BioTime Receives Authorization to Begin Pivotal Human Clinical Trial of Renevia in Europe

Renevia has the potential to be the first approved product that allows cells to be easily transplanted through a syringe and then safely polymerized into three-dimensional tissue constructs within the human body, said William Tew, Ph.D., BioTimes Chief Commercial Officer. We are excited to enter this last phase of clinical trials for Renevia as well as by the promise of this technology for the transplantation of other types of cells to address unmet medical needs. BioTime considers Renevia a key strategic asset for its future regenerative medicine programs which are focused on the development of human embryonic stem cell-derived brown adipocytes, vascular, and osteochondral cells to treat tissues afflicted with degenerative disease. If the pivotal trial meets its primary end points, then we would expect to submit Renevia for CE Mark approval in 2016.

About the Renevia Clinical Trial

The Spanish Agency of Medicines and Medical Devices (AEMPS) authorized BioTime to conduct a randomized, evaluator-blinded, delayed-treatment-controlled study of the effectiveness and safety of Renevia as a resorbable matrix for the delivery of autologous adipose-derived cells to treat subcutaneous facial lipoatrophy defects arising from HIV infection. The study will include a minimum of 56 and up to 92 HIV positive males and females between 18-65 years of age. Subjects will be randomized with half in the treatment group and half in a delayed-treatment cohort, each receiving a single treatment course of Renevia with autologous adipose cells harvested by liposuction and implanted in the mid-facial region. The primary effectiveness measure will be the comparison of the change in skin thickness between the treatment and delayed treatment groups. A secondary endpoint will be mid-face volume deficit and global aesthetic improvement scores. Patients will be monitored at one, three, and six-month intervals after treatment. Patient enrollment, which has begun, is expected to be completed in 2015. Additional information on the trial will be made available on BioTimes website at http://www.biotimeinc.com.

The trial will be conducted at The Stem Center in Palma de Mallorca, Spain, an innovative patient therapy center, laboratory, and professional research facility located within the Clinica USP Palma Planas hospital in Palma. The Medical Director of The Stem Center and Principal Investigator for the Renevia studies, Ramon Llull, MD, PhD, is a leading expert on advanced regenerative therapies based on adipose technology.

About Facial Lipoatrophy

Facial lipoatrophy is a condition characterized by localized loss of fat under the skin. It is common in HIV-infected patients on antiretroviral therapy (ART), and the resulting facial wasting ages the individuals appearance prematurely and, along with a thinning of the skin, allows musculature and vasculature to be easily seen, resulting in what is commonly known as the face of AIDS. Treatment of the condition has been determined to be medically advisable to improve the individuals self esteem and quality of life.

While the use of highly active ART in the treatment of HIV-positive patients has greatly increased longevity, the reported incidence of HIV-associated lipoatrophy has correspondingly risen. According to statistics published by AVERT (www.avert.org), worldwide there were 34 million people living with HIV/AIDS in 2011 with 900,000 of these in western and central Europe and 1.4 million in North America. UNICEF, UNAIDS, and the World Health Organization (WHO) reported in 2013 that the number of people receiving ART has tripled in five years to approximately 10 million people. A substantial effort is underway to reach a global target of 15 million people receiving ART by the end of 2015.

At present, commonly-used products for the treatment of HIV-related lipoatrophy include dermal fillers or products that trigger fibrotic reactions which create fibrous tissue that has an effect of bulking the skin, but not a restoration of natural subcutaneous fat with its associated texture and appearance. A full course of treatment of those products can require multiple injections over a period of several months. BioTime expects that a single treatment of Renevia with adipose-derived cells when injected with a small gauge cannula will result in a reconstitution of normal subcutaneous fat and restoration of skin contour.

HyStemTechnology and Renevia

BioTimes HyStem hydrogels, including Renevia, are a family of unique and proprietary biomaterials that are designed to function as adhesion matrices for the stable attachment and survival of cells. The failure rate in many applications of cell grafts without such a matrix is high because of difficulties in achieving cell attachment and survival. The achievement of high success rates for cell grafts would create opportunities to develop cell therapies for many high unmet medical needs. A unique feature of the proprietary technology is that it allows the mixture of cells with the matrix in a liquid form such that the cells and matrix can be injected easily and safely through a small gauge syringe, and then the matrix can polymerize around the cells to create a three-dimensional tissue within the body. HyStem hydrogels are currently sold worldwide by BioTime and its distributors for pre-clinical research for a wide array of applications in regenerative medicine including the engraftment of cells in the brain, liver, cartilage and bone, heart, and vocal cords. Premvia,TM a HyStem based hydrogel, is a recently FDA-cleared medical device indicated for the management of wounds. BioTimes HyStem technology is covered by two issued US patents with applications pending in the EU, Canada, Japan, and Australia.

More here:
BioTime Receives Authorization to Begin Pivotal Human Clinical Trial of Renevia in Europe