Onconase fails to show expected results

Alfacell Corp. this week released a statement indicating that Onconase, a chemotherapy agent, did not meet the “statistical significance for the primary endpoint of survival in unresectable malignant mesothelioma.” Or, in plain English, the drug Onconase isn’t as effective at treating mesothelioma as the company had hoped. It had previously been hoped that Onconase would prove to be an effective chemotherapy treatment for people who had malignant mesothelioma and weren’t eligible for surgery. The most recently completed Onconase trial, Phase IIIb, was designed to show that Onconase mesothelioma treatment significantly improved overall survival times for people with inoperable malignant mesothelioma. People in the trial were treated with a combination of Onconase and Doxorubicin, another chemotherapy agent. The results obtained were compared with people who were treated with Doxorubicin only. While it had been expected that people receiving the combination therapy would have significantly improved survival time, that wasn’t the case. People receiving Doxorubicin alone had a mean survival time of 10.7 months, while those receiving Onconase and Doxorubicin had a mean survival time of 11.1 months, which, while a slightly higher number, isn’t enough to be considered statistically significant. However, although the trial results showed no statistically significant improvement for people with inoperable mesothelioma receiving Onconase and Doxorubicin, there was one positive result. Initial results from the trial indicate that a statistically significant survival time improvement was seen in people with inoperable malignant mesothelioma who had “failed” one prior chemotherapy treatment course. In this case, the mean survival time for people receiving only Doxorubicin was 8.7 months, while people receiving both drugs had a mean survival time of 10.5 months. The preliminary results with Onconase are based on clinical trials with a total of 428 patients participating. As a result of the unexpected positive, Alfacell plans to submit a New Drug Application to the FDA, and to eventually use Onconase for the treatment of this group of people, which, it says, represent a group of people with an unmet medical need. Onconase for the treatment of malignant meosthelioma has been granted “fast track” status by the FDA. The drug itself is a protein isolated from the leopard frog. Kuslima Shogen, Alfacell’s chief executive officer, said of the trial, “I am pleased that we have reached this important milestone for both Alfacell and Onconase. We are deeply appreciative of the cancer patients and clinical investigators who participated in this important trial.” (Source: Asbestos and Mesothelioma News)