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JUNE 2011

Greetings from the Prolacta Team

LATCH… "to acquire understanding of, to comprehend"

Prolacta Bioscience's eNewsletter serves to extend our mission of "making a meaningful difference in the lives of thousands of the most vulnerable infants through world class research and innovative products" by providing the health care professional with a brief overview of evolving research, current clinical issues and emerging strategies relevant to the care of the premature infant and sick newborn.

Prolacta Clinical Trial Presented at PAS

PAS 2011 - Denver, COLead investigator Elizabeth Cristofalo, M.D., a neonatologist at the Johns Hopkins Children's Center, presented new data from a multi-center clinical trial at the Pediatric Academic Societies meeting held in Denver this spring. This trial was the first ever randomized, double-blind, controlled trial to look at a difference in outcomes between babies born at less than 1250g receiving a nutritionally adequate, completely human milk-based diet, including the human milk fortifier, and those receiving a diet of premature infant formula. The mothers of the babies offered participation in this study were, for any one of a number of medical or social reasons, not going to supply their own breast milk. The endpoints of the trial were days on total parenteral nutrition (TPN) as well as the incidence of sepsis and necrotizing enterocolitis (NEC). An abstract describing the results of the study can be found here at: http://www.abstracts2view.com/pas. After registering, use the index to search for Cristofalo – the lead author. It is anticipated that the full results of the clinical trial will be published later this year.

Safety of Human Milk Banks

FDAThe Food and Drug Administration (FDA) Pediatric Advisory Committee met this past December to discuss human milk banking practices, including infectious disease risks, state regulations and strategies to avoid contamination of donated breast milk. Milk banks collect, pool, process and distribute donated breast milk from lactating women for use in other infants. The committee noted that processing adopted by Prolacta Bioscience® and the Human Milk Banking Association of North America (HMBANA), appears to control the risks adequately. The FDA, while recognizing the benefits associated with breastfeeding, did warn against feeding or obtaining breast milk acquired directly from individuals or through the Internet. Instead, breast milk should come from a source that has screened its donors and takes other precautions to help ensure the safety of its milk. For additional information please go to http://aapnews.aappublications.org/cgi/content/citation/32/2/6.

FDA Issues Warning to Halt Feeding Thickening Product to Infants

On May 13, 2011 the FDA announced a possible link to disease and death in premature infants related to a thickening product used during infant feeding. There have been 2 reported infant deaths and 15 cases of Necrotizing Enterocolitis (NEC) that were possibly associated with the use of this thickening product in and out of hospital care. The FDA is currently investigating the possible link between the deaths and the product, and has recommended that the use of this thickening product in premature infant feeding be halted to prevent any further risk.

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm256250.htm

The HAMLET Project

HAMLET - a folding variant of alpha-lactalbumin from human milk that induces tumor cell deathA substance found in breast milk, Human Alpha-lactalbumin Made LEthal to Tumor cells (HAMLET) has been reported to induce tumor cell death while not harming healthy cells. http://www.sciencedaily.com/releases/2010/04/100419132403.htm.

Laboratory experiments have shown that HAMLET kills 40 different types of cancer. HAMLET has not been proven to spontaneously form in breast milk, but may form in the uniquely acidic environment of the stomach of the breast fed infant. Researchers are studying its effect on skin cancer, tumors in mucous membranes, and bladder and brain tumors.

The HAMLET Project at Lund University School of Medicine in Sweden (Visit Website) have discovered that the HAMLET complex binds to the cancer cell surface and then accumulates in the cell nuclei where it interacts with histones. Nuclear uptake and tumoricidal activity occurs exclusively in cells that are sensitive to HAMLET, sparing normal cells. The HAMLET Project is studying the effect in vivo in gliblastoma, papilloma and bladder cancer models.

Prolacta Bioscience Awarded Patent

Prolacta Bioscience was awarded a patent for its unique method of producing nutritional products from human milk tissue and compositions thereof.This past March Prolacta Bioscience was awarded a patent for its unique method of producing nutritional products from human milk tissue and compositions thereof.

The patent is based on Prolacta's exclusive methods of collecting a human milk sample, storing and processing, obtaining a nutritional analysis, and pasteurization of donated human milk. Prolacta Bioscience remains committed to the science of developing practices that improve the safe collection, processing and use of human milk and human milk products for use in the NICU population.


To learn more about Prolacta's human milk products, please go to www.prolacta.com.