Salvage therapy

Growing Body of Clinical Evidence Points to the Potential of Profound Medical’s TULSA Procedure Becoming a Mainstream Treatment Modality Across the Entire Prostate Disease Spectrum

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Lunedì, Maggio 6, 2024
Congress, Society, Interventional radiology, Mayo Clinic, Urology, Safety, American Urological Association, Poster, American Roentgen Ray Society, TSX, Prostate cancer, Prostate, Salvage therapy, Abdominal Radiology, Patient, ARRS, AUA, ECR, Clinical trial, SIR, Annual general meeting, JUA, BPH, Turku University Hospital, EAU

TORONTO, May 06, 2024 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue, is pleased to announce that a total of 25 paper, poster and podium presentations highlighting the Transurethral Ultrasound Ablation (“TULSA”) procedure’s ability to effectively, safely and efficiently treat an unrivaled variety of prostate cancer and/or benign prostatic hyperplasia (“BPH”) patients have been made at major medical meetings already in 2024.

Key Points: 
  • “The TACT 5-year clinical trial data, along with multiple real-world reports on the safety, efficacy and durability of TULSA from U.S. commercial centers, such as Mayo Clinic in Florida, Busch Center in Georgia, and UT Southwestern Medical Center in Texas, as well as international user sites, like Sapporo Hokuyu Hospital in Japan, ALTA Klinik in Germany, and Turku University Hospital in Finland, add to the growing body of evidence supporting the potential of TULSA as a mainstream treatment for prostate disease,” said Arun Menawat, Profound’s CEO and Chairman.
  • “The various presentations made at AUA and other major medical conferences have highlighted TULSA’s clinical use across the entire prostate disease spectrum; ranging from low-, intermediate-, or high-risk prostate cancer; to hybrid patients suffering from both prostate cancer and BPH; to men with BPH only; and also, to patients requiring salvage therapy for radio-recurrent localized prostate cancer,” added Dr. Menawat.
  • “Importantly, real-world data from top institutions is also consistently demonstrating similar outcomes to the TACT FDA regulatory study.
  • We would like to take this opportunity to thank the many esteemed researchers and clinicians who have contributed to the growing awareness of TULSA among urologists, both at home and abroad, and look forward to continuing to build on that positive momentum as the year progresses.”

Bio-Path Holdings Announces Successful Completion of Higher Dose Second Cohort in Phase 1/1b Clinical Trial of BP1002 in Refractory/Relapsed Acute Myeloid Leukemia (AML) Patients

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Giovedì, Aprile 18, 2024
FDA, University, RNA interference, Hospital, Hope, Safety, Survival, Weill Cornell Medicine, Holding, AML, Salvage therapy, Cornell University, D.O, MD Anderson Cancer Center, Patient, Clinical, Medicine, Acute myeloid leukemia, Messenger, Clinical trial, Scripps Health, BH3, Cancer, Pharmaceutical industry

By targeting Bcl-2 at the mRNA level rather than the protein, BP1002 may overcome and prevent some of the mechanisms of resistance that affect venetoclax treatment.

Key Points: 
  • By targeting Bcl-2 at the mRNA level rather than the protein, BP1002 may overcome and prevent some of the mechanisms of resistance that affect venetoclax treatment.
  • The approved treatment cycle is two doses per week over four weeks, resulting in eight doses administered over twenty-eight days.
  • The Phase 1b portion of the study is expected to commence after completion of BP1002 monotherapy cohorts and will assess the safety and efficacy of BP1002 in combination with decitabine in refractory/relapsed AML patients.
  • Gail J. Roboz, M.D., is the National Principal Investigator for the Phase 1/1b trial.

MEI Pharma Board of Directors Aligns on Strategy to Advance Voruciclib and ME-344

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Giovedì, Aprile 11, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Agreement, Patient, Cancer, Mutation, CDK9, Venetoclax, Colorectal cancer, MEI, Bevacizumab, AML, Research, Cohort, Salvage therapy, Disease, Exercise, Therapy, IDH, Incidence, Neoplasm, Toxicity, Acute myeloid leukemia, FLT3, Standard of care, Death, Clinical trial, VEGF, Calendar, Pharmaceutical industry

With the MEI Board aligned around our strategy, we have a productive framework to advance both clinical programs in a manner intended to address significant medical needs while prioritizing a measured and objective-based allocation of our resources,” said David Urso, president and chief executive officer of MEI Pharma.

