The U.S. Food and Drug Administration (FDA) has granted fast track designation with rolling review to Lumicell’s LUM Imaging System for the detection and treatment of breast cancer. Fast track is given to accelerate the development and review of investigational therapies aimed at treating serious or life-threatening conditions, and addressing an unmet medical need. With…
Most of the mild to moderate Alzheimer’s patients enrolled in the atuzaginstat (COR388) Phase 2/3 trial show evidence of systemic infection due to Porphyromonas gingivalis, a bacteria linked to periodontal disease whose toxic enzymes are thought to contribute to Alzheimer’s and are targets for this candidate therapy. A “high proportion” also test positive for biomarkers associated with this neurodegenerative disease.…
Immune cells that have been genetically engineered using CRISPR technology will be tested for a first time as a potential treatment of metastatic gastrointestinal cancer in a clinical trial. The Phase 1/2 trial (NCT04426669) is enrolling up to 20 eligible patients at the University of Minnesota’s Masonic Cancer Center. Contact information for this single-site study can be…
The Puerto Rico Health Insurance Administration (ASES) has signed an agreement with miR Scientific to evaluate the economic and health benefits of using the miR Sentinel PCC4 Assay, also called the miR Sentinel Prostate Test, to alleviate the burden of prostate cancer in the U.S. territory. Prostate cancer is the most common form of cancer and…
The University of Texas’ MD Anderson Cancer Center, in collaboration with the National Cancer Institute and Golfers Against Cancer, is evaluating the usefulness of a blood test called CA-125 at detecting ovarian cancer at early stages in low-risk women. Cancer antigen 125 (CA-125) is a protein found at higher levels in people with ovarian and other types of cancer.…
Genmab is launching a Phase 3 clinical trial investigating its bispecific antibody epcoritamab as a treatment for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) patients who fail to respond to, or are ineligible for, autologous stem cell transplant (ASCT). The open-label trial (NCT04628494) is expected to enroll up to 480 people whose tumors are positive…
The U.S. Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab), in combination with chemotherapy, to treat people with advanced triple-negative breast cancer (TNBC) and at least 10% of tumor cells positive for PD-L1. The indication includes patients with locally recurrent and inoperable or metastatic tumors, not previously treated with chemotherapy. Tumor PD-L1 status will be…
The last participant has completed the planned 24 weeks in the Phase 2 PEGASUS clinical trial, which is assessing the safety and biological activity of Amylyx Pharmaceuticals‘ investigational therapy AMX0035 in people with Alzheimer’s disease. Top-line results from the trial are expected in the first half of 2021. “The PEGASUS trial design and broad inclusion…
An artificial intelligence (AI) program that aims to make it easier to identify bone metastases in men with prostate cancer has been granted 501(k) clearance by the U.S. Food and Drug Administration (FDA), its developer announced. The program uses a neural network — a type of AI — to identify hotspots on bone scans indicative of bone…
ImmunoGen has announced a collaboration with Hangzhou Zhongmei Huadong Pharmaceutical Co, a subsidiary of Huadong Medicine, to develop and commercialize the ovarian cancer treatment mirvetuximab soravtansine to patients in China, Hong Kong, Macau, and Taiwan. The partnership will combine ImmunoGen’s expertise in cancer medication development with Huadong Medicine’s familiarity with regulatory agencies and connections to…
