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Regenerative Meds Future & Floridas Connection

NewsRx.com

10-23-08

As body parts (albeit fake plastic ones) adorn the outside of homes, decorate parties and give kids some laughs and scares in preparation for Halloween, Florida experts from both the corporate world and new and specialized industry institutes are working on the real deal -- re-growing tissues in limbs, and discovering new genes and cell-based therapies that extend healthy lifespans, treat previously untreatable diseases and repair damage caused by trauma and aging (see also Cancer Gene Therapy).

Welcome to the 'growing' field of regenerative medicine one that experts say has the potential to impact the whole spectrum of health care (and combat rising healthcare costs) and liken its impact on the health care industry to that of antibiotics. At the heart of this field is the premise that cells are the best healing solution and have all the genetic information needed to make new tissue. Today, that has meant transformative breakthroughs including: forgoing complex surgeries; transplant procedures where doctors are implanting organs grown with a patient's own cells; specially grown powders that have re-grown fingertips; platelet concentrated injections to grow new tissue; and discoveries of new genes to treat and even cure conditions.

There's more. Consider these industry drivers:

(1) Aging baby boomers are creating demand. From 2000-2010, the 55 to 64-year-old age bracket will grow 47% (the fastest growing in the U.S.), giving a boost to the bone repair and regenerative worldwide product market -- which experts estimate to be $500 billion by 2010;

(2) The U.S. military has become a huge proponent of this field. Just this year, the Armed Forces announced the development of a new Institute of Regenerative Medicine to treat trauma and injuries;

(3) In the U.S. Department of Health and Human Service's report "2020: A New Vision A Future For Regenerative Medicine," there is a strong call for more government support for the industry and a proposal to establish a Federal Initiative for Regenerative Medicine (FIRM) similar to the establishment of SEMATECH for the semiconductor industry. For more on the report, visit: http://www.hhs.gov/reference/newfuture.shtml. The report hints at the enormous impact regenerative medicine could have on certain conditions and their current costs of treatment, including:

250,000 patients receiving heart valves, at a cost of $27 billion annually

950,000 people dying of heart disease or stroke, at a cost of $351 billion annually

17 million patients with diabetes, at a cost of $132 billion annually

Experts in Florida, one of the nation's growing hubs for the biotech industry and where a new global and unprecedented Regeneration Project resides, are working on the 'future of the future' in regenerative medicine and offer insights into their work and where new technologies are heading.

In addition, you have an opportunity to listen to a Florida expert webinar on personalized medicine on Thursday, November 6 at 3 p.m. ET.

To register, go to http://www.fiercebiotech.com/webinars/personalized-medicine-concept-reality.

Regenerative's Future & Florida's Connection

Key growth areas:

Peripheral nerve regeneration

Gene discoveries to treat and potentially cure genetic disorders and neurodegenerative diseases

Cell therapies for heart damage and failure

University-led research and tech commercialization

The Nerve

In this age of superhero mania, Jamie Grooms is Florida's 'Allograft Man' and is fighting the 'bad guys' of damaged nerves and inadequate or outdated medical technology and equipment with dreams of saving people and changing the industry and the world. With a long career in the tissue bank and grafting business, leading work to machine bone, campaigning for increased tissue donation in Florida, and developing several new allograft implants, Grooms launched a company called Regeneration Technologies Inc. -- a spin-out of the University of Florida that focuses on tissue-based innovations for the repair and natural healing of human bone and other human tissues. The company eventually launched a dozen new graft /implant products and perfected a patented tissue sterilization system that both preserves tissue strength and biocompatibility and diminishes the chance of infection. Revenue grew from $35 million in 1998 to $122 million in 2000, when the company went public. Today!

, the company (with the new name RTI Biologics), is one of the largest processors of precision-tooled biologics in the U.S.

