Data monitoring committee

Clearmind Medicine CEO Issues Letter to Shareholders

Retrieved on: 
Tuesday, April 9, 2024
Data monitoring committee, Depression, Obesity, Mevalonate pathway, Psychiatry, Dyskinesia, Addiction, Safety, Binge drinking, Data, DSM-IV codes, Research, MEAI, Clinical trial, Johns Hopkins University, Phase, Patent, Therapy, Ministry, FDA, Impulsivity, CTS, IRB, Pharmaceutical industry

Recently, our efforts reached a key inflection point as the Israeli Ministry of Health approved our Phase I/IIa clinical trial for CMND-100 for AUD.

Key Points: 
  • Recently, our efforts reached a key inflection point as the Israeli Ministry of Health approved our Phase I/IIa clinical trial for CMND-100 for AUD.
  • CMND-100, a pioneering MEAI-based (5-methoxy-2-aminoindane) formula, has exhibited encouraging results in pre-clinical studies.
  • Notably, it has shown the ability to disrupt the destructive cycle of binge drinking without inducing hallucinations—a common concern with existing treatments.
  • The journey ahead is filled with potential, and we eagerly anticipate sharing impactful updates with our shareholders."

Galectin Therapeutics Reports the Positive Outcome of the Fifth Data and Safety Monitoring Board Meeting for NAVIGATE Phase 2b/3 Study of Belapectin in Patients with Cirrhotic Portal Hypertension Caused by Metabolic Dysfunction-Associated SteatoHepatitis

Retrieved on: 
Tuesday, April 9, 2024
Data monitoring committee, Cirrhosis, Metabolism, Disease, Risk, Patient, Hope, MASH, Final Analysis, Therapy, GALT, Safety, DSMB, Interim, Plasma protein binding, Esophageal varices, Liver, Pharmaceutical industry

The objective of this fifth DSMB meeting was to further review the emerging tolerance and safety profiles of belapectin.

Key Points: 
  • The objective of this fifth DSMB meeting was to further review the emerging tolerance and safety profiles of belapectin.
  • Based on its deliberation, which included an unblinded review of the data collected thus far, the DSMB concluded that NAVIGATE can continue as designed, without modifications.
  • The Phase 2b/3 NAVIGATE study is a global, seamless, adaptive, randomized, placebo-controlled, double-blind trial.
  • Enrolled patients have been randomized to receive every two weeks a blinded infusion of belapectin at 2 mg/kg/LBM or 4 mg/kg/LBM or placebo.

BioRestorative Therapies Announces Filing of 2023 Annual Report on Form 10-K

Retrieved on: 
Monday, April 1, 2024
Administration, Annual report, B cell, Obesity, Development, Cell, Patent, Library, Visual analogue scale, Patient, DSM-IV codes, Data monitoring committee, Form 10-K, Security (finance), Functional, Adipocyte, Type 2 diabetes, Small business, Investment, Research and development, NOA, European Patent Convention, Safety, Infrared spectroscopy correlation table, Orthopaedic Research Society, Annual general meeting, Pharmaceutical industry

MELVILLE, N.Y., April 01, 2024 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ: BRTX ), a clinical stage company focused on stem cell-based therapies, announced today the filing of its Form 10-K annual report with the Securities and Exchange Commission ("SEC") for the year ended December 31, 2023.

Key Points: 
  • MELVILLE, N.Y., April 01, 2024 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ: BRTX ), a clinical stage company focused on stem cell-based therapies, announced today the filing of its Form 10-K annual report with the Securities and Exchange Commission ("SEC") for the year ended December 31, 2023.
  • The annual report can be accessed on the SEC's website at www.sec.gov , and on the Company's website at www.biorestorative.com under "SEC Filing" in the Investors and Media section.
  • A total of up to 99 eligible subjects will be enrolled at up to 16 clinical sites in the United States.
  • At December 31, 2023, BioRestorative had cash, cash equivalents and investments in marketable securities of $11.07 million.

Galectin Therapeutics Reports 2023 Financial Results and Provides Business Update

Retrieved on: 
Friday, March 29, 2024
Research, Data monitoring committee, Cirrhosis, Disease, Metabolism, AASLD, Safety, Patient, Food and Drug Administration, Liver, Mortality, Liver transplantation, Hope, Hepatology, Fibrosis, Clinical trial, Annual report, Therapy, GALT, Pharmacokinetics, Data, DSMB, NASH, Food, Esophageal varices

NORCROSS, Ga., March 29, 2024 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the year ended December 31, 2023.