Key Points: 
  • With the MEI Board aligned around our strategy, we have a productive framework to advance both clinical programs in a manner intended to address significant medical needs while prioritizing a measured and objective-based allocation of our resources,” said David Urso, president and chief executive officer of MEI Pharma.
  • The plan builds on encouraging recently reported voruciclib clinical data and ME-344 data separately reported today.
  • Under the plan, the ongoing voruciclib development strategy will be guided by future clinical trial results and applicable regulatory authority advice.
  • The goal of the formulation effort is to increase biological activity, improve patient convenience of administration and increase commercial opportunity.

MEI Pharma Reports Update from Clinical Study Evaluating Oral CDK9 Inhibitor Voruciclib in Combination with Venetoclax in Patients with Relapsed and Refractory Acute Myeloid Leukemia

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Martedì, Marzo 26, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Toxicity, Aplastic anemia, Salvage therapy, CLL, AML, CRi, Patient, Venetoclax, Biomarker, Diarrhea, BCL2, University, Acute myeloid leukemia, ELN, Safety, Pharmacokinetics, CDK9, Phase 1, Associate professor, Pharmaceutical industry

The study is currently enrolling a 12-patient expansion cohort evaluating voruciclib administered at 300 mg daily for two weeks in a four-week cycle in combination with venetoclax.

Key Points: 
  • The study is currently enrolling a 12-patient expansion cohort evaluating voruciclib administered at 300 mg daily for two weeks in a four-week cycle in combination with venetoclax.
  • A total of 29 patients with R/R AML, median age 67 years (range 34-89), enrolled in the dose escalation stage of the study evaluating voruciclib in combination with venetoclax.
  • The primary objectives of the study are to determine the safety and biologic effective dose of voruciclib monotherapy or voruciclib in combination with venetoclax.
  • Secondary objectives of the study include assessing the preliminary efficacy, pharmacokinetics, pharmacodynamics, and biomarkers of voruciclib monotherapy or voruciclib in combination with venetoclax.

American Urological Association Releases Salvage Therapy for Prostate Cancer Guideline

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Giovedì, Febbraio 29, 2024
Therapy, Recurrence, Salvage therapy, Prostate cancer, Professor, ASTRO, Quality of life, Metastasis, Patient, Radiation, Risk, Society, University, AUA, SUO, Guideline, MPH, American Urological Association, Radiation therapy, Panel, Partnership, Medical imaging

BALTIMORE, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Today, the American Urological Association (AUA), in partnership with the American Society for Radiation Oncology (ASTRO) and the Society of Urologic Oncology (SUO), released the 2024 clinical practice guideline on salvage therapy for prostate cancer.

Key Points: 
  • BALTIMORE, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Today, the American Urological Association (AUA), in partnership with the American Society for Radiation Oncology (ASTRO) and the Society of Urologic Oncology (SUO), released the 2024 clinical practice guideline on salvage therapy for prostate cancer.
  • Understanding the evaluation and appropriate use of salvage therapies for patients with biochemical recurrence is a critical area of prostate cancer care.
  • “Thanks to the incredible expertise of the entire Panel, this guideline helps provide a roadmap that combines the latest advancements with thoughtful recommendations, empowering patients and clinicians alike.”
    This guideline has 30 recommendations and is a useful reference for effective evidence-based care related to salvage therapy for prostate cancer.
  • Salvage therapy for prostate cancer: AUA/ASTRO/SUO guideline part I: introduction and treatment decision-making at the time of suspected biochemical recurrence after radical prostatectomy.

