Preclinical trials will establish dosage and safety

Tampa, FL (Oct. 5, 2010) – The National Institutes of Health has awarded a three-year, $2.6-million grant to the University of South Florida and Tampa-based biotechnology company Saneron-CCEL Therapeutics, Inc., to establish dosing and safety guidelines for transplanting human umbilical cord blood cells (HUBC) into animal models of Alzheimer’s disease. The researchers hope to use the pre-clinical data to gain U.S. Food and Drug Administration approval to carry out clinical trials with patients suffering from Alzheimer’s disease.

“Our immediate goal is to move our beneficial findings with cord blood cells into clinical trials for patients with mild to moderate Alzheimer’s disease,” said the grant’s principal investigator Dr. Jun Tan, a USF neuroscientist and professor of psychiatry.

The NIH Phase II Small Business Technology Transfer grant is based on the success of an ongoing research partnership between USF and Saneron aimed at determining the therapeutic benefits HUBCs offer when transplanted into animal models of a variety of neurological diseases, including Parkinson’s disease, Lou Gehrig’s disease (ALS), Alzheimer’s disease and stroke.

“Our next stage of research is translational. This study’s primary aims are the completion of preclinical safety and validation studies and the submission of an Investigational New Drug application to the FDA for a Phase I clinical trial,” said Nicole Kuzmin-Nichols, president and chief operating officer of Saneron. “Saneron is very pleased and excited that our long-standing research partnership with USF has provided this opportunity to further the commercialization of technology that was developed at USF and transferred to Saneron for further development.”

Additional funding will be provided by a Florida High Tech Corridor Industry Matching Grant through USF Connect.

Previous research by USF and Saneron has shown that injecting HUBC into laboratory (in vitro) and animal models (in vivo) of neurodegenerative diseases does not promote a strong immune response, so rejection is not a problem, said Dr. Tan, who is a consultant for Saneron. The potential for HUBCs to promote an anti-inflammatory response may provide overall benefits. Inflammation is a biochemical component of Alzheimer’s disease.

Saneron CCEL Therapeutics, Inc. worked with USF to develop a HUBC cell technology platform called the U-CORD-CELL ™ program. The program aims to improve the quality of life for patients by developing and producing innovative, high-quality treatments for neurological and cardiac diseases.

“This grant will afford Saneron the opportunity to bring the U-CORD-CELL™ technology to the clinic in the pursuit of a potential therapy for those suffering from Alzheimer’s disease,” Kuzmin-Nichols said.

The collaborative work between USF and Saneron is the “essence of technology transfer,” said Karen Holbrook, PhD, USF senior vice president for research and innovation.

“The best outcome for this kind of collaboration is when technology developed at the university is taken to the patient’s bedside,” Dr. Holbrook said. “USF is proud to be working with Saneron on this most important research.”

About USF Health

 
USF Health (www.health.usf.edu) is dedicated to creating a model of health care based on understanding the full spectrum of health. It includes the University of South Florida’s colleges of medicine, nursing, pharmacy and public health; the schools of biomedical sciences, and physical therapy & rehabilitation sciences; as well as the USF Physicians Group. With more than $394.1 million in research grants and contracts in FY2009/2010, the University of South Florida is one of the nation’s top 63 public research universities and one of only 25 public research universities nationwide with very high research activity that is designated as community-engaged by the Carnegie Foundation for the Advancement of Teaching.

About Saneron CCEL Therapeutics, Inc.

Saneron is a biotechnology R&D company, focused on neurological and cardiac cell therapy for the early intervention and treatment of several devastating or deadly diseases, which lack adequate treatment options. Saneron, a University of South Florida spin-out company is located at the Tampa Bay Technology Incubator. An affiliate of Cryo-Cell International, Inc., Saneron is committed to providing readily available, non-controversial stem cells for cellular therapies and has patented and patent-pending technology relating to our platform technology of umbilical cord blood and Sertoli cells.

For further information please contact:
Saneron CCEL Therapeutics Inc.,
Nicole Kuzmin-Nichols, MBA
3802 Spectrum Blvd., Suite 147
Tampa, FL 33612
Phone: 813-977-7664 x2
nkn@saneron-ccel.com

Release by Randolph Fillmore, USF Center of Excellence for Aging and Brain Repair