Poniard Pharmaceuticals Announces Positive Preliminary Bioavailability Data From Ongoing Phase 1 Trial of Oral Picoplatin in Patients With Solid Tumors
SOUTH SAN FRANCISCO, Calif., November 06, 2007 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. , a biopharmaceutical company focused on oncology, today announced preliminary data from an ongoing Phase 1 clinical trial of oral picoplatin in patients with advanced cancer. These initial results showed that picoplatin can achieve oral bioavailability of 30 to 40 percent in doses tested, which is consistent with earlier preclinical oral bioavailability studies. Picoplatin, the Company's lead product candidate, is a new generation platinum chemotherapy agent with the potential to become a platform product addressing multiple indications, combinations and formulations.
"We are very encouraged by these initial oral bioavailability results because they support further clinical development of oral picoplatin," said Jerry McMahon, Ph.D., chairman and CEO of Poniard. "Our progress with the intravenous formulation of picoplatin also suggests potential for an oral formulation of the same chemical entity delivered by the oral route. We plan to develop oral picoplatin as a distinct product opportunity for multiple tumor indications. We believe there is a significant unmet need for improved platinum therapies and that oral platinum-based chemotherapeutics, such as picoplatin, have the potential for use in new indications and in novel combinations with other orally administered cancer treatments or radiation therapy. Oral picoplatin may potentially offer flexible dosing that may optimize safety and efficacy as well as to provide more convenience to patients."
In preclinical studies, picoplatin has been shown to have up to 40 percent oral bioavailability. Picoplatin also has been demonstrated in preclinical studies to have a higher therapeutic index and higher efficacy against platinum-sensitive and -resistant tumor variants than those of currently marketed platinum-based therapeutics. The oral formulation of picoplatin has the same active pharmaceutical ingredient as the intravenous formulation.
The ongoing Phase 1, randomized, open-label, dose-ranging study is comparing the bioavailability, pharmacokinetics, pharmacodynamics and safety of picoplatin administered orally with picoplatin administered intravenously in patients with advanced solid tumor malignancies. Bioavailability refers to the fraction of an administered dose of an unchanged drug that reaches systemic circulation. The trial is being conducted at clinical sites in the United States. The Company plans to present data from the Phase 1 trial at scientific meetings in 2008.
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 small cell lung cancer (SCLC), (2) as a first-line treatment in metastatic colorectal cancer (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 hormone-refractory prostate cancer (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.
Poniard is currently 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. Intravenous picoplatin is also under evaluation in two Phase 2 trials: an ongoing Phase 2 trial for first line treatment of metastatic CRC in combination with 5-flurouracil and leucovorin, and an ongoing Phase 2 trial for the treatment of metastatic HRPC in combination with docetaxel (Taxotere(R)) and prednisone. In addition, the oral formulation of 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 two Phase 2 trials, in metastatic colorectal and hormone- refractory prostate cancers, as well as a Phase 1 clinical trial of oral picoplatin in solid tumors.
This release contains forward-looking statements, including statements regarding the Company's business objectives and strategic goals, drug development plans, and the 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.
Posted: November 2007