Alfacell Corp., a biotechnology company that manufactures Onconase, released a disappointing report Wednesday regaring its Onconase product, which was hoped to be a significant treatment for mesothelioma. The drug already has orphan-drug status for the treatment of malignant mesothelioma in the U.S., Europe and Australia.

Results of the company’s late-stage trial of the drug showed that Onconase did not achieve significantly higher survival rates among patients with unresectable malignant mesothelioma when given in combination with doxorubicin, another cancer chemotherapy drug.

According to a report on Pharmaceutical Online, the preliminary results are based on 320 evaluable events that occurred in the clinical trial out of a total of 428 patients randomized. The analysis of the data did not show a statistically significant improvement for evaluable patients receiving Onconase plus doxorubicin. The median survival time (MST) for evaluable patients who received Onconase plus doxorubicin was 11.1 months as compared to 10.7 months for patients who received doxorubicin as a single agent.

However, there is a silver lining to the study. Pharmaceutical Online reports those patients who failed a previous chemotherapy regimen who received Onconase plus doxorubicin experienced a MST of 10.5 months compared with 8.7 months for those patients who received doxorubicin, which is considered a statistically significant result.

Reuters reports as a result of this secondary finding, Alfacell will now submit a marketing application to the Food and Drug Administration for use of the drug on those patients, with hopes to have it approved by the end of the year.

Tags: Alfa, Alfacell Corporation, Australia, chemotherapy, hope, meso, mesothelioma, OMB, ONCONASE, UAB

This entry was posted on Friday, May 30th, 2008 at 1:53 pm and is filed under News, Research/Treatment. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.