Decompression (diving)

VBI Vaccines Announces New Tumor Response Data from Ongoing Randomized Controlled Phase 2b Study of VBI-1901 in Recurrent Glioblastoma Patients

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星期三, 五月 29, 2024
Research, Infectious Diseases, FDA, Clinical Trials, Other Health, Biotechnology, Pharmaceutical, Health, Science, Oncology, GBM, Decompression (diving), Patient, Survival, VBI, Vaccine, Toxicity, Doctor of Philosophy, Disease, Poster, ASCO, PR, Society, DCR, Combination therapy, Annual general meeting, Pharmaceutical industry

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced new interim tumor response data from the ongoing randomized, controlled Phase 2b study of VBI-1901, the Company’s immunotherapeutic cancer vaccine candidate, in recurrent glioblastoma (rGBM) patients.

Key Points: 
  • VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced new interim tumor response data from the ongoing randomized, controlled Phase 2b study of VBI-1901, the Company’s immunotherapeutic cancer vaccine candidate, in recurrent glioblastoma (rGBM) patients.
  • These data will be presented in a poster session at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting on Saturday, June 1, 2024.
  • The approved treatments for recurrent GBM patients have limited to no efficacy, which is consistent with the data seen in the standard-of-care arm in this study.
  • Throughout the remainder of 2024, we expect to have additional tumor response data and initial survival data.

VBI Vaccines Presents Encouraging Early Tumor Response Data From Randomized Controlled Phase 2b Study of VBI-1901 in Recurrent Glioblastoma

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星期三, 四月 3, 2024
Research, Infectious Diseases, FDA, Clinical Trials, Other Health, Biotechnology, Pharmaceutical, Health, Science, Oncology, Toxicity, Combination therapy, SOC, Survival, Disease, Patient, GBM, Vaccine, Neoplasm, Decompression (diving), Safety, VBI, Pharmaceutical industry

The multi-center, randomized, controlled, open-label study has been designed to evaluate overall survival, tumor response rates, and safety and tolerability of VBI-1901 as a monotherapy in rGBM patients.

Key Points: 
  • The multi-center, randomized, controlled, open-label study has been designed to evaluate overall survival, tumor response rates, and safety and tolerability of VBI-1901 as a monotherapy in rGBM patients.
  • Dr. Anderson commented: “In recurrent GBM, tumors typically double or triple in size within six weeks, with no effective treatments available to improve survival.
  • Early indications from this ongoing study suggest tumor growth behavior in-line with expectations for both the standard-of-care arm and the VBI-1901 arm, based on positive data seen from the Phase 1/2a study.
  • As of March 22, 2024, 17 patients have been randomized 1:1 to either the active, VBI-1901 treatment arm, or to the control, standard-of-care treatment arm (SoC).

Plus Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Business Highlights

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星期二, 三月 5, 2024
Glioblastoma, Breast cancer, PSTV, Rhenium, Decompression (diving), FDA, Food, GMP, PD-1, Ependymoma, Conference, Safety, Plus Therapeutics, Respect, Therapy, Food and Drug Administration, Webcast, Patient, CSF, LM, PD-L1, Pharmaceutical industry

AUSTIN, Texas, March 05, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided an overview of recent and upcoming business highlights.

Key Points: 
  • ET
    AUSTIN, Texas, March 05, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV ) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided an overview of recent and upcoming business highlights.
  • Complete ReSPECT-LM Phase 1 dose escalation trial enrollment, determine the maximum tolerated dose, and recommended Phase 2 dose.
  • Implement Plus’ CNSide cerebral spinal fluid (CSF)-based tumor cell quantification assay as an exploratory clinical endpoint in all ReSPECT-LM trial patients in Q1 2024.
  • The Company will hold a conference call and live audio webcast at 5:00 pm Eastern Time today to discuss its financial results and provide a general business update.

Medicenna Therapeutics Reports Third Quarter Fiscal 2024 Financial Results and Corporate Update

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星期三, 二月 14, 2024
IPR, Research, CMO, Decompression (diving), PR, Society, Bifunctional, MNP, PRS, Bank statement, Melanoma, OTCQB, ICI, Toronto Stock Exchange, SITC, CBV, Annual general meeting, European Medicines Agency, Partnership, BTD, Highlight, AACR, Conference, Safety, Clinical trial, Survival, Neurology, CFO, EMA, Enzyme, MD, ECA, FDA, TSX, Cancer, EDGAR, Pembrolizumab, Response, MDNA, SNO, Patient, Pharmaceutical industry

Today, the Company reports promising clinical data from the on-going monotherapy escalation and expansion arms of the ABILITY-1 study.

