After promising results from patients enrolled to date, Atossa Therapeutics halted an Australian Phase 2 clinical trial evaluating its investigative oral therapy Endoxifen in women newly diagnosed with invasive, estrogen receptor (ER)-positive breast cancer and scheduled for surgery. “It is a welcome event to halt an ongoing clinical trial because the results are so overwhelmingly…
NeurMedix has announced it will soon open a pivotal Phase 3 clinical trial of its lead investigational therapy, NE3107, for people with Alzheimer’s disease, following authorization by the U.S. Food and Drug Administration (FDA). The trial (NCT04669028), to be conducted at about 30 clinical U.S. sites, will be looking to recruit up to 316 people with mild to…
China’s regulatory agency has approved the start of a Phase 3 clinical trial testing ATG-010 (selinexor), in combination with Velcade (bortezomib) and dexamethasone, in multiple myeloma patients after one to three prior lines of treatment. The trial will include about 150 patients in China with relapsed of refractory multiple myeloma, and randomly assign them to the…
Cytovia Therapeutics has entered into a licensing agreement with the National Cancer Institute (NCI) to develop a new “off-the-shelf” immunotherapy for solid tumors. The immunotherapy is based on “natural killer” or NK immune cells, which have been genetically modified to produce a chimeric antigen receptor, or CAR, that targets a specific cancer protein, Cytovia said…
Dosing has begun in a Phase 1 clinical trial testing Forma Therapeutics’ investigational therapy FT-7051 in people with metastatic castration-resistant prostate cancer (mCRPC). Recruiting at sites in Arizona and South Carolina, the open-label trial (NCT04575766) is expected to enroll 45 patients who failed to respond to at least one potent anti-androgen treatment. Contact and site information…
Sutro Biopharma‘s Phase 1 clinical trial has begun testing the recommended dose of STRO-002 in heavily pretreated patients with advanced ovarian cancer. “We are excited to be part of the STRO-002-GM1 dose-expansion study and to provide additional clinical data to show the potential of this therapeutic for ovarian patients with limited treatment options,” Lainie Martin, MD,…
Theralink Technologies announced that it has begun testing its new profiling biomarker assay — a test that could potentially provide oncologists with key information about a patient’s specific tumor — in people with breast cancer. “The Theralink assay for breast cancer may reveal therapeutic options for oncologists and in turn, may provide better outcomes for…
Ovarian cancer cells harboring mutations in the ARID1A tumor suppressor gene tend to use the amino acid glutamine as a source of energy more often, making the cells more vulnerable to compounds that interfere with glutamine metabolism, scientists found. As proof, they demonstrated that a compound that inactivates glutaminase (the enzyme that normally breaks down…
An accelerated review will be given an application for European Union approval of ciltacabtagene autoleucel (cilta-cel), a potential CAR T-cell therapy for heavily pre-treated multiple myeloma patients, its developer, Janssen, announced. An accelerated assessment, given to medications expected to have a major impact on public health, shortens the regulatory review process in Europe to 150 days from the…
Keytruda (pembrolizumab) has been recommended for approval in the European Union (EU) to treat adults and children, 3 years and older, with relapsed or refractory classical Hodgkin’s lymphoma (cHL) whose disease failed to respond to autologous stem cell transplant (ASCT) or who received at least two prior therapies when ineligible for ASCT. The therapy is…