Blue Earth Diagnostics Highlights Clinical Utility of POSLUMA® (Flotufolastat F 18) PET and Post-scan Changes in Management in Patients with Suspected Recurrence of Prostate Cancer at ASCO GU

Retrieved on: 
Giovedì, Gennaio 25, 2024
Neurology, Radiology, Biotechnology, Pharmaceutical, Oncology, Health, Health Technology, Clinical Trials, Radiopharmaceutical, Patient, Prostate cancer, F 18, Multimedia, ASCO, PET, Recurrence, Metastasis, PSA, Disease, Salvage therapy, FDA, PSMA, PET/CT, Physician, Medical imaging

The sub-analysis assessed the impact of POSLUMA on treatment plans for patients with recurrent prostate cancer after curative-intent primary therapy.

Key Points: 
  • The sub-analysis assessed the impact of POSLUMA on treatment plans for patients with recurrent prostate cancer after curative-intent primary therapy.
  • View the full release here: https://www.businesswire.com/news/home/20240125625091/en/
    POSLUMA® (flotufolastat F 18) PET/CT image showing uptake in the prostate bed, consistent with recurrent prostate cancer.
  • Photo courtesy of Blue Earth Diagnostics
    Flotufolastat F 18 PET imaging was positive for recurrent prostate cancer in 84% (81/97) of patients in the sub-analysis.
  • In 89% (86/97) of patients, management plans were changed following review of the flotufolastat F 18 PET scan results.

NeuExcell's AAV Gene Therapy for Malignant Glioma Granted Orphan Drug Designation by FDA

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Lunedì, Dicembre 18, 2023
Huntington's disease, Glioma, Safety, ATN, Food, ODD, Glioblastoma, GBM, Clinical trial, Mortality, Patient, Multimedia, Radiation, FDA, Alzheimer's disease, Survival rate, Stroke, Health, Salvage therapy, Recurrence, Survival, Quality of life, AAV, Pharmaceutical industry, ALS

PHILADELPHIA, Dec. 18, 2023 /PRNewswire/ -- On December 7, 2023, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation ("ODD") to NXL-004, an investigational AAV gene therapy product being developed by NeuExcell Therapeutics Inc. ("NeuExcell"), for the treatment of malignant glioma.

Key Points: 
  • PHILADELPHIA, Dec. 18, 2023 /PRNewswire/ -- On December 7, 2023, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation ("ODD") to NXL-004, an investigational AAV gene therapy product being developed by NeuExcell Therapeutics Inc. ("NeuExcell"), for the treatment of malignant glioma.
  • This is the world's first AAV gene therapy product for malignant glioma to receive FDA ODD designation.
  • Malignant gliomas are the most common primary malignant brain tumors in adults, about 60% of which are glioblastoma (GBM).
  • Recurrence is virtually inevitable for malignant glioma and there is no clear standard salvage therapy.

PHAXIAM Therapeutics announces high coverage performance of its two anti-Staphylococcus aureus phages over clinical strains

Retrieved on: 
Lunedì, Ottobre 9, 2023
IVD, Salvage therapy, PST, CEST, Therapy, Phage therapy, AAC, Staphylococcus aureus, Medical device, Pharmaceutical industry

A retrospective analysis was carried out with 105 clinical Staphylococcus aureus strains which were tested using PHAXIAM’s phagogram in the context of clinical trials, salvage therapy and early access program (AAC).

Key Points: 
  • A retrospective analysis was carried out with 105 clinical Staphylococcus aureus strains which were tested using PHAXIAM’s phagogram in the context of clinical trials, salvage therapy and early access program (AAC).
  • The results demonstrated that 98% of these pathogenic S. aureus strains were susceptible to at least one of the two PHAXIAM’s anti-S. aureus phages (PP1493 and PP1815).
  • Phagogram is an in vitro diagnostic (IVD) test designed to determine the in-vitro activity of PHAXIAM’s phages to patients’ bacterial strains.
  • The 98% spectrum of activity of our anti-S. aureus phages is exceptionally high when compared with other competing solutions.

