AiVita CEO Comments on Recent Milestone Achievements in Asterias’ SCiStar Trial for Spinal Cord Injury

Safety, suggestions of efficacy, and dose escalation represent significant achievements for the stem cell field

Date: Sep 13, 2016

IRVINE, C.A., September 13, 2016 – AiVita CEO and neuroscientist Dr. Hans Keirstead offered his congratulations today for milestones reached in Asterias Biotherapeutics’ Phase 1 and Phase 1/2a clinical studies for newly injured patients with sensory and motor complete cervical spinal cord injury (SCI). The recognition follows recent announcements highlighting positive long-term follow up from its prior Phase 1 safety study, and expanded enrollment for its current Phase 1/2a study following positive preliminary results. The Phase 1 trial, initially launched by Geron Corporation, made headlines in 2010 for being the first-in-man trial of any stem cell therapy derived from human embryonic stem cells (hESCs). The trial was thought to be defunct only a year later when Geron was forced to shut down its stem cell programs citing financial concerns.

Asterias, a BioTime subsidiary, acquired the SCI trial, intellectual property, and related assets from Geron Corporation in 2013, and has since made notable progress. In May, Asterias reported that four of the five patients in its completed Phase 1 safety study showed a long-term reduction in spinal cord cavitation, a process which leads to spinal cord tissue deterioration and a permanent loss of motor function. More recently, the Keck Medical Center of USC reported the restoration of arm and hand function in a 21-year old paralyzed man that received the treatment. Asterias’ ongoing Phase 1/2a study, supported by a $14.3 million grant from the California Institute of Regenerative Medicine, has thus far demonstrated safety and improved upper extremity motor function in patients with complete spinal injury. The company is now preparing to treat its second cohort of 5 patients with a higher dose, and has received FDA approval to expand the study to include two additional cohorts of patients with sensory incomplete injuries.

To date, there have been no serious or unexpected adverse events related to the therapy or its administration in any of the patients treated, including the five patients from the previous Phase 1 trial with neurologically complete thoracic SCI.

“I want to congratulate the Asterias team, clinical investigators, and all those facilitating the two clinical trials which have thus far generated impressive results,” said Dr. Keirstead. “This trial has achieved several milestones for the stem cell field, and its continued progress is a testament to the masterful clinical execution by the Asterias and Keck teams. In a sector so dogged by disappointing developmental timelines, it is encouraging to see the continual progress of a treatment which has a real chance to improve quality of life. The hearts and best wishes of the AiVita team go out to the patients receiving treatment.”

Dr. Keirstead continues to advocate for and develop stem cell therapies, having pioneered and licensed the 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 advancing commercial and clinical-stage programs utilizing curative and regenerative medicines. Built upon expertise in stem cell growth and directed, high-purity differentiation, AiVita Biomedical has engineered safe, efficient and economical manufacturing systems to support the development and commercialization of its curative and regenerative medicines. For more information, visit www.aivitabiomedical.com.

###