Spectrum Pharmaceuticals Announces Presentation of SPI-1620 Data at the 10th International Conference on Endothelin
IRVINE, Calif., September 19, 2007 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc., announced that preclinical data on SPI-1620 were presented today via four poster presentations at the 10th International Conference on Endothelin in Bergamo, Italy. SPI-1620 is a drug that is being developed for use with chemotherapy. SPI-1620 is a highly selective endothelin-B agonist that has demonstrated in preclinical animal models a more than 300% transient and selective increase in blood flow to tumors, resulting in an increase of the efficacy of anticancer drugs, while essentially sparing normal tissues and organs.
"SPI-1620 has shown evidence in preclinical mouse models of selectively targeting tumors to increase the uptake of anti-cancer agents such as Taxol and doxorubicin," said Rajesh C. Shrotriya, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. "We believe that SPI-1620 could have a broad range of applications for use with chemotherapy in the treatment of solid tumors. We expect to begin enrolling patients with recurrent or progressive carcinoma in a Phase 1 open label, dose-escalation study before the end of the year or soon thereafter."
The four posters presented on SPI-1620 were: 1. Toxicokinetic Evaluation of SPI-1620 in a 4-Week Toxicology Study in Rats 2. Effect of SPI-1620 on Respiration Rate and Tidal Volume in Sprague Dawley Rats 3. Improvement In The Uptake And Efficacy Of Chemotherapeutic Agents By SPI-1620 In Prostate Tumor Rats 4. Oral Poster Presentation -- Radiation Induced Survival And Reduction In Tumor Volume In Dalton's Lymphoma Ascites Tumor Model Was Significantly Enhanced By SPI-1620
SPI-1620 improved the efficacy of radiation treatment in tumor bearing mice by enhancing the reduction in tumor volume and improving survival, and significantly enhanced the uptake and efficacy of anticancer agents in a prostate cancer animal model. It was concluded that SPI-1620 did not have any effect on the respiration rate of rats at therapeutically relevant doses, and that there is dose linearity, using both Cmax and AUC analysis. Blood clearance is rapid as shown by CL and T1/2.
The American Cancer Society estimates there will be more than 1.4 million new cases of cancer in the U.S. in 2007. 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. Spectrum Pharmaceuticals is developing a novel approach that takes advantage of endothelin biology and the unique angioarchitecture of tumor blood vessels to overcome these problems.
In animal models, SPI-1620 caused a selective and transient increase in blood flow to tumors. Increased blood flow in turn led to an increase in drug delivery to tumors, which in turn enhanced the efficacy of the chemotherapeutic drugs. Proof-of-principle studies have been done in several tumor models, such as breast and prostate tumor models in rats, and melanoma and ovarian tumor models in mice. An increase in the delivery to tumors of different chemotherapeutic drugs such as paclitaxel, cisplatin, doxorubicin, cyclophosphamide, and 5-FU has been shown in animal models. Furthermore, SPI-1620 enhanced the efficacy of chemotherapeutic drugs as demonstrated by improved efficacy of paclitaxel against breast tumor models and improved efficacy of cisplatin and cyclophosphamide against ovarian tumor models. Similarly SPI-1620 improved the efficacy of doxorubicin and 5-FU in prostate tumor models.
Spectrum has proprietary worldwide rights to SPI-1620.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals acquires, develops and commercializes a diversified portfolio of oncology 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, such as at-home chemotherapy and new treatment regimens for refractory disease. For more information, please visit our website at http://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 could have a broad range of applications for use with chemotherapy in the treatment of solid tumors, that we will begin enrolling patients with recurrent or progressive carcinoma in a Phase 1 open label, dose-escalation study before the end of the year or soon thereafter, 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 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.
COMPANY CONTACTS MEDIA CONTACT Russell Skibsted Susan Neath SVP & Chief Business Officer Porter Novelli Life Sciences 619-849-6007 Paul Arndt Manager, Investor Relations 949-788-6700
CONTACT: Company, Russell Skibsted, SVP & Chief Business Officer, or PaulArndt, Manager, Investor Relations, +1-949-788-6700, both of SpectrumPharmaceuticals, Inc.; or Media, Susan Neath, of Porter Novelli LifeSciences, +1-619-849-6007, for Spectrum Pharmaceuticals, Inc.
Web site: http://www.spectrumpharm.com/
Ticker Symbol: (NASDAQ-NMS:SPPI)
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Posted: September 2007