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Satraplatin is an investigational drug and is a member of the platinum family of compounds developed by Professor Ken Harrap's research group at CRT. For the past two decades, platinum-based drugs have become a critical part of modern chemotherapy treatments and are used to treat a wide variety of cancers. Worldwide sales of these drugs exceeded $2.2 billion in 2004. Unlike the platinum drugs currently available in the market, all of these require intravenous administration, Satraplatin is an orally bioavailable compound and is given in the form of capsules that patients can take at home. An oral platinum drug could offer many advantages, including ease of administration and patient convenience, in a variety of applications. Target enrollment has been achieved in a Phase 3 registration trial - the SPARC trial - as a second-line chemotherapy treatment for HRPC. GPC Biotech has recently completed a Special Protocol Assessment with the U.S. FDA and has received the Scientific Advice letter from the European regulatory authority, the European Medicines Agency.
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Satraplatin binds to the DNA of cancer cells and makes the cell incapable of dividing. This causes the tumor to stop growing and eventually leading to the death of the cancer cells. Anti-tumor activity in preclinical models is almost comparable to cisplatin and carboplatin with less cross-resistance.
In 950 patients with hormone-refractory prostate cancer the study data show that the results for progression-free survival are highly statistically significant using the protocol-specified log-rank test. PFS is the basic endpoint for submission for accelerated approval in the U.S. and will also serve as the primary basis for a Marketing Authorization Application in Europe.
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