Titan Pharmaceuticals Inc announced that it has discontinued treatment with the combination regimen for the remaining patients on study as an interim safety analysis by an independent data monitoring committee (IDMC) for its phase II b study of Pivanex in non-small cell lung cancer has identified significant safety issues in the combination treatment of Pivanex with docetaxel.
Titan has not yet been provided with detailed data from the analysis performed by the IDMC. At present, the study will continue and Titan and the IDMC will review data available to determine any appropriate further steps.
There has been no evidence of significant toxicity in prior single agent phase I and Phase II clinical studies, or in the prior dose ranging study of Pivanex in combination with docetaxel. Pivanex is an anti-cancer agent that inhibits histone deacetylases, a class of enzymes involved in cell growth.
"We are surprised by this result, since Pivanex has not been associated with any significant, dose limiting toxicity in previous studies that might explain these preliminary finding," stated Louis R Bucalo, chairman, president and CEO of Titan.
Titan also plans to withhold further treatment and enrollment in the open label phase IIa studies in CLL and melanoma until further analysis of the data from the phase IIb study is available.
Titan Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of treatments for central nervous system disorders, cancer and cardiovascular disease.