Key Points: 
  • Today, the Company reports promising clinical data from the on-going monotherapy escalation and expansion arms of the ABILITY-1 study.
  • Clinical update from the combination arm of the ABILITY-1 study evaluating MDNA11 in with KEYTRUDA® expected in H1 and H2 of 2024.
  • Research and development expenses of $3.0 million were incurred during the quarter ended December 31, 2023, compared with $2.9 million incurred in the quarter ended December 31, 2022.
  • General and administrative expenses of $1.8 million were incurred during the quarter ended December 31, 2023, compared with $2.0 million during the quarter ended December 31, 2022.

Biodexa Reports 12 Month Survival in MAGIC-G1 Study of MTX110 in Recurrent Glioblastoma Patients

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星期四, 二月 8, 2024
GBM, Type 1, Duke Cancer Institute, Survival, Safety, Convection, Patient, Decompression (diving), Journal, Pharmaceutical industry

CARDIFF, United Kingdom, February 8, 2024 (GLOBE NEWSWIRE) -- Biodexa Pharmaceuticals PLC (“Biodexa” or the “Company”) (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs including Type 1 diabetes and rare/orphan brain cancers, today provided survival updates from its MAGIC-G1 study (NCT05324501) of MTX110 in patients with recurrent glioblastoma (“rGBM”) being conducted at Duke Cancer Institute and Baptist MD Anderson Cancer Center.

Key Points: 
  • In October 2023, Biodexa announced completion of recruitment of Cohort A of an ongoing open-label Phase I dose-escalation study designed to assess the feasibility and safety of intermittent infusions of MTX110 administered by convection enhanced delivery (“CED”) via implanted refillable pump and catheter.
  • Because no drug-related adverse events were observed within the first 30 days from start of treatment, the minimum number of four patients were recruited into Cohort A.
  • Patients #2, 3 and 4 each received weekly infusions of 90µM of MTX110, the expected optimum dose, and remain in the study.
  • GBM universally recurs and once it does median overall survival according to a retrospective analysis of 299 patients reported in the Journal of Neuro-Oncology is 6.5 months1.

Erasca Achieves Key Milestones for Naporafenib and ERAS-801 Programs and Extends Cash Runway

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星期二, 十一月 28, 2023
MTD, CRC, Index, ASCO, BRAF, Absorption, FDA, Colorectal cancer, EGFR, FTD, Cetuximab, Decompression (diving), ODD, Clinical trial, Glioblastoma, CNS, GBM, NRAS, Patient, Central nervous system, Safety, Food and Drug Administration, Pharmaceutical industry

SAN DIEGO, Nov. 28, 2023 (GLOBE NEWSWIRE) -- Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, today announced program updates for pan-RAF inhibitor naporafenib and central nervous system (CNS)-penetrant EGFR inhibitor ERAS-801, as well as a strategic program prioritization that extends its projected cash runway from H2 2025 to H1 2026.

Key Points: 
  • “To further maximize resources, we have strategically refined our pipeline to focus on programs with the greatest therapeutic potential for patients with high unmet needs using a data-driven approach.
  • As such, we are deprioritizing our ERAS-601 clinical trial (FLAGSHP-1) and our preclinical ERAS-5 ULK inhibitor and ERAS-10 protein degrader programs.
  • ERAS-801 monotherapy has been granted Orphan Drug and Fast Track Designations (ODD and FTD) by the FDA.
  • Though ERAS-601 achieved confirmed responses as a monotherapy and in combination with cetuximab, preliminary data do not justify further development of this combination in FLAGSHP-1 indications

Plus Therapeutics Reports New Interim ReSPECT-GBM Phase 2 Trial Data at the Society for NeuroOncology Annual Meeting and will Host Key Opinion Leader Webinar

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星期一, 十一月 20, 2023
MTD, Neurology, Neoplasm, PSTV, Index, IND, University of Texas System, Catheter, SNO, EBRT, Neuro-oncology, Plus, Neuro, Decompression (diving), MD, Doctor of Philosophy, Therapy, Clinical trial, Standard of care, CED, Society, Annual general meeting, Bevacizumab, MFD, Plus Therapeutics, NIH, Patient, University, Safety, Phase II, SOC, Radiation, KOL, Pharmaceutical industry

The Company is hosting a virtual key opinion leader (KOL) webinar to discuss the data today at 10:00 am ET.

Key Points: 
  • The Company is hosting a virtual key opinion leader (KOL) webinar to discuss the data today at 10:00 am ET.
  • Rhenium (186Re) obisbemeda continues to be generally safe and well tolerated, consistent with data accumulated in the Phase 1 trial.
  • Plus Therapeutics is hosting a virtual KOL event today, November 20, 2023 at 10:00 am ET to discuss the data presented at SNO.
  • A replay of the event will be available on Investor Relations section of the Plus Therapeutics website after the event.

