Post by
conspiTheory on Oct 26, 2015 9:51am
SPPIs back... fails the first time
Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations and a primary focus in Hematology and Oncology, announced today the Company has initiated the planned Phase 3 clinical study for apaziquone, its novel, potent pro-drug, and the first patient was dosed on Friday, October 23, 2015. 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.”
https://www.stockwatch.com/News/Item.aspx?bid=U-b005478-U%3aSPPI-20151026&symbol=SPPI®ion=U
Comment by
Frogger2 on Oct 26, 2015 12:21pm
I have read this article before, it is a pump for Hear. It also stated that TST has manufacturing issues. Not credible.
Comment by
txbioinv on Oct 26, 2015 2:32pm
yes frogger,,,,,,,,,,,,,,plus look at the date of article , april. noinstinct more like no shame...........