Prolacta Bioscience Enrolls First Infant in Japan-based Clinical Trial to Evaluate the Effect of an Exclusive Human Milk Diet on Growth and Safety in Premature Infants

Company Meets PMDA Stringent Quality Standards; Continues Efforts to Serve More Premature Infants Throughout the World

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Dec 01, 2021, 09:07 ET

DUARTE, Calif., Dec. 1, 2021 /PRNewswire/ -- Prolacta Bioscience^®, the world's leading hospital provider of 100% human milk-based nutritional products for premature and critically ill infants, today announced the enrollment of the first baby into a Japan-based clinical trial evaluating growth and safety associated with an Exclusive Human Milk Diet including Prolacta's 100% human milk-based fortifiers (Prolacta's EHMD).

The Japan-based study — "JASMINE: A Randomized, Controlled Study to Assess Growth and Safety of the Exclusive Human Milk Diet (EHMD) in Very Low Birth Weight (VLBW) Infants" — began in October 2021. In Japan, Prolacta's human milk-based products will be registered as a drug.

"Initiation of this study in Japan is another industry first, being led by Prolacta," said Scott Elster, CEO of Prolacta. "Japan's regulatory authorities have very strict requirements for conducting drug trials. Our industry-leading quality and safety standards meet Pharmaceuticals and Medical Devices Agency

(PMDA) regulations, allowing us the opportunity to conduct this study and introduce an exceptional level of nutritional care for preterm babies in Japan."

"We know that Prolacta's EHMD is the gold standard diet for premature infants," said principal investigator, senior professor of pediatrics Dr. Katsumi Mizuno, MD, PhD, of the Showa University School of Medicine in Tokyo. "This study is necessary to bring a higher level of nutritional care to our very low birth weight babies in Japan."

Mizuno-sensei, in association with a clinical research organization, will oversee the 10-site study taking place at Showa University Hospital, Showa University Koto Toyosu Hospital, Showa University Northern Yokohama Hospital, Nara Medical University Hospital, Saitama City Hospital, Fujita Health University, Tokyo Metropolitan Bokutoh Hospital, Nagano Children's Hospital, Takatsuki General Hospital, and Gifu Prefectural General Medical Center.

The study will evaluate three of Prolacta's 100% human milk-based products:

Prolact+6 H²MF^® and +8 H²MF^® human milk fortifier (human, pasteurized)
Prolact+ H²MF is the first commercially available human milk fortifier made from 100% human milk.

Intended for premature/very low birth weight infants
Provides concentrated nutrition to help support appropriate growth by providing essential calories, protein, and minerals
Retains properties of human milk such as bioactivity content closest to that of fresh human milk

Prolact CR^®human milk caloric fortifier (human, pasteurized)
Human milk caloric fortifier is ideal for neonatal infants receiving low caloric content. Data show that 65% of the time, term mother's own milk (MOM)¹ is less than 20 Cal/fl oz. Prolact CR caloric fortifier can meet the need for additional calories.

Intended for use with mother's own milk or donor milk to increase lipids and achieve adequate growth
Formulated to deliver at least 2.6 Cal/mL

About Prolacta Bioscience

Prolacta Bioscience^® Inc. is a privately held, global life sciences company dedicated to Advancing the Science of Human Milk^® to improve the health of premature and critically ill infants. Prolacta's 100% human milk-based nutritional products have demonstrated, in more than 20 peer-reviewed studies, to improve health and reduce the most serious complications of prematurity. More than 70,000 premature infants have benefited from Prolacta's nutritional products worldwide to date.² Established in 1999, Prolacta is the world's leading provider of human milk-based nutritional products for hospital use and is also exploring the therapeutic potential of human milk across a wide spectrum of diseases. Prolacta maintains the industry's strictest quality and safety standards for screening, testing, and processing donor milk. Operating the world's first pharmaceutical-grade human milk processing facilities, Prolacta uses vat pasteurization and a patented, U.S. Food and Drug Administration-reviewed manufacturing process to ensure pathogen inactivation while protecting the nutritional bioactivity of its human milk-based products. Prolacta is headquartered in Duarte, California, and can be found online at www.prolacta.com, on Twitter, Instagram, Facebook and LinkedIn.

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Media Contact:

Loren Kosmont
[email protected]
310-721-9444

References

Woijcik KY et al. Macronutrient analysis of a nationwide sample of donor breast milk. J Am Diet Assoc 2009;109:137-140.
Estimated number of premature infants fed Prolacta's products from January 2007 to May 2021; data on file.

SOURCE Prolacta Bioscience