New Jersey-based Alfacell took a major hit this morning as it announced that its drug Onconase missed the primary endpoint in a Phase III study. The drug failed to improve survival rates of patients with inoperable malignant mesothelioma. However, a statistically significant improvement in survival was seen in the treatment of UMM patients who failed one prior chemotherapy regimen. Alfacell plans to submit an NDA for this patient population, which it says represents a currently unmet medical need. It expects to complete the filing by the end of 2008. Investors were not impressed with Alfacell's good news/bad news announcement, and took a bite out of the company's stock.
- see this release for more
- read the Forbes report