IRVINE, Calif., April 13 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. announced the presentation of new preclinical data on SPI-1620 at the 97th Annual Meeting of the American Association for Cancer Research (AACR) in Washington, DC, earlier this month.
A poster entitled “IRL-1620, a tumor selective vasodilator, enhances the uptake and efficacy of doxorubicin (DOX) in a rat prostate tumor model” (Abstract # 2126, authors N.V. Rajeshkumar, G. Matwyshyn and A. Gulati, University of Illinois at Chicago) showed that SPI-1620 increased the prostate tumor perfusion by approximately 100% and also increased the accumulation of DOX in the tumors by 115%. It is important to note that SPI-1620 did not increase the DOX levels in other organs, confirming the tumor selectivity of the drug. Administration of SPI-1620 15 minutes prior to administration of DOX significantly reduced tumor volume compared to rats treated with saline and DOX. These results show that SPI-1620 significantly enhances the tumor delivery and effectiveness of DOX in an animal model of prostate cancer and may be used as an adjuvant to increase the efficacy of chemotherapeutic agents.
“This is the second set of significant preclinical data on the success of SPI-1620 in selectively and transiently increasing blood flow to tumors and thus delivery of anticancer agents to those tumors,” said Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer and President of Spectrum Pharmaceuticals, Inc. “We have now shown enhanced uptake of paclitaxel in breast cancer tumors and doxorubicin in prostate cancer tumors in animal models. We believe SPI-1620 will prove to have a broad range of applications as an adjuvant to chemotherapy in solid tumor treatment. We have discussed our development plans with the FDA and plan to file an investigational new drug application in late 2006, as soon as the required preclinical studies are completed.”
SPI-1620 is an endothelin B agonist that stimulates receptors on endothelial cells, the innermost layer of cells lining the blood vessels, to selectively dilate blood vessels in the tumor, resulting in a transient increase in blood flow and a consequent increase in the delivery of anti-cancer drugs to the tumor, as shown in animal studies to date. Tumors get their blood supply from blood vessels that are different from normal blood vessels and lack the surrounding smooth muscle cells -- and associated innervations -- found in the blood vessels of healthy tissues. Thus, this technology increases blood flow in tumors, allowing the delivery of cytotoxic agents more selectively to those tumors. Spectrum has proprietary worldwide rights to SPI-1620.
The American Cancer Society estimates there are more than 500,000 new cases of breast and prostate cancer in the U.S. each year. Chemotherapy is one of the mainstays of therapy for solid tumor cancers in the breast, lung and prostate. However, chemotherapy often fails because adequate and uniform distribution of the cytotoxic agents is not achieved in the tumor and serious side effects result from toxicity to normal cells. In this study, SPI-1620 was shown to selectively increase the delivery of anti-cancer agents to prostate cancer tumors in rats.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals, Inc. is a specialty pharmaceutical company based in Irvine, California, 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 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, that SPI-1620 has good tumor selectivity, that SPI-1620 will significantly enhance the tumor delivery and effectiveness of chemotherapy in cancer and will be used in a broad range of application as an adjuvant to increase the efficacy of chemotherapeutic agents, that we will file an IND in late 2006 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 past results will not be indicative of future results, 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. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.
Contacts: Rajesh C. Shrotriya, M.D. Jeanie D. Herbert Chairman, CEO and President Investor Relations Spectrum Pharmaceuticals, Inc. (949) 743-9216 (949) 743-9295
Spectrum Pharmaceuticals, Inc.
CONTACT: Rajesh C. Shrotriya, M.D., Chairman, CEO and President,+1-949-743-9295, or Investor Relations, Jeanie D. Herbert, +1-949-743-9216,both of Spectrum Pharmaceuticals, Inc.
Web site: http://www.spectrumpharm.com/
