Erasmus

AIM ImmunoTech Announces Publication of Positive Data from Late-Stage Pancreatic Cancer Early Access Program (EAP) in the Cancers Special Issue: Combination and Innovative Therapies for Pancreatic Cancer

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Tuesday, March 8, 2022
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OCALA, Fla., March 08, 2022 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE: American AIM) (“AIM” or the “Company”), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus, today announced the publication of positive data from a single-center named patient program treating advanced and metastatic pancreatic cancer patients. The manuscript titled, “Rintatolimod (Ampligen®) enhances numbers of peripheral B cells and is associated with longer survival in patients with locally advanced and metastasized pancreatic cancer pre-treated with FOLFIRINOX: a single-center named patient program1,” was published in the peer-reviewed journal, Cancers Special Issue: Combination and Innovative Therapies for Pancreatic Cancer.

Key Points: 
  • We are very encouraged by these data, which we believe reaffirm the potential of Ampligen to offer an important treatment option to patients living with pancreatic cancer.
  • These data now in hand play a key role in the overall advancement of our pancreatic cancer program and provide valuable insight as we continue to execute the path forward.
  • The Company plans to conduct a Phase 2 study of Ampligen as a therapy for locally advanced pancreatic cancer.
  • However, we have been corresponding with the FDA and we anticipate, but cannot assure, that the hold will be lifted.

Active Biotech enters into global patent license agreement with Oncode Institute for tasquinimod in myelofibrosis

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Wednesday, February 9, 2022
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Under the terms of the agreement, Oncode Institute, a foundation incorporated under the laws of the Netherlands, acting on behalf of Erasmus Universiteit Medisch Centrum (Erasmus MC), grants a global exclusive license to develop and commercialize tasquinimod worldwide in MF to Active Biotech.

Key Points: 
  • Under the terms of the agreement, Oncode Institute, a foundation incorporated under the laws of the Netherlands, acting on behalf of Erasmus Universiteit Medisch Centrum (Erasmus MC), grants a global exclusive license to develop and commercialize tasquinimod worldwide in MF to Active Biotech.
  • Active Biotech will pay to Oncode Institute, contingent of marketing approval, milestones as well as low single-digit royalties on net sales.
  • The results suggest that tasquinimod can act as a disease modifying agent in MF.
  • Active Biotech and Erasmus MC will initiate a research collaboration related to use of tasquinimod in MF, that includes preclinical as well as a clinical proof of concept study in patients with MF.

LAVA Therapeutics Announces Treatment of First Patient in Phase 1/2a Clinical Trial of LAVA-1207 for Metastatic Castration-Resistant Prostate Cancer

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Tuesday, February 1, 2022
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Despite current treatment options for prostate cancer, there is an unmet need for the many patients who experience relapse or become refractory to existing therapies.

Key Points: 
  • Despite current treatment options for prostate cancer, there is an unmet need for the many patients who experience relapse or become refractory to existing therapies.
  • I am delighted the Erasmus MC Cancer Institute is participating in this important study and to have the first patient treated.
  • The open-label, multi-center, Phase 1/2a clinical trial will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary antitumor activity of LAVA-1207 in patients with mCRPC.
  • A Phase 1/2a clinical study to evaluate LAVA-1207 in patients with metastatic castration-resistant prostate cancer (mCRPC) is enrolling.

DGAP-News: Thrombolytic Science, LLC: Thrombolytic Science Granted US Patent on Novel Clot Dissolving Therapy, Complementing Patent Protection in Europe, Japan, China, Hong Kong, Mexico, & CIS

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Friday, October 29, 2021
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CAMBRIDGE, MA, October 29, 2021 -- Thrombolytic Science, LLC (TSI) today announced the granting of a new patent by the USPTO. Most strokes and all heart attacks are caused by a blood clot blocking essential blood flow to a portion of the brain or heart. Since neither organ can long survive without blood flow, reperfusion must be as rapid as possible. Biological dissolution of the clot, or thrombolysis, remains the fastest and simplest way to reestablish blood flow. The invention relates to methods for a safe and effective clot dissolution that mimics the natural biological system.

