CerRx Inc. Secures World-Wide Exclusive License from John Wayne Cancer Institute and Children's Hospital Los Angeles on New Formulation of Vitamin A Analog to Treat Cancer.

LOS ANGELES -- John Wayne Cancer Institute at Saint John's Health Center, the National Institutes of Health (NIH) and Children's Hospital Los Angeles (CHLA) have granted CerRx Inc., worldwide exclusive rights to intellectual property and know-how related to a novel formulation of a Vitamin A analog to treat cancer, as a single agent or in combination with partnering agents.

The technology, developed over the last decade, resulted from a collaboration between Myles C. Cabot, Ph.D., at John Wayne Cancer Institute at Saint John's Health Center in Santa Monica, Calif.; Shanker Gupta, Ph.D., and. B. Rao Vishnuvajjala, Ph.D., at the NIH in Bethesda, Md.; and C. Patrick Reynolds, M.D., Ph.D., and Dr. Barry Maurer, M.D., Ph.D., while at CHLA but currently at Texas Tech University Health Sciences Center School of Medicine.

The use of a Vitamin A analog called 4-HPR, or fenretinide, in combination with certain other drugs, or "partnering agents," is showing promise for selectively killing certain types of cancer cells. Fenretinide works by stimulating overproduction of normal cellular waxes in cancer cells, that when produced in excess are lethal to cancer cells. Fenretinide, either as a single agent or in combination with a partnering drug that slows degradation of the lethal waxes, appears to be therapeutic, especially in the case of recurring or relapsed malignant disease. The application would be for both adults and children.

Making the treatment more palatable was a key to being able to deliver fenretinide to the disease sites at clinically effective concentrations. "In prior clinical trials in children with neuroblastoma, it was found that large capsules of fenretinide were difficult to swallow and hard for the body to absorb," Dr. Cabot said. "The solution was to develop a unique way to effectively deliver fenretinide by combining it in a formulation that tastes like cookie dough, and that is where the intravenous emulsion and the 'cookie dough' formulations came to the rescue."

Dr Cabot continued: "Based on studies thus far, when delivered in therapeutically effective formulations, either alone or in combination with a partnering drug, fenretinide will likely be effective in the treatment of malignant solid tumors, leukemia and lymphomas."

Intravenous fenretinide emulsion is in Phase I trials for pediatric neuroblastomas and leukemia, and in adult solid tumor and blood cancers. In a Phase II study of recurrent ovarian cancer, high plasma levels of fenretinide were associated with improved outcome.

A new company, CerRx, Inc., located in Lubbock, Texas, has been formed to commercially develop the innovative technology.

John Wayne Cancer Institute at Saint John's Health Center

Since 1981, the John Wayne name has been committed by the Wayne family to groundbreaking cancer research and education in memory of their father, who died of cancer. The John Wayne Cancer Institute at Saint John's Health Center has received worldwide acclaim for advances in melanoma (skin cancer), breast and colon cancer as well as for immune therapy of cancer. Other areas of research include prostate and liver cancer. With its unique ability to rapidly turn scientific breakthroughs into innovative approaches to treatment and early detection, the JWCI provides immediate hope to cancer patients around the globe. For more information, visit www.jwci.org

National Institutes of Health

The National Institutes of Health (NIH) -- The Nation's Medical Research Agency -- includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

Childrens Hospital Los Angeles

Founded in 1901, Childrens Hospital Los Angeles has been treating the most seriously ill and injured children in Los Angeles for more than a century, and is acknowledged throughout the United States and around the world for its leadership in pediatric and adolescent health. Childrens Hospital is one of America's premier teaching hospitals, affiliated with the Keck School of Medicine of the University of Southern California since 1932. It is a national leader in pediatric research. Since 1990, U.S. News & World Report and its panel of board-certified pediatricians have named Childrens Hospital Los Angeles one of the top pediatric facilities in the nation, and it is ranked among the Top 10 children's hospitals in the country - and first among the 13 children's hospitals in California - in the current magazine rankings.