SOUTH SAN FRANCISCO, Calif., Sept. 4 PoniardPharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused ononcology, today announced that updated results of its Phase 2 clinical trialof picoplatin confirm and extend the previously announced interim dataanalysis, which demonstrated a survival benefit in patients with recurrentsmall cell lung cancer (SCLC) who have relapsed within six months offirst-line therapy. The company also for the first time announced the medianone-year survival rate of 17.6 percent in the Phase 2 population of mostlyplatinum-refractory and -resistant patients studied in this trial.Picoplatin, the Company's lead product candidate, is currently being evaluatedin the pivotal Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse)trial in SCLC, which is being conducted under a Special Protocol Assessment(SPA) agreement with the U.S. Food and Drug Administration (FDA). The SPEARtrial is being conducted in platinum-refractory, -resistant, and -sensitiveSCLC patients who have failed or relapsed from initial therapy within sixmonths of initial treatment and is comparing picoplatin treatment with bestsupportive care to best supportive care alone. The median overall survival isapproximately 17 to 22 weeks for patients with recurrent SCLC who are treatedwith existing second-line chemotherapies, according to the 2007 NationalComprehensive Cancer Network practice guidelines.
"These updated Phase 2 data are consistent with earlier studies ofpicoplatin in this difficult-to-treat patient population and compare favorablywith the median survival for the entire population of relapsed patients whoreceive other second-line chemotherapy," said Jerry McMahon, Ph.D., chairmanand CEO of Poniard. "These results are promising because patients withplatinum-resistant and -refractory small cell lung cancer have very limitedtreatment options. They typically experience rapid disease progression andlow overall survival following treatment with existing chemotherapies, whichhave significant toxicities."
The updated picoplatin Phase 2 data were presented during a posterdiscussion session at the International Association for the Study of LungCancer's (IASLC) 12th World Conference on Lung Cancer in Seoul, Korea.
Additional Phase 2 Study Findings
In addition to the overall and one-year survival findings, the updatedanalysis of results from the open-label, multi-center Phase 2 trial showedthat the disease control rate was 48.1 percent in the 77 evaluable patients.This is similar to that observed with currently available treatments, but witha more manageable side effect profile and less frequent administration. Atthe time of the updated analysis, 63 patients had died from diseaseprogression. The most common side effects were hematologic and includedthrombocytopenia, anemia and neutropenia. No grade 3 or 4 neurotoxicity ornephrotoxicity and no treatment-related deaths occurred.
Pivotal Phase 3 SPEAR Trial Design
Poniard's ongoing international, multi-center, randomized, controlledSPEAR trial is comparing picoplatin plus best supportive care to bestsupportive care alone to evaluate the efficacy of picoplatin after relapse.Best supportive care includes care and treatment to optimize the comfort ofpatients and their ability to function, as well as to minimize the sideeffects of palliative cancer treatments. The primary efficacy endpoint isoverall survival, with overall response rates, progression-free survival anddisease control also being evaluated. The trial, which is enrolling patientswho are refractory to, or who have progressed within six months of completing,treatment with first-line platinum chemotherapy (cisplatin or carboplatin), isbeing conducted at clinical sites in Europe and India.
"Since the initiation of the SPEAR trial in the second quarter of 2007, wehave made significant progress in open