Key Points: 
  • Thrombolytic Science, LLC: Thrombolytic Science Granted US Patent on Novel Clot Dissolving Therapy, Complementing Patent Protection in Europe, Japan, China, Hong Kong, Mexico, & CIS
    The issuer is solely responsible for the content of this announcement.
  • Thrombolytic Science Granted US Patent on Novel Clot Dissolving Therapy, Complementing Patent Protection in Europe, Japan, China, Hong Kong, Mexico, & CIS
    US Patent to Support Global Partnering of Novel, Nature-inspired Clot-dissolving Therapy
    CAMBRIDGE, MA, October 29, 2021 -- Thrombolytic Science, LLC (TSI) today announced the granting of a new patent by the USPTO.
  • Most strokes and all heart attacks are caused by a blood clot blocking essential blood flow to a portion of the brain or heart.
  • Since neither organ can long survive without blood flow, reperfusion must be as rapid as possible.

SIDM presents Laura Zwaan, PhD with Mark L. Graber Diagnostic Quality Award

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Wednesday, October 27, 2021
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EVANSTON, Ill., Oct. 27, 2021 /PRNewswire-PRWeb/ --The Society to Improve Diagnosis in Medicine today announced that it will present Laura Zwaan, PhD, with its annual Mark L. Graber Diagnostic Quality Award in recognition for unwavering commitment to expanding the field of diagnostic quality and safety.

Key Points: 
  • EVANSTON, Ill., Oct. 27, 2021 /PRNewswire-PRWeb/ --The Society to Improve Diagnosis in Medicine today announced that it will present Laura Zwaan, PhD, with its annual Mark L. Graber Diagnostic Quality Award in recognition for unwavering commitment to expanding the field of diagnostic quality and safety.
  • "Laura has chaired SIDM's Research Committee, the Research Summits at Diagnostic Error in Medicine Conference, and organized and chaired European Conference on Diagnostic Error.
  • "I'm incredibly honored to be this year's recipient of the Mark L. Graber award for diagnostic quality," said Laura Zwaan, PhD.
  • The Mark L. Graber Diagnostic Quality award, named in honor of Mark L. Graber, MD, FACP, SIDM Founder, is given to a person, group, or organization that has made an important contribution to the study and practice of reduction of diagnostic error.

Accuray CyberKnife® Robotic Radiotherapy Platform Could Significantly Improve Survival in Early-Stage Breast Cancer Patients

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Monday, October 25, 2021
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SUNNYVALE, Calif., Oct. 25, 2021 /PRNewswire/ --Accuray Incorporated(NASDAQ: ARAY) announced today that a study published in Frontiers in Oncology found early-stage breast cancer patients could experience significant improvements in survival if treated with accelerated partial breast irradiation (APBI) delivered using the Accuray CyberKnife robotic radiotherapy platform.

Key Points: 
  • SUNNYVALE, Calif., Oct. 25, 2021 /PRNewswire/ --Accuray Incorporated(NASDAQ: ARAY) announced today that a study published in Frontiers in Oncology found early-stage breast cancer patients could experience significant improvements in survival if treated with accelerated partial breast irradiation (APBI) delivered using the Accuray CyberKnife robotic radiotherapy platform.
  • The addition of radiotherapy can extend survival that may be offset by the development of a secondary cancer like lung tumors many years following treatment.
  • This study reinforces the unparalleled accuracy of a 4-like robotic CyberKnife platform and shows its tremendous potential as a treatment for early-stage breast cancer," said Suzanne Winter, president at Accuray.
  • Breast cancer stage distribution and number of new cases were obtained from the North American Association of Central Cancer Registries (NAACCR).

