March 13, 2018 03:39, TOKYO — SanBio Group and Hitachi Chemical Co., Ltd. (Hitachi Chemical) jointly announced today that, through an agreement with Hitachi Chemical Advanced Therapeutics Solutions, LLC (HCATS; formerly PCT Cell Therapy Services, LLC), Hitachi Chemical’s US subsidiary that engages in contract manufacturing and development of regenerative medicine products*1, they will manufacture SB623, a proprietary regenerative medicine product under development by SanBio. Under the agreement, late stage clinical products and commercial products of SB623 for the US and Japanese markets will be manufactured using Hitachi Chemical’s global facilities. [Read more…]
SanBio, a stem cell and regenerative medicine company specializing in neurological disorders, announced that it has been issued a key patent by the Australian Patent Office covering its proprietary modified stem cells, SB623, for the treatment of traumatic brain injury. Australian Patent No. 2013263417 was formally issued on September 8, 2016.
To secure its proprietary technology, SanBio filed a global patent application for it modified stem cells (SB623), doocumenting its ability to support regenerative processes in the central nervous system (CNS). The patent also documents the ability of these cells to provide therapeutic support for a range of neurological disorders, including traumatic brain injury (TBI).
Australia was the first country to grant the patent to SanBio. The company is also seeking patent protection in other regions.
According to Dr. Damien Bates, Chief Medical Officer and Head of Research at SanBio, “There are 5.3 million people living with chronic disabilities from traumatic brain injury in the United States and more than 700,000 in Australia. We hope that SanBio’s regenerative medicine, SB623, will be able to serve as a treatment option for these patients.”
On December 21, 2015, SanBio, Inc., and strategic partner Sunovion Pharmaceuticals announced they were recruiting patients for a Phase 2b clinical trial to evaluate the safety and efficacy of SB623 cells, a cell therapy product, for improving motor function in patients afflicted by ischemic stroke. When administered into neural tissue in laboratory settings (in vitro) and animal models, “SB623 cells have been shown to restore function to damaged neurons associated with stroke, traumatic brain injury, retinal diseases, and Parkinson’s disease.”
For more information, see the full press release below, printed with permission from SanBio.
SanBio and Sunovion Begin Patient Recruitment for Phase 2b Trial to Test Regenerative Treatment for Chronic Stroke in North America
Studying patients impaired six months to five years following ischemic stroke
PRESS RELEASE – December 21, 2015; Mountain View, CA: SanBio, Inc., a scientific leader in regenerative medicine for neurological disorders, announced today that it has initiated patient recruitment for a Phase 2b clinical trial to further test the safety and efficacy of its proprietary cell therapy. SanBio is working closely with Sunovion Pharmaceuticals, Inc., a wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., on the conduct of the clinical trial. Earlier clinical trial results suggested the therapy’s potential to improve motor function following an ischemic stroke. SanBio and Sumitomo Dainippon Pharma have entered into a joint development and license agreement for exclusive marketing rights in North America for SB623 for chronic stroke.
Ischemic strokes account for approximately 87 percent of all strokes in the United States and occur when there is an obstruction in a blood vessel supplying oxygen to the brain. With approximately 800,000 strokes occurring in the United States every year, stroke is the leading cause of acquired disability in the United States. Therapies for acute stroke generally do not result in meaningful improvement beyond the first six months following a stroke.
The ACTIsSIMA “Allogeneic Cell Therapy for Ischemic Stroke to Improve Motor Abilities” trial will examine the safety and efficacy of SB623 cells in patients who have experienced an ischemic stroke in the previous six months to five years and still suffer from motor impairments. SB623 cells are modified allogeneic mesenchymal stem cells, derived from bone marrow stromal cells isolated from healthy donors. When administered into neural tissue, SB623 cell therapy is designed to promote recovery from injury by triggering the brain’s natural regenerative ability.
Damien Bates, M.D., Chief Medical Officer & Head of Research at SanBio, said, “While existing drug treatments for stroke focus on prevention or acute care, there are no medical treatments currently available for people living with the debilitating effects of stroke, months or even years after the stroke occurred. We are optimistic that SB623 may provide a new treatment option for these patients.”
“This collaboration represents our shared commitment to patients with serious conditions where no effective drugs exist for whom regenerative therapies may offer a truly innovative therapeutic approach,” said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer, Sunovion Pharmaceuticals Inc., and Head of Global Clinical Development for Sumitomo Dainippon Pharma Group.
The ACTIsSIMA Phase 2b clinical trial follows a Phase 1/2a clinical trial in which the SB623 cell treatment suggested improvements in motor function. The Phase 2b clinical trial will further evaluate the safety and efficacy of SB623 treatment. There are expected to be approximately 60 clinical trial sites throughout the United States, and total enrollment is expected to reach 156 patients.
About the ACTIsSIMA Trial
The ACTIsSIMA trial will examine the efficacy of SB623, modified adult bone-marrow-derived stem cells, when administered to patients with chronic motor deficit secondary to ischemic stroke. A secondary purpose is to evaluate the safety of SB623 in these patients.
About SanBio, Inc. (SanBio)
SanBio is a regenerative medicine company with cell based products in various stages of research, development and clinical trials. Its proprietary cell based product, SB623, is beginning Stage 2b clinical trials for treatment of chronic stroke. SanBio is expected to begin Stage 2 clinical trials for treatment of traumatic brain injury later in 2015. More information about SanBio, Inc. is available at www.san-bio.com.
About Sunovion Pharmaceuticals Inc. (Sunovion)
Sunovion is a leading pharmaceutical company dedicated to discovering, developing and commercializing therapeutic products that advance the science of medicine in the Psychiatry, Neurology and Respiratory disease areas to improve the lives of patients and their families. Sunovion, an indirect, wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., is headquartered in Marlborough, Mass. More information about Sunovion Pharmaceuticals Inc. is available at www.sunovion.com.
About Sumitomo Dainippon Pharma Co., Ltd. (Sumitomo Dainippon Pharma)
Sumitomo Dainippon Pharma is a top-ten listed pharmaceutical company in Japan. Sumitomo Dainippon Pharma aims to produce innovative pharmaceutical products in the Psychiatry & Neurology area and the Oncology area, which have been designated as the company’s therapeutic focus areas. Sumitomo Dainippon Pharma was formed by the 2005 merger of Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has about 7,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at www.ds-pharma.com.
Press Contact: Rebecca McRoberts