Auckland City Hospital

Surmodics Announces 24-Month Data from the SWING Trial Presented at VEITHsymposium

Retrieved on: 
Thursday, November 16, 2023

The SWING Trial is a 35-subject prospective, multi-center, single-arm, feasibility study to evaluate the safety and performance of the Sundance Sirolimus DCB when used to treat occlusive disease of the infrapopliteal arteries.

Key Points: 
  • The SWING Trial is a 35-subject prospective, multi-center, single-arm, feasibility study to evaluate the safety and performance of the Sundance Sirolimus DCB when used to treat occlusive disease of the infrapopliteal arteries.
  • Both primary endpoints of the SWING Trial were achieved.
  • Primary safety endpoint data showed no perioperative deaths or major amputations at 30 days, and just one major re-intervention was reported among the 35 trial subjects.
  • “These results are promising and will inform future trials, which we hope will continue to advance improved treatments for our patients.”

One-Year Results from the AAA-SHAPE Early Feasibility Study to be Presented at VEITH 2023

Retrieved on: 
Monday, November 13, 2023

AAA-SHAPE is the Company’s prospective, multicenter, early feasibility study of the IMPEDE-FX RapidFill® Device when used for abdominal aortic aneurysm (AAA) sac management during elective endovascular aneurysm repair (EVAR).

Key Points: 
  • AAA-SHAPE is the Company’s prospective, multicenter, early feasibility study of the IMPEDE-FX RapidFill® Device when used for abdominal aortic aneurysm (AAA) sac management during elective endovascular aneurysm repair (EVAR).
  • Michel Reijnen, MD, PhD, vascular surgeon at Rijnstate Hospital in Arnhem, the Netherlands and principal investigator for AAA-SHAPE Netherlands will present the data.
  • “We are encouraged by the one-year results and how shape memory polymer technology may ultimately influence sac behavior,” stated Professor Reijnen.
  • In the United States, IMPEDE-FX RapidFill is an investigational device, limited by Federal (or United States) law to investigational use.

Vir Biotechnology to Present New Data from Its Ongoing Phase 2 Chronic Hepatitis Delta and B Trials Today at AASLD’s The Liver Meeting® 2023

Retrieved on: 
Monday, November 13, 2023

To date, no participants receiving the combination therapy or VIR-3434 monotherapy have experienced ALT elevations relative to their baseline.

Key Points: 
  • To date, no participants receiving the combination therapy or VIR-3434 monotherapy have experienced ALT elevations relative to their baseline.
  • “Chronic hepatitis delta is the most aggressive form of viral hepatitis.
  • Vir will host an investor conference call to discuss the Phase 2 CHD & CHB AASLD data at 1:45 p.m. Pacific Time / 4:45 p.m. Eastern Time on November 13th.
  • A live webcast will be available on https://investors.vir.bio and will be archived on www.vir.bio for 30 days.

Vir Biotechnology to Present Late-Breaking Data from Its Ongoing Phase 2 Chronic Hepatitis B and Delta Trials at AASLD’s The Liver Meeting® 2023

Retrieved on: 
Friday, November 10, 2023

Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that it will be presenting new data from its Phase 2 trials evaluating the potential clinical impact that VIR-3434 and VIR-2218 could have for chronic hepatitis B (CHB) and chronic hepatitis delta (CHD) patients at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting®, taking place in Boston, MA, from November 10-14, 2023.

