Heart drug from Nuvelo buyer rejected - San Francisco Business Times:

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said the FDA asked the company to do additional clinicapl studies on itslead Gencaro. In saying that Gencarpo didn’t prove it was effective, the FDA also questiones the integrityof Arca’x trial data based on an audit of some clinical trial sites. The FDA, however, said it had not reviewe several amendments that Arca filed in May to its new drug Gencaro — the centerpiecee of a reverse merger in Januaryg between Arca and Nuvelo — had been shelved by BMY) in 1999 after it didn’t show a significanr statistical difference compared to a Yet researchers later discovered that some of the triall enrollees were hyper-responsive to the drug due to commobn genetic variations.
Arca said it and had developed an accompanyinhg genetic test to weed out patients who hadthat response. The revers e merger with Nuvelo, which itself had stallede afterits clot-buster drug alfimeprase failes a late-stage clinical trial in Decembet 2006, made Arca publicly traded. The deal also gave Arca accessdto Nuvelo’s remaining Arca (NASDAQ: ABIO), based in Colo., north of Denver, is led by President and CEO Richarrd Brewer, a Santa Cruz resident and former chief of Fremont’s Scios Inc. Scios and its ill-fated heart failurwe drug Natrecor were sold six years ago tofor $2.
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