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Published on 1/6/2006 in the Prospect News Biotech Daily.

Maui General Store, Trinity BioGenics prepare for clinical studies using adult stem cells to treat heart failure patients

By E. Janene Geiss

Philadelphia, Jan. 6 - Maui General Store, Inc. and Palmera Holdings, Inc. dba Trinity BioGenics, announced Friday that The Stowe Foundation, from which Trinity holds a license to commercialize stem cell technology, is preparing to begin treatment of chronic heart failure patients with adult stem cells early this year.

As part of the preparation for the upcoming clinical studies on adult stem cells in Mexico City, Mexico, the company has retained the services of May Jacobson of The CBR institute for Biomedical Research, according to a company news release.

Jacobson, an affiliate of Harvard's medical school, will assist the foundation in regulatory compliance issues and review the company's technology platform to ensure the study meets standards of the U.S. Food and Drug Administration, officials said.

These study data will form the basis for a preclinical meeting with the FDA later in the year for approval to test the protocol in the United States, officials said.

Jacobson spent several days at Angeles Hospital in Mexico City reviewing the protocol and interviewing the transplant medical team. He made several technical corrections to the protocol to ensure the clinical trial will meet FDA guidelines, officials said.

The Stowe Foundation's technology platform is the basis for Maui General Store and Trinity BioGenics' entry into adult stem cell therapy.

Trinity BioGenics is a biotechnology company engaged in research and development of unique adult stem cell procedures and patient-specific immune therapies with applications for various conditions and diseases, with a current clinical focus on therapies for heart disease. A merger of Trinity with Maui-based Maui General Store and Palmera Holdings, Inc. was announced last month.

Maui does not have significant operations, but it intends to acquire one or more operating businesses or properties. Prior to March 2005, the company, through its subsidiary, Hana Pearl, LLC, provided proprietary line of specialty pearl jewelry. The company was incorporated in 1995 as Kelly Green Products, Inc. and changed its name to Maui General Store, Inc. in 2001.


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