Ductal carcinoma

Atossa Therapeutics Announces Year-End 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, April 1, 2024

SEATTLE, April 01, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”), today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided an update on recent Company developments.

Key Points: 
  • SEATTLE, April 01, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”), today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided an update on recent Company developments.
  • Full enrollment was achieved in November 2023 and data is expected in the second half of 2024.
  • Factors contributing to the increased operating expenses in the year ended December 31, 2023 are explained below.
  • The following table provides a breakdown of major categories within R&D expense for the years ended December 31, 2023 and 2022, together with the dollar change in those categories (in thousands):

Atossa Therapeutics Announces First Patient Dosing of (Z)-Endoxifen in the Ongoing RECAST DCIS Study

Retrieved on: 
Thursday, February 22, 2024

RECAST DCIS is an ongoing Phase 2 platform study designed to offer women diagnosed with DCIS six months of neoadjuvant endocrine therapy with the intent of determining their suitability for long-term active surveillance without surgery.

Key Points: 
  • RECAST DCIS is an ongoing Phase 2 platform study designed to offer women diagnosed with DCIS six months of neoadjuvant endocrine therapy with the intent of determining their suitability for long-term active surveillance without surgery.
  • A short 'explainer' video about Ductal Carcinoma In Situ and the RECAST DCIS study can be found here: DCIS Video Explainer.
  • “This is an overly aggressive treatment approach, especially when you consider most DCIS cases will not progress to invasive breast cancer if left untreated.
  • RECAST DCIS features the assessment of imaging and molecular-based biomarkers in addition to evaluating new investigational agents in this setting.

PreludeDx Appoints Chris Emery, VP of Strategic Marketing and Business Development

Retrieved on: 
Thursday, February 8, 2024

LAGUNA HILLS, Calif., Feb. 8, 2024 /PRNewswire/ -- Prelude Corporation (PreludeDx™), a leader in molecular diagnostics and precision medicine for early-stage breast cancer, today announced the appointment of Chris Emery to the newly created position of VP of Strategic Marketing and Business Development.

Key Points: 
  • LAGUNA HILLS, Calif., Feb. 8, 2024 /PRNewswire/ -- Prelude Corporation (PreludeDx™), a leader in molecular diagnostics and precision medicine for early-stage breast cancer, today announced the appointment of Chris Emery to the newly created position of VP of Strategic Marketing and Business Development.
  • "With his extensive experience in healthcare and specifically molecular diagnostics, I am pleased to welcome Chris to PreludeDx's leadership team.
  • Chris brings more than 25 years of experience in healthcare across laboratory services, medical device and biopharmaceutical companies, with senior leadership roles in marketing, sales and business development in the cancer diagnostics market.
  • He joins PreludeDx from HALO Precision Diagnostics where he served as the Chief Business Officer – Molecular Diagnostics.

Atossa Therapeutics Issues Letter to Shareholders

Retrieved on: 
Tuesday, January 9, 2024

SEATTLE, Jan. 09, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer, today announces the issuance of the following Letter to Shareholders from Steven Quay, M.D., Ph.D., the Company’s President and Chief Executive Officer:

Key Points: 
  • SEATTLE, Jan. 09, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer, today announces the issuance of the following Letter to Shareholders from Steven Quay, M.D., Ph.D., the Company’s President and Chief Executive Officer:
    2023 marked another year of significant progress for Atossa.
  • If you would like to learn more about the study, please visit www.atossatherapeutics.com to view a short video interview I conducted with Dr.
  • Adding to the issue is the fact that there are currently no approved treatments to reduce breast density.
  • On behalf of the board of directors, management, and employees of Atossa Therapeutics, we thank you for your investment and continued support of our Company.

PreludeDx to Present New Data on the Clinical Utility of DCISionRT in Australian Patients with DCIS at the 2023 San Antonio Breast Cancer Symposium

Retrieved on: 
Tuesday, December 5, 2023

LAGUNA HILLS, Calif., Dec. 05, 2023 (GLOBE NEWSWIRE) -- Prelude Corporation (PreludeDx), a leader in molecular diagnostics and precision medicine for early-stage breast cancer, today announced it will present data demonstrating the decision impact on physician recommendations for radiation therapy (RT) in ductal carcinoma in situ (DCIS) patients in Australia.

Key Points: 
  • LAGUNA HILLS, Calif., Dec. 05, 2023 (GLOBE NEWSWIRE) -- Prelude Corporation (PreludeDx), a leader in molecular diagnostics and precision medicine for early-stage breast cancer, today announced it will present data demonstrating the decision impact on physician recommendations for radiation therapy (RT) in ductal carcinoma in situ (DCIS) patients in Australia.
  • The data will be presented at the 2023 San Antonio Breast Cancer Symposium (SABCS), held on December 5 - 9, 2023 at the Henry B. Gonzalez Convention Center, San Antonio, Texas.
  • Specifically, in the interim analysis of 483-patients treated with breast conserving surgery in Australia, the use of the test resulted in a 41% change in RT recommendations and a 9% change in hormone therapy (HT) recommendations.
  • “The integration of DCISionRT into the clinical decision-making processes has a substantial impact on recommendations to personalize care and prevent over- and under-treatment,” said Dr. Yvonne Zissiadis, MBBS, FRANZCR, radiation oncologist, GenesisCare and principal investigator.

iCAD’s ProFound AI Can Predict 1-2 Year Risk for Breast Cancer and Reveal Insights for Heart Disease

Retrieved on: 
Monday, November 27, 2023

NASHUA, N.H., Nov. 27, 2023 (GLOBE NEWSWIRE) -- iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader in innovative cancer-detection solutions, will present new studies validating its artificial intelligence (AI) powered ProFound Breast Health Suite for uncovering hidden heart or vascular disease and predicting a woman’s risk for developing breast cancer in the next one- or two-years. Researchers will present their findings at the Radiological Society of North America’s (RSNA) annual meeting in Chicago, Nov. 27 – 30, 2023.

