Poniard Pharmaceuticals Announces Positive First-line Phase 1 Safety and Efficacy Data With Picoplatin in Metastatic Prostate Cancer Patients
SOUTH SAN FRANCISCO, Calif., February 15, 2008 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. , a biopharmaceutical company focused on oncology, today announced that it is presenting safety and efficacy data in prostate cancer patients from its Phase 1 study of picoplatin, the Company's lead product candidate, at the 2008 Genitourinary (GU) Cancers Symposium, a meeting of the American Society of Clinical Oncology (ASCO) that is being held in San Francisco.
The poster presentation includes safety and efficacy data from a dose-escalating Phase 1 study of picoplatin in combination with full-dose docetaxel (75 mg/m squared) with prednisone as a first-line treatment for metastatic hormone refractory prostate cancer (mHRPC). The Phase 1 study sought to establish the maximum tolerated dose of picoplatin and provide information on the safety and efficacy of picoplatin in combination with docetaxel and prednisone, the standard of care for the first-line treatment of mHRPC.
"The data we have generated with picoplatin in prostate cancer indicate a PSA (prostate specific antigen) response of 65 percent which suggests an improvement compared to docetaxel therapy alone," said Jerry McMahon, Ph.D., chairman and CEO of Poniard Pharmaceuticals. "In addition, the tolerability of picoplatin with full-dose docetaxel supports our ongoing Phase 2 study that we believe will confirm and extend these initial findings. The combination of platinums and taxanes, such as docetaxel, is used to treat many other solid tumors, such as non-small cell and ovarian cancers. We believe that our data support additional evaluation of picoplatin and docetaxel combinations in these cancers in addition to prostate cancer."
In the combination Phase 1 dose-escalating study, 33 patients were treated with one of four doses (60, 80, 100 or 120 mg/m squared) of picoplatin, as well as either 60 mg/m squared or 75 mg/m squared (full-dose) docetaxel plus 5 mg prednisone twice daily. Nine patients received 120 mg/m squared picoplatin and 75 mg/m squared docetaxel every 21 days plus 5 mg prednisone twice daily. This dose, which is also the dose currently under study in the Phase 2 trial, was well tolerated.
Hematological toxicity, including neutropenia, anemia and thrombocytopenia, was dose-dependent and reversible. Neutropenia was the dose-limiting toxicity (DLT). Mild neuropathy (grade 1) was observed in 3 of 33 patients (9 percent) and was unrelated to cumulative picoplatin dose. Neuropathy was infrequent, and no neuropathy of grade 2 or greater was observed. PSA response rate was 65 percent (20 of 31 evaluable patients). Survival data are not yet available. Patient withdrawal from study treatment occurred from death in four patients, progressive disease in eight patients, and withdrawal of consent in one patient. Patients in the Phase 1 trial received a median number of 7 cycles, and 13 of 33 patients completed the maximum of 10 cycles of treatment according to the study protocol.
Based on safety and efficacy data from the Phase 1 study, the recommended Phase 2 regimen of intravenous picoplatin (120 mg/m squared) and docetaxel (75 mg/m squared) every 21 days with prednisone (5 mg) orally twice daily is being evaluated in a Phase 2 study in chemotherapy naive mHRPC patients. PSA response is the primary endpoint; secondary endpoints include radiological response using RECIST criteria, time to progression and survival (1-year, progression-free and overall). The Phase 2 trial completed enrollment in December 2007. The Company expects to present the results of this study in scientific forums later this year.
Picoplatin is an intravenous chemotherapeutic agent that has an improved safety profile compared to existing platinum-based chemotherapeutics. It was designed to overcome platinum resistance associated with the treatment of solid tumors. Picoplatin has been evaluated in more than 800 patients and has demonstrated activity in multiple indications with no evidence of significant kidney, nerve toxicity or hearing loss, toxicities commonly observed with other platinum chemotherapy drugs.
In addition to the Phase 2 clinical trial in patients with mHRPC, Poniard is evaluating intravenous picoplatin in an ongoing pivotal Phase 3 trial, known as SPEAR (Study of Picoplatin Efficacy After Relapse), in small cell lung cancer. This registrational trial is being conducted under a Special Protocol Assessment from the U.S. Food and Drug Administration and is evaluating overall survival as the primary endpoint. The Company also is evaluating intravenous picoplatin in an ongoing Phase 2 clinical trial for the treatment of colorectal cancer. Oral picoplatin is being evaluated in a Phase 1 clinical trial in solid tumors.
About Poniard Pharmaceuticals
Poniard Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative oncology products to impact the lives of people with cancer. Picoplatin, the Company's lead platform product candidate, is a new generation platinum therapy with an improved safety profile. Picoplatin is designed to overcome and prevent platinum resistance associated with chemotherapy in solid tumors, and is being studied in multiple cancer indications, combinations and formulations. Clinical trials of intravenous picoplatin include a Phase 3 trial in small cell lung cancer and Phase 2 trials in metastatic colorectal and hormone-refractory prostate cancer, as well as a clinical trial of oral picoplatin in solid tumors. Picoplatin has not been approved by regulatory authority for use in humans.
This release contains forward-looking statements, including statements regarding the Company's business objectives and strategic goals, drug development plans, results of clinical trials and the potential safety and efficacy of its products in development. The Company's actual results may differ materially from those indicated in these forward-looking statements based on a number of factors, including risks and uncertainties associated with the Company's research and development activities; the results of pre-clinical and clinical testing; the receipt and timing of required regulatory approvals; the market's acceptance of the Company's proposed products; the Company's anticipated operating losses, need for future capital and ability to obtain future funding; competition from third parties; the Company's ability to preserve and protect intellectual property rights; the Company's dependence on third-party manufacturers and suppliers; the Company's lack of sales and marketing experience; the Company's ability to attract and retain key personnel; changes in technology, government regulation and general market conditions; and the risks and uncertainties described in the Company's current and periodic reports filed with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K for the year ended December 31, 2006, as amended, and most current Quarterly Report on Form 10-Q. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to update any forward-looking statement to reflect new information, events or circumstances after the date of this release or to reflect the occurrence of unanticipated events.
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Posted: February 2008