Alfacell Corporation announced it has confirmed that 290 evaluable events (patient deaths) have occurred in the Phase IIIb clinical trial of its lead compound, ONCONASE, for the treatment of patients with unresectable malignant mesothelioma. The number of evaluable events was confirmed after the company learned that total events in the study had reached 316. In accordance with the statistical plan for the study, the company must wait until 316 evaluable events have occurred to conduct the formal statistical analysis required to complete the ONCONASE New Drug Application (NDA). Enrollment in the ONCONASE Phase IIIb clinical trial is scheduled to close on Sept. 30, 2007. To date, a total of 425 patients have been enrolled in the trial.
To be considered evaluable, patients must meet all of the eligibility requirements for the study and receive at least one dose of study drug. Alfacell projects that 316 evaluable events will occur before the end of 2007.
The study has to measure deaths using ONCONASE because it is the only way to acquire the data needed for FDA approval. An explanation can be found here.
Upon reaching this milestone, the company expects to proceed using the following schedule to provide updates regarding the potential completion of the final sections of its ONCONASE rolling NDA submission:
- Report occurrence of 316 evaluable events via news release within 72 hours of confirmation by Alfacell
- If data are positive, submit final clinical section of rolling NDA within four months of reporting 316 evaluable events and announce submission via news release
Alfacell estimates that it has sufficient cash resources available to continue to fund the completion of the ONCONASE Phase III program and the rolling NDA submission.
In addition, the company also plans to initiate quarterly conference calls with investors and analysts to discuss financial performance and to provide corporate updates, beginning with a call currently anticipated to be conducted in early October to discuss the company’s fiscal 2007 performance.