Key Points: 
  • Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that it will be presenting new data from its Phase 2 trials evaluating the potential clinical impact that VIR-3434 and VIR-2218 could have for chronic hepatitis B (CHB) and chronic hepatitis delta (CHD) patients at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting®, taking place in Boston, MA, from November 10-14, 2023.
  • These include one late-breaking poster presentation and one late-breaking oral presentation.
  • Title: VIR-2218 and VIR-3434 With or Without Pegylated Interferon Alfa-2A for the Treatment of Chronic HBV Infection: End of Treatment (EOT) Results After 24 Weeks of Therapy (March Study Part B) (Abstract #48500)
    Presenter: Edward Gane, M.D., Professor of Medicine at the University of Auckland, New Zealand, and Chief Hepatologist, Transplant Physician and Deputy Director of the New Zealand Liver Transplant Unit at Auckland City Hospital
    Title: The Monoclonal Antibody VIR-3434 And siRNA VIR-2218 for the Treatment of Chronic Hepatitis D Virus: Preliminary Results from the Phase 2 SOLSTICE Trial (Abstract #5004)
    Presenter: Tarik Asselah, M.D., Ph.D., Professor of Hepatology at the Hôpital Beaujon, APHP, Clichy, France, and at the University of Paris, and Head of Viral Hepatitis at INSERM UMR1149, France
    Vir will host an investor conference call to discuss the Phase 2 CHD & CHB AASLD data at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time on November 13th.
  • A live webcast will be available on https://investors.vir.bio and will be archived on www.vir.bio for 30 days.

Vaccitech to Host KOL Webinar on Seeking a Functional Cure for Chronic Hepatitis B on September 20, 2023

Retrieved on: 
Wednesday, September 13, 2023

Details are as follows:

Key Points: 
  • Details are as follows:
    To register for the event, click here .
  • The Vaccitech management team will provide a clinical overview of VTP-300, the first antigen-specific immunotherapy that has been shown to induce sustained reductions in Hepatitis B surface antigen, a marker of the disease.
  • Vaccitech is studying VTP-300, including in combination with siRNA and low-dose anti-PD-1 antibodies, as part of the search for a regimen that could lead to a potential functional cure for HBV.
  • A live Q&A session will follow the formal presentations.

Advanced NanoTherapies (ANT) Secures $4M Strategic Investment to Accelerate Clinical Development of SirPlux Duo Drug-Coated Balloon (DCB) for Treating de novo Coronary Artery Disease (CAD)

Retrieved on: 
Tuesday, August 22, 2023

LOS GATOS, Calif., Aug. 22, 2023 /PRNewswire/ -- Advanced NanoTherapies Inc. (ANT), a clinical-stage medical device company committed to solving the most significant challenges in vascular disease through the creative applications of nanotechnology, today announced a $4M Series A extension from a prominent undisclosed strategic medical device company. Additionally, ANT successfully treated the first cohort of study participants in its ADVANCE-DCB first-in-human (FIH) trial, demonstrating initial short-term safety data for the next-generation SirPlux Duo Drug-Coated Balloon (DCB). The trial is evaluating the safety and performance of the SirPlux Duo DCB in de novo coronary artery disease (CAD).

Key Points: 
  • Additionally, ANT successfully treated the first cohort of study participants in its ADVANCE-DCB first-in-human (FIH) trial, demonstrating initial short-term safety data for the next-generation SirPlux Duo Drug-Coated Balloon (DCB).
  • The trial is evaluating the safety and performance of the SirPlux Duo DCB in de novo coronary artery disease (CAD).
  • "Today, we celebrate two remarkable accomplishments for ANT and SirPlux Duo DCB," said Marwan Berrada, Co-Founder and CEO of ANT.
  • "I welcome the participation of a new strategic partner as this additional investment will bolster ANT's clinical programs and accelerate the path toward U.S. IDE approval for the SirPlux Duo DCB.

Geneos Therapeutics Announces Eight of 34 Patients to Achieve Complete Response, Complete Molecular Response, or, Secondary Resectability in Ongoing Clinical Trial of Personalized Therapeutic Cancer Vaccination in Second Line Advanced Liver Cancer

Retrieved on: 
Tuesday, August 22, 2023

PLYMOUTH MEETING, Pa., Aug. 22, 2023 /PRNewswire/ -- Geneos Therapeutics, a clinical stage biotherapeutics company focused on the development of personalized therapeutic cancer vaccines (PTCV), today announced updated data from GT-30, an ongoing single-arm open-label multi-center Phase 1b/2a study in second-line advanced hepatocellular carcinoma (HCC). Previously, Geneos reported three patients to have achieved a complete response (CR) and a fourth patient to be cancer-free, whose liver and lung lesions shrank to become fully responsive to surgery and radiation (secondary resectability).

