Spectrum Pharmaceuticals Presents Data on Lucanthone, a Novel Anticancer Drug, at...
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Spectrum Pharmaceuticals Presents Data on Lucanthone, a Novel Anticancer Drug, at the Meeting of the American Association of Cancer Research
-- Lucanthone Is A Small Molecule Inhibitor Of DNA Repair
-- Preclinical Data Demonstrates Potential Applications In Lung
Cancer Therapy
-- Has Shown Activity In Earlier Studies In Metastatic Brain
Tumor
-- Phase 1 Clinical Trial For The Treatment Of Brain Tumors Is
Expected to Initiate Shortly
IRVINE, Calif.--(Business Wire)--
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.
About Lucanthone
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.
About Cancer
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.
SPECTRUM PHARMACEUTICALS, INC. (TM), TURNING INSIGHTS INTO
HOPE(TM) and the Spectrum Pharmaceutical logos are trademarks owned by
Spectrum Pharmaceuticals, Inc. All other trademarks and trade names
are the property of their respective owners.
(C) 2008 Spectrum Pharmaceuticals, Inc. All Rights Reserved
Spectrum Pharmaceuticals
Russell Skibsted, SVP & Chief Business Officer
949-788-6700, ext. 234
Paul Arndt, Manager, Investor Relations
949-788-6700, ext. 216
Copyright Business Wire 2008
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