Grooms went on to launch another company in 2006 called AxoGen, which creates patented technologies and new products to repair and regenerate peripheral nerves (about a half billion dollar U.S. market). Grooms is coming to the rescue of surgeons, who see several hundred thousand people each year suffering from traumatic injuries or procedures which may impact the function of their peripheral nerves. AxoGen does something the other approximate 10 companies in this niche industry segment don't it uses an allograft nerve that is minimally processed to preserve the 3D structure of the graft and key biological components of the tissue (and their naturally occurring growth promoters). It also clears cells and cellular debris and does not require immunosuppression. The company's first human nerve graft was successfully implanted last year to repair a severed nerve in a patient who suffered a traumatic injury to the face.

The Heart

With more than 5 million Americans suffering from congestive heart failure, Bioheart focuses on heart muscle regeneration. It discovers, develops and commercializes autologous (derived or transferred from the same individual's body) cell therapies for the treatment of chronic and acute heart damage. Its lead product candidate is MyoCell, an innovative clinical therapy designed to populate regions of scar tissue within a patient's heart with autologous muscle cells (myoblasts), or cells from the patient's body, for the purpose of improving cardiac function in chronic heart failure patients. The core technology used in MyoCell has been the subject of human clinical trials conducted over the last six years involving 84 enrollees and 70 treated patients.

Other notable work in the cell-heart arena is coming from the University of Miami. Dr. Joshua Hare is conducting some groundbreaking trials for treating heart failure using stem cells. Also, his team is performing the first trial of a new catheter system to inject stem cells into the heart.

Discoveries in diseases and injuries

The University of Florida (UF) McKnight Brain Institute and UF's Program in Stem Cell and Regenerative Medicine formed The Regeneration Project last year to take innovative and bold new approaches in developing human therapies that treat and cure human diseases and injuries. The Project is bringing together hundreds of the world's best scientific minds in diverse fields such as clinical transplant medicine, stem cell biology, developmental biology, engineering, and materials science that, right now, rarely overlap. Through annual "think tank" meetings, these leading scientists will educate each other about how their individual fields can help improve regenerative medicine and get to clinical use faster. The group will design a series of "out-of-the-box" experiments to bridge current gaps between fields and to solve known problems in regenerative medicine using novel approaches. One key requirement for all experiments will be a focus on creating new human therapies for dise!

ases as diverse as neurodegenerative diseases, central nervous system injuries, diabetes and blindness. Each year, The Regeneration Project will sponsor two post-doctoral level research Fellows to execute the proposed experiments collaboratively among the participating labs. Right now, cross-university-institute experiments involve tissue and organ engineering to treat cancer and genetically engineering spinal cords.

UF also has a Center of Excellence for Regenerative Health Biotechnology where research and technology commercialization around treatments and cures for diseases is conducted. In addition, this center is also addressing the national shortage of trained workers able to develop, manufacture, and test new drug products. Last year, the center trained more than 500 biotech students and industry workers. At the same time, the center launched a non-profit off-shoot called Florida Biologix, which provides industry and research institutes with biopharmaceutical process development and testing, clinical trial material production and other support services to get products to the market.

The University of Miami Diabetes Research Institute is working on new cell-based therapies to restore insulin production. The Miami Institute for Human Genomics (MIHG) affiliated with the University of Miami Miller School of Medicine is leading work on discoveries of genetic influences on human health (which genes predispose people to certain diseases). Dr. Margaret Pericak-Vance, director of the MIHG and a recognized leader in human genomics research, recently led a team of researchers to the discovery (the first in 30 years) of a gene linked to multiple sclerosis (MS) that could pave the way for future research and treatment options. MIHG was recently awarded $80 million from the state to continue its leading work in genetic research.

Florida is also the home of the Center for Regenerative Medicine in Miami, which focuses on arthritic and injured people by using non-surgical techniques and orthopedic medicine. The center's expertise is in the treatment of conditions of the spine, knees, shoulders, hip, ankle, wrist, elbow and other cartilage damages. It performs autologous Platelet Concentrated (PC) injections, which allow the body to take advantage of the normal healing pathways at a greatly accelerated rate. PC is a by-product of blood (plasma) that is rich in platelets. Until now, its use has been confined to the hospital setting. This was due mainly to the cost of separating the platelets from the blood and the large amount of blood needed to produce a suitable quantity of platelets. New technology permits the doctor to harvest and produce a sufficient quantity of platelets from only 50 cc of blood drawn from the patient while they are in the office setting.

