Alfacell Corporation reported that it has conducted a pre-NDA meeting with the U.S. Food and Drug Administration (FDA) to discuss the company's planned submission of the final components of the ONCONASE rolling New Drug Application (NDA) for the treatment of unresectable malignant mesothelioma (UMM) patients.

"At the pre-NDA meeting, the FDA provided guidance to the company recommending that an additional clinical trial be conducted in UMM patients..."

BUT...

"The company's current financial situation does not allow it to pursue additional clinical trials until other sources of capital are secured. The company will effect a reduction in force on January 30, 2009 and otherwise reduce its operations to the minimum sustainable level required to pursue strategic alternatives and additional capital. Based upon these actions the company expects that its current cash reserves will enable it to maintain its reduced operations through December 2009."

Looks like ONCONASE is on a dead end trail...?

Source(s):
PharmaLive.com
ONCONASE® Malignant Mesothelioma Trial