SOUTH SAN FRANCISCO, Calif., July 31 PoniardPharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused ononcology, today reported on its corporate progress and financial results forthe second quarter ended June 30, 2008.
"Our strategy and focus are to develop picoplatin as an oncology platformcompound addressing multiple indications, combinations and formulations. Ouraccomplishments during the second quarter are consistent with this objective,"said Jerry McMahon, Ph.D., chairman and CEO of Poniard. "We are on track tocommercialize picoplatin for the treatment of small cell lung cancer (SCLC) in2010. We presented data at the American Society of Clinical Oncology (ASCO)Annual Meeting in June, illustrating the platform potential of picoplatin inmultiple solid tumor indications, including metastatic colorectal cancer(CRC), hormone refractory prostate cancer (HRPC) and ovarian cancer. Datafrom these trials could support future trials and may be of significantinterest to potential partners. We are building a comprehensive strategy todirect our clinical development plan for further development of picoplatin ina wide range of tumor types."
-- Small Cell Lung Cancer: Presented final data in April from our Phase 2trial of picoplatin in SCLC at the International Association for the Study ofLung Cancer and the European Society for Medical Oncology's 1st European LungCancer Conference. Final efficacy results confirmed previously announcedinterim results showing median overall survival in the picoplatin Phase 2trial was 27 weeks for platinum-refractory and -resistant SCLC patients, apopulation for which there are very few treatment options.
-- Colorectal Cancer: Completed enrollment in our randomized, controlledPhase 2 trial in patients with CRC and presented positive preliminary resultsfrom this study at ASCO. Preliminary data suggested that picoplatin givenonce every four weeks in combination with 5-fluorouracil and leucovorin in theFOLPI regimen may have similar anti-tumor activity to oxaliplatin incombination with 5-fluorouracil and leucovorin in the FOLFOX regimen, which isthe current standard of care in the first-line treatment of CRC.
We also presented expanded and updated results from our Phase 1dose-escalation study in patients with CRC treated with FOLPI treatmentadministered every two or four weeks. None of the patients treated withpicoplatin at doses of up to a cumulative dose of 1,350 mg/m2 exhibited severeneuropathy (Grade 3 or 4) in 62 evaluable patients. Current use of FOLFOX inCRC patients is associated with substantial neurotoxicity related toincreasing cumulative doses of oxaliplatin at greater than 800 mg/m2. Inaddition, nephrotoxicities and ototoxicities were rare and mild with the FOLPIregimen.
-- Prostate Cancer: Presented preliminary safety and efficacy at ASCO datafrom our ongoing Phase 2 clinical trial of picoplatin in combination withdocetaxel and prednisone, the standard of care for the first-line treatment ofHRPC. Results to date demonstrated that picoplatin can be safely administeredat full-dose docetaxel. Prostate specific antigen levels, or PSA normalizedin 23 percent of patients. The data also demonstrated that reductions in PSAof at least 50 percent were achieved in 69 percent of evaluable patients.This compares favorably to published docetaxel treatment PSA response rates ofapproximately 45 percent.
-- Ovarian and Other Advanced Solid Tumors: Announced positive safety andefficacy data at ASCO from a Phase 1 clinical trial of picoplatin combinedwith liposomal doxorubicin in patients with advanced solid tumors, includingovarian cancer. Results demonstrated robust signals of clinical efficacy inovarian cancer patients and acceptable toxicity with this combination.
-- Oral Picoplatin: Presented results at the Annual Meeting of theAmerican Association for Cancer Rese