MENLO PARK, Calif., June 8, 2015 /PRNewswire/ — Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company focused on the emerging field of regenerative medicine, today announced that the first patient was successfully dosed at the Atlanta-based Shepherd Center in a Phase 1/2a clinical trial evaluating activity of escalating doses of AST-OPC1 (oligodendrocyte progenitor cells) in newly injured patients with sensory and motor complete cervical spinal cord injury (SCI). The Phase 1/2a trial is part of the planned registration program for AST-OPC1, with neurologically complete cervical SCI as the first targeted indication.
The open-label, single-arm study, which will be conducted at a total of up to eight centers in the United States, will test three sequential escalating doses of AST-OPC1 administered at up to 20 million AST-OPC1 cells in 13 patients with sub-acute, C-5 to C-7, neurologically complete cervical SCI. These individuals have essentially lost all sensation and movement below their injury site with severe paralysis of the upper and lower limbs. AST-OPC1 will be administered 14 to 30 days post-injury. Patients will be followed by neurological exams and imaging methods to assess the safety and activity of the product. Additional information on the Phase 1/2a study, including trial sites, can be found at www.clinicaltrials.gov, using Identifier NCT02302157.
More than 12,000 people sustain a spinal cord injury each year, but there are no FDA-approved therapeutics or devices that could potentially restore some function in individuals who have recently sustained a spinal cord injury.
“If AST-OPC1 could deliver even modest improvements in motor or sensory function, it would result in significant improvements in quality of life for people with SCI,” said Donald Peck Leslie, M.D., medical director of Shepherd Center and principal investigator for this study site.
Upon achievement of initial safety data from the first two cohorts of this study, Asterias plans to seek concurrence from the U.S. Food and Drug Administration to increase the robustness of the proof of concept in the Phase 1/2a clinical trial by expanding enrollment from 13 patients to up to 40 patients. The Company believes this change will increase the statistical confidence of the safety and efficacy readouts, reduce the risks of the AST-OPC1 program and position the product for potential accelerated regulatory approvals. Asterias has received a Strategic Partnerships Award grant from the California Institute for Regenerative Medicine, which provides $14.3 million of non-dilutive funding for the Phase 1/2a clinical trial and other product development activities for AST-OPC1.
The Phase 1/2a trial follows successful results from the completed Phase 1 trial of AST-OPC1, which showed that a low dose of two million AST-OPC1 cells was safe and well-tolerated in five patients with neurologically complete, thoracic SCI.
“The commencement of dosing in this Phase 1/2a trial is a significant advancement of our AST-OPC1 development program in that this study is specifically designed to evaluate the product at the doses and in the population where it has the maximum potential to bring benefit to patients,” said Pedro Lichtinger, President and CEO of Asterias. “Individuals with SCI have severe disabilities that can significantly shorten projected lifespan, impact quality of life and result in lifetime costs of care of $3 million to $4 million. We are grateful for the interest of patients with SCI to participate in this program.”
PRINCETON, N.J., June 8, 2015 /PRNewswire/ — Braeburn Pharmaceuticals, an Apple Tree Partners company, today reported positive topline results from the Phase 3 double-blind, double-dummy clinical study of Probuphine®, the investigational subdermal implant containing buprenorphine HCl for the long-term maintenance treatment of opioid addiction. The study met the pre-specified primary endpoint of non-inferiority, as well as all secondary efficacy endpoints, which were established in consultation with the U.S. Food and Drug Administration (FDA) prior to initiating the study. Braeburn has exclusive commercialization rights to Probuphine in the United States and Canada under a license from Titan Pharmaceuticals, Inc. (OTCQB: TTNP). read more
Studies Show that RapidArc® Radiosurgery is a Viable, Time Efficient Way to Treat Multiple Brain Metastases
PALO ALTO, Calif., June 5, 2015 /PRNewswire/ — Treating multiple brain metastases with single isocenter RapidArc® radiosurgery—a technique for treating several tumors at once rather than one at a time—can deliver results that are equal or comparable to other types of radiosurgery, according to research teams from the University of California, San Diego (UCSD), the University of Birmingham, Alabama (UAB), and other institutions.
RapidArc Radiosurgery, which is a term for volumetric modulated arc radiosurgery delivered using a medical linear accelerator (linac) from Varian Medical Systems (NYSE: VAR), can also be completed in substantially less time, researchers report. One reason for the speed are the properties of the Varian beam-shaping device, called a multileaf collimator, which features 120 narrow slats that can slide in and out and past each other to produce multiple apertures of virtually any shape, making it possible to target more than one tumor at a time during a treatment. Cone-based and cobalt-based systems like Cyberknife® and Gamma Knife® are generally limited to targeting one tumor at a time. read more