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Spectrum Pharmaceuticals (NasdaqGS: SPPI) has begun a Phase 3 clinical study for its novel, potent pro-drug apaziquone. The first patient was dosed on Friday, October 23.
Spectrum Pharmaceuticals (NasdaqGS: SPPI) has begun a Phase 3 clinical study for its novel, potent pro-drug apaziquone. The first patient was dosed on Friday, October 23.
According to the press release:
Apaziquone is an alkylating agent being investigated as intravesical treatment to address the unmet medical need for patients with non-muscle invasive bladder cancer (NMIBC), administered as one or two instillations immediately following transurethral resection of bladder tumors (TURBT).
“Apaziquone has the potential to usher in an importantly needed paradigm shift in the treatment of NMIBC, as the first new drug in its indication in over 40 years,” said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. “This Phase 3 study has been specifically designed to address important lessons learned from the previous apaziquone Phase 3 studies, as well as recommendations from the FDA that improve chances of a successful study outcome. Pooled data from the previously completed Phase 3 studies that enrolled over 1,600 patients, showed a statistically significant reduction in the 2-year Recurrence rate and strong safety data. These existing Phase 3 data form the basis of the NDA that we plan to submit to FDA before the end of the year. Because of the high frequency of recurrences, the overall cost for the treatment of bladder cancer in the U.S. is a staggering $3.4 billion annually, most of which is related to direct treatment of the disease. We are hopeful that we can get this drug to the market as soon as possible to meet the significant unmet medical need.”
“I am impressed with the data and the activity of apaziquone in NMIBC that I have seen so far in clinical trials,” said Lawrence Karsh, MD, FACS, Director of Research at The Urology Center of Colorado. “In bladder cancer patients, there is, unfortunately, a high rate of recurrence that necessitates frequent surgeries. Due to the high rate of recurrence, there is significant patient morbidity and the disease is expensive to treat. There is a strong scientific rationale for the use of a chemotherapeutic agent post-TURBT, and NCCN guidelines recommend the post-TURBT instillation of a chemotherapeutic agent. However, no drug has been specifically approved for post-TURBT instillation in the US for this group of patients. The addition of a new effective therapy for this recurring disease would help to address the high unmet medical need, offer patients an important new treatment option, and potentially reduce the healthcare costs associated with the treatment of NMIBC.”
Click here to read the press release.