During the healing process, the body rushes many cells and cell-types to the injected area in order to accelerate the healing process. One of those cell types is platelets. Platelets perform many functions, including formation of a blood clot and release of growth factors (GF) into the diseased or arthritic and injured sites. These GFs function to assist the body in repairing itself by stimulating stem cells to regenerate new tissue. The more growth factors released sequestered into the damaged cells, the more stem cells stimulated to produce new host tissue.

Florida Assets

"When we launched RTIX and our subsequent companies, there wasn't a better place to be than in Florida," said Allen. "The state embraced and put its support behind the biotech industry and that has paid off. Today, it's a place where top minds in the industry are moving."

Dr. Dennis Steindler, executive director of the University of Florida McKnight Brain Institute and who oversees The Regeneration Project believes Florida is one of the nation's key and perhaps 'best kept secret' states driving the booming regenerative industry, thanks, in part, to a significant older population residing here and the "Moffits, Mayos, Torreys, Maxes and Scripps that are here" (referring to the Moffitt Cancer Center, Mayo Clinic and others identified below).

As the medical tech revolution continues to gain momentum in the U.S., Florida's innovative companies and people have taken a front seat. Biotech is writing Florida's new biography. And scientists, heads of companies, inventors and investors are taking note. Five powerhouse biotech institutes have set or are setting up shop here Scripps Florida, Burnham Institute for Medical Research, Torrey Pines Molecular Research Institute, Florida Max Planck Institute of Bio-imaging and the Vaccine and Gene Therapy Institute. Leading R & D is taking place here in the industry-leading fields of regenerative health biotechnology, cancer, human genomics, robotics, neurological and Alzheimer's research, biopharmaceuticals and medical devices. And the state's economic development organization, Enterprise Florida, is focused on growing the life sciences industry here.

"Florida is one of our nation's greatest biotechnology success stories," says James C. Greenwood, president and CEO of the Biotechnology Industry Organization (BIO). "The state continues to attract established research institutions and supports homegrown innovation through bold funding initiatives. Its world class universities and research institutions provide an ideal growth environment for the life sciences industry. The Sunshine State set out to establish itself as a leading technology hub, and has delivered quick results."

In addition to regenerative medicine, Florida's bio industry leadership includes those in minimally invasive/robotics and trauma treatment and training, personalized medicine and telemedicine, medical marine science and molecular imaging. Florida's nationally top-ranked hospitals round out leading R & D capabilities.

"I can't say enough about the critical role of universities in tech and start-up development," added Grooms. "For us, the University of Florida played an enormous role. They brought people and resources to us. They have the technology to spin-off and license. The Sid Martin Biotechnology Incubator at the University of Florida is second to none. And they, along with other Florida colleges and universities, are churning out phenomenal talent. Florida is just the place to be."

# # #

Contact:

Jackie Kelvington

Consultant, Enterprise Florida

407.898.8489

[email protected]

www.eflorida.com

Keywords: Aging, Antibiotics, Bioengineering, Biologics, Biomedical Engineering, Biomedicine, Biotechnology, Biotechnology Business, Biotechnology Company, Bone, Cancer Gene Therapy, Cancer Vaccines, Cardiology, Catheter System, Cell Biology, Central Nervous System Disease, Central Nervous System Injury, Chronic Heart Failure, Clinical Trial Research, Congestive Heart Failure, Coronary Artery Disease, Developmental Biology, Diabetes, Drug Development, Genetic Disorders, Genetics, Genomics, Heart Attack, Heart Disease, Immunization, Medical Device, Mental Health, Muscle Regeneration, Neurodegenerative, Neurodegenerative Disease, Neurology, Organ Transplant, Patents Actions, Peripheral Nerve Regeneration, Pharmaceuticals, Regenerative Medicine, Stem Cell Research, Tissue Bank, Tissue Engineering, Treatment.

This article was prepared by Cancer Gene Therapy Week editors from staff and other reports. Copyright 2008, Cancer Gene Therapy Week via NewsRx.com.

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