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Apaziquone
Being investigated as intravesical instillation in non-muscle invasive bladder cancer.
Target Indications
Non-Muscle Invasive Bladder Cancer (NMIBC)
Cystoscopic appearance of tumors in the bladder.
Route of Administration
Intravesical Instillation (instilled directly into the bladder)
Mode of Action
Apaziquone is a bio-reductive agent activated by reductase enzymes, such as DT-diaphorase, expressed by bladder tumor cells, to form the cytotoxic alkylating agent.
A) Bladder tumor before intravesical therapy.
B) In a Phase 2 study, after 6 weekly intravesical instillations of apaziquone, tumor is no longer present.
Status
Single Intravesical Instillation Studies:
Spectrum conducted two multi-center, randomized, double-blind, placebo controlled, Phase 3 pivotal trials of single dose intravesical apaziquone to be instilled into the bladder in the immediate post-operative period after surgical resection of low-risk, non-muscle invasive bladder tumors. The primary endpoints were the rate of tumor recurrence at 2 years between apaziquone and placebo.
These two trials were analyzed individually and did not meet their primary endpoint of a statistically significant difference in the rate of tumor recurrence at 2 years between the two arms.
The company is considering to request a meeting with the FDA to discuss future steps.
Multiple Intravesical Instillation Studies:
Spectrum is currently accruing patients in two Phase 3 multi-instillation studies for patients with low/intermediate-risk NMIBC.
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Bladder Cancer
The American Cancer Society estimates that the 2010 incidence of bladder cancer in the United States will be approximately 70,530. As of 2007, SEER estimated the prevalence of the disease to be 535,236 in the U.S.
The global prevalence of bladder cancer is estimated at 2.7 million.
Risk factors for bladder cancer include smoking and exposure to certain industrial chemicals. Symptoms may include hematuria, painful or burning urination without evidence of a urinary tract infection, or abdominal pain. If detected early, bladder cancer is a managable disease.
The initial treatment of this cancer is complete surgical removal of the tumor (TURBT). However, bladder cancer is a highly recurrent disease with approximately 80% of patients recurring within 5 years, and a majority of these patients recur within 2 years.
Because bladder cancer patients have a high risk of recurrence, bladder cancer is the most expensive cancer to treat on a per patient lifetime basis. (Botteman et al., Pharmacoeconomics, 2003).
For additional information on bladder cancer, please refer to the following links:
The American Urological Association (AUA)
www.AUAnet.org
The Bladder Cancer Advisory Network (BCAN)
www.bcan.org
American Bladder Cancer Society (ABLCS) www.bladdercancersupport.org
Bladder Cancer Web Café
www.blcwebcafe.com
National Cancer Institute
www.cancer.gov/cancertopics/types/bladder
The U.S. National Cancer Institute's website (http://www.cancer.gov) provides accurate, up-to-date information about many types of cancer, information about clinical trials, resources for people dealing with cancer, and information for researchers and health professionals.
The links provided by Spectrum are for informational purposes only and are not meant to replace your physician's medical advice. Spectrum Pharmaceuticals, Inc. accepts no responsibility for the content of these sites. Spectrum does not control these sites, and the opinions, claims, or comments expressed on these sites should not be attributed to Spectrum. We recommend that you consult with your physician or other healthcare provider to obtain more information.
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