By Kim Coghill

Washington Editor

NitroMed Inc., a private company that develops nitric oxide-enhanced medicines, raised $31.4 million to be used for the ongoing development of BiDil, a therapy designed to extend the lives of African-American heart failure patients.

The company now has between $30 million and $40 million in available cash and expects it to last two years. To date NitroMed has raised $75 million in multiple financings.

The round was led by Rho Ventures, of New York. New investors are Care Capital LLC, of Princeton, N.J.; Morgan Stanley Venture Partners, of New York; and Quintiles Transnational Corp., of Research Triangle Park, N.C. Existing investors participating included HealthCare Ventures, of Princeton; Boston University¿s Community Technology Fund, of Boston; and Johnson & Johnson Development Corp., of New Brunswick, N.J.

¿We are pleased that our investors see the same opportunity that we see,¿ Michael Loberg, CEO of Bedford, Mass.-based NitroMed, told BioWorld Today.

At the request of the FDA, BiDil, NitroMed¿s lead product, currently is in confirmatory clinical trials involving 600 patients at 120 sites. Loberg said the company expects to file a new drug application in early 2003.

The confirmatory trial, A-HeFT (African-American Heart Failure Trial), is being conducted with the assistance of the Association of Black Cardiologists, and monitors patients for survival, hospitalization and quality of life over a six- to 12-month period. A-HeFT is the first heart failure trial conducted exclusively in African-American patients.

BiDil is a combination drug containing isosorbide dinitrate and hydralazine hydrochloride.

BiDil was evaluated based on two vasodilator heart failure trials (V-HeFT I and II), large-scale clinical studies in heart failure patients. Published analysis from V-HeFT I and II showed that BiDil provides a selective benefit to black patients with heart failure as compared to nonblack patients receiving the drug. (See BioWorld Today, March 9, 2001.)

Following those studies and upon submitting a data package seeking approval of BiDil, NitroMed received an approvability letter requesting the ¿small and short¿ confirmatory trial, Loberg said. ¿Actually, I can say that we looked at the [confirmatory] trial as an opportunity,¿ he said.

¿The prevalence of heart failure in African-Americans is roughly twice that of the non-African-American population, so we think it is an important drug,¿ Loberg said. ¿We and others share the view that more African-Americans need to be included in clinical trials and we are pleased to be a part of that movement.¿

In 1999, NitroMed acquired BiDil and related intellectual property from Jay Cohn, a professor at the University of Minnesota.

Other than BiDil, NitroMed is developing a product to treat sexual dysfunction in men, which is in clinical trials, and intends to start clinical trials on sexual dysfunction in women shortly, Loberg said.