New Class of Blockbuster Therapeutics from Total ReCord, Inc. Poised to Begin Clinical Trials

Business Wire, Nov 3, 2005

WORCESTER, Mass. -- Massachusetts-based company Total ReCord, Inc. plans to begin clinical trials in January 2006 on RMx(TM), its remarkable alternative to embryonic stem cells in the treatment of spinal cord injuries. Total ReCord is looking to raise capital to fund these clinical trials and further R&D into its other innovative products starting at today's MassOpps Investment Conference in Boston, MA, where some of its key results will be unveiled for the first time in public. Other technologies in Total ReCord's portfolio include Trans-Neural Implants(TM), neural stem cells, and SpheroGel(TM) (exclusively licensed from NeuroVita) which is currently in Phase I/II clinical trials.

Total ReCord's RMx and other innovations can potentially provide restored functionality to victims of paralysis, stroke, multiple sclerosis and other neurodegenerative diseases. The total economic cost (direct indirect) for treating and supporting patients with injuries and neurodegenerative diseases of the central nervous system is over $200 billion annually in the United States alone, a significant financial opportunity considering that RMx's regeneration-inducing abilities may prove useful in the treatment of many of these neurodegenerative diseases. Founder and CEO Jan-Eric Ahlfors is hopeful that following the first phases of human clinical trials, RMx will be placed on fast-track status for FDA approval and may soon be used to treat diseases that have kept patients permanently wheelchair-bound for decades.

RMx(TM), Total ReCord's lead product, is a new non-cellular, non-drug based class of biotherapeutics that draws on the body's natural regenerative processes to stimulate the growth of new central nervous system tissue. "RMx is a promising alternative to embryonic stem cells that may have significant potential in the treatment of spinal cord injuries," says Dr. John McDonald, the Executive VP and Director of the International Center for Spinal Cord Injury at the Kennedy Krieger Institute.

RMx's regenerative matrix is a new method of treatment for spinal cord injuries that has shown promising results in preclinical studies in animal models. Total ReCord has created RMx based on the principle of suppressing certain wound healing processes that interfere with central nervous system (CNS) tissue regeneration, while enhancing the desirable traits of these processes.

RMx first works to clean out the site of damaged tissue and allow for new cell growth. It then slows the development of scar tissue that can inhibit the regeneration of surviving axons while simultaneously promoting new blood vessel formation. Both of these processes are crucial for the formation of new, healthy CNS tissue. Furthermore, RMx has certain stimulatory effects on the formation and elongation of new neurites. After this new tissue is grown, it can be trained to function in the body to restore movement, even weight-bearing steps in patients with spinal cord injuries.

In pre-clinical studies, animals that had experienced traumatic damage to their spinal cords and were initially completely paralyzed were soon able to move about after treatment with RMx. In most cases, they were able to make weight-bearing steps. Total Record is confident that the human implants that have been successfully used in their animal studies will be effective in treating patients with spinal cord injuries. However, the extent of recovery that can be achieved with RMx in human patients will only become evident during the human clinical studies. RMx has been found to have no toxic side-effects in animals.