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Poniard Pharmaceuticals Announces Positive Efficacy and Safety Data From Phase 2 Clinical Trial of Picoplatin in Men With Metastatic Prostate Cancer
Thursday, May 28, 2009 8:01 AM


- New Progression-Free Survival Data To Be Presented at 2009 ASCO Annual Meeting Support Further Clinical Development of Picoplatin in Combination with Docetaxel/Prednisone as First-Line Therapy for Metastatic Castration-Resistant Prostate Cancer -

- Poniard Management Team to Host Analyst and Investor Briefing to Discuss Data on Sunday, May 31st -

SOUTH SAN FRANCISCO, Calif., May 28 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on innovative oncology therapies, today announced updated efficacy and safety data from its Phase 2 clinical trial of picoplatin in patients with metastatic castration-resistant (hormone-refractory) prostate cancer (CRPC). The data demonstrate that picoplatin in combination with docetaxel and prednisone is active as first-line therapy for metastatic CRPC. This was demonstrated by several endpoints, including reductions in prostate specific antigen (PSA) levels, disease control as measured by tumor response, and progression-free survival (PFS). Results also continue to show that picoplatin can be safely administered every three weeks for up to 10 cycles concurrently with full doses of docetaxel and prednisone, the standard treatment for CRPC. In addition, no neurotoxicity was observed in these patients.

'The PSA response, disease control and PFS in this Phase 2 trial are encouraging and suggest that picoplatin in combination with docetaxel and prednisone is active as first-line therapy for CPRC,' said William K. Oh, M.D., clinical director of the Lank Center for Genitourinary Oncology at the Dana Farber Cancer Institute and associate professor, Harvard Medical School. 'There is no platinum-based chemotherapy approved for use in the treatment of prostate cancer. I believe these results to date support the further development of picoplatin in combination with docetaxel and prednisone as a first-line chemotherapy regimen for metastatic CRPC, which no longer responds to hormonal therapies and for which there are limited therapeutic choices.'

Picoplatin, the Company's lead product candidate, is a new generation platinum-based chemotherapy agent. Clinical studies to date suggest that picoplatin has an improved safety profile. It is in clinical development for multiple indications, combinations and formulations. The picoplatin CRPC data will be presented at the American Society of Clinical Oncology's (ASCO) 2009 Annual Meeting in Orlando, Fla., during the General Poster Session on Sunday, May 31, from 2:00 p.m. to 6:00 p.m. Eastern Time (abstract #5140).

Phase 2 CRPC Trial Design and Updated Results

The Phase 2 trial evaluated the efficacy and safety of intravenous picoplatin (120 mg/meter squared) administered every three weeks in combination with full doses of docetaxel (75 mg/meter squared) with daily prednisone (5 mg) as a first-line treatment in 32 patients with metastatic CRPC who have not received prior chemotherapy. PSA response (defined as a PSA reduction of at least 50 percent from baseline maintained for at least four weeks) is the primary endpoint. Secondary endpoints include duration of PSA response, time to progression, radiologic response, survival and safety.

The Phase 2 data, scheduled for presentation at the ASCO Annual Meeting, demonstrated that:

  • PSA response was achieved in 78 percent of evaluable patients.


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