Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE

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

By Pharmaceutical Processing | June 2, 2005

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.

Related Articles Read More >

Driving success in fast-paced high-tech pharma construction projects
This is a photo of the Fujifilm Diosynth Biotechnologies plant under construction in Holly Springs, North Carolina.
Fujifilm, Regeneron ink $3B U.S. manufacturing agreement
This is the logo of Johnson & Johnson.
J&J breaks ground on $2B manufacturing facility in North Carolina
sherwin-williams-pharma-facility (1)
Sherwin-Williams expands flooring solutions for pharma facilities
“ppw
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news, technologies, and developments in Pharmaceutical Processing.

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Pharmaceutical Processing World
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index
  • R&D 100 Awards

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE