Introduction
Theregen, Inc. is a cell therapy company that develops cell-based therapies for patients with cardiovascular disease. Theregen has worldwide exclusive rights to research, manufacture, develop and commercialize its lead product, Anginera™, for cardiovascular and vascular applications.
The company is conducting two Phase I human clinical safety trials for Anginera, a cell-based epicardial therapy. Anginera has been shown in animal models to have the potential to induce remodeling and angiogenesis in the ischemic heart, leading to functional changes that may benefit patients with heart failure.
The company's early-stage financial strategy calls for partnerships with institutional and corporate investors to fund clinical development and provide the resources to research additional product candidates. The company has received equity investments from Sanderling Ventures and Boston Scientific Corporation to help fund clinical development of Anginera. Sanderling continues in 2007 to provide funding necessary to advance the company's clinical programs. Theregen's platform technology also provides attractive product development partnering opportunities. Research into exciting new technologies such as gene therapy and targeted drug delivery has run into serious obstacles. Biotechnology and pharmaceutical companies have begun to recognize the need for living, cell-based, three-dimensional constructs, such as Anginera, as a means of overcoming these barriers and bringing these technologies to fruition.
Company History
Michael Siani-Rose and H. Martin Lades, Ph.D founded Theregen in 2003. The two founders shared an interest in cell-based regenerative medicine and its therapeutic potential for treating numerous diseases. Research led the co-founders to the cell-based therapies addressing cardiovascular disease of the former company Advanced Tissue Sciences (ATS).
In 2004 Iken acquired worldwide exclusive rights to the ATS Cardiovascular Profile, including Anginera technology and a supply agreement for manufactured tissue for clinical trials.
In 2005 the U.S. Food and Drug Administration approved Theregen's Investigational New Drug application (IND) to conduct a Phase 1 safety trial for use of Anginera as an adjunct therapy to coronary arterial bypass graft (CABG) surgery. The Company then received additional private funding to conduct the studies. In 2006 Theregen announced the application of Anginera to its first Phase I patient.
A second Phase I trial was launched in 2007 to examine the effect of Anginera on heart tissue derived from patients suffering from late-stage heart failure. The significance of this study is that treated patient heart tissue will be available for gross pathology following heart transplant.
Theregen Management and Advisors
Paul Quadros, Chief Executive Officer, recently joined Theregen to provide the next stage of strategic leadership in the company's strategic and financial development. Paul brings extensive start-up experience to the company. He was a co-founder, President and CEO of GenStar Therapeutics which was the top performing biotechnology stock on the AMEX in 2000. GenStar later merged with Vascular Genetics to form Corautus Genetics which partnered with Boston Scientific to deliver VEGF II directly to the heart. Paul served as Chairman of Corautus through 2004. He is also a co-founder and former Chairman of Cardiac Science (NASDAQ:CSCX). Paul received a BA degree in Finance from California State University, Fullerton, and an MBA degree from the Anderson School of Management at UCLA.
Michael Siani-Rose, President and Founder, has 15 years of biotechnology experience. He has extensive experience in the computational chemistry and drug discovery fields, including managerial and scientific positions at Protos/Chiron Corporation, Kosan Biosciences and Affymetrix. Michael has published 35 peer-reviewed articles, is inventor on five patents in the field of drug discovery/drug design, and has a dozen patent applications in the fields of bioinformatics and tissue engineering.
Gary D. Gentzkow, M.D., Chief Medical Officer, was educated at Harvard University and trained in Internal Medicine. For the past 18 years his research has focused on burns and wound healing, first with growth factors and then bioengineered human tissue. He served as Medical Director for Advanced Tissue Sciences where he was responsible for the clinical development of Dermagraft and Transcyte, which are now FDA-approved human tissues for chronic wounds and burns, respectively.
Gilbert R. Mintz, Ph.D., Licensing and Business Development, brings 23 years of experience in the biotechnology industry to Theregen. His experience includes 15 years in business development and licensing activities. Gil has provided strategic planning, business development and transactional expertise to several public and pre-IPO companies. In addition, he has executed several in/out licensing agreements of therapeutic products for partnerships in the U.S., Europe and Japan.
Gianine M. Figliozzi, Director of Operations, brings over 15 years of experience in biotechnology and drug discovery to our laboratory facilities in San Diego, Calif. Gianine has a B.S. degree in Chemistry from the University of California, Berkeley. She has held R&D positions at Liposome Technology Inc., Chiron Corporation and Discovery Partners International. Her professional experience spans pharmaceutical development from early stage drug discovery research to process development and manufacture of clinical material under GMP conditions.
Professional Service Providers
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