The last participant has completed all predefined assessments in the Phase 3 COGNITE clinical trial, which is assessing the safety and effectiveness of AZTherapies’ treatment candidate ALZT-OP1 for people with early Alzheimer’s disease. The trial’s top-line results are expected in the first months of 2021. The biopharmaceutical company hopes its investigational therapy will be found…
Conditions
Conditions
Onconova Seeking FDA Approval for Phase 1 Trial of ON 123300 for Breast Cancer
Onconova Therapeutics is seeking the green light from the U.S. Food and Drug Administration (FDA) to begin a Phase 1 clinical trial for its small molecule ON 123300 in certain types of breast cancer. The trial would include, but not be limited to, people with relapsed/refractory advanced breast cancer, including those with hormone receptor-positive (HR+), human…
Phase 2 Trial Begins Testing VS-6766, Defactinib Combo in Low-grade Serous Ovarian Cancer
Verastem Oncology has started a Phase 2 clinical trial evaluating its inhibitors, VS-6766 and defactinib, for the treatment of people with recurrent low-grade serous ovarian cancer (LGSOC), the company announced. The trial seeks to recruit up to 100 female patients — more information is available here — and will investigate the company’s RAF/MEK inhibitor VS-6766,…
Tislelizumab Safely Prolongs Survival in Advanced Lung Cancer Patients, Interim Data Show
When given as a second- or third-line therapy, BeiGene’s tislelizumab is superior to docetaxel at prolonging the survival of people with locally advanced or metastatic non-small cell lung cancer (NSCLC), whose disease progressed while receiving platinum-based chemotherapy. Additionally, tislelizumab had a favorable safety profile that was consistent with that of previous studies, and its use…
FDA Puts RV001 on Fast Track for Treating Prostate Cancer
The U.S. Food and Drug Administration (FDA) has granted fast track status to RV001, RhoVac‘s investigational therapy for prostate cancer, the company announced. Fast track designation helps speed the approval of potential medicines that address unmet medical needs in serious or life-threatening conditions. It grants RhoVac greater access to FDA input throughout the regulatory process…
Cortexyme’s COR388 GAIN Trial Advances to Endpoint; Results Expected Late 2021
Cortexyme’s ongoing Phase 2/3 GAIN clinical trial, which is evaluating the investigational treatment COR388 (atuzaginstat) in people with mild to moderate Alzheimer’s disease, has been approved to continue as planned to its one-year endpoint, the company said. Topline results from the study, testing whether COR388 can lessen dementia and neurodegeneration in Alzheimer’s, are expected on time…
‘Unassuming’ Non-medicinal Plant Can Stop Growth of Breast Cancer Cells, Study Shows
Scientists have discovered that an unassuming non-medicinal plant can stop the growth of human breast cancer cells without affecting non-cancerous cells. Their research into Arabidopsis thaliana, a small annual flowering plant in the mustard family, could lead to potential new treatments for breast cancer and other diseases. The study, “Jasmonates induce Arabidopsis bioactivities selectively inhibiting the…
Xpovio Approval Sought for Myeloma Indications in 3 Asian Pacific Markets
Antengene is asking health authorities in Singapore, Australia, and Hong Kong to approve Xpovio (selinexor) for the treatment of multiple myeloma, the company announced in a press release. Specifically, the new drug applications will cover myeloma patients who have received at least four therapies, and failed to respond to at least two immunomodulatory therapies, two…
Anixa Enters License Agreement With Cleveland Clinic for Ovarian Cancer Vaccine
Anixa Biosciences has entered in a license agreement with the Cleveland Clinic to obtain the exclusive, global rights for a new ovarian cancer vaccine technology. “Through this collaboration we are expanding into additional preventive and therapeutic areas and we look forward to seeing the development of this ovarian cancer vaccine,” Vincent Tuohy, PhD, an immunologist at…
Canada Approves Lynparza for Metastatic CRPC Patients With Certain Gene Mutations
Canadian authorities have approved Lynparza (olaparib) as an oral treatment for people with metastatic castration-resistant prostate cancer (mCRPC) who carry mutations in BRCA or ATM genes, both of which are involved in DNA repair. The approval, granted under priority review, is specifically indicated for patients who progressed after treatment with new forms of hormone therapy, such as Xtandi (enzalutamide)…
Yescarta Shows Promise in Advanced Non-Hodgkin Lymphomas, Trial Data Show
Yescarta (axicabtagene ciloleucel), Kite Pharma’s CAR T-cell therapy, leads to a high rate of strong and sustained responses in adults with relapsed or refractory (resistant) follicular lymphoma, known as FL, or marginal zone lymphoma, called MZL, who received at least two prior therapy lines, according to interim data from a Phase 2 trial. Both FL and MZL are…
Roche’s Cevostamab Leads to Durable, Deep Responses in Heavily Pre-Treated Patients
Cevostamab (BFCR4350A), a bispecific antibody developed by Roche, induces durable and deep responses in heavily pre-treated patients with relapsed or refractory multiple myeloma, according to early data from a Phase 1 trial. Preliminary data from the trial, called GO39775 (NCT03275103), also showed cevostamab had a manageable safety and toxicity profile when given in a single…