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Alfacell Says 290 Patients Died in Phase 3 Onconase 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. 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
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.
ONCONASE is a first-in-class product candidate based on Alfacell's proprietary ribonuclease (RNase) technology. A natural protein isolated from the leopard frog, ONCONASE has been shown in the laboratory and clinic to target cancer cells while sparing normal cells. ONCONASE triggers apoptosis, the natural death of cells, via multiple molecular mechanisms of action.