Poniard Announces Positive First-Line Efficacy and Safety Data From Ongoing Phase 2 Trial of Picoplatin in Patients with Metastatic Hormone Refractory Prostate Cancer
The Company presented the Phase 2 data (abstract #5153) in the GeneralPoster Session during the 44th Annual Meeting of the American Society ofClinical Oncology (ASCO) at McCormick Place in Chicago. Picoplatin, theCompany's lead product candidate, is a new generation platinum chemotherapyagent with the potential to become a platform product addressing multipleindications, combinations and formulations.
"The promising results of this Phase 2 trial in HRPC support furtherdevelopment of picoplatin in the treatment of prostate cancer," said Robert DeJager, M.D., chief medical officer of Poniard. "A prospective randomized trialis under consideration. The combination of picoplatin with a taxane could befurther evaluated in other tumor types, such as ovarian cancer and non-smallcell lung cancer."
Phase 2 HRPC Study Preliminary Results
In the ongoing Phase 2 trial, the efficacy and safety of intravenouspicoplatin (120 mg/m squared) administered every 21 days in combination withfull-dose docetaxel (75 mg/m squared) with daily prednisone (5 mg) as afirst-line treatment is being evaluated in 30 patients with metastatic HRPC.PSA response (defined as a PSA reduction of at least 50 percent from baseline)is the primary endpoint; secondary endpoints include safety, response rate,time to progression and overall survival. The trial completed enrollment inDecember 2007.
Results to date have shown a PSA response in 18 of 26 (69 percent)evaluable patients. Furthermore, PSA levels have normalized in six patients(21 percent). The combination of picoplatin and docetaxel can be safelyadministered with manageable and reversible neutropenia as the mainhematologic toxicity. These data confirm earlier results observed in the Phase1 trial. In contrast to picoplatin monotherapy, thrombocytopenia was lesssevere and less frequent. Neurotoxicity has not been observed in this study.
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 ongoing Phase 2 clinical trial in HRPC, Poniard isevaluating intravenous picoplatin in an ongoing pivotal Phase 3 trial, knownas SPEAR (Study of Picoplatin Efficacy After Relapse), in small cell lungcancer. This registration trial currently is being conducted under a SpecialProtocol Assessment (SPA) from the U.S. Food and Drug Administration and isevaluating overall survival as the primary endpoint. Picoplatin is also beingevaluated in an ongoing Phase 2 clinical trial in patients with metastaticcolorectal cancer. Oral picoplatin is being evaluated in a Phase 1 clinicaltrial in solid tumors. The oral formulation of picoplatin has the same activepharmaceutical ingredient as the intravenous formulation. Picoplatin has notbeen approved by any regulatory authority for use in humans.
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