IRVINE, Calif., Sept. 19 SpectrumPharmaceuticals, Inc., (Nasdaq: SPPI) announced that preclinical data onSPI-1620 were presented today via four poster presentations at the 10thInternational Conference on Endothelin in Bergamo, Italy. SPI-1620 is a drugthat is being developed for use with chemotherapy. SPI-1620 is a highlyselective endothelin-B agonist that has demonstrated in preclinical animalmodels a more than 300% transient and selective increase in blood flow totumors, resulting in an increase of the efficacy of anticancer drugs, whileessentially sparing normal tissues and organs.
"SPI-1620 has shown evidence in preclinical mouse models of selectivelytargeting tumors to increase the uptake of anti-cancer agents such as Taxoland doxorubicin," said Rajesh C. Shrotriya, President and Chief ExecutiveOfficer of Spectrum Pharmaceuticals, Inc. "We believe that SPI-1620 couldhave a broad range of applications for use with chemotherapy in the treatmentof solid tumors. We expect to begin enrolling patients with recurrent orprogressive carcinoma in a Phase 1 open label, dose-escalation study beforethe end of the year or soon thereafter."
SPI-1620 improved the efficacy of radiation treatment in tumor bearingmice by enhancing the reduction in tumor volume and improving survival, andsignificantly enhanced the uptake and efficacy of anticancer agents in aprostate cancer animal model. It was concluded that SPI-1620 did not have anyeffect on the respiration rate of rats at therapeutically relevant doses, andthat there is dose linearity, using both Cmax and AUC analysis. Bloodclearance is rapid as shown by CL and T1/2.
The American Cancer Society estimates there will be more than 1.4 millionnew cases of cancer in the U.S. in 2007. Chemotherapy is one of the mainstaysof therapy for solid tumors. However, chemotherapy often fails becauseadequate tissue levels of the cytotoxic agents are not achieved in the tumorand serious side effects result from toxicity to normal cells. SpectrumPharmaceuticals is developing a novel approach that takes advantage ofendothelin biology and the unique angioarchitecture of tumor blood vessels toovercome these problems.
In animal models, SPI-1620 caused a selective and transient increase inblood flow to tumors. Increased blood flow in turn led to an increase in drugdelivery to tumors, which in turn enhanced the efficacy of thechemotherapeutic drugs. Proof-of-principle studies have been done in severaltumor models, such as breast and prostate tumor models in rats, and melanomaand ovarian tumor models in mice. An increase in the delivery to tumors ofdifferent 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 byimproved efficacy of paclitaxel against breast tumor models and improvedefficacy of cisplatin and cyclophosphamide against ovarian tumor models.Similarly SPI-1620 improved the efficacy of doxorubicin and 5-FU in prostatetumor models.
Spectrum has proprietary worldwide rights to SPI-1620.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals acquires, develops and commercializes adiversified portfolio of oncology drug candidates that meet critical healthchallenges for which there are few other treatment options. The company'spipeline includes promising early and late-stage drug candidates with uniqueformulations and mechanisms of action that address the needs of seriously illpatients, such as at-home chemotherapy and new treatment regimens forrefractory disease. For more information, please visit our website athttp://www.spectrumpharm.com.
Forward-looking statement -- This press release may containforward-looking statements regarding future events and the future performanceof Spectrum P