NIH funded study shows HIV can spread early, evolve in patients’ brains

Researchers funded by the National Institutes of Health (NIH) have discovered that the AIDS virus can genetically evolve and independently replicate in patients’ brains early in the illness process.  An analysis of cerebral spinal fluid (CSF), a window into brain chemical activity, revealed that for a subset of patients HIV had started replicating within the brain within the first four months of infection. CSF in 30 percent of HIV-infected patients tracked showed at least transient signs of inflammation – suggesting an active infectious process – or viral replication within the first two years of infection. There was also evidence that the mutating virus can evolve a genome in the central nervous system that is distinct from that in the periphery.



“These results underscore the importance of early diagnosis and treatment with antiretroviral therapy,” said Dianne Rausch, Ph.D., director of the Division of AIDS Research of the NIH’s National Institute of Mental Health (NIMH). “Any delay runs the risk that the virus could find refuge and cause damage in the brain, where some medications are less effective – potentially enabling it to re-emerge, even after it is suppressed in the periphery.”

Cell Cure seeks US FDA permission to begin phase I/IIa

HBL Hadasit Bio-Holdings Ltd., and Cell Cure Neurosciences Ltd. (Cell Cure) announced that Cell Cure has filed an Investigational New Drug (IND) application with the United States Food and Drug Administration (FDA) seeking to initiate a phase I/IIa clinical trial of OpRegen in patients with geographic atrophy (GA), the advanced stage of the dry form of age-related macular degeneration (dry-AMD).

OpRegen consists of retinal pigment epithelial (RPE) cells derived from human embryonic stem cells and is intended to be administered as a single dose into the subretinal space of patients’ eyes in order to treat this leading cause of visual impairment.

The design of the proposed clinical trial, “Phase I/IIa Dose Escalation Safety and Efficacy Study of Human Embryonic Stem Cell-Derived Retinal Pigment Epithelium Cells Transplanted Subretinally in Patients with Advanced Dry-Form Age-Related Macular Degeneration with Geographic Atrophy,” is based on a pre-IND meeting with the FDA.. Patients will undergo a single transplantation and the study will explore three different doses of OpRegen. Following transplantation, the patients will be followed over 12 months at specified intervals and then at longer time periods, to evaluate the safety and tolerability of the product. A secondary objective of the clinical trial will be to explore the ability of transplanted OpRegen to moderate the disease progression.

Boston Scientific begins RESPOND Registry

Boston Scientific Corporation has initiated the RESPOND Post Market Registry to assess real world performance of the Lotus Valve System.  The RESPOND Registry will collect data on clinical outcomes and device performance in 1,000 patients implanted at 50 centres around the world.

Three patients enrolled in the RESPOND Registry thus far have been successfully implanted with the Lotus Valve System.  Dr. Nicolas Van Mieghem and Prof. Peter De Jaegere led the first transcatheter aortic valve implantation (TAVI) procedure at Erasmus Medical Centre in Rotterdam, the Netherlands using the Boston Scientific Safari Pre-Shaped TAVI Guidewire.  The Safari Guidewire, which received FDA clearance and CE Mark in 2013, is compatible with the Lotus Valve System and other TAVI devices and is designed to facilitate stable, atraumatic valve placement.