WHO recommends generic name for liver cancer drug candidate

WHO’s International Nonproprietary Name group has recommended the generic name mipsagargin for GenSpera’s G-202 in the treatment of hepatocellular carcinoma, according to a press release.

G-202, a thapsigargin prodrug, was approved by the FDA for clinical trials in 2009. It currently is being tested in phase 2 trials among patients with hepatocellular carcinoma and glioblastoma. Based on recent interim data from phase 1b/2 trials, 80% of HCC patients who were intolerant of sorafenib and/or progressed to mipsagargin showed stable disease at 2 months, while 50% remained stable, without tumor growth, at 4 months, the release said.

“We are pleased that the INN division of WHO and the [US Adopted Names Council] recognized the unique nature of mipsagargin by affording it the new suffix of ‘gargin,’ ” Craig A. Dionne, PhD, chief executive officer of GenSpera, said in the release. “The WHO issues approximately 160 name recommendations per year with only 1% to 2% having new suffixes. New suffixes are generally given to compounds with a unique mechanism of action or structure and serve to define such compound as the first in a possible new class of pharmacological agents. We believe mipsagargin’s name recommendation is the result of G-202’s novel nature and our innovative approaches to cancer therapy.”

Mipsagargin’s pre-stem — gargin — indicates it is unlike any named drug currently or previously on the market or in development. It may become an established stem, usually as other later drugs are recognized to be related in structure or activity to mipsagargin, according to the release.