Obsidio, Inc. Expands Clinical Advisory Board With Two New Members

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Wednesday, October 20, 2021
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The new advisors will join existing clinical advisory board(CAB) members Riad Salem, MD, MBA, and Ziv Haskal, MD.

Key Points: 
  • The new advisors will join existing clinical advisory board(CAB) members Riad Salem, MD, MBA, and Ziv Haskal, MD.
  • The experience and insights of our CAB members will be critical to achieving that goal."
  • The two new members of the Clinical Advisory Board include:
    Dr. Jafar Golzarian is a co-founder of the Global Embolization Symposium & Technologies (GEST) and a Professor of Radiology and Director of the Division of Interventional Radiology and Vascular Imaging at the University of Minnesota.
  • He was a radiology resident at the Erasme Hospital, Brussels, and completed his Fellowship for Interventional Radiology at the same University.

AIM ImmunoTech Provides Clinical Updates on Planned Phase 2 Study of Ampligen in Patients with Locally Advanced or Metastatic Late-Stage Pancreatic Cancer

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Monday, October 4, 2021
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OCALA, Fla., Oct. 04, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) today announced that it has finalized the protocol for a planned Phase 2 study of the company’s drug Ampligen as a therapy for locally advanced or metastatic late-stage pancreatic cancer. The company expects to submit both an Investigational New Drug application (IND) and an application for Fast Track status with the U.S. Food and Drug Administration (FDA) no later than October 18, 2021.

Key Points: 
  • The new proposed study is based on statistically significant clinical data in an early-access program where 27 subjects were treated at Erasmus MC in The Netherlands.
  • These detailed data were filed with and supported the recent approval of orphan drug status for Ampligen by both the FDA and the European Medicines Agency.
  • Based on the Erasmus data and our preclinical data, were optimistic about the activity of Ampligen in treating pancreatic cancer.
  • There is the potential for delays in clinical trial enrollment and reporting because of the COVID-19 medical emergency.

Spectrum Pharmaceuticals Presents Late Breaker Oral Presentation of Poziotinib Data in First-Line NSCLC Patients with HER2 Exon 20 Insertion Mutations at ESMO Congress 2021

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Saturday, September 18, 2021
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This data is from 48 first-line patients with non-small cell lung cancer (NSCLC) with HER2 exon 20 insertion mutations who received 16mg of oral poziotinib once daily.

Key Points: 
  • This data is from 48 first-line patients with non-small cell lung cancer (NSCLC) with HER2 exon 20 insertion mutations who received 16mg of oral poziotinib once daily.
  • There currently is no specific approved treatment for NSCLC patients with HER2 exon 20 insertion mutations.
  • Cohort 4 of the ZENITH20 clinical trial is enrolling treatment-nave NSCLC patients with HER2 exon 20 insertion mutations.
  • Poziotinib demonstrated clinically meaningful anti-tumor activity in newly diagnosed NSCLC patients with HER2 exon 20 mutations with 16mg QD dosing.

HeartFlow Announces Enrollment of First Three Patients in FUSION Trial

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Thursday, September 2, 2021
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With the FUSION trial, we anticipate a 33% reduction in unnecessary ICAs which we believe will lead to cost savings for the overall healthcare system.

Key Points: 
  • With the FUSION trial, we anticipate a 33% reduction in unnecessary ICAs which we believe will lead to cost savings for the overall healthcare system.
  • The FUSION trial is planned to enroll 528 patients from six Dutch hospitals including Erasmus MC, UMCG, UMC Utrecht, the Admiraal de Ruyter Hospital in Goes, St Jansdal in Lelystad and Gelre hospitals Apeldoorn.
  • Patients whose CTA shows coronary artery disease will be randomized between the HeartFlow FFRct arm or the ICA arm.
  • Once the trial is complete, it is anticipated that the data will support insurance reimbursement in the Netherlands for the HeartFlow Analysis.