- SPI-1620 Demonstrates Preclinical Evidence of Significantly Increasing
the Uptake of Anticancer Agents in Tumors
- Phase 1 Dose-Escalation Study to Begin Recruiting Patients Shortly
IRVINE, Calif., Oct. 24 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc., (Nasdaq: SPPI) announced that preclinical data on SPI-1620 was presented today via poster presentations at the International Conference of the AACR-NCI-EORTC on Molecular Targets and Cancer Therapeutics, being held in San Francisco October 22-26, 2007. SPI-1620 is a drug that is being developed for use with chemotherapy.
"SPI-1620 continues to show preclinical evidence of selectively targeting tumors to increase the uptake of anti-cancer agents, and improve their therapeutic index," said Rajesh C. Shrotriya, M.D., President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. "We believe SPI-1620 may have a broad range of applications for use in conjunction with chemotherapy in the treatment of solid tumors. We expect to begin enrolling patients in a Phase 1 open label, dose-escalation study shortly after we receive IRB approval."
Effect Of SPI-1620 On Tumor Perfusion And Uptake Of Paclitaxel In A Melanoma Model
Tumor bearing animals were randomly grouped to receive either saline or SPI-1620, and received paclitaxel 15 minutes after SPI-1620 was administered. Paclitaxel concentration was determined in the tumor, and in a number of normal tissues.
Mice administered with SPI-1620 increased tumor perfusion by up to approximately 200% from baseline and the effect lasted over 2 hours, compared to no significant change in saline treated mice. SPI-1620 treated mice also had over 5 fold increased concentration of paclitaxel in tumors, and no significant change in normal tissues compared to saline treated animals.
It was concluded that, in mice, SPI-1620 significantly increased tumor blood perfusion, and significantly enhanced the uptake and delivery of paclitaxel to the tumor tissues without affecting other organs.
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 in a Phase 1 open label, dose-escalation study shortly after we receive IRB approval, 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, that results of pre-clinical animal studies do not necessarily predict the results of later-stage clinical trials, 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.
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Russell Skibsted Susan Neath
SVP & Chief Business Officer Porter Novelli Life Sciences
Manager, Investor Relations
|SOURCE Spectrum Pharmaceuticals, Inc.|
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