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"Our receipt of fast track designation is the result of our ongoingcommunications with the FDA, and has the potential to accelerate thedevelopment of picoplatin for the treatment of small cell lung cancer, adifficult-to-treat disease, and a patient population with very limitedtreatment options," said Jerry McMahon, Ph.D., chairman and CEO of Poniard."We are focused on executing our ongoing Phase 3 SPEAR trial to facilitate theexpeditious filing of a New Drug Application and obtaining the approvalsrequired to make picoplatin available to this severely underserved patientpopulation."
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About Fast Track Designation
The fast track programs of the FDA are designed to facilitate thedevelopment and expedite the review of drugs and biologics that are intendedto treat serious or life-threatening conditions and that demonstrate thepotential to address unmet medical needs. Fast track designation enables theproduct candidate to become approved and reach the market expeditiously. Thismay include priority review (i.e., six-month versus the standard ten-monthreview) and the option to submit a New Drug Application on a rolling basis,enabling FDA to begin reviewing sections of the application before receivingthe complete application. According to the FDA, picoplatin is eligible forFast Track designation due to the unmet medical need -- with no approvedtherapy for refractory disease, responses seen in two Phase 2 studies, andPoniard's randomized, controlled Phase 3 trial of picoplatin and bestsupportive care (BSC) versus BSC alone.
About Picoplatin
Picoplatin is a new generation platinum chemotherapy agent. It wasdesigned to overcome platinum resistance and to prolong the time to relapseafter chemotherapy in the treatment of solid tumors, and to have an improvedsafety profile compared with existing platinum-based chemotherapeutics.Poniard received orphan drug designation from the FDA in November 2005 forpicoplatin for the treatment of SCLC.
In addition to the SPEAR trial of intravenous picoplatin in SCLC, Poniardis also evaluating intravenous picoplatin in an ongoing Phase 1 clinical trialas a first-line treatment for metastatic colorectal cancer and in an ongoingPhase 2 trial in combination with docetaxel (Taxotere(R)) and prednisone inpatients with metastatic hormone-refractory prostate cancer. Oral picoplatinis being evaluated in a Phase 1 clinical trial in solid tumors.
About Small Cell Lung Cancer
SCLC is the most aggressive and deadly form of lung cancer and accountsfor approximately 20 percent of all lung cancer cases. The current two-yearsurvival rate for patients with extensive SCLC is less than 10 percent withcurrent management options. The estimated incidence of lung cancer in theUnited States in 2006 was 174,500, according to the National