Ocean Biomedical Announces Newly Published Findings Demonstrating Ability to Restore Treatment Sensitivity to AstraZeneca’s Leading Lung Cancer Drug After Resistance Has Formed, and Enhanced Tumor Suppression in EGFR-Mutation Lung Cancers

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Martedì, Ottobre 3, 2023
Yale University, BioRxiv, RI, FRG, Osimertinib, Lung cancer, TUNEL, TKI, Research, Targeted therapy of lung cancer, Cell, Immunotherapy, AstraZeneca, Glioblastoma, Preprint, Gefitinib, Patient, EGFR, Growth, Neoplasm, Salvage therapy, Pharmaceutical industry, Vaccine, Dietary supplement, Medical imaging, Ocean Biomedical, CHI3L1, NSCLC, Cancer

Providence, RI, Oct. 03, 2023 (GLOBE NEWSWIRE) -- Ocean Biomedical, Inc. (NASDAQ: OCEA) announced today that its cancer-targeting immunotherapy antibody candidate has demonstrated effective tumor reduction against an aggressive subset of Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) mutations. These research findings, which may be the most important Ocean Biomedical has announced to date, generated by Ocean’s Scientific Co-founder Dr. Jack A. Elias and colleagues from Yale University and Brown University, and first published as a preprint last week in bioRxiv, are the first to uncover the role of Chitinase 3-like-1 (CHI3L1) in the pathogenesis of EGFR-mutant cancers, with potential applications not just in NSCLC, but in all EGFR-mutant cancers, including glioblastoma and colon cancer.

Key Points: 
  • Additionally, the findings demonstrate a stunning ability to restore therapeutic sensitivity to current tyrosine kinase inhibitor (TKI) therapies after resistance sets in, including the third-generation TKI, Osimertinib (marketed as Tagrisso by AstraZeneca).
  • In 2022, AstraZeneca’s top pharmaceutical product by revenue was Tagrisso, a medication used in the treatment of non-small-cell lung carcinomas.
  • Non-Small Cell Lung Cancer (NSCLC) is a leading cause of cancer deaths globally, accounting for 85% of all lung cancers.
  • The EGFR-mutant lung cancer is found in 30%-50% of NSCLC patients with Asian heritage and 10%-20% of patients with Caucasian backgrounds.

NexImmune Presents Initial Positive Data from the NEXI-001 Phase 1 Trial for Relapsed/Refractory Post Allo-HSCT AML at the American Society of Clinical Oncology 2023 Annual Meeting

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Lunedì, Giugno 5, 2023
Ohio State University, Antigen, Nanoparticle, AIM, MI, Solar cycle 1, CRS, American Society of Clinical Oncology, Clinical trial, DLT, Cancer, Bone marrow, Transplant, BMT, Chimera, Immunotherapy, Associate, Pleural effusion, Trial of the century, Șaeș, Acute myeloid leukemia, ASCO, City of Hope National Medical Center, AML, City, Influenza, MD, Patient, ECOG, Blood, Internal medicine, NEXI, PET/CT, Periodic breathing, Countersurveillance, Poster, Neoplasm, Phenotype, Society, Memory, Safety, Salvage therapy, Vaccine, Pharmaceutical industry, Medical imaging, Hematology

GAITHERSBURG, Md., June 05, 2023 (GLOBE NEWSWIRE) -- NexImmune, Inc. (Nasdaq: NEXI), a biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells for liquid and solid malignancies, today announced results from its Phase 1/2 clinical trial of NEXI-001 in patients with relapsed/refractory acute myeloid leukemia (AML) post-allogeneic hemopoietic stem cell transplant (allo-HSCT). In this clinical trial to date, NEXI-001 is well tolerated with a favorable safety profile while eliciting an immune response to target antigens and a clinical effect in some patients. The data describing two patients from the dose escalation study of NEXI-001 are being presented in a poster session at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting in Chicago on Monday, June 5 at 8 AM in Hall A.

Key Points: 
  • “We have seen a clinical response maintained for seven months, which is an additional update from the data reported in our poster.
  • These data have established the ability of our AIM nanoparticles to expand healthy, multi-antigen-specific T cells with anti-tumor activity.
  • The data also show these T cells persist and maintain their memory phenotype at the site of tumor.
  • These data indicating both immunologic and clinical dose responses and observed durability in the patient at the higher dose support further clinical study of NEXI-001.