SOUTH SAN FRANCISCO, Calif. and GENEVA, Oct. 22 Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical companyfocused on oncology, today announced positive incremental data from itsrandomized, controlled Phase 2 clinical trial of picoplatin in patients withmetastatic colorectal cancer (CRC). The expanded and updated results continueto indicate that picoplatin, given once every four weeks in combination with5-fluorouracil and leucovorin (FOLPI), is associated with less frequent andsevere neurotoxicity than oxaliplatin given in combination with 5-fluorouraciland leucovorin in the modified FOLFOX-6 regimen (FOLFOX). In addition, resultscontinue to suggest that both regimens have similar anti-tumor activity infirst-line metastatic CRC.
"Picoplatin appears to be an active platinum in colorectal cancer withoutthe neurotoxicity of the other active platinum agents," said Richard Goldberg,M.D., associate director of clinical research for the University of NorthCarolina Comprehensive Center and physician-in-chief of the N.C. CancerHospital. Dr. Goldberg also is a member of Poniard's Clinical Advisory Board."These early results may support a Phase 3 trial."
The data were presented in a poster session (abstract #210/poster #210)during the 20th EORTC-NCI-AACR Symposium on "Molecular Targets and Cancer" inGeneva, Switzerland. Picoplatin, the Company's lead product candidate, is anew generation platinum chemotherapy agent with the potential to become aplatform product addressing multiple indications, combinations andformulations for the treatment of multiple solid tumor indications.
Phase 2 CRC Trial Design and Preliminary Results
The randomized, controlled, Phase 2 study enrolled 101 patients who hadnot received prior chemotherapy. The trial is comparing the safety andefficacy of intravenous picoplatin given once every four weeks in combinationwith bi-weekly 5-fluorouracil and leucovorin (the FOLPI regimen) withoxaliplatin given in combination with 5-fluorouracil and leucovorin in theFOLFOX regimen, which is the current standard of care. Severe neuropathy iscommonly seen in CRC patients treated with oxaliplatin in combination with5-fluorouracil and leucovorin as part of the FOLFOX regimen at cumulativedoses above 800 mg/m squared.
Interim Phase 2 results presented at the Symposium showed that 65 percentof 37 evaluable FOLFOX-treated patients showed evidence of neurotoxicity with5 percent of these patients exhibiting severe Grade 3 or 4 neurotoxicities.This is in contrast to 18 percent of 34 evaluable patients treated with FOLPIwho exhibited resolvable low-grade (Grade 2 or lower) neurotoxicities. Inaddition, the FOLPI-treated patients did not show any severe Grade 3 or 4neurotoxicities. Nephrotoxicities and ototoxicities were rare and mild withthe FOLPI regimen.
Non-neurologic tolerability was similar between the two treatment groups.Acute gastrointestinal toxicity was similar in the two groups, whilethrombocytopenia and neutropenia were more frequent and severe in the FOLPI-treated patients, but considered to be manageable. These findings confirm andextend earlier results presented at the 44th Annual Meeting of the AmericanSociety of Clinical Oncology in May.
Anti-tumor activity also was found to be similar in the FOLPI and FOLFOXgroups. Of the 35 evaluable patients in the FOLPI arm, 20 achieved diseasecontrol (partial response combined with stable disease), including six withpartial responses (or 17 percent of evaluable patients). Fifteen patients inthe FOLPI arm were not evaluable or too early to evaluate. Of 51 patients inthe FOLFOX arm, 23 achieved disease control, including five with partialresponses (or 13 percent of evaluable patients). Nine patients in the FOLFOXarm were either not evaluable or too early to evaluate.
"These interim, proof-of-concept Phase 2 colorectal cancer study resultsare encouraging and continue to suggest the potential of picoplatin as aneuropathy-sparing first-line therapy for metastatic colorectal cancer," saidRobert De Jager, M.D., chief medical officer of Poniard. "We are committed todeveloping picoplatin as a preferred platinum therapy for patients withmetastatic colorectal cancer who cannot tolerate the toxicity profile ofcurrently marketed platinums, and we are optimistic that the additional datafrom this trial support that strategy. We are continuing to observe the studypopulation in order to obtain progression-free and overall survival data,potentially supporting the future development of picoplatin."
Picoplatin has an improved safety profile relative to existingplatinum-based cancer therapies and is designed to overcome platinumresistance associated with chemotherapy in solid tumors. It is being studiedin multiple cancer indications, combinations and formulations. Picoplatin hasbeen evaluated in more than 750 patients and has demonstrated anti-tumoractivity in multiple indications with less severe kidney toxicity(nephrotoxicity) and nerve toxicity (neurotoxicity) than is commonly observedwith other platinum chemotherapy drugs.
In addition to the Phase 2 clinical trial in CRC, Poniard is evaluatingintravenous picoplatin in an ongoing pivotal Phase 3 trial, known as SPEAR(Study of Picoplatin Efficacy After Relapse), in small cell lung cancer. Thisregistration trial currently is being conducted under a Special ProtocolAssessment (SPA) from the U.S. Food and Drug Administration and is evaluatingoverall survival as the primary endpoint. Picoplatin is also being evaluatedin an ongoing Phase 2 clinical trial in patients with metastatichormone-refractory prostate cancer. Oral picoplatin is being evaluated in aPhase 1 clinical trial in solid tumors. The oral formulation of picoplatin hasthe same active pharmaceutical ingredient as the intravenous formulation.Picoplatin has not been approved by any regulatory authority for use inhumans.
About Poniard Pharmaceuticals
Poniard Pharmaceuticals, Inc. is a biopharmaceutical company focused onthe development and commercialization of innovative oncology products toimpact the lives of people with cancer. For additional information pleasevisit http://www.poniard.com.
This release contains forward-looking statements, including statementsregarding the Company's business objectives and strategic goals, drugdevelopment plans, timing and results of clinical trials and the potentialsafety and efficacy of its products in development. The Company's actualresults may differ materially from those indicated in these forward-lookingstatements based on a number of factors, including risks and uncertaintiesassociated with the Company's research and development activities; the resultsof pre-clinical and clinical testing; the receipt and timing of requiredregulatory approvals; the market's acceptance of the Company's proposedproducts; the Company's anticipated operating losses, need for future capitaland ability to obtain future funding; competition from third parties; theCompany's ability to preserve and protect intellectual property rights; theCompany's dependence on third-party manufacturers and suppliers; the Company'slack of sales and marketing experience; the Company's ability to attract andretain key personnel; changes in technology, government regulation and generalmarket conditions; and the risks and uncertainties described in the Company'scurrent and periodic reports filed with the Securities and Exchange Commission(SEC), including the Company's Annual Report on Form 10-K for the year endedDecember 31, 2007 and its Quarterly Report on Form 10-Q for the period endedJune 30, 2008. Readers are cautioned not to place undue reliance on theseforward-looking statements, which speak only as of the date of this release.The Company undertakes no obligation to update any forward-looking statementto reflect new information, events or circumstances after the date of thisrelease or to reflect the occurrence of unanticipated events.
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