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EOquin®

Apaziquone for intravesical instillation

Non Muscle Invasive Bladder Cancer

Bladder Cancer Tumors prior to TUR

Instillation directly into the bladder

EOquin® is a bioreductive prodrug activated by reductase enzymes that form the cytotoxic alkylating agent.

Bladder tumor cells are hypoxic and have high levels of the enzyme DT-diaphorase, an enzyme that activates EOquin®

Marker lesion (after TUR) before (A) and (B) after 6 weekly intravesical administrations of EOquin®

Under a Special Protocol Assessment (SPA) procedure, Spectrum Pharmaceuticals received concurrence from the FDA for the design of the Phase 3 study protocol.

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

Spectrum initiated two double-blinded, placebo controlled, multi-center, randomized Phase 3 pivotal trial for EOquin for single post operative intravesical instillation following surgical resection of low-risk, non-invasive bladder tumors.

In January 2008, the EMEA agreed that the current placebo-controlled studies should be sufficient for a regulatory decision regarding European Registration.

For more information on the SPA procedure, please click the link above.

The protocol calls for two Phase 3 clinical studies, each with 562 evaluable patients with low-risk non muscle invasive bladder cancer. The primary endpoint will be a statistically significant difference in the rate of tumor recurrence between the two treatment groups by year two. The first patient was enrolled in May 2007.

The American Cancer Society estimates that the 2008 incidence and prevalence of bladder cancer in the United States will be approximately 68,810 and over 500,000, respectively.

Based on Globocan data, we estimate that the 2008 incidence and prevalence of bladder cancer in Europe is approximately 149,000 and 944,000, respectively.

According to Botteman et al., (Pharmacoeconomics, 2003), bladder cancer is the most expensive cancer to treat on a lifetime basis.

The initial treatment of this cancer is complete surgical removal of the tumor. However, bladder cancer is a highly recurrent disease with approximately 75% of patients recurring within 5 years, and a majority of patients recurring within 2 years.

This high recurrence rate is attributed to:

The highly implantable nature of cancer cells that are dispersed during surgery
Incomplete tumor resection
Tumors present in multiple locations in the bladder which may be missed or too small to visualize at the time of resection

Despite evidence in the published literature and guidance from the American and European Urology Associations, instillation of a chemotherapeutic agent immediately following surgery is not a standard clinical practice. Currently, there are no approved drugs for this indication which may, in part, explain the difference between the literature and urology guidelines and actual clinical management of this disease.

For more than 30 years no new drugs have been introduced in the market for the treatment of NMIBC.

EOquin® is available for outlicensing outside the U.S.

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