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Spectrum Authorized by FDA to Conduct Phase I/II Clinical Trial in the U.S. With SPI-153 in Hormone Dependent Prostate Cancer.

Publication: PR Newswire
Publication Date: 31-MAY-05 		Format: Online - approximately 830 words
Delivery: Immediate Online Access

Article Excerpt
- SPI-153 is a Fourth Generation LHRH (Luteinizing Hormone Releasing Hormone) Antagonist Administered as a Depot Formulation

- Currently SPI-153 is in Phase II Trials in Europe for Two Indications; Hormone Dependent Prostate Cancer and Benign Prostate Hypertrophy (BPH)

IRVINE, Calif., May 31 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. today 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...

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