Spectrum Pharmaceuticals Presents Data on SPI-1620, a Novel Adjunct to Cancer Therapy, at the 6th International Symposium on Targeted Anticancer Therapies
"In this mouse-model study, SPI-1620 demonstrated evidence of increasing the sensitivity to radiation on tumors that have become resistant to radiation," said Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. "In previous mouse model studies we have demonstrated that SPI-1620 enhances the efficacy of a wide variety of chemotherapeutics in different tumor models. We believe that SPI-1620, currently in a Phase 1 clinical trial, could have a broad range of applications for use in conjunction with radiation and chemotherapy in the treatment of cancer."
Abstract #35 - SPI-1620 Significantly Improves Survival in Mice Treated with Radiation
The study was conducted to determine the effect of SPI-1620 on radiation therapy in tumor bearing mice inoculated with Dalton's Lymphoma Ascites cells. The animals were exposed to radiation with and without SPI-1620 on alternate days for a total of 5 doses. Tumor diameter was measured twice a week for 70 days.
Radiation alone was not effective in reducing the tumor volume, indicating that tumors had become non-responsive (possibly due to hypoxic conditions). However, treatment with SPI-1620 followed by radiation significantly increased (more than 64%) the reduction in tumor volume. Survival of mice was improved from 0/10 at 56 days in vehicle plus radiation group to 6/10 at 70 days in SPI-1620 plus radiation group.
It was concluded that SPI-1620 significantly improves the efficacy of radiation treatment in tumor bearing mice by enhancing the reduction in tumor volume and improving survival.
According to the most recent American Cancer Society estimates, in the United States, approximately 1.4 million new cancer cases were expected to be diagnosed in 2008 and over 565,000 persons were expected to die from the disease in 2008. Cancer is the second most common cause of death in the United States. Chemotherapy is one of the mainstays of therapy for solid tumors. However, chemotherapy often fails because adequate tissue levels of the cytotoxic agents are not achieved in the tumor and serious side effects result from toxicity to normal cells. Consequently, any means to increase the delivery of a cytotoxic agent selectively to tumors, while minimizing its concentration in normal tissues, would be beneficial.
SPI-1620 is a highly selective endothelin-B agonist that causes a selective and transient increase in blood flow to tumors, thereby, as demonstrated in preclinical studies, increasing the delivery of anticancer agents to the tumor, and as a result increasing the efficacy of these drugs. In these pre-clinical studies, when anti-cancer drugs, such as paclitaxel, doxorubicin, cisplatin, 5-FU, cyclophosphamide and others, were administered shortly after SPI-1620, the anti-cancer drug concentration in the tumor increased several fold. This resulted in increased anti-tumor efficacy at a given dose of the cytotoxic agent, and thus might allow physicians to maximize efficacy of reduced cytotoxic agent doses with resultant decreased toxicity to the normal organs. Preclinical proof of principle studies have been successfully conducted in a wide variety of indications such as breast, ovarian, melanoma, and prostate cancer.
Spectrum has proprietary worldwide rights to SPI-1620.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals acquires, develops and commercializes a diversified portfolio of oncology and urology drug candidates that meet critical health challenges for which there are few other treatment options. The company's pipeline includes promising early and late-stage drug candidates with unique formulations and mechanisms of action that address the needs of seriously ill patients, and new treatment regimens for refractory disease. For more information, please visit our website at www.spectrumpharm.com.
Forward-looking statement - 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, Spectrum's ability to identify, acquire, develop and commercialize its portfolio of drug candidates, the Company's promising pipeline, that SPI-1620 might allow physicians to maximize efficacy of reduced cytotoxic agent doses with resultant decreased toxicity to the normal organs, that SPI-1620 could have a broad range of applications for use in conjunction with radiation and chemotherapy in the treatment of cancer, the safety and efficacy of SPI-1620 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 preclinical studies are not indicative of the results of future clinical studies, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of revenues, our limited marketing experience, 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.
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Spectrum Pharmaceuticals, Inc.
Russell Skibsted, SVP & Chief Business Officer
Paul Arndt, Manager, Investor Relations
Porter Novelli Life Sciences
Posted: March 2008