Ethics committee

Autonomix Medical, Inc. Reports Third Quarter FY2024 Financial Results and Reiterates Upcoming Key Milestones

Retrieved on: 
Wednesday, February 14, 2024
Engineering, Ethics committee, Nervous system, Research, POC, AMIX, Collateral damage, Marketing, Quality of life, Pain, Calendar, Ethics, IPO, Advertising, Launch, Completeness, Patient, Clinical trial, Disease, Pancreatic cancer, Trial of the century, Ethanol, Medical imaging

THE WOODLANDS, TX, Feb. 14, 2024 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated, reported financial results yesterday for the third quarter FY2024 ended December 31, 2023 and provided a corporate update.

Key Points: 
  • “I am incredibly pleased with the progress we have made on the corporate, financial and clinical fronts in such a short period of time.
  • We are grateful for the continued support and remain focused on successfully executing on the milestones laid out ahead of us,” commented Lori Bisson, Chief Executive Officer of Autonomix.
  • Achieving “proof-of-concept” in this area could open the door to blockbuster diseases, expanding the horizons for the Company’s technology.
  • Summary of Financial Results for Q3 FY2024 Ended December 31, 2023
    For the nine months ended December 31, 2023 and 2022, the Company incurred net losses of $10.0 million and $1.3 million, respectively.

AIM ImmunoTech Receives Erasmus Medical Center Ethics Board Authorization for Phase 2 Study of Ampligen® for the Treatment of Locally Advanced Pancreatic Cancer

Retrieved on: 
Wednesday, January 24, 2024
AIM, Patient, Cancer, MD, Erasmus MC, Ethics committee, FOLFIRINOX, Safety, Ethics, Doctor of Philosophy, Clinical trial, Pancreatic cancer, Pharmaceutical industry

OCALA, Fla., Jan. 24, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that it has received authorization from the Erasmus Medical Center (“Erasmus MC”) Ethics Committee to open a European site for the ongoing Phase 2 study (“AMP-270”) of Ampligen as a therapy for locally advanced pancreatic cancer.

Key Points: 
  • OCALA, Fla., Jan. 24, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that it has received authorization from the Erasmus Medical Center (“Erasmus MC”) Ethics Committee to open a European site for the ongoing Phase 2 study (“AMP-270”) of Ampligen as a therapy for locally advanced pancreatic cancer.
  • “Approval from the governing ethics board is an important step toward enrolling subjects in the European arm of the AMP-270 clinical trial for locally advanced pancreatic cancer,” stated Prof. Casper H.J.
  • van Eijck, MD, PhD, Pancreato-biliary Surgeon at Erasmus MC in the Netherlands.
  • AMP-270 is expected to enroll approximately 90 subjects in the United States and Europe.

Arrowhead Pharmaceuticals Files for Regulatory Clearance to Initiate Phase 1/2a Study of ARO-CFB for Complement Mediated Kidney Disease

Retrieved on: 
Thursday, December 21, 2023
Health, Medical Devices, Other Health, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Committee, RNA, Liver, RNA interference, System, CFB, Kidney, Kidney disease, Glomerulonephritis, Translational medicine, Arrowhead Pharmaceuticals, Arrowhead, MBA, Clinical trial, Pharmacokinetics, Complement factor B, Ethics committee, Discovery, Safety, Patient, Pharmaceutical industry

Additionally, ARO-CFB may have clinical applications in non-renal diseases involving complement activation.

Key Points: 
  • Additionally, ARO-CFB may have clinical applications in non-renal diseases involving complement activation.
  • ARO-CFB is designed to reduce hepatic expression of complement factor B (CFB), which plays an important regulatory role in amplifying complement alternative pathway activation and has been identified as a promising therapeutic target.
  • James Hamilton, M.D., MBA, Chief of Discovery and Translational Medicine at Arrowhead, said: “IgAN is the most common glomerular disease worldwide, accounting for up to 40% of all cases of glomerulonephritis.
  • Pending clearance, Arrowhead intends to proceed with AROCFB-1001, a Phase 1/2a dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARO-CFB in up to 66 healthy volunteers and patients with complement mediated kidney disease.

Tenet Healthcare Appoints Vineeta Agarwala to Board of Directors

Retrieved on: 
Wednesday, December 13, 2023
Managed Care, Hospitals, Health, Practice Management, Andreessen Horowitz, Biophysics, Genetics, Research, Broad Institute, NYSE, Quality, THC, Investment, Tenet Healthcare, Internal medicine, Computational biology, Doctor of Philosophy, General partnership, Intelligence, Stanford University, Ethics committee, Harvard Medical School, Drug development, Management, Tenet

Tenet Healthcare Corporation (NYSE: THC) today announced the appointment of Vineeta Agarwala, M.D., PhD, to its Board of Directors, effective immediately.