Key Points: 
  • Geneos reports today that four additional patients have achieved a complete molecular response (CMR) by ultrasensitive, third-generation, circulating tumor DNA (ctDNA) analysis.
  • By RECIST1.1, three of these four patients are durable partial responses (PR) and one a durable stable disease (SD).
  • By either RECIST1.1 or by ctDNA response, 11 of 32 evaluable have achieved either a complete response, partial response, or complete molecular response.
  • Cancer vaccines based on our DNA vaccine platform are showing complete responses in patients with late-stage, advanced cancer.

Vir Biotechnology Presents New Data Evaluating the Potential for VIR-2218 and VIR-3434 as Therapies for Chronic Hepatitis B and Hepatitis D

Retrieved on: 
Saturday, June 24, 2023

SAN FRANCISCO, June 24, 2023 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced new data from its robust hepatitis B and D virus (HBV and HDV) portfolio that were presented at the EASL™ (European Association for the Study of the Liver) Congress.

Key Points: 
  • These data further support the clinical development of these investigational medicines for the treatment of HDV.
  • “I am very excited by the progress we are making toward our goal of achieving HBV functional cure.
  • Our data to-date with VIR-2218 and PEG-IFN-⍺ support our hypothesis of using a cocktail of antivirals combined with immunomodulators.
  • The majority of adverse events were consistent with the known effects of PEG-IFN-⍺ and resolved after the end of treatment.

Vir Biotechnology Announces Multiple Abstracts Highlighting New Hepatitis B and D Data Accepted for Presentation at EASL™ Congress 2023

Retrieved on: 
Wednesday, June 7, 2023

SAN FRANCISCO, June 07, 2023 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that five abstracts highlighting new data from the Company’s broad hepatitis portfolio addressing both hepatitis B virus (HBV) and hepatitis D virus (HDV) have been accepted for presentation at the annual meeting of the European Association for the Study of the Liver, EASL™ Congress 2023, taking place in Vienna from June 21-24.

Key Points: 
  • SAN FRANCISCO, June 07, 2023 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that five abstracts highlighting new data from the Company’s broad hepatitis portfolio addressing both hepatitis B virus (HBV) and hepatitis D virus (HDV) have been accepted for presentation at the annual meeting of the European Association for the Study of the Liver, EASL™ Congress 2023, taking place in Vienna from June 21-24.
  • “The accepted abstracts underscore the progress Vir is making with our robust hepatitis B and D portfolio and the potential impact the combination of VIR-3434 and VIR-2218 could have on both viruses,” said Phil Pang, M.D., Ph.D., Vir’s Executive Vice President, Chief Medical Officer and Interim Head of Research.
  • A second oral presentation will share follow-up data from Part A of the Phase 2 MARCH trial.
  • Initial on-treatment data from the 24-week cohorts are anticipated in the second half of 2023.

Shape Memory Medical Announces Publication of Study Results in Vascular

Retrieved on: 
Tuesday, May 30, 2023

Shape Memory Medical Inc., developer of shape memory polymer for peripheral and neurovascular markets, announced the publication of results from the Company’s prospective, open-label, single-arm, safety study of the IMPEDE Embolization Plug in peripheral vascular embolization.

Key Points: 
  • Shape Memory Medical Inc., developer of shape memory polymer for peripheral and neurovascular markets, announced the publication of results from the Company’s prospective, open-label, single-arm, safety study of the IMPEDE Embolization Plug in peripheral vascular embolization.
  • Ted Ruppel, Chief Executive Officer of Shape Memory Medical Inc. said, "We would like to congratulate the investigators and clinical research team at Auckland City Hospital for completing the study and retrospective review of follow-up imaging.
  • “We look forward to seeing how shape memory polymer in clinical practice continues to evolve.”
    “Shape memory polymer technology in peripheral vascular embolization” was first published online in Vascular on May 22, 2023 and is available via open access .
  • Shape Memory Medical Inc. is dedicated to developing innovative therapeutic solutions with its proprietary shape memory polymers.