logo


Poniard Pharmaceuticals Announces Progression-Free Survival Data From Phase 2 Clinical Trial of Picoplatin in Metastatic Colorectal Cancer
Thursday, May 28, 2009 8:03 AM


- New Progression-Free Survival, Disease Control and Neurotoxicity Data To Be Presented at 2009 ASCO Annual Meeting Continue to Support Picoplatin as a Neuropathy-Sparing Alternative to Oxaliplatin for First-Line Treatment of Colorectal 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 clinical data from its randomized, controlled Phase 2 trial of picoplatin in patients with metastatic colorectal cancer (CRC). The new data demonstrated that picoplatin, given once every four weeks in combination with 5-fluorouracil and leucovorin in the FOLPI regimen, and oxaliplatin, given in combination with 5-fluorouracil and leucovorin in the modified FOLFOX-6 regimen, have similar anti-tumor activity in the treatment of first-line metastatic CRC, as assessed by progression-free survival (PFS) and disease control measured by tumor response rate. New data derived by three independent assessments of neurotoxicity indicated a statistically significant reduction in neurotoxicities with the use of picoplatin in FOLPI compared with oxaliplatin in FOLFOX (p<0.0019).

'Oxaliplatin given as part of the FOLFOX-based regimen is the current standard of care for metastatic colorectal cancer, but is associated with severe neuropathy at increasing cumulative doses approaching 800 mg/meter squared. This significant side effect may cause patients extreme pain, numbness and weakness, which is often long-lasting and, in many cases, requires patients to discontinue treatment,' said Richard Goldberg, M.D., associate director of clinical research for the University of North Carolina Comprehensive Center and physician-in-chief of the N.C. Cancer Hospital. Dr. Goldberg also is a member of Poniard's Clinical Advisory Board. 'I am encouraged that the Phase 2 data continue to suggest that picoplatin is an active platinum agent in patients with advanced colorectal cancer with comparable clinical benefit to oxaliplatin but with significantly less neurotoxicity.'

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 and combinations and in two formulations. The picoplatin CRC data will be presented at the American Society of Clinical Oncology's 2009 Annual Meeting in Orlando, Fla., during the General Poster Session on Monday, June 1, from 8:00 a.m. to noon Eastern Time (abstract #4026) in W240A, Level 2, with a discussion of the poster scheduled from 11:30 a.m. to 11:45 a.m. in West Hall E1, Level 2.

Phase 2 CRC Trial Design and Updated Results

The randomized, controlled Phase 2 trial is evaluating picoplatin as a neuropathy-sparing alternative to oxaliplatin for the first-line treatment of metastatic CRC in 101 patients who have not received prior chemotherapy. The trial is comparing the safety and efficacy (assessed by objective tumor response, PFS and overall survival) of intravenous picoplatin given once every four weeks in combination with bi-weekly 5-fluorouracil and leucovorin (the FOLPI regimen) with oxaliplatin given in combination with 5-fluorouracil and leucovorin in the FOLFOX regimen.



(0)
No Comments
Post Comment
Name:  
Alert for new comments:
Your email:
Your Website:
Title:
Comments:
   
 
 
 
 
   
 

  
Related Press Releases
Advertisement
Popular Articles
Advertisement
Partner Center
Fundamental data is provided by Zacks Investment Research, market data is provided by AlphaTrade. , and Commentary and Press Releases provided by Quotemedia