Medicenna Announces Compelling Survival Benefit from Phase 2b Study of Bizaxofusp in Recurrent Glioblastoma at the 28th Annual Meeting of the Society for NeuroOncology

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星期五, 十一月 17, 2023
Annual general meeting, Hope, Medical director, University of Pennsylvania, Toxin, Glioblastoma, Neurology, Patient, ECA, Radiation, MDNA, Pakistan Society of Neuro-Oncology, Convection, University, Survival, Administration, IL4R, Recurrence, TSX, Poster, OTC, Decompression (diving), Society, SNO, Pharmaceutical industry

TORONTO and HOUSTON, Nov. 17, 2023 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. (“Medicenna” or the “Company”) (TSX: MDNA, OTC: MDNAF), a clinical-stage immunotherapy company focused on the development of Superkines, today announced that a poster presentation and an oral summary highlighting longer term follow up results from the Phase 2b clinical trial of bizaxofusp (formerly known as MDNA55), the Company’s first-in-class IL-4R targeted therapy for the treatment of patients with recurrent glioblastoma (rGBM), will be presented by Dr. Steven Brem, M.D. (Medical Director, Centre for Precision Surgery, Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania) at the Society for Neuro-Oncology (SNO) 2023 Annual Meeting, taking place from November 15-19, 2023, in Vancouver, Canada.

Key Points: 
  • “Bizaxofusp represents an exciting new approach by demonstrating a dose-dependent effect on the receptor of IL-4, an immuno-suppressive cytokine.
  • The data offers new hope for patients with glioblastoma who have few treatment options at recurrence,” said Dr. Steven Brem.
  • The data demonstrated that a single treatment with bizaxofusp increased median overall survival (mOS) by 72% compared to the ECA (12.4 months vs. 7.2 months).
  • Overall survival (OS) for bizaxofusp-treated patients increased 370% at Year 1 and increased more than 50% at Year 2.

Plus Therapeutics to Host Virtual KOL Event on New Phase 2 ReSPECT-GBM Data in Recurrent Glioblastoma Presented at the Society for NeuroOncology (SNO) Conference on Monday, November 20, 2023

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星期三, 十一月 15, 2023
Therapy, PSTV, Glioblastoma, Patient, Neuro, Conference, Plus Therapeutics, Rhenium, Neurosurgery, Neuro-oncology, Neurology, Society, SNO, KOL, Decompression (diving), Pharmaceutical industry, Medicine

To register, click here.

Key Points: 
  • To register, click here.
  • The event will feature presentations from neuro-oncology expert and principal investigator Andrew Brenner, M.D., Ph.D. (Professor-Research, Departments of Medicine, Neurology, and Neurosurgery & S & B Kolitz/CTRC-Zachry Endowed Chair Neuro-Oncology Research, Mays Cancer Center at UT Health San Antonio) and neurosurgeons Toral Patel, M.D.
  • Brain Institute) and John Floyd, M.D.
  • A live question and answer session will follow the formal presentations.

Medicenna Therapeutics Reports Second Quarter Fiscal 2024 Financial Results and Operational Highlights

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星期二, 十一月 14, 2023
Doctor of Philosophy, Bispecific monoclonal antibody, Pancreatic cancer, MSI, Brain, Research, Annual general meeting, Glioblastoma, Metalloproteinase, Toronto Stock Exchange, Patient, MDNA, Pakistan Society of Neuro-Oncology, Intellectual property, Pembrolizumab, OTC Markets Group, Neuro-Oncology (journal), Conference, Standard of care, Melanoma, SITC, Survival, Partnership, Cancer, Neoplasm, Bifunctional, TSX, SNO, Microsatellite instability, Decompression (diving), Society, MMR, Patent, Pharmaceutical industry, Cryptocurrency, Immunotherapy

TORONTO and HOUSTON, Nov. 14, 2023 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. (“Medicenna” or the “Company”) (TSX: MDNA; OTC: MDNAF), a clinical-stage company focused on the design and development of novel evolutionary superkines to create revolutionary immunotherapies, today announced financial results and corporate highlights for the second quarter of fiscal 2024, ended September 30, 2023.

Key Points: 
  • We look forward to reporting initial Phase 2 dose expansion data from both the monotherapy and combination arms during the first half of 2024,” concluded Dr.
  • Clinical update from the ABILITY study’s MDNA11 plus pembrolizumab Phase 2 combination arm expected in the first half of 2024.
  • Research and development expenses of $3.1 million were incurred during the quarter ended September 30, 2023, compared with $2.4 million incurred in the quarter ended September 30, 2022.
  • General and administrative expenses of $2.3 million were incurred during the quarter ended September 30, 2023, compared with $2.4 million during the quarter ended September 30, 2022.