI (magnetic resonance imaging) measurements showed increases in multiple brain tissue compartments and reductions in CSF volume.

FSD Pharma Achieves Milestone in Completion of Dosing of Sentinel Subjects in First-in-Human Clinical Trial of Lucid-MS (Lucid-21-302) for Multiple Sclerosis

Retrieved on: 
Monday, April 17, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, Infection, Injection, CSE, Central nervous system, Depression, Prevalence, FSD, Spasm, Anxiety, Blurred vision, Spinal cord, Atlas, Clinical trial, Deficit spending, Hypoesthesia, Research, Brain, Immobilization, Multiple sclerosis, FRA, MS, Multiple Sclerosis Society, Pain, Nerve, New chemical entity, Fatigue, Dizziness, Death, Patient, Respiratory failure, FIH, Diagnosis, Safety, Disease, Pharmaceutical industry, Lithium

The sentinel dose was completed on Sunday, April 16, 2023.

Key Points: 

Aditxt Issues Shareholder Update

Retrieved on: 
Monday, April 17, 2023
Health, Infectious Diseases, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, GMP, Allergy, Plague, DNA, Therapy, Safety, COVID-19, CTA, Research, Infection, CNS, Sale, Psoriasis, Acquisition, Patient, Immune system, Autoimmune disease, Medicine, Viral, FIH, FDA, Bankruptcy, Vaccine, Auction, Management, Pharmaceutical industry, Fine chemical, Lucira

Aditxt,® Inc, (NASDAQ: ADTX) (“Aditxt” or the “Company”), a global innovation company focused on therapeutics and technologies that monitor and modulate the immune system, is pleased to provide an important update regarding its three innovation programs and strategic M&A initiatives.

Key Points: 
  • Aditxt,® Inc, (NASDAQ: ADTX) (“Aditxt” or the “Company”), a global innovation company focused on therapeutics and technologies that monitor and modulate the immune system, is pleased to provide an important update regarding its three innovation programs and strategic M&A initiatives.
  • On April 11, 2023, Aditxt filed an objection to the sale of the assets of Lucira to the winning bidder, raising issues as to the fairness and the good faith of Lucira, as well as questioning value maximization for creditors.
  • “The interest in the Lucira assets at auction shows the sheer value of the test-to-treat model,” said Amro Albanna, co-founder, chairman and CEO of Aditxt and current acting CEO of Pearsanta.
  • Aditxt has also completed the in-life portion of the toxicology studies.