Clinical trial

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."

Atossa Therapeutics Presents Data from 40mg Cohort of Phase 2 EVANGELINE Clinical Trial Showing 100% Disease Control Rate After 24-Weeks of Treatment with (Z)-Endoxifen

Retrieved on: 
Tuesday, April 9, 2024
Plasma, MRI, Neoplasm, Atossa, Ki-67, Associate, RECIST, Magnetic resonance imaging, Incidence, Patient, MD, Woman, AACR, Clinical trial, Therapy, Breast cancer, Safety, Division, Recurrence, Exemestane, Annual general meeting, Medical imaging

SEATTLE, April 09, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”) today announced promising safety and efficacy data from the Company’s Phase 2 EVANGELINE (Endoxifen Versus exemestANe GosEreLIn) clinical trial.

Key Points: 
  • SEATTLE, April 09, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”) today announced promising safety and efficacy data from the Company’s Phase 2 EVANGELINE (Endoxifen Versus exemestANe GosEreLIn) clinical trial.
  • Atossa is a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer.
  • The data, which is being presented at the American Association for Cancer Research (AACR) Annual Meeting, is from the 40mg pharmacokinetic (PK) run-in cohort of the study.
  • At 28 days, six of the seven had Ki-67 levels below 10% and stayed on treatment for an additional five months.

ALX Oncology Reports Encouraging Clinical Data of Evorpacept in Combination with Standard-of-Care in an Ongoing Phase 1/2 Clinical Trial in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (“R/R B-NHL”)

Retrieved on: 
Tuesday, April 9, 2024
Drug design, Rituximab, R2, ALT, Assistant, Patient, SAN, CRR, University, CD47, MD Anderson Cancer Center, Clinical trial, Anemia, Fatigue, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., April 09, 2024 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology” or “the Company”) (Nasdaq: ALXO), an immuno-oncology company developing therapies that block the CD47 immune checkpoint pathway, today reported encouraging clinical data from the ongoing Phase 1/2 investigator-sponsored trial (“IST”) of evorpacept in combination with R2 in patients with indolent and aggressive R/R B-NHL. The new data were presented in an oral presentation at the 2024 American Association for Cancer Research (“AACR”) Annual Meeting.

Key Points: 
  • The new data were presented in an oral presentation at the 2024 American Association for Cancer Research (“AACR”) Annual Meeting.
  • Patients received evorpacept 30 mg/kg Q2W (n=3) or 60 mg/kg Q4W (n=17) in combination with standard R2 treatment.
  • “We are pleased evorpacept in combination with R2 demonstrated a favorable safety profile and encouraging response in this patient population.
  • We look forward to applying these and other clinical trial data to inform new evorpacept combinations in our expanding pipeline.

Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against Ventyx, and Anavex and Encourages Investors to Contact the Firm

Retrieved on: 
Tuesday, April 9, 2024
Psoriasis, Form, Patient, Defendant, News, IPO, Crohn's disease, Security (finance), Inflammation, Rett syndrome, Prospectus, Complaint, P.C, Clinical trial, MCI, Radar, File, Register, Pharmaceutical industry

The Company's lead clinical product candidate is VTX958, a selective allosteric tyrosine kinase type 2 inhibitor for psoriasis, psoriatic arthritis, and Crohn's disease.

Key Points: 
  • The Company's lead clinical product candidate is VTX958, a selective allosteric tyrosine kinase type 2 inhibitor for psoriasis, psoriatic arthritis, and Crohn's disease.
  • In addition, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and prospects.
  • On November 6, 2023, during after-market hours, Ventyx issued a press release announcing results from the Phase 2 SERENITY Trial.
  • For more information on the Anavex class action go to: https://bespc.com/cases/AVXL

Kineta Reports Initial Clinical Response Data at AACR 2024 of its Ongoing Phase 1/2 VISTA-101 Clinical Trial

Retrieved on: 
Monday, April 8, 2024
Combination, CPI, Immunosuppression, Patient, Tumor microenvironment, Immunoglobulin G, Merck, Cancer, Pembrolizumab, Lung cancer, AACR, DLT, Clinical trial, Merck & Co., Kineta, NK, VISTA, Pharmaceutical industry

SEATTLE, April 08, 2024 (GLOBE NEWSWIRE) -- Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, announced today at the American Association for Cancer Research (AACR) in San Diego, CA an update on its ongoing VISTA-101 Phase 1/2 clinical trial evaluating KVA12123, an anti-VISTA monoclonal antibody, as monotherapy and in combination with Merck’s anti-PD1 therapy, KEYTRUDA® (pembrolizumab), in patients with advanced solid tumors.

