Spectrum Pharmaceuticals, Inc. has announced that its recently submitted Investigational New Drug Application (IND) for SPI-153 received concurrence from the U.S. Food and Drug Administration (FDA) to conduct a phase I/II clinical trial in patients with hormone-dependent prostate cancer in the United States.
“The SPI-153 IND authorization from the FDA represents the accomplishment of one of our key objectives for 2005,” stated Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer and President of Spectrum Pharmaceuticals, Inc. “In clinical studies conducted to date, SPI-153 has been shown to have potential advantages over other LHRH antagonists, related to the improved solubility and decreased potential for histamine release, and we hope that this will translate into an improved safety profile, including the absence of significant hypersensitivity reactions, with no restriction in the use of the drug. We recently initiated clinical studies in prostate cancer and in benign prostatic hypertrophy in Europe, and we are now in a position to expand the studies to the U.S., and accelerate the development program.”
SPI-153 is a fourth generation LHRH (Luteinizing Hormone Releasing Hormone), also known as GnRH (Gonadotropin Releasing Hormone) antagonist. LHRH antagonists have the potential to treat hormone-dependent cancers, as well as benign proliferative disorders such as benign prostatic hypertrophy and endometriosis.
