Science Editor

Diabetics are in a complicated relationship with their insulin. Type I diabetics, as well as some Type II diabetics, need to inject insulin to survive.

But the amount of insulin needs to be carefully calibrated: "Once conventional insulin is injected, it's going to exert its effects no matter what you do," Todd Zion told BioWorld Today. As a result, diabetics need to keep constant tabs on their blood sugar, keep strict control over their diet and inject insulin - some multiple times daily - or they risk severe health consequences.

But Beverly, Mass.-based SmartCells Inc., of which Zion is the president and CEO, hopes to make it easier for diabetics to keep their blood sugar in a safe range. The company is developing chemically modified insulin designed to be sensitive to blood sugar levels, releasing itself only when blood sugar levels are within a certain range.

"Clearly, the most important advantage is that it eliminates the risk of dangerously low blood sugar or hypoglycemia," Zion said. "The system can shut itself off or keep working" depending on blood sugar levels.

The formulation, named SmartInsulin by the company, works essentially by competitive binding - the insulin molecules are modified chemically and complexed into a polymer with several different sugars. Those sugars, in turn, compete with blood glucose for binding, so that when blood sugar is high, it will displace the SmartInsulin polymer's sugars and free insulin from the sugar complex.

Zion said the method ideally would work for treating both Type I and Type II diabetes, though the rationale is somewhat stronger for Type I, which is a straightforward insulin deficiency due to the autoimmune destruction of pancreatic cells. Type II diabetes includes a component of insulin resistance. The goal is to enable diabetics to inject themselves once daily with insulin and then not have to worry about their insulin levels for the next 24 hours.

Blood sugar levels also would be measured once daily, and even if the daily dose were somehow miscalculated, Zion said, "it would take many days of overdosing before you see blood sugar levels drop into a range of concern." But that's an outcome that can be avoided by measuring blood sugar once daily to make sure it is not trending either upward or downward over time. The technology, which came out of Zion's graduate work, has been licensed to SmartCells by the Massachusetts Institute of Technology, and "is not necessarily limited to insulin," Zion said.

Other potential applications include infertility, the treatment of growth- and thyroid hormone deficiencies, and "improving treatments that suffer from a narrow therapeutic window or poor adherence," the company said.

But SmartCells, which was founded officially in 2003, commenced operations in the fall of 2004, and currently has 13 employees (Zion noted that the company is "always looking for good folks" and is currently hiring) has focused "almost single-mindedly on the diabetes application" as an area of both large-scale need and opportunity.

The company has lived off of a mix of investor funding, most recently completing a $1.2 million Series C financing in April 2007, and grant support, including several Small Business Innovation Research grants.

This week, it added to its coffers with a partnership from the Juvenile Diabetes Research Foundation. Under the terms, JDRF will provide $1 million in first-year funding to support preclinical safety and efficacy testing. The partnership is intended to accelerate progress into the clinic, and will provide milestone-based funding through proof-of-concept human clinical trials.