Key Points: 
  • Tenet Healthcare Corporation (NYSE: THC) today announced the appointment of Vineeta Agarwala, M.D., PhD, to its Board of Directors, effective immediately.
  • Dr. Agarwala will serve as a member of the Quality, Compliance, and Ethics Committee, as well as the Human Resources Committee, increasing the size of the Board to 13 directors.
  • “We are pleased to welcome Dr. Vineeta Agarwala to the Tenet Board,” said Saum Sutaria, M.D., Chairman and Chief Executive Officer of Tenet.
  • “Vineeta is a leader in healthcare in her own right.

Arrowhead Pharmaceuticals Files for Regulatory Clearance to Initiate Phase 1/2a Study of ARO-DM1 for Type 1 Myotonic Dystrophy

Retrieved on: 
Tuesday, November 28, 2023
Biotechnology, Medical Devices, Health, Pharmaceutical, Clinical Trials, Life expectancy, Safety, Cataract, RNA interference, Exercise, Arrowhead, Clinical trial, DMPK, DM1, Wheelchair, Pharmacokinetics, Muscle weakness, Messenger, Therapy, Ethics committee, MBA, Committee, Wasting, Myotonia, Arrowhead Pharmaceuticals, Patient, Facial muscles, Discovery, Translational medicine, RNA, Pharmaceutical industry

Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it has filed an application for clearance to initiate a Phase 1/2a clinical trial of ARO-DM1, the company’s investigational RNA interference (RNAi) therapeutic being developed as a potential treatment for type 1 myotonic dystrophy (DM1), the most common adult-onset muscular dystrophy.

Key Points: 
  • Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it has filed an application for clearance to initiate a Phase 1/2a clinical trial of ARO-DM1, the company’s investigational RNA interference (RNAi) therapeutic being developed as a potential treatment for type 1 myotonic dystrophy (DM1), the most common adult-onset muscular dystrophy.
  • ARO-DM1 is designed to reduce expression of the dystrophia myotonica protein kinase (DMPK) gene.
  • Treatments have focused on symptomatic management, including physical therapy, exercise, ankle-foot orthoses, wheelchairs, and other assistive devices.
  • Pending clearance, Arrowhead intends to proceed with ARODM1-1001, a Phase 1/2a dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARO-DM1 in up to 48 subjects with DM1.

Arch Biopartners Submits Application to the Turkish Ministry of Health to Conduct a Phase II Cardiac Surgery Associated-Acute Kidney Injury Trial for LSALT Peptide

Retrieved on: 
Friday, September 22, 2023
Conlon, CABG, Prevalence, Science Advances, Acute kidney injury, Oxygen, MOH, OTCQB, CPB, Arch, IRI, Inflammation, Ethics committee, AKI, Dialysis, Data monitoring committee, Cardiopulmonary bypass, Ministry, Ischemia, Investigational New Drug, Patient, TMX Group, Risk, Renal replacement therapy, Disease, Kidney, Ministry of Health (Kuwait), Reperfusion, Liver, Mortality, FDA, Food, Safety, National Research Council, Pharmaceutical industry, Hospital

LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.

Key Points: 
  • LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.
  • This application in Turkey follows the Company’s submission of an Investigational New Drug Application to the U.S. Food and Drug Administration’s (FDA).
  • The FDA subsequently granted the Company permission to proceed with this Phase II trial in late June .
  • Of this total, the application to the MoH requests permission to recruit up to 150 patients in Turkey.

Charlotte's Web Reports 2023 Second Quarter Financial Results

Retrieved on: 
Thursday, August 10, 2023
Coalition, CWEB, Sportsmen's Heritage And Recreational Enhancement Act of 2013, Congress, Natural American Spirit, Toxicology, Sport, American Legion, Press release, House, American Tobacco Company, NYSE, Interstate Commerce Committee, Nielsen Holdings, The Vitamin Shoppe, Auckland CBD, PBC, Human, Ethics committee, ACV, Hearing, TSX, Growth, FDA, IND, Safety, Legislation, LSE, Request, Energy, Millennials, Access, BTI, Charlotte's Web, Partnership, Stark Industries, Financial services, All, Clinical trial, Cannabinoid, Ethics, Premier Lacrosse League, Richard Genzer, Regulation of tobacco by the U.S. Food and Drug Administration, Food, Pharmaceutical industry, Dietary supplement, Online shopping, CBD, Operation

Net revenue of $16.0M vs. $18.9M YoY

Key Points: 
  • Net revenue of $16.0M vs. $18.9M YoY
    LOUISVILLE, Colo., Aug. 10, 2023 /PRNewswire/ - (TSX: CWEB) (OTCQX: CWBHF), Charlotte's Web Holdings, Inc. ("Charlotte's Web" or the "Company"), the market leader in full spectrum hemp extract wellness products, today reported financial results for the second quarter ended June 30, 2023.
  • During the second quarter, the U.S. Food and Drug Administration ("FDA") committed to "work at speed" with Congress to resolve a regulatory pathway for hemp-derived CBD.
  • Recent progress has been encouraging surrounding The Hemp Derived Consumer Protection and Market Stabilization Act of 2023, (bill H.R.
  • Charlotte's Web and industry peers have compiled and shared safety and toxicology data with Congress to address concerns raised by the FDA.