Key Points: 
  • KVA12123 cleared the fifth of six monotherapy dose levels and the second of four cohorts in combination with pembrolizumab.
  • KVA12123 was well tolerated with no dose limiting toxicities (DLT) or cytokine related adverse events at any dose level.
  • Patients currently enrolled in the trial will be permitted to continue to participate.
  • KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Positive Results for Patients with Non-obstructive Hypertrophic Cardiomyopathy Treated with Ninerafaxstat in the Phase 2 IMPROVE-HCM Trial Presented During a Late-Breaking Clinical Trial Session at ACC.24

Retrieved on: 
Monday, April 8, 2024
Blood pressure, Exercise, MRCP, Patient, Heart rate, Heart, Journal, Aes, Medical Center, Quality of life, Efficacy, Heart failure, American College, HCM, Clinical trial, CPET, ACC, Pharmaceutical industry

BOSTON, April 08, 2024 (GLOBE NEWSWIRE) -- Imbria Pharmaceuticals, Inc., a clinical stage, cardiometabolic company developing novel therapies designed to improve patient symptoms and functional capacity by enhancing cellular energetics, today announced that results from the Phase 2 IMPROVE-HCM clinical trial, evaluating ninerafaxstat in patients with symptomatic nHCM, were presented in a late-breaking clinical trial session at the American College of Cardiology’s Annual Scientific Session & Expo (ACC.24) and published in the Journal of the American College of Cardiology (JACC).

Key Points: 
  • “We are pleased with the IMPROVE-HCM clinical trial results presented today at ACC and simultaneously published in JACC, confirming the importance of these results for patients living with nHCM,” said Anne Prener, M.D., Ph.D., president and chief executive officer of Imbria Pharmaceuticals.
  • “Based on these positive results, we plan to initiate the Phase 3 FORTITUDE-HCM clinical trial in patients with symptomatic nHCM later this year.
  • Most treatment emergent adverse events (AEs) were self-limiting and mild to moderate in severity occurring in 24 ninerafaxstat treated patients (70.6%) vs. 20 patients on placebo (60.6%).
  • improved) from 31.2 to 30.9 in the ninerafaxstat treated group and worsened from 32.7 to 34.3 in the placebo group.

Gritstone bio to Participate in Upcoming Investor and Scientific Conferences

Retrieved on: 
Monday, April 8, 2024
Vaccine, Gritstone bio, Clinical trial

EMERYVILLE, Calif., April 08, 2024 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, today announced that management will be participating in the following investor and scientific conferences.

Key Points: 
  • EMERYVILLE, Calif., April 08, 2024 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, today announced that management will be participating in the following investor and scientific conferences.
  • Select events (marked by *) will be webcasted live and webcast details will be available on the ‘Events’ page of Gritstone bio’s website: https://ir.gritstonebio.com/investors/events .
  • Archived replays will be accessible for 30 days following each event.
  • Presentation Title: Clinical Trial Results with a Personalised Neoantigen Vaccine in a Cold Tumour—Can We Bring the Heat?

Inozyme Pharma Announces Positive Topline Data from Ongoing Phase 1/2 Trials of INZ-701 in Adults with ABCC6 Deficiency (PXE) and ENPP1 Deficiency

Retrieved on: 
Monday, April 8, 2024
Patient, Cerebrovascular disease, Stroke, Accelerated approval (FDA), European Medicines Agency, Doctor of Philosophy, Osteomalacia, PROMIS, Therapy, Conditional, Natural history, CTX, Pros, ADAS, Risk, DSM-IV codes, Cohort, Aes, Alkaline phosphatase, Rickets, EMA, PXE, Safety, Epilepsy, Clinical trial, Food, Hospital, Disability, BSAP, Cardiovascular disease, Disease, PD, Paresis, Consultant, Hypophosphatemia, Fatigue, Survivor, Sclera, FDA, Observational study, Pyrophosphate, Choroid, Incidence, Retina, Biomarker, Life, Event, Medical imaging

