Neoprobe on Track to File New Drug Application this Summer

Neoprobe has reported it is on track to file a new drug application with the FDA for its cancer detecting drug Lymphoseek – a drug that has been under development for five yeas.  The company filed final results of human trials with the FDA in December 2009.  Neoprobe met with FDA officials to review results from its Phase 3 clinical trials.  David Bupp, Neoprobe CEO, reported that positive comments from the FDA signal that the study results look good.

Neoprobe, a Dublin-based biotech company, licensed Lymphoseek from the University of California – San Diego to pair with its hand-held radiation-detection device as a system for diagnosing the spread of cancer in patients with breast cancer or melanoma.  Lymphoseek binds to lymph tissue so that the first lymph node collecting fluid from a tumor can be tested to see if cancer has spread.

Lymphoseek is an alternative to other radioactive drugs in off-label use, therefore not covered by insurance – and blue dye which can cause severe allergic reactions.  In addition, during testing, Lymphoseek found nodes not identified by the dye.

For more, see the story in Business First