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Apaziquone (EOquin®)

Being investigated for intravesical instillation in non-muscle invasive bladder cancer

Target Indication
  • Non-Muscle Invasive Bladder Cancer
Before and After EOquin picture

Cystoscopic appearance of tumors in the bladder.

Route of Administration
  • Intravesical Instillation (instilled directly into the bladder)

EOquin Mode of Action

Apaziquone is a bio-reductive prodrug activated by reductase enzymes, such as DT-diaphorase expressed by bladder tumor cells, that form the cytotoxic alkylating agent.

Before and After EOquin picture

A) Bladder tumor before intravesical therapy.
B) After 6 weekly intravesical instillations of apaziquone, tumor is no longer present.

EOquin Status

Low-Risk:

Spectrum Pharmaceuticals received concurrence from the FDA for the design of the Phase 3 study protocols under Special Protocol Assessment (SPA).  The FDA has also granted Fast-Track status for the apaziquone development program.

Scientific Advice (equivalent to SPA in the US) was also received from EU regulatory authorities.

Spectrum is conducting 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 endpoint is the rate of tumor recurrence at 2 years between apaziquone and placebo.

High Risk:

Spectrum is currently planning a Phase 3 study in high-risk NMIBC.

EOquin

Bladder Cancer Market

The American Cancer Society estimates that the 2009 incidence of bladder cancer in the United States will be approximately 70,980. As of 2006, SEER estimated the prevalence of the disease to be 527,496 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 UTI, 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 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.


Apaziquone (EOquin®) is available for outlicensing in Asia

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