About Revivicor

Revivicor addresses large markets and solutions for diseases with large unmet clinical need:

Regenerative medicine offers the promise that failing organs or nonfunctional cells need no longer be tolerated; instead, they can be rejuvenated or replaced with healthy cells, tissues or organs. Many products can be envisioned in a regenerative medicine world that can overcome the destruction of human degenerative disease, from transplanted islet cells that can cure diabetes, to whole organ replacement.

Revivicor’s vision is the commercialization of therapies that can treat and cure serious human disease through regenerative medicine; namely, the replacement of cells, tissues, and organs. Revivicor's focus is the commercialization of treatments for diabetes and whole organ transplantation, developed from the significant advances made in the fields of xenografts and tolerance technologies, which are core competencies of Revivicor. In addition to the regenerative medicine portfolio, Revivicor also has a rapidly progressing research program for the production of polyclonal antibodies in livestock. Revivicor was formed as a spinout of PPL Therapeutics plc to address this emerging field of regenerative medicine, and includes 25 dedicated professionals from PPL's US division in Virginia as well as a Pennsylvania subsidiary that will conduct pivotal animal and clinical studies involving pancreatic islet cells and whole organs. PPL plc has spun out its US division in an effort to focus its existing capital on late stage programs, while providing the regenerative medicine unit the ability to devote its own focus to these emerging technologies in development. Revivicor's investors are the University of Pittsburgh Medical Center (UPMC) Health System, Highmark Health Ventures Investment Fund, L.P., and Fujisawa Investments for Entrepreneurship, LP UPMC Logo

Revivicor has established a portfolio of platform technologies largely built around our world-leading research in animal cloning and cellular reprogramming. The parent company, PPL Therapeutics Plc, from which Revivicor was formed, is widely known for its groundbreaking efforts in cloning, having produced "Dolly" the cloned sheep. Revivicor's lead program in xenografts is focused on the production of whole organs and therapeutic cells, including insulin-producing cells for diabetes, from genetically modified pigs. Revivicor's scientific team leads the field in the production of cloned, transgenic pigs, having produced the world's-first cloned pigs (March 2000), as well as the first cloned "knockout" pigs lacking both copies of the gene responsible for triggering acute immune rejection in humans. This development now advances the long-held hope for supplying unlimited quantities of tissues and organs available for transplant to humans. Revivicor is collaborating with Dr. Thomas E. Starzl and other leading scientists at the University of Pittsburgh on key pig-to-primate studies, looking at long term survival and function of pig organs, as well as islet cell transplants for reversal of diabetes. Dr. Starzl is a transplant pioneer and the developer of the immunosuppressive drug, FK506. With the initiation of these studies, Revivicor is now approximately two years away from human clinical trials. This is an unprecedented medical, societal, and commercial opportunity in bringing a major advance to the entire field of transplantation.

Worldwide, 3 million patients suffer with Type 1 diabetes (these patients are unable to produce sufficient levels of insulin due to a defective pancreas) and 50 million patients have Type 2 diabetes (these patients are unable to effectively utilize insulin). The total economic burden in the US has been estimated to be $98 billion. Today, transplantation of donated islets has been shown to be technically feasible. The Edmonton protocol (Shapiro et al.) demonstrated that patients with Type 1 diabetes and a history of severe hypoglycemia can become insulin-free through islet cell transplantation. Islet cells isolated from harvested cadaver pancreases are injected into the portal vein of the liver. This procedure, which has been perfected at a number of clinical centers worldwide, including at the University of Pittsburgh Medical Center, offers the opportunity to forever change the field of diabetes treatment. However, it suffers from the same problem affecting whole organ transplant: a limited supply of donor material. The protocol requires 600,000 functional islets, the equivalent of two donor organs after islet isolation. As human pancreases are in very short supply, there is clearly a huge unmet clinical need in sourcing islets or insulin-producing cells.

The field of diabetes therapeutics is obviously quite competitive, primarily due to the large patient population, unmet clinical need, and sizable market potential. Revivicor’s porcine-derived genetically modified islet cells provide a number of advantages over existing technologies and therapies. Unlike insulin therapy, which has a number of serious side effects, and is difficult to regulate, whole islets or insulin-producing cells offer natural, glucose-responsive, endogenous control of insulin levels. Because these cells have been modified to inhibit rejection, they can be maintained in the body without encapsulation, using protocols similar to those developed by the Edmonton group for human islets. The pig source of islets is unlimited, fully scalable in specific-pathogen-free (SPF) pig facilities, and thus would be amenable to large scale, FDA-regulated manufacturing practices.

In the case of donated organs or tissues from another individual, allotransplantation works reasonably well (e.g. kidneys, hearts, bone marrow), however, there are two major disadvantages. One is the very limited supply: The United Network for Organ Sharing reports there are approximately 80,000 on the waiting list in the US alone, and every day, 16 people die waiting for available organs. Another is the high cost of human-to-human organ transplantation and the economic burden to keep patients alive while they wait (the US spends almost $35 billion annually to care for patients with end stage organ failure.). An unlimited supply of donor organs from genetically modified pigs offers a unique solution to these problems.

The core research and development arm of Revivicor is headquartered in Virginia, while the clinical work is focused in Pennsylvania at UPMC. The scientific programs of Revivicor have received funding from both internal PPL R&D expenditure of more than $8 million since 1996, as well as external funding from the Advanced Technology Program ("ATP"), part of the U.S. Department of Commerce.

Using the Company’s core competency in genetic modification of livestock for therapeutics, Revivicor has also received a 3-year $3.1 million contract from the US Dept. of Defense (DARPA) to produce human antibodies in pigs and cattle as biowarfare countermeasures against agents including anthrax and other infectious agents. The DARPA funded program is focused on using gene knockout and cloning technology to delete the pig and cow antibody producing genes and to replace them with human equivalents such that these animals will produce fully human polyclonal antibodies for infectious disease applications. Revivicor retains full commercialization rights for all nonmilitary applications. Polyclonal antibodies for a broad range of infectious disease targets including influenza, HIV, hepatitis, CMV, antibiotic resistant pediatric infections, autoimmunity, and cancer, comprise a very large market which is projected to be in excess of $5 billion by 2010.

Revivicor has core competencies in nuclear transfer (cloning), embryology, stem cell biology, molecular biology, immunology, and transgenic animal technology, and has delivered world-leading results in these fields. The application of this know-how has led to opportunities in the emerging field of regenerative medicine, and offers unprecedented potential for the treatment of human disease.