AIVITA Comments on Positive Findings from Asterias’ SCiStar Trial for Spinal Cord Injury

9-month efficacy and safety data demonstrates remarkable recovery in patients with complete cervical spinal cord injury

Date: Jun 13, 2017

IRVINE, C.A., June 13, 2017 – AIVITA Biomedical offered its congratulations today following the announcement of positive 9-month efficacy and safety data from Asterias Biotherapeutics’ SCiStar Phase 1/2a clinical study for patients with complete cervical spinal cord injury (SCI). The data, presented during a pre-meeting workshop at the International Society for Stem Cell Research (ISSCR) 2017 Annual Meeting, demonstrated that three of six AIS-A patients treated with 10 million cells achieved two motor levels of improvement over baseline on at least one side after treatment. In addition, all six patients achieved at least one motor level of improvement on at least one side. Patients designated AIS-A are those who have no sensory or motor function beneath their injury site.

Asterias’ SCiStar trial is an open-label, single-arm trial testing the company’s AST-OPC1 treatment in as many as 35 patients with subacute, C-5 to C-7, motor complete (AIS-A or AIS-B) cervical spinal cord injury. The preceding Phase 1 trial, launched by Geron Corporation, made headlines in 2010 for being the first human stem cell-based treatment administered to spinal cord injured human patients. Asterias subsequently acquired the SCI trial, its intellectual property and related assets from Geron Corporation in 2013 after Geron had shut down its stem cell programs citing financial concerns. The recent data release from Asterias is highly encouraging, showcasing the success of a promising treatment with a once uncertain future.

“My congratulations go out to the Asterias team for these remarkable results,” said Dr. Hans Keirstead, CEO of AIVITA Biomedical. “That this treatment has demonstrated such significant potential means a great deal to SCI patients, and indeed, the entire stem cell field. The AIVITA team sends its best wishes to the patients of the trial.”

Dr. Keirstead, a long-time advocate for stem cell-based therapies, led the team that pioneered Asterias’ SCI treatment during his professorship at the Reeve-Irvine Research Center and the Sue and Bill Gross Stem Cell Research Center at the University of California, Irvine.

About SCI

It is estimated that roughly 40 people per million incur SCI each year in the United States alone. In addition to impaired limb function, individuals with SCI suffer from a wide range of disabilities which can significantly reduce quality of life, and may even be life threatening. It is estimated that there are between 225,000 and 296,000 individuals living with spinal cord injuries in the United States today. There are currently no approved treatments for spinal cord injury.

About AIVITA Biomedical

AIVITA Biomedical is a privately held company engaged in the advancement of commercial and clinical-stage programs utilizing curative and regenerative medicines. Founded in 2016 by pioneers in the stem cell industry, AIVITA Biomedical utilizes its expertise in stem cell growth and directed, high-purity differentiation to enable safe, efficient and economical manufacturing systems which support its commercial line of skin care products and therapeutic pipeline. All proceeds from the sale of AIVITA’s skin care products directly support its clinical development program, including a platform immunotherapy for the treatment of advanced cancers. For more information, visit www.aivitabiomedical.com.

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