- Significant clinical progress noted in small cell lung, prostate and
colorectal cancer trials -
SOUTH SAN FRANCISCO, Calif., Nov. 27 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on oncology, today provided an update of its picoplatin development program in small cell lung cancer (SCLC), colorectal cancer (CRC) and hormone refractory prostate cancer (HRPC), and its oral formulation in solid tumors. Presenting at the Lazard Capital Markets Healthcare Conference in New York, Jerry McMahon, Ph.D., chairman and CEO of Poniard, noted that the Company has made significant progress in 2007 in its clinical development program for picoplatin, its lead product candidate.
"2007 has been an important year for Poniard, as we have continued to advance our development of picoplatin, a new generation chemotherapy agent with the potential to become a platform product addressing multiple indications, combinations and formulations," said Dr. McMahon. "We continue to drive our clinical programs toward completion and have achieved significant milestones this year. In addition, we remain on track to file our NDA for picoplatin in 2009."
Poniard is providing an update on the progress on all four of its picoplatin clinical trials, as follows:
Phase 3 SPEAR Trial:
Poniard is evaluating intravenous picoplatin in an ongoing pivotal Phase 3 trial, known as SPEAR (Study of Picoplatin Efficacy After Relapse), in SCLC. This registrational trial is being conducted under a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA) and is evaluating overall survival as the primary endpoint.
To date, 73 of the approximately 100 clinical sites in the SPEAR study are active, and the balance of sites is to be opened as planned. Based on recent enrollment data, Poniard estimates that it will complete enrollment in 3Q 2008.
Poniard continues to anticipate filing a New Drug Application with the FDA in 2009. The Company received fast track designation from the FDA for picoplatin for the second-line treatment of refractory or resistant SCLC, allowing a rolling NDA submission.
"We are encouraged by the enrollment pace at our sites that have been open for three months or more, because these are enrolling patients better than at the anticipated rate," added Dr. McMahon. "Based on our prior trial in SCLC, and our experience at many of our active SPEAR sites, we anticipate an acceleration of enrollment as more sites are open longer and new sites are opened. In addition to patients that have already enrolled, we are following approximately 200 additional SCLC patients currently receiving first-line treatment who may be eligible to participate in the SPEAR trial."
Phase 2 CRC Trial:
Poniard is also evaluating intravenous picoplatin as a replacement for oxaliplatin in an ongoing Phase 2 trial for the first-line treatment of metastatic CRC with picoplatin in combination with 5-fluorouracil and leucovorin, or FOLPI, compared to the standard-of-care FOLFOX regimen, including oxaliplatin, in a 100-patient randomized trial.
The Company has opened 18 of the planned 23 clinical sites and is enrolling patients in this randomized trial, which is evaluating picoplatin as a first-line agent in CRC. The Company is treating patients in the trial and expects to fully enroll the trial in the first half of 2008. Poniard expects to present clinical data from the Phase 1 and Phase 2 CRC trials at scientific meetings throughout 2008.
Phase 2 HRPC Trial:
Intravenous picoplatin also is under evaluation in an ongoing Phase 2 trial for the treatment of metastatic HRPC in combination with full-dose docetaxel (Taxotere(R)) and prednisone. The Company continues to expect to fully enroll this trial by the end of 2007. The Company expects to present clinical data from the Phase 1 and Phase 2 HRPC trials at scientific meetings throughout 2008.
Phase 1 Oral Picoplatin Trial:
An oral formulation of picoplatin is being evaluated in an ongoing Phase 1 clinical trial in solid tumors. Poniard has completed the planned enrollment of the planned dose levels and has expanded the enrollment to include additional testing of various dose levels to provide additional data to support further development. This Phase 1 study compares the bioavailability, pharmacokinetics, pharmacodynamics and safety of picoplatin administered orally with picoplatin administered intravenously in patients with advanced solid tumor malignancies. The company plans to present data from the Phase 1 trial at scientific meetings in 2008.
Lazard Presentation and Webcast Information
Dr. McMahon will present at the Lazard Capital Markets Fourth Annual Healthcare Conference today at 9:30 a.m. Eastern Time at The New York Palace Hotel. A live audio webcast of the presentation will be available for 10 business days on the "Events" page of the "News & Events" section of the Company's website at http://www.poniard.com.
Picoplatin is a new generation platinum chemotherapy agent with the potential to become a platform product addressing multiple indications, combinations and formulations. Picoplatin has an improved safety profile compared to existing platinum-based chemotherapeutics and was designed to overcome platinum resistance. Picoplatin has been evaluated in more than 750 patients and has demonstrated activity in multiple indications with no evidence of significant kidney, nerve toxicity and hearing loss. The Company is evaluating picoplatin in four different areas: (1) as a second-line agent for use in patients who are resistant or refractory to currently available platinums, such as SCLC, (2) as a first-line treatment in metastatic CRC patients, who cannot tolerate the toxicity profile of currently marketed platinums, (3) as an agent for use in combination chemotherapeutic regimens where platinums are currently not used, such as in the first line treatment of HRPC patients, and (4) as an oral formulation of picoplatin to provide additional convenience to patients and potential new uses in combination with orally administered cancer therapeutics.
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. For additional information please visit http://www.poniard.com.
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.
(C) 2007 Poniard Pharmaceuticals, Inc. All Rights Reserved.
Poniard and Poniard Pharmaceuticals are trademarks of Poniard Pharmaceuticals, Inc.
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