BOSTON, April 08, 2024 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (Nasdaq: INZY) (“the Company” or “Inozyme”), a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of pathologic mineralization and intimal proliferation, today announced positive topline safety, pharmacokinetic (PK), pharmacodynamic (PD) and exploratory efficacy data from the Company’s ongoing Phase 1/2 clinical trials of INZ-701 in adults with ABCC6 Deficiency (PXE, pseudoxanthoma elasticum) and ENPP1 Deficiency.

Key Points: 
  • “We are excited by the excellent safety and preliminary efficacy profile of INZ-701 in adults with ABCC6 Deficiency,” said Douglas A. Treco, Ph.D., CEO of Inozyme Pharma.
  • The patients were assigned to three dose cohorts of INZ-701: 0.2 mg/kg (n=3), 0.6 mg/kg (n=3), and 1.8 mg/kg (n=4).
  • For trial design details, please see the section entitled “INZ-701 in ABCC6 Deficiency Phase 1/2 Clinical Trial Design” below.
  • For trial design details, please see the section entitled “INZ-701 in ENPP1 Deficiency Phase 1/2 Clinical Trial Design” below.

IntelGenx Announces First Parkinson’s Disease Patients Dosed with Montelukast VersaFilm® in Phase 2 ‘MONTPARK’ Clinical Trial

Retrieved on: 
Monday, April 8, 2024
Karolinska University Hospital, EudraCT, PD, L-DOPA, Patient, IGX, Doctor of Philosophy, MD, TSX, Clinical trial, Pharmaceutical industry

SAINT LAURENT, Quebec, April 08, 2024 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx") today announced that Montelukast VersaFilm® has been administered to the first Parkinson’s Disease (“PD”) patients in the Phase 2 (‘MONTPARK’) clinical trial.

Key Points: 
  • SAINT LAURENT, Quebec, April 08, 2024 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx") today announced that Montelukast VersaFilm® has been administered to the first Parkinson’s Disease (“PD”) patients in the Phase 2 (‘MONTPARK’) clinical trial.
  • MONTPARK (EudraCT number 2023-504278-39-00) is a Phase 2, randomized, double-blind, placebo-controlled, parallel arm, multicentre trial that will investigate the efficacy of oral high-dose Montelukast on the progression of early-to-moderate PD.
  • The study will enroll up to 90 patients who will receive 30 mg Montelukast VersaFilm® or placebo twice daily for 18-months, followed by a 3-month washout period.
  • Eligible candidates must be on levodopa treatment at the time of enrolment and may also be on other dopaminergic symptomatic agents.

BioRestorative Therapies Partners with Galen Patient Recruitment to Accelerate Completion of Enrollment in Phase 2 Trial of BRTX-100 in Chronic Lumbar Disc Disease

Retrieved on: 
Monday, April 8, 2024
Online, Systematic review, PMID, Partnership, Clinical trial, Meta-analysis, Safety, Pharmaceutical industry

MELVILLE, N.Y., April 08, 2024 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a clinical stage company focused on stem cell-based therapies, today announced a collaboration with Galen Patient Recruitment, Inc. (“Galen”) which, combined with the recent expansion of clinical trial capacity from approximately 10 to 30 participants per month, is expected to help accelerate the completion of patient enrollment in the ongoing Phase 2 study of BioRestorative’s lead clinical candidate, BRTX-100, in chronic lumbar disc disease (“cLDD”).

Key Points: 
  • BRTX-100 is a novel cell-based therapeutic engineered to target areas of the body that have little blood flow.
  • The safety and efficacy of BRTX-100 in treating cLDD is being evaluated in a Phase 2, prospective, randomized, double-blinded and controlled study.
  • A total of up to 99 eligible subjects will be enrolled at up to 16 clinical sites in the United States.
  • Subjects included in the trial will be randomized 2:1 to receive either BRTX-100 or placebo.