Entrada Therapeutics Reports Second Quarter 2023 Financial Results

Retrieved on: 
Tuesday, August 8, 2023
Ethics committee, Research and development, Pharmacokinetics, G&A, Research, Duchenne, Entrada, REC, MHRA, Clinical trial, Patient, Administration, United Kingdom, Medicines and Healthcare products Regulatory Agency, R, FDA, Wells Fargo, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, General Administration of Press and Publication, Therapy, Safety, Conference, Food, Cryptocurrency, Pharmaceutical industry, Video game

BOSTON, Aug. 08, 2023 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA), a biopharmaceutical company aiming to transform the lives of patients by establishing intracellular Endosomal Escape Vehicle (EEV™)-therapeutics as a new class of medicines, today reported financial results for the second quarter ending June 30, 2023, and highlighted recent business updates.

Key Points: 
  • – $377 million in cash, cash equivalents and marketable securities as of June 30, 2023 –
    BOSTON, Aug. 08, 2023 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA), a biopharmaceutical company aiming to transform the lives of patients by establishing intracellular Endosomal Escape Vehicle (EEV™)-therapeutics as a new class of medicines, today reported financial results for the second quarter ending June 30, 2023, and highlighted recent business updates.
  • Research & Development (R&D) Expenses: R&D expenses were $26.3 million for the second quarter of 2023, compared to $16.2 million for the same period in 2022.
  • General & Administrative (G&A) Expenses: G&A expenses were $8.2 million for the second quarter of 2023, compared to $7.3 million for the same period in 2022.
  • Net Loss: Net loss was $25.9 million for the second quarter of 2023, compared to a net loss of $23.2 million for the same period in 2022.

Biophytis receives a positive opinion for its SARA-31 phase 3 study in sarcopenia in Europe

Retrieved on: 
Tuesday, August 8, 2023
Disease, Euronext Growth, CET, Therapy, COVID-19, Clinical trial, Ageing, Life expectancy, Sarcopenia, Abivax, EMA, European Medicines Agency, Ethics committee, Walking, Patient, FDA, Notifiable disease, Food, Respiratory failure, Pharmaceutical industry

The launch of the Phase 3 program follows the promising results obtained in the SARA-INT Phase 2b study, and the scientific advice given in 2022 by the EMA (European Medicine Agency), which helped define the conditions for starting such a study in Europe, specifying the Phase 3 protocol.

Key Points: 
  • The launch of the Phase 3 program follows the promising results obtained in the SARA-INT Phase 2b study, and the scientific advice given in 2022 by the EMA (European Medicine Agency), which helped define the conditions for starting such a study in Europe, specifying the Phase 3 protocol.
  • Final authorization depends on a positive opinion from the Ethics Committee in Belgium.
  • Further authorizations may be requested in other countries, depending on the needs of the study.
  • Despite the enormous medical need posed by this disease, no drug is currently approved anywhere in the world.

Entrada Therapeutics Receives Authorization in the United Kingdom to Initiate Phase 1 Clinical Trial of ENTR-601-44 for the Potential Treatment of Duchenne Muscular Dystrophy

Retrieved on: 
Tuesday, August 1, 2023
Ethics committee, Duchenne muscular dystrophy, Therapy, Pharmacokinetics, Duchenne, Entrada, REC, MHRA, Clinical trial, Patient, Medicines and Healthcare products Regulatory Agency, Phase 1, Safety, Pharmaceutical industry

BOSTON, Aug. 01, 2023 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA), a biopharmaceutical company aiming to transform the lives of patients by establishing intracellular Endosomal Escape Vehicle (EEV™)-therapeutics as a new class of medicines, today announced that it has received authorization from the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) and Research Ethics Committee (REC) for its CTIMP (Clinical Trial of an Investigational Medicinal Product) for a Phase 1 clinical trial in healthy volunteers for ENTR-601-44. ENTR-601-44 is Entrada’s lead product candidate within its Duchenne franchise and is being developed for the potential treatment of individuals with Duchenne who are exon 44 skipping amenable.

Key Points: 
  • ENTR-601-44 is Entrada’s lead product candidate within its Duchenne franchise and is being developed for the potential treatment of individuals with Duchenne who are exon 44 skipping amenable.
  • “We are looking forward to this important next step in advancing ENTR-601-44 for the potential treatment of people with exon 44 skipping amenable Duchenne muscular dystrophy, where there exists a profound unmet medical need,” said Dipal Doshi, President and Chief Executive Officer of Entrada Therapeutics.
  • The trial will also evaluate tolerability, pharmacokinetics and target engagement as measured by exon skipping in the skeletal muscle.
  • The first participant is expected to be dosed in September of this year with data anticipated in the second half of 2024.