Poniard Pharmaceuticals Announces Picoplatin Abstract Accepted for Publication by ASCO's 2007 Prostate Cancer SymposiumCompany Provides Clinical Development Update for Picoplatin in Hormone- Refractory Prostate Cancer
SOUTH SAN FRANCISCO, Calif., Feb. 22 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. , a biopharmaceutical company focused on oncology, today announced that an abstract on picoplatin, the Company's lead product candidate, has been selected for publication by the 2007 Prostate Cancer Symposium, a meeting of the American Society of Clinical Oncology (ASCO), which is being held February 22, 2007-24 in Orlando, Fla. The abstract includes data from an ongoing Phase 1/2 study of picoplatin and docetaxel (Taxotere(R)) in chemotherapy-naive patients with metastatic hormone- refractory prostate cancer (HRPC). The Company also announced an update on its clinical development plans for picoplatin in HRPC.
"Preliminary results from our ongoing Phase 1/2 trial suggest that picoplatin has better tolerability than expected when combined with docetaxel in HRPC patients. The positive safety profile we are seeing to date reinforces our confidence in picoplatin and its potential for use in other solid tumor indications for which taxane combinations are the standard of care, including non-small cell lung, bladder and ovarian cancers," said Jerry McMahon, Ph.D., chairman, president and CEO of Poniard. "We are working to determine the optimal dose of picoplatin to evaluate in combination with docetaxel in the Phase 2 component of our trial, and hope that combining the two treatments will lead to improved clinical benefit for patients."
Poniard initiated the Phase 1/2 clinical trial evaluating picoplatin for the first-line treatment of metastatic HRPC in May 2006. The multi-center study is evaluating picoplatin as first-line therapy in the treatment of patients with stage IV (metastatic) HRPC who have not received previous chemotherapy. The trial is designed to determine the safety and efficacy of picoplatin when administered every three weeks with docetaxel. The Company expects to complete the Phase 1 dose-finding component of the trial and initiate the Phase 2 efficacy determination component in the first half of 2007. Additional data from this study are expected to be announced in mid- 2007.
Results from a previous Phase 2 study that administered picoplatin as a single agent as first-line treatment of metastatic HRPC demonstrated evidence of activity, including measurable responses. Results from that study, which was conducted by Chris Tyrrell, M.D., of Plymouth Oncology Centre in Plymouth, U.K., were published as an abstract in the Proceedings of the 2002 ASCO Annual Meeting. Updated results from the Tyrrell study showed that of 20 patients evaluable for response, four patients (20 percent) experienced a partial response, one patient experienced an unconfirmed partial response, five patients (25 percent) had stable disease, eight patients (40 percent) had disease progression and two patients who received only one cycle of treatment were non-evaluable for response. Of the four patients with a partial response, three achieved a prostate-specific antigen (PSA) response (>50 percent reduction in PSA level). The remaining patient with a partial response had a 42 percent reduction in PSA level. Results from that study also demonstrated manageable toxicity and no clinically significant nephro-, neuro- or ototoxicities. In addition, results from an earlier Phase 1 study indicated that picoplatin can be combined safely with taxanes, such as docetaxel or paclitaxel, for the treatment of solid tumors.
"If determined to be safe and effective, picoplatin may become the first platinum approved for use in combination with docetaxel to treat patients with HRPC," said David A. Karlin, M.D., senior vice president of clinical development and regulatory affairs of Poniard. "This could be of great benefit to HRPC patients, for whom docetaxel is the current standard of care. Not only may the combination of picoplatin plus docetaxel be more effective than either docetaxel or picoplatin alone, but the use of picoplatin as a front-line treatment for HRPC potentially could reduce the likelihood of chemoresistance."
Picoplatin is a new generation platinum therapy with an improved safety profile. It is designed to overcome and prevent platinum resistance associated with chemotherapy in solid tumors. In addition to HRPC, Poniard is evaluating picoplatin in an ongoing Phase 2 clinical trial in small cell lung cancer (SCLC) and in a Phase 1/2 clinical trial in colorectal cancer. The Company plans to initiate the pivotal Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) trial of picoplatin for the treatment of SCLC in the first half of 2007.
Poniard received orphan drug designation from the FDA in November 2005 for picoplatin for the treatment of SCLC and entered into a Special Protocol Assessment (SPA) agreement with the FDA in January 2007 for the SPEAR trial.
About Prostate Cancer
Prostate cancer is the most common type of cancer in men in the United States, apart from skin cancer, and the third leading cause of cancer death in men. An estimated 219,000 new cases will occur in the United States in 2007, and about 27,000 men will die of the disease, according to the American Cancer Society. In Europe, there are approximately 225,000 prostate cancer cases and 83,000 deaths annually, according to the International Agency for Research on Cancer's GLOBOCAN 2002 database.
Prostate tumors that have stopped responding to or are growing despite the use of active hormone treatment strategies are characterized as hormone- refractory. At that point, other options, such as chemotherapy, are often considered. Docetaxel, in combination with prednisone, was approved by the FDA in 2004 for the treatment of patients with metastatic HRPC. The majority (more than 80 percent) of newly diagnosed stage IV patients who fail hormone therapy are currently treated with docetaxel either alone or in combination. Other options include mitoxantrone, estramustine or prednisone monotherapy as second-line treatment.
About Poniard Pharmaceuticals
Poniard Pharmaceuticals, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of innovative oncology products to impact the lives of people with cancer. Picoplatin, the Company's lead 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. Picoplatin is currently being studied in clinical trials for the treatment of small cell lung, colorectal and hormone-refractory prostate cancers. As part of the Company's strategic goal of building a diverse oncology pipeline, the Company is collaborating with The Scripps Research Institute on the discovery of novel, small-molecule, multi-targeted protein kinase inhibitors.
This release contains forward-looking statements, including statements regarding the Company's business model, drug development plans, clinical trial results 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 research, development, clinical trials, results of later clinical testing, receipt of regulatory approvals, anticipated operating losses, future capital needs, availability of additional financing, competition, intellectual property, dependence on third-party manufacturers, suppliers and collaborators, lack of sales and marketing experience, loss of key personnel, market acceptance, technology change, 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, 2005, and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2006. 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.
NOTE: (C) 2007 Poniard Pharmaceuticals, Inc. All Rights Reserved.
Poniard and Poniard Pharmaceuticals are trademarks of Poniard Pharmaceuticals, Inc.
Posted: February 2007