Stromedix, with Biogen Idec Roots, Seeks Exit from Regulatory Limbo

Xconomy Boston — 

Cambridge, MA-based Stromedix is behind schedule on developing drugs that could stymie a cellular process that causes peoples’ bodies to transplanted kidneys to fail. Yet schedule delays are common in the unpredictable biotech business, and we’re only hearing about this one because of the candid nature of its co-founder and CEO, Michael Gilman.

When Stromedix closed its $25 million Series B funding round in April 2008, Gilman told Xconomy he wanted to be well into a mid-stage clinical trial of the firm’s lead drug for interstitial fibrosis in kidney transplant recipients by this point in 2010. However, the FDA has concerns about the safety of how the drug works in those patients, and Gilman and his startup now find themselves more than a year behind in their development plan.

The company’s drug, STX-100, is a therapeutic antibody licensed from the Weston, MA-based biotech giant Biogen Idec (NASDAQ: BIIB), where Gilman used to be a research executive. The antibody targets molecules linked to a cellular process called fibrosis, which causes organs to form scar tissues and ultimately fail. While fibrosis is common among all organ failures, Stromedix initially targeted kidney transplant patients because they are easily identified compared with other victims of fibrosis, and there’s a great need for ways to help them keep their new kidneys functioning for as long as possible.

Fibrosis is also a leading cause of peoples’ heart tissues to fail, something that hit close to home for Gilman last year. The 55-year-old CEO got an aortic valve replacement in November 2009 that sidelined him for six or seven weeks, he says. “I feel … Next Page »

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