Spectrum Authorized By FDA to Conduct Phase I/II Clinical Trial in the U.S. With SPI-153 in Hormone Dependent Prostate Cancer
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 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.
About Prostate Cancer
Prostate cancer is the second leading cause of cancer deaths in men. According to figures released by the American Cancer Society, approximately 232,090 new cases and 30,350 deaths will occur in the U.S. during 2005. The initial treatment of prostate cancer includes surgery along with radiation therapy and hormonal therapy. Although hormonal therapy is generally very effective, and produces a response in most patients, it may be non-curative. For those patients relapsing after hormone therapy, treatment currently involves chemotherapy, which may result in improvement of symptoms of cancer and prolongation of survival.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals is a specialty pharmaceutical company engaged in the business of acquiring, developing and commercializing prescription drug products for the treatment of cancer and other unmet medical needs. By leveraging its operational flexibility and regulatory proficiency, and using the extensive research and development capabilities of its strategic alliance partners, Spectrum has built a diversified portfolio of proprietary and generic drug products in various stages of development and regulatory approval. For more information, please visit our website at http://www.spectrumpharm.com/.
Forward-looking statements
This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to our business and its future, the Company’s operational flexibility and regulatory proficiency, the extensive research and development capabilities of the Company’s strategic alliance partners, the potential advantages of SPI-153 over other LHRH antagonists, related to the improved solubility and decreased potential for histamine release, and the 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, the acceleration of the development program for SPI-153, LHRH antagonists’ potential to treat hormone-dependent cancers, as well as benign proliferative disorders such as benign prostatic hypertrophy and endometriosis, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates, may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that price and other competitive pressures may make the marketing and sale of our generic drugs not commercially feasible, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of revenues, our limited experience in establishing strategic alliances, our limited marketing experience, our limited experience with the generic drug industry, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company’s reports filed with the Securities and Exchange Commission.
Contacts:
Rajesh C. Shrotriya, M.D.,
CEO and President
(949) 743-9295
Laurie Little
Director, Investor Relations
(949) 743-9216
Spectrum Pharmaceuticals, Inc.
CONTACT: Rajesh C. Shrotriya, M.D., CEO and President,+1-949-743-9295,or Laurie Little, Director, Investor Relations, +1-949-743-9216, both ofSpectrum Pharmaceuticals, Inc.
Web site: http://www.spectrumpharm.com/