Key Points: 
  • NORCROSS, Ga., March 29, 2024 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the year ended December 31, 2023.
  • Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, said “We have been focused on advancing our Metabolic Dysfunction-Associated Steatohepatitis (MASH, formerly known as NASH) cirrhosis program.
  • Dr. Jamil’s extensive experience in advanced liver disease, specifically for late-stage cirrhotic patients, is a tremendous asset to our program.
  • These results are included in the Company's Annual Report on Form 10-K, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov .

Matinas BioPharma Reports 2023 Financial Results and Provides a Business Update

Retrieved on: 
Wednesday, March 27, 2024
Malignancy, Colitis, Survival, BioNTech, Patient, Lung, City, Standard of care, Quality of life, Fungal infection, Aspergillosis, Nationwide, Clinical trial, Bone marrow, Melanoma, Aspergillus fumigatus, Therapy, Human, Psoriasis, Partnership, World Health Organization, Coccidioides, Safety, Clutch (eggs), University, Kidney, Amphotericin B, Neoplasm, Research, Data monitoring committee, Infection, Skin, Vanderbilt University Medical Center, Hospital, Immunodeficiency, FDA, Critical, Element, Toxicity, IL-17A, Brain, Conference call, Conference, Johns Hopkins, Nephrotoxicity, Docetaxel, Serum, Inflammation, Mouse, Mortality, Fusarium, Bangladesh Technical Education Board, Pharmaceutical industry

BEDMINSTER, N.J., March 27, 2024 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE American: MTNB), a clinical-stage biopharmaceutical company focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform delivery technology, reports 2023 financial results and provides a business update.

Key Points: 
  • Aspergillus fumigatus is also included in the FDA qualified designation list of pathogens that pose a serious and life-threatening risk.
  • Revenue for 2023 was $1.1 million, which was generated from the Company’s research collaborations with BioNTech SE and Genentech Inc.
  • Cash, cash equivalents and marketable securities as of December 31, 2023 were $13.8 million compared with $28.8 million as of December 31, 2022.
  • Matinas will host a conference call and webcast today beginning at 4:30 p.m. Eastern time.

Atea Pharmaceuticals Completes Patient Enrollment in Global Phase 3 SUNRISE-3 Trial Evaluating Oral Antiviral Bemnifosbuvir for COVID-19 in High-Risk Patients

Retrieved on: 
Wednesday, March 27, 2024
Infection, Risk, COVID-19, Patient, Fast Track, Viral, Data monitoring committee, Death, Doctor of Philosophy, Safety, DSMB, Immunodeficiency, Atea, Food, Hospital, Pharmaceutical industry

BOSTON, March 27, 2024 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (Atea), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today announced that the company has completed enrollment of the global Phase 3 SUNRISE-3 trial evaluating bemnifosbuvir, an oral nucleotide polymerase inhibitor, or placebo for the treatment of COVID-19. Over 2,200 patients were randomized into the supportive care monotherapy cohort and less than 80 patients were randomized into the combination cohort. The primary endpoint of the trial is all-cause hospitalization or death through Day 29 post-treatment in the bemnifosbuvir supportive care monotherapy cohort of high-risk patients. Secondary endpoints include other measurements of patient outcomes through Day 60 post-treatment.

Key Points: 
  • Over 2,200 patients were randomized into the supportive care monotherapy cohort and less than 80 patients were randomized into the combination cohort.
  • The primary endpoint of the trial is all-cause hospitalization or death through Day 29 post-treatment in the bemnifosbuvir supportive care monotherapy cohort of high-risk patients.
  • Secondary endpoints include other measurements of patient outcomes through Day 60 post-treatment.
  • “COVID-19 continues to be a threat, leaving the most vulnerable at risk for severe outcomes from infection.

Panbela Provides Business Update and Reports Q4 and FY 2024 Financial Results

Retrieved on: 
Tuesday, March 26, 2024
Research, Topotecan, PBLA, Neuroblastoma, Patient, Data monitoring committee, Acquisition, Celecoxib, Doctor of Philosophy, AACR, MSN, CPP, Pancreatic cancer, Therapy, DSMB, Poster, DFMO, Cyclophosphamide, Pharmaceutical industry

MINNEAPOLIS, March 26, 2024 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (NASDAQ:PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today provides a business update and reports financial results for the quarter and full year ended December 31, 2023.

Key Points: 
  • MINNEAPOLIS, March 26, 2024 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (NASDAQ:PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today provides a business update and reports financial results for the quarter and full year ended December 31, 2023.
  • “Looking ahead, Panbela remains unwavering in its commitment to patients and in its pursuit of maximizing value for stockholders.
  • Notes payable, plus accrued interest, on the balance sheet, the result of the acquisition of CPP, totaled approximately $5.4 million.
  • Gross proceeds from the raise, which closed on January 31, 2024, were approximately $9 million.

BrainStorm Cell Therapeutics Announces Agreement with FDA on a Special Protocol Assessment (SPA) for Phase 3b Trial in ALS

Retrieved on: 
Tuesday, April 9, 2024
Neurology, Neuroprotection, Element, Conference call, Institutional review board, Cerebrospinal fluid, Survival, Disease, ALS, SPA, Bone marrow, CSF, Data monitoring committee, Webcast, Patient, Protocol, Biomarker, Mortality, Microsoft Exchange Server, Stem cell, DMC, Screening, Agency, Safety, CAFS, Brainstorm, Therapy, Marketing, FDA, BLA, Neuroinflammation, Food, Pharmaceutical industry

NEW YORK, April 9, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that it received written agreement from the U.S. Food and Drug Administration (FDA), under a Special Protocol Assessment (SPA), on the design for a Phase 3b trial of NurOwn® in amyotrophic lateral sclerosis (ALS). 

Key Points: 
  • (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that it received written agreement from the U.S. Food and Drug Administration (FDA), under a Special Protocol Assessment (SPA), on the design for a Phase 3b trial of NurOwn® in amyotrophic lateral sclerosis (ALS).
  • The SPA agreement with the FDA validates the clinical trial protocol and statistical analysis of the planned Phase 3b trial of NurOwn, demonstrating their adequacy for addressing objectives that support a future BLA (Biologics License Application) in ALS.
  • We appreciate the Agency's engagement and guidance during the SPA process and look forward to moving forward with the study."
  • The Phase 3b trial (Study BCT-006-US) will be a two-part, multicenter, study designed to assess the efficacy and safety of NurOwn in patients with ALS.

AN2 Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Business and Scientific Highlights

Retrieved on: 
Thursday, March 28, 2024
Science, Biotechnology, Research, Pharmaceutical, Health, FDA, Infectious Diseases, Clinical Trials, Administration, Nontuberculous mycobacteria, Conference, Bill, AN2, Entrepreneurship, NTM, Boron, Tuberculosis, University, Patient, Melioidosis, Data monitoring committee, G&A, MAC, Insurance, Infection, Wellcome Trust, Investment, Clinical trial, Chagas disease, Therapy, Malaria, Safety, Poster, Research and development, Mycobacteroides abscessus, IDSA, Trust, Pharmaceutical industry

Patients in the Phase 2 trial have reached the six-month mark, and we plan to report topline results this summer.

Key Points: 
  • Patients in the Phase 2 trial have reached the six-month mark, and we plan to report topline results this summer.
  • Net loss: Net loss for the full year 2023 was $64.7 million, compared to $41.0 million in the prior year.
  • Net loss for the fourth quarter of 2023 was $16.9 million, compared to $11.8 million for the same period during 2022.
  • Cash Position: The Company had cash, cash equivalents, and investments of $134.5 million at December 31, 2023.

Merck’s KEYTRUDA® (pembrolizumab) Plus Chemoradiotherapy (CRT) Significantly Improved Overall Survival (OS) Versus CRT Alone in Patients With Newly Diagnosed High-Risk Locally Advanced Cervical Cancer

Retrieved on: 
Friday, March 15, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, MSD, OS, Chemoradiotherapy, CRT, Obstetrics, Congress, Gynaecology, CPS, Survival, Disease, Progression-free survival, Data monitoring committee, Cervical cancer, Patient, Neoplasm, Merck & Co., Overalls, Humanitas University, Bevacizumab, MRK, Cancer, ESMO, PFS, FIGO, PD-L1, Food, Pharmaceutical industry

At a pre-specified interim analysis conducted by an independent Data Monitoring Committee, KEYTRUDA in combination with concurrent CRT showed a statistically significant and clinically meaningful improvement in OS versus concurrent CRT alone.

Key Points: 
  • At a pre-specified interim analysis conducted by an independent Data Monitoring Committee, KEYTRUDA in combination with concurrent CRT showed a statistically significant and clinically meaningful improvement in OS versus concurrent CRT alone.
  • The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety signals were identified.
  • Results will be presented at an upcoming medical meeting and shared with regulatory authorities worldwide.
  • As previously reported , KEYNOTE-A18 met its other primary endpoint of progression-free survival (PFS) in 2023.