HAVAH THERAPEUTICS


Associated tags: Breast pain, Therapy, Woman, Quality of life, Breast cancer

Locations: ADAM

Quantum Leap Healthcare Collaborative Initiates Landmark Phase 2 RECAST DCIS Platform Trial to Evaluate Alternative DCIS Treatments with Atossa Therapeutics, Havah Therapeutics, and the Menarini Group

Retrieved on: 
Monday, October 30, 2023
DCIS, FDA, NCI, Atossa, Testosterone, Biomarker, SERM, MD, Breast disease, Growth, Ductal carcinoma, Disease, Risk, Tamoxifen, National Cancer Institute, Breast cancer, SAN, Woman, Safety, Anastrozole, Patient, Toxicity, Breast, Pharmaceutical industry, Birth control

SAN FRANCISCO, Oct. 30, 2023 /PRNewswire/ -- Quantum Leap Healthcare Collaborative (QLHC) announces the enrollment launch for the Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: Ductal Carcinoma In Situ (RECAST DCIS), a Phase 2 platform study aimed at preventing the progression of DCIS to breast cancer. The study is evaluating three investigational endocrine therapy arms: (Z)-endoxifen, a selective estrogen receptor modulator (SERM) in development by Atossa Therapeutics (Nasdaq: ATOS); HAVAH T+Ai™, a proprietary combination of testosterone (T) and anastrozole (Ai) that targets the androgen and estrogen receptor pathways in development by Havah Therapeutics; and ORSERDU® (elacestrant), the only FDA approved oral selective estrogen receptor degrader (oSERD) in development by Stemline Therapeutics Inc. (Stemline), a wholly-owned subsidiary of the Menarini Group. 

Key Points: 
  • Surgery is the current standard treatment for DCIS even though many patients never progress to breast cancer, which means that patients are often over-treated with invasive procedures.
  • A key element in reducing overtreatment of DCIS is identifying biomarkers that reflect the risk of progression so that those with low-risk lesions are spared surgery.
  • RECAST DCIS features the assessment of imaging and molecular-based biomarkers in addition to evaluating new investigational agents in this setting.
  • The three collaborators for this trial, Atossa Therapeutics, Havah Therapeutics, and Stemline, all aim to find alternative solutions for DCIS patients and are providing different agents for assessment.

Clarus Therapeutics And HavaH Therapeutics Announce Licensing Agreement For Product To Treat Androgen-Dependent Inflammatory Breast Disease And Certain Forms Of Breast Cancer

Retrieved on: 
Tuesday, May 25, 2021

If approved, CLAR-121 would be the first T treatment of its kind for inflammatory breast disease.

Key Points: 
  • If approved, CLAR-121 would be the first T treatment of its kind for inflammatory breast disease.
  • If approved, CLAR-121 would be the first T treatment of its kind for inflammatory breast disease, including inflammatory periductal mastitis (PDM) and estrogen receptor-positive (ER+) breast cancer.
  • Under the terms of the licensing agreement, Clarus will be responsible for future global development and regulatory activities for CLAR-121, excluding Australia.
  • Reedland Capital Partners, acting through Weild & Co., member FINRA/SIPC, served as financial advisor to HavaH in connection with this transaction.