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Archive - Mar 11, 2019

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tACS (Transcranial Alternating Current Stimulation) of Brain Improves Symptoms of Major Depression, Restores Brain Waves in Clinical Study; New Approach Might Significantly Help Depressed Patients in Inexpensive, Non-Invasive Way, Lead Researcher Says

University of North Carolina (UNC) School of Medicine researchers, led by Flavio Frohlich, Ph.D., are the first to use transcranial alternating current brain stimulation (tACS) to significantly reduce symptoms in people diagnosed with major depression. With a weak alternating electrical current sent through electrodes attached to the scalp, University of North Carolina (UNC) School of Medicine researchers successfully targeted a naturally occurring electrical pattern in a specific part of the brain and markedly improved depression symptoms in about 70 percent of participants in a clinical study. The research, published online on March 5, 2019 in Translational Psychiatry, lays the groundwork for larger research studies to use a specific kind of electrical brain stimulation called transcranial alternating current stimulation (tACS) to treat people diagnosed with major depression. The open-access article is titled “Double-blind, randomized pilot clinical trial targeting alpha oscillations with transcranial alternating current stimulation (tACS) for the treatment of major depressive disorder (MDD).” "We conducted a small study of 32 people because this sort of approach had never been done before," said senior author Flavio Frohlich, PhD, Associate Professor of Psychiatry and Director of the Carolina Center for Neurostimulation. "Now that we've documented how this kind of tACS can reduce depression symptoms, we can fine-tune our approach to help many people in a relatively inexpensive, noninvasive way." Dr. Frohlich, who joined the UNC School of Medicine in 2011, is a leading pioneer in this field who also published the first clinical trials of tACS in schizophrenia and chronic pain. Dr.

Roche's VENTANA PD-L1 (SP142) Assay Approved As First Companion Diagnostic to Identify Triple-Negative Breast Cancer Patients Eligible for Treatment with Tecentriq in Combination with Abraxane

On March 11, 2019, Roche (SIX: RO, ROG; OTCQX: RHHBY) announced the the US Food and Drug Administration had approved the VENTANA PD-L1 (SP142) Assay as the first companion diagnostic to aid in identifying triple-negative breast cancer (TNBC) patients eligible for treatment with the Roche cancer immunotherapy Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]). Assessment of PD-L1 biomarker status on tumor-infiltrating immune cells with the assay is essential for identifying those patients most likely to benefit from the treatment. A diagnosis of triple-negative breast cancer means that the three most common proteins associated with breast cancer growth (estrogen receptor, progesterone receptor, and HER2/neu) are not expressed on the tumor. "Triple-negative breast cancer is an aggressive disease that, until now, has had limited treatment options," said Michael Heuer, CEO of Roche Diagnostics. "This assay plays a pivotal role in helping physicians identify patients who can benefit from Tecentriq therapy, providing better patient care. At Roche, we build on our capacity to research both targeted medicines and companion diagnostics under one roof, so we can provide the right treatment to the right patient at the right time." Each year about 300,000 women are diagnosed globally with triple-negative breast cancer, an aggressive disease with limited treatment options that represents 15 percent of all breast cancer cases. The VENTANA PD-L1 (SP142) Assay was developed to enhance visual contrast of tumor-infiltrating immune cell staining. In triple-negative breast cancer, PD-L1 is primarily expressed on tumor-infiltrating immune cells rather than on tumor cells themselves.

FDA Grants Roche’s Tecentriq, in Combination with Abraxane, Accelerated Approval for People With PD-L1-Positive, Metastatic Triple-Negative Breast Cancer; First Cancer Immunotherapy Regimen Approved for Breast Cancer

On March 11, Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Tecentriq® (atezolizumab) (an anti-PD-L1 monoclonal antibody), plus chemotherapy (Abraxane® [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]), for the treatment of adults with unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) in people whose tumors express PD-L1, as determined by an FDA-approved test. “The FDA approval of this Tecentriq combination is an important treatment advance for people with PD-L1-positive, metastatic triple-negative breast cancer, a disease with high unmet medical need,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “This Tecentriq combination is the first cancer immunotherapy regimen to be approved in breast cancer, representing a meaningful step forward in the understanding of this disease.” This indication is approved under accelerated approval based on progression-free survival (PFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). The FDA’s Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious or life-threatening disease or condition. This accelerated approval is based on data from the Phase III IMpassion130 study, which demonstrated that Tecentriq, plus nab-paclitaxel, significantly reduced the risk of disease worsening or death (PFS) by 40% compared with nab-paclitaxel alone (median PFS=7.4 vs.