Spectrum Pharmaceuticals Presents Data on Lucanthone, a Novel Anticancer Drug, at the Meeting of the American Association of Cancer ResearchIRVINE, Calif.--(BUSINESS WIRE)--April 17, 2008 - Spectrum Pharmaceuticals, Inc., (Nasdaq:SPPI) announced preclinical data on lucanthone via poster presentation at the 2008 Annual Meeting of the American Association of Cancer Research (AACR), held in San Diego, California. Lucanthone is an orally administered small molecule inhibitor of DNA repair. The Company is expected to initiate shortly a Phase I dose-escalation study of lucanthone in patients with recurrent malignant gliomas receiving temozolomide. Data presented demonstrates that lucanthone improves the activity of pemetrexed (Alimta(R), Eli Lilly & Co.) in lung cancer animal models.
"Based on preclinical data presented today, we believe we may have expanded the potential use of lucanthone to the treatment of lung cancer," said Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. "While we continue to develop lucanthone for the treatment of brain tumors, we are exploring potential clinical trial design options in the treatment of lung cancer, where it is estimated that more than 215,000 new cases will be diagnosed in 2008, resulting in more than 161,000 deaths."
#5675 Lucanthone Potentiates the Anti-Tumor Activity of Pemetrexed in A Lung Cancer Model
Lucanthone is an orally available small molecule inhibitor of DNA repair (AP endonuclease). Inhibition of AP endonuclease by lucanthone leads to the accumulation of abasic sites in DNA that are converted to lethal double-strand breaks leading to sensitization of tumor cells to alkylating agents and to radiation. Since DNA damage that is caused by pemetrexed is repaired by Base Excision Repair (BER) and since lucanthone inhibits AP endonuclease, a key component of BER pathway, it is hypothesized that lucanthone will potentiate the activity of pemetrexed.
Nude mice, bearing H460 non-small cell lung carcinona xenografts, were treated with vehicle control, lucanthone alone, pemetrexed alone or combination of lucanthone and pemetrexed (10 animals/group). Animals were treated for 4 cycles over a period of 16 days. Animals treated with pemetrexed alone (200 mg/kg in a 4-day treatment cycle) showed 9.7% tumor growth inhibition. Animals treated with lucanthone alone (four courses of 40 mg/kg each over 2 days in a 4-day treatment cycle) showed 20% tumor growth inhibition. Animals treated with a combination of lucanthone and pemetrexed showed an approximately 45% tumor growth inhibition demonstrating that lucanthone is synergistic with pemetrexed.
These results suggest that combination therapy of lucanthone and pemetrexed can be explored in the treatment of human lung cancer.
Lucanthone is an orally administered small-molecule which inhibits Topoisomerase II and AP endonuclease. In preclinical tests, lucanthone was shown to enhance the sensitivity of animals to an anticancer agent in a time dependent and reversible manner.
Lucanthone has structural and biochemical similarities to Actinomycin D but has no hematological or GI toxicity at clinically tolerated doses. More recent research shows that lucanthone sensitizes tumor cells to radiation and chemotherapy by inhibiting DNA repair (AP endonuclease). Lucanthone is currently in clinical development for the treatment of brain tumors.
According to the American Cancer Society's 2008 Facts & Figures, cancer is the second most common cause of death in the United States. The ACS estimates that 1,437,180 new cancer cases are expected to be diagnosed in 2008, resulting in 565,650 cancer deaths, or more than 1,500 people a day. The ACS also estimates that 215,020 new cases of lung cancer will be diagnosed in 2008, resulting in 161,840 deaths, and 21,810 new cases of brain tumors, resulting in 13,070 deaths in 2008.
About Spectrum Pharmaceuticals
We are a biopharmaceutical company that acquires, develops and commercializes a diversified portfolio of drug products, with a focus on oncology, urology and other critical health challenges. Our strategy is comprised of the following four parts: acquiring and developing a broad and diverse pipeline of late-stage clinical and commercial products with a focus on oncology and urology; establishing a commercial organization for the drug products in our pipeline as they are approved; continuing to build a team with significant drug development and commercialization expertise in our areas of focus, and; leveraging the expertise of partners around the world in areas of manufacturing, development and commercialization to assist us in the execution of our strategy. 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 execution of the Company's strategy, the safety and efficacy of lucanthone, the initiation of the Phase 1 study, that we may have expanded the potential use of lucanthone to the treatment of lung cancer, that lucanthone may improve the activity of pemetrexed in lung cancer, that potential clinical trial design options for lucanthone in the treatment of lung cancer will ever be achieved, 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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Russell Skibsted, SVP & Chief Business Officer
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Paul Arndt, Manager, Investor Relations
949-788-6700, ext. 216
Posted: April 2008