In the fall of 2009, a group of New Zealand scientists were putting the finishing touches on a new therapeutic to help cancer patients recover from chemotherapy, in preparation for a clinical trial. All they had left to do was choose a flavor.
“It was no easy task,” says Arie Geursen, general manager of LactoPharma, the entity developing the therapeutic, presented in the form of an ice cream. “Everyone has their favorites. We were already leaning toward strawberry since one of the bioactive agents was tinting the ice cream pink… But the decision really came down to who won the taste tests. Strawberry came out on top.”
Development of the ice cream, named ReCharge, began 8 years ago with the formation of LactoPharma, a collaborative research venture between the University of Auckland, the New Zealand government, and the country’s largest dairy company, Fonterra Ltd.
Various components of milk have demonstrated antimicrobial, antiviral, and anti-inflammatory properties, and in the past decade, scientists have begun to identify the molecular components driving these reactions. LactoPharma was created with the goal of trying to incorporate milk’s protective mechanisms into food, health supplements, and pharmaceuticals.
One protein in particular, lactoferrin, has been shown to inhibit tumor growth, promote intestinal cell growth, and regulate immune response in the intestine (Biochem Cell Biol, 89:95–102, 2002). The scientists reasoned it could therefore help patients receiving chemotherapy, which can damage normal cells that multiply quickly, such as infection-fighting white blood cells, known as neutrophils, and intestinal cells. A lack of neutrophils exposes cancer patients to a high risk of infection, while the destruction of intestinal cells can lead to digestive problems, such as diarrhea and poor nutrient uptake. Geoff Krissansen, a molecular biologist at the University of Auckland, and colleagues began testing whether bovine lactoferrin and other dairy components could reduce these side effects of chemotherapy.
Indeed, when fed to mice 2 weeks prior to chemotherapy, bovine lactoferrin helped increase immunoresponsive cytokines in the intestine, decreasing cell damage caused by chemo, and restored both red blood cell and neutrophil numbers (Immunol Cell Biol, 86:277–88, 2008). The researchers also found that another bioactive component present naturally in milk—a type of “lipid fraction,” according to Krissansen—demonstrated similar results in mice. The scientists expect to publish these results in 2010.
“Since lactoferrin has been shown to help restore immune response, it makes sense to incorporate it into a therapy for chemo side effects, which can cause immunosuppression,” says Marian Kruzel, a biologist at the University of Texas Medical School in Houston, who was not involved with ReCharge. “But the dosing levels are very important; too much of it and its immune-regulating effects may be negated.”
To figure out how to deliver these milk ingredients to patients, Krissansen and LactoPharma looked to Kate Palmano at the Fonterra Research Center. “We needed to formulate a product that was acceptable and palatable to patients, but that was also suitable for the bioactives,” says Palmano. They had to avoid anything that would require high temperatures during production, she explains, since the heat could change the protein structure and the bioactives’ functions.
Palmano considered incorporating the bioactives into a liquid drink or yogurt, but in the end, ice cream won out. “Creating a frozen product meant we didn’t have to worry about the bioactives’ shelf life,” she says. “Plus, people going through chemotherapy typically lose their appetite. Why not give them a treat like ice cream?”
The scientists worked with New Zealand’s top ice cream manufacturers to create six tons of strawberry-flavored ReCharge. They then made a placebo ice cream with the same taste, color, and calorie count. ReCharge started its Phase II clinical trial in October 2009, in which 200 prechemotherapy cancer patients will be required to eat 100 grams of either ReCharge or the placebo ice cream each day.
“It has been a wonderful ride creating this product,” says Geursen. “We don’t know if ReCharge will work—it is always a challenge going from mice to humans—but we are keeping our fingers crossed.”