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Results of Progression-Free Survival Rate for Satraplatin Are Statistically Significant

IRVINE, Calif., Sept. 24 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI - News) today announced positive results from the Phase 3 satraplatin pivotal registrational trial known as SPARC (Satraplatin and Prednisone Against Refractory Cancer). The trial is evaluating satraplatin, the first orally available platinum-based chemotherapy in advanced clinical development, plus prednisone versus placebo plus prednisone as a second-line treatment in 950 patients with hormone-refractory prostate cancer (HRPC). The study data show that the results for progression-free survival (PFS) are highly statistically significant (p "We are excited about the positive outcome of this pivotal Phase 3 trial of satraplatin as it validates our team's ability to identify promising drugs and select the most efficient method of moving these drugs through development and toward commercialization," stated Raj Shrotriya, M.D., President and CEO of Spectrum Pharmaceuticals. "This news is the first of what we expect will be a number of near-term announcements as we continue to advance our rich pipeline of ten drug candidates."

The milestone payments due to Spectrum, on acceptance and approval of regulatory applications in the U.S. and Europe, are approximately $20 million. Further payments are due on achieving certain sales targets. In addition to milestones, Spectrum will receive royalties on worldwide sales of satraplatin. The company also has co-promotion rights in the U.S., if the partner markets the drug in the U.S.

Patients in the SPARC trial who received satraplatin plus prednisone had a 40% reduction in the risk of progression (hazard ratio of 0.6; 95% Confidence Interval: 0.5-0.7) compared with patients who received prednisone plus placebo.

The improvement in PFS in the satraplatin arm was not affected by the type of prior chemotherapy; in particular, the improvement was seen equally for patients who had received prior Taxotere® (docetaxel), as well as those who received other types of chemotherapy treatments. All disease progression events were adjudicated by an independent expert review committee of medical oncologists and radiologists. The majority of progression events were based on radiological progressions and pain progressions.

As anticipated, the most common adverse reactions consisted of myelosuppression (bone marrow functions, such as lowered platelet count or lowered white blood cell count) and gastrointestinal events, such as nausea, vomiting and diarrhea. These adverse reactions were mostly mild to moderate in severity.

"Based on my almost forty years of experience in developing oncology drugs, I believe satraplatin, with the data demonstrated in this trial, and its oral formulation, could have great potential in several oncology indications. It is the most advanced compound in development for second-line chemotherapy for hormone-refractory prostate cancer, an area for which there are currently no approved therapies," stated Luigi Lenaz, M.D., Chief Scientific Officer of Spectrum Pharmaceuticals, who has been involved with the development of oncology drugs, especially platinum-based chemotherapies, since the 1970s. "If satraplatin is approved, we believe it could improve the lives of thousands of cancer patients each year who currently have no other options."

It is expected that a complete New Drug Application (NDA) will be submitted to the U.S. Food and Drug Administration (FDA) by year-end, and that the European marketing application will be filed in the first half of 2007. Satraplatin has been granted fast track designation from the FDA. If approved, it could be on the market in the U.S. in the second half of 2007.

About Prostate Cancer
Prostate cancer is the most common cancer among men in the U.S. and Europe. Approximately 234,000 men in the U.S. are expected to be diagnosed with the disease in 2006 and more than 27,000 men are expected to die from the disease. In the European Union, over 200,000 new cases are expected to be diagnosed, and more than 60,000 patients are expected to die each year. Since the incidence of prostate cancer increases with age, the aging of the overall population is expected to further increase the number of prostate cancer patients.

Most patients diagnosed with prostate cancer initially receive surgery or radiation therapy, and some of these patients are cured. For many others, though, the disease recurs. Recurrent disease is treated with hormone therapy, and most patients initially respond well to this treatment. Eventually, however, the tumor cells become resistant to the hormones - or "hormone-refractory" - and the tumor again progresses. Increasingly, chemotherapy is being used as an effective first-line treatment for HRPC. However, it is not a cure. Consequently, there is a growing need for effective therapeutic options, such as second-line chemotherapy treatments, for patients once they have progressed.

About Satraplatin
Satraplatin, a fourth-generation, oral investigational drug, is a member of the platinum family of compounds. Over the past three decades, platinum- based drugs have become a critical part of modern chemotherapy treatments and are used to treat a wide variety of cancers. Unlike the platinum drugs currently on the market, all of which require intravenous administration, satraplatin is an oral compound and is given as capsules that patients can take at home.

In addition to HRPC, satraplatin has been studied in clinical trials involving a range of tumors, and Phase 2 trials have been completed in ovarian cancer and small cell lung cancer. Other trials evaluating the effects of satraplatin in combination with radiation therapy, in combination with other cancer therapies and in various other cancers are underway or planned.

Source: Spectrum Pharmaceuticals

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