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news.Molecular Insight Pharmaceuticals, a biopharmaceutical company, has provided positive detailed data on its Phase II clinical trial for Zemiva.
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Zemiva is a molecular imaging radiopharmaceutical the company is developing to detect cardiac ischemia, the lack of sufficient blood flow to the heart.
In this trial, the combination of Zemiva (BP-23) imaging with initial clinical information resulted in improved sensitivity (85%) compared to the sensitivity of the initial clinical diagnosis alone (52.2%) (p<0.0001), while maintaining specificity (p=NS). In addition, Zemiva was well tolerated; there were no serious adverse effects associated with the product; and no patients discontinued the product due to adverse events, said Molecular Insight. According to the company, these results were consistent for the subset of patients with acute coronary syndrome (ACS), the most severe form of cardiac ischemia. In patients with ACS, sensitivity (89%) and negative predictive value (93.3%) were significantly (p<0.001) improved while specificity also improved but not with statistical significance. In patients with a negative Zemiva scan, there were no hard cardiac events, including myocardial infarctions or death from cardiac causes during the 30-day follow-up. The trial enrolled 510 patients over 14 months at 50 hospitals throughout North America. The primary objective was to evaluate the ability of Zemiva to identify myocardial ischemia in patients who present to the emergency department (ED) with suspected ACS. John Babich, CEO, president and chief scientific officer of Molecular Insight, said: "With the successful BP-23 results, the Phase II clinical development requirements have been met and we will proceed to Phase III. "In recent discussions with the FDA to review these Phase II clinical development results and our proposal for Phase III clinical trial design, the agency indicated that a single Phase III trial, with robust results, would be sufficient to support Zemiva's approval. We will continue to work with the FDA to reach agreement on a Phase III protocol and expect the Phase III trial to begin in early 2010."