THIS STORY HAS BEEN FORMATTED FOR EASY PRINTING

Patch may replace IV drug infusions

By Lindsey Hoshaw
Globe Correspondent / July 11, 2011

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Patients who receive frequent intravenous injections to treat chronic illness typically endure arduous hospital visits.

A new device could change that.

SpringLeaf Therapeutics is developing a drug-filled patch patients can attach to their skin to dispense such medications.

“You just put it on and do your daily activities,’’ said Frank Bobe, chief executive of SpringLeaf. “You’re in control because you don’t give control of your life to a nurse or physician, which, psychologically, brings a huge positive impact to patients.’’

On Friday the company announced the completion of its second major round of funding after receiving a $4 million boost from Excel Venture Management, a venture capital firm, bringing its total funding to $19 million. That second round comes mainly from SR One, the venture capital arm of GlaxoSmithKline.

“Looking at the likelihood of success, it was a venture we felt very comfortable backing,’’ said Enrico Petrillo, managing director of Excel.

If the company receives approval from the Food and Drug Administration and the European Medicines Agency - the European Union’s FDA equivalent - it intends to sell the device internationally.

The device can be used to treat a range of illnesses, including multiple sclerosis, cancer, and hepatitis C, according to a patent the company filed with the Massachusetts Institute of Technology, where the technology was developed. But Bobe said SpringLeaf will focus on using one drug to treat one illness in the device’s first iteration.

He would not disclose the disease the company intends to treat or the drug it plans to use, due to the pending patents on the technology. He said the company focuses on biologics drugs, which are made inside special, live cells rather than by combining chemicals.

Common biologic drugs such as Humira, Rituxan, and Stelara are used to treat rheumatoid arthritis, non-Hodgkin’s lymphoma, and psoriasis respectively. Global sales of biologic drugs were $138 billion of total pharmaceutical sales in 2010 and are expected to reach $200 billion by 2015, according to the IMS Institute for Healthcare Informatics, a market research company.

Patients who use SpringLeaf’s target drug visit the hospital every few weeks for intravenous injections, which include a large dose of a biologic drug.

With the new technology, a patient can pick up the device at a pharmacy, attach it to the abdomen, upper arm, or thigh at home, and leave it in place until the appropriate dose has been dispensed.

SpringLeaf said its device will also help patients save money on hospital bills and doctors’ fees.

“These are very safe, very thoughtful devices. I think the advantages are pretty obvious - it certainly will be cheaper, it will be self-contained and disposable,’’ said Dr. Dennis Ausiello the chief of medicine at Massachusetts General Hospital and an adviser to SpringLeaf.

He also said wearing the device for several hours or a few days may reduce the likelihood of side effects because the dose is dispensed in small amounts over an extended period of time.

But one physician said home treatments prevent direct interaction with a doctor or nurse, an important part of patient care.

“When you’re giving a drug at home, you hope the patient understands everything fully and if things are going wrong will know enough to actually call you,’’ said Dr. David Ryan, the clinical director of Massachusetts General Hospital’s Cancer Center. “Sometimes patients think it’s normal to have side effects, when we would be reducing the dose if they were with us.’’

Bobe pointed out that patients have been self-administering insulin for decades and said that doctors will prescribe an appropriate dose for each patient with SpringLeaf’s device.

The device was developed by two MIT researchers, Yet-Ming Chiang and Michael Cima, who founded SpringLeaf in 2007.

Chiang was developing batteries for electric vehicles and saw that the batteries changed shape when they discharged. Though that typically is considered a problem, Chiang saw an opportunity.

“The ‘aha’ moment for me was realizing that we could turn lemons to lemonade and use this problematic expansion and contraction in a beneficial way - to convert stored electrical energy to mechanical energy,’’ Chiang said.

He approached Cima, a colleague, about possible applications of the battery. Cima, who has experience developing medical products, suggested a wearable drug-infusion device.

The two immediately set about testing the battery and received funding from MIT’s Deshpande Center for Technological Innovation to continue research over the next two years. The result was a battery that could push against a pouch to dispense drugs under the skin.

Chiang describes the shape-shifting battery as “electrochemical origami.’’

“We designed a flat battery that morphs in shape as it discharges, converting its own stored electrical energy to a mechanical displacement that dispenses the drug from a reservoir,’’ Chiang said.

Cima said they are receiving patient calls about the technology.

“The challenge is: How do we provide low risk and high reward for patients and their caregivers too?’’ he said.

SpringLeaf will start clinical trials with patients late next year.

Lindsey Hoshaw can be reached at lhoshaw@gmail.com.