Key Points: 
  • Blending artificial intelligence with computer-aided detection (AI CAD), the iCAD software platform, ProFound Breast Health Suite, can screen a single mammogram for two of the top causes of death for women: breast cancer and heart disease.
  • In fact, women with breast arterial calcifications, or BAC, are 51% more likely to develop heart disease.
  • He and his colleagues found the ProFound Heart Health AI algorithm highly accurate in uncovering BAC in mammograms.
  • ProFound Heart Health***: a new solution for measuring cardiovascular calcium deposits, alerting to possible vascular or heart disease (pending FDA clearance).

Atossa Therapeutics Announces Full Enrollment of Phase 2 Karisma-Endoxifen Clinical Trial

Retrieved on: 
Monday, November 20, 2023

MBD change is used as a proxy for therapy response.

Key Points: 
  • MBD change is used as a proxy for therapy response.
  • “Many of the risk factors for breast cancer, including breast density, are known, which means treating at-risk patient populations before the disease develops could significantly lower incidence rates,” said Dr.
  • “While significant progress has been made in breast cancer treatment, the same cannot be said about breast cancer prevention, particularly in high-risk women.
  • Both diagnoses are strong, independent predictors of breast cancer risk that we feel are modifiable with (Z)-endoxifen.”

PreludeDx™ to Present Multiple Presentations at the 2023 San Antonio Breast Cancer Symposium

Retrieved on: 
Thursday, November 16, 2023

LAGUNA HILLS, Calif., Nov. 16, 2023 (GLOBE NEWSWIRE) -- Prelude Corporation (PreludeDx), a leader in molecular diagnostics and precision medicine for early-stage breast cancer, today announced that data will be presented in two separate poster presentations at the 2023 San Antonio Breast Cancer Symposium (SABCS), held on December 5 - 9, 2023 at the Henry B. Gonzalez Convention Center, San Antonio, Texas.

Key Points: 
  • LAGUNA HILLS, Calif., Nov. 16, 2023 (GLOBE NEWSWIRE) -- Prelude Corporation (PreludeDx), a leader in molecular diagnostics and precision medicine for early-stage breast cancer, today announced that data will be presented in two separate poster presentations at the 2023 San Antonio Breast Cancer Symposium (SABCS), held on December 5 - 9, 2023 at the Henry B. Gonzalez Convention Center, San Antonio, Texas.
  • “We are pleased to present additional data on the development of our invasive Stage 1/2 breast cancer test for radiation therapy, as well as expanded international data from our PREDICT Australia study at the prestigious SABCS,” said Dan Forche, President and CEO of PreludeDx.
  • “Both studies demonstrate our deep commitment to continual improvement of personalized medicine for early-stage breast cancer patients and their clinicians.”
    Title: Changes in Treatment Recommendation for Patients with Ductal Carcinoma in Situ Using a 7-Gene Predictive Biosignature: Analysis of the Predict Australia Study

Atossa Therapeutics Announces Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, November 13, 2023

Four ongoing Phase 2 studies evaluating (Z)-endoxifen, including recently announced study in DCIS

Key Points: 
  • Four ongoing Phase 2 studies evaluating (Z)-endoxifen, including recently announced study in DCIS
    SEATTLE, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative proprietary medicines to address significant unmet needs in oncology with a focus on breast cancer, today announces financial results for the quarter ended September 30, 2023, and provides an update on recent company developments.
  • Key developments from Q3 2023 and year to date include:
    80% Enrollment in Ongoing Phase 2 Karisma-Endoxifen Clinical Trial – the study is investigating (Z)-endoxifen in premenopausal women with measurable breast density.
  • Participants receive daily doses of (Z)-endoxifen for six months, over the course of which mammograms are conducted to measure reduction in breast density.
  • Full enrollment is expected by the end of 2023 and data is expected in the second half of 2024.

Exai Bio’s RNA- and AI-based Liquid Biopsy Platform Detects Early Stage Breast Cancer with High Accuracy, Overcoming Many Limitations of DNA-based Approaches

Retrieved on: 
Wednesday, December 6, 2023

Overall sensitivity across all invasive breast cancer stages was 88% at 90% specificity, far exceeding any DNA-based liquid biopsy performance.

Key Points: 
  • Overall sensitivity across all invasive breast cancer stages was 88% at 90% specificity, far exceeding any DNA-based liquid biopsy performance.
  • These results will be presented at a poster session today at the San Antonio Breast Cancer Symposium (SABCS) 2023 meeting.
  • The data released today further support the potential of the Exai platform to complement mammography and enable earlier detection of breast cancer for more women.
  • Exai’s universal platform can be used across multiple cancer care settings such as screening and early detection, monitoring, molecular residual disease and therapy selection.