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Poniard Pharmaceuticals Reports Second Quarter 2009 Financial Results and Provides a Corporate Update
Tuesday, August 04, 2009 4:01 PM


- Conference Call Today at 4:30 p.m. Eastern Time -

SOUTH SAN FRANCISCO, Calif., Aug. 4 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on oncology, today reported financial results for the second quarter ended June 30, 2009, and provided a corporate update.

"During the American Society of Clinical Oncology Annual Meeting, we reported promising Phase 2 picoplatin data from our colorectal and prostate cancer programs. These data further enhance the value of picoplatin and are playing an important role in our discussions with potential global commercialization and development partners," said Jerry McMahon, Ph.D., chairman and chief executive officer of Poniard. "We remain on track to report results from our pivotal Phase 3 SPEAR trial of picoplatin in small cell lung cancer in the fourth quarter of 2009 with the goal of commercializing picoplatin in 2010."

Recent Clinical and Corporate Developments

Picoplatin Clinical Developments

  • Cardiac Safety Study: Announced results from a cardiac safety study of picoplatin in patients with solid tumors. The study was designed in collaboration with the U.S. Food and Drug Administration (FDA), and evaluated the cardiac safety of picoplatin by determining its effect on the cardiac QT/QTc interval by using time-matched pharmacokinetics and electrocardiograms. A total of 45 patients with advanced solid malignancies received 150 mg/meter squared of picoplatin at seven clinical sites in the United States. Results from the study showed no clinical cardiac-related events. Data from this trial will be incorporated into picoplatin's rolling New Drug Application (NDA) filing, which the Company plans to initiate by the end of this year.

  • Colorectal Cancer (CRC): Presented new progression-free survival (PFS), disease control and neurotoxicity data from a randomized, controlled Phase 2 trial of picoplatin for the first-line treatment of metastatic CRC at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting. The results continue to support picoplatin as a neuropathy-sparing alternative to oxaliplatin with similar anti-tumor activity as assessed by PFS and disease control measured by tumor response rate. New data derived by three independent assessments indicated a statistically significant reduction in neurotoxicities with the use of picoplatin in the FOLPI regimen compared with oxaliplatin in the FOLFOX regimen (p<0.0019).

  • Castration-Resistant Prostate Cancer (CRPC): Presented new progression-free survival data from a Phase 2 clinical trial of picoplatin for the first-line treatment of patients with metastatic CRPC at the 2009 ASCO Annual Meeting. The updated efficacy and safety data demonstrated that picoplatin in combination with docetaxel and prednisone is active as first-line therapy for metastatic CRPC as demonstrated by several endpoints, including reductions in prostate specific antigen (PSA) levels, disease control as measured by tumor response, and 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.

Corporate Developments

  • Announced the appointment of Gary A. Lyons to the Board of Directors in July 2009. His appointment increases the number of directors to 10. Mr. Lyons has been and will continue to serve as a consultant to Poniard on matters of corporate and business development as the Company moves forward with its commercialization and partnering activities for picoplatin.

  • Filed a shelf registration statement that was declared effective by the Securities and Exchange Commission on June 2, 2009. This will allow Poniard from time to time to offer and sell up to $60 million aggregate amount of its common stock and warrants.

Second Quarter 2009 Unaudited Financial Results

The Company reported a net loss of $9.7 million ($0.28 diluted loss per share on a loss applicable to common shares of $9.8 million) for the quarter ended June 30, 2009, compared with a net loss of $12.5 million ($0.36 diluted loss per share on a loss applicable to common shares of $12.7 million) for the quarter ended June 30, 2008.



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