8-K

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934

September 4, 2007

Date of Report (Date of
earliest event reported)

Poniard Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in Charter)

Washington	0-16614	91-1261311
(State or Other Jurisdiction of Incorporation)	(Commission File No.)	(IRS Employer Identification No.)
7000 Shoreline Court, Suite 270, South San Francisco, California		94080
(Address of principal executive offices)		(Zip Code)

(650) 583-3774

(Registrant’s telephone number, including area code)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

o Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Section 8 – Other Events

Item 8.01.Other Events.

On September 4, 2007, the Company announced that updated results of its Phase 2 clinical trial of picoplatin confirm and extend its previously announced interim data analysis, which demonstrated a survival benefit in patients with recurrent small cell lung cancer (SCLC) who have relapsed within six months of first-line therapy. The company also for the first time announced the median one-year survival rate of 17.6 percent in the Phase 2 population of mostly platinum-refractory and -resistant patients studied in this trial.   The updated picoplatin Phase 2 data were presented during a poster discussion session at the International Association for the Study of Lung Cancer’s (IASLC) 12th World Conference on Lung Cancer in Seoul, Korea.  See press release dated September 4, 2007 attached hereto as Exhibit 99.1 and incorporated herein by reference.

On September 5, 2007, the Company announced that it had been granted fast track designation by the U.S. Food and Drug Administration (FDA) for its lead product candidate, picoplatin, for the second-line treatment of refractory or resistant small cell lung cancer (SCLC).  See press release dated September 5, 2007 attached hereto as Exhibit 99.2 and incorporated herein by reference.

Section 9 – Financial Statements and Exhibits

Item 9.01.Financial Statements and Exhibits.

(d)Exhibits.

99.1 – Press release dated September 4, 2007

99.2 – Press release dated September 5, 2007

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	Poniard Pharmaceuticals, Inc.
Dated: September 7, 2007	By:	/s/Anna Lewak Wight
		Name: Anna Lewak Wight
		Title: Vice President, Legal

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EXHIBIT INDEX

Exhibit No.	Description
99.1	Press Release dated September 4, 2007
99.2	Press Release dated September 5, 2007

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EX-99.1

Exhibit 99.1

Poniard Pharmaceuticals Announces Updated Results of Picoplatin Phase 2 Trial Demonstrating
Survival Benefit in Small Cell Lung Cancer Patients

Results Presented at 12th World Conference on Lung Cancer in Seoul

South San Francisco, Calif. (September 4, 2007) – Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on oncology, today announced that updated results of its Phase 2 clinical trial of picoplatin confirm and extend the previously announced interim data analysis, which demonstrated a survival benefit in patients with recurrent small cell lung cancer (SCLC) who have relapsed within six months of first-line therapy. The company also for the first time announced the median one-year survival rate of 17.6 percent in the Phase 2 population of mostly platinum-refractory and - -resistant patients studied in this trial. Picoplatin, the Company’s lead product candidate, is currently being evaluated in the pivotal Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) trial in SCLC, which is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). The SPEAR trial is being conducted in platinum-refractory, -resistant, and -sensitive SCLC patients who have failed or relapsed from initial therapy within six months of initial treatment and is comparing picoplatin treatment with best supportive care to best supportive care alone. The median overall survival is approximately 17 to 22 weeks for patients with recurrent SCLC who are treated with existing second-line chemotherapies, according to the 2007 National Comprehensive Cancer Network practice guidelines.

“These updated Phase 2 data are consistent with earlier studies of picoplatin in this difficult-to-treat patient population and compare favorably with the median survival for the entire population of relapsed patients who receive other second-line chemotherapy,” said Jerry McMahon, Ph.D., chairman and CEO of Poniard. “These results are promising because patients with platinum-resistant and -refractory small cell lung cancer have very limited treatment options. They typically experience rapid disease progression and low overall survival following treatment with existing chemotherapies, which have significant toxicities.”

The updated picoplatin Phase 2 data were presented during a poster discussion session at the International Association for the Study of Lung Cancer’s (IASLC) 12th World Conference on Lung Cancer in Seoul, Korea.

Additional Phase 2 Study Findings

In addition to the overall and one-year survival findings, the updated analysis of results from the open-label, multi-center Phase 2 trial showed that the disease control rate was 48.1 percent in the 77 evaluable patients. This is similar to that observed with currently available treatments, but with a more manageable side effect profile and less frequent administration. At the time of the updated analysis, 63 patients had died from disease progression. The most common side effects were hematologic and included thrombocytopenia, anemia and neutropenia. No grade 3 or 4 neurotoxicity or nephrotoxicity and no treatment-related deaths occurred.

Pivotal Phase 3 SPEAR Trial Design

Poniard’s ongoing international, multi-center, randomized, controlled SPEAR trial is comparing picoplatin plus best supportive care to best supportive care alone to evaluate the efficacy of picoplatin after relapse. Best supportive care includes care and treatment to optimize the

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comfort of patients and their ability to function, as well as to minimize the side effects of palliative cancer treatments. The primary efficacy endpoint is overall survival, with overall response rates, progression-free survival and disease control also being evaluated. The trial, which is enrolling patients who are refractory to, or who have progressed within six months of completing, treatment with first-line platinum chemotherapy (cisplatin or carboplatin), is being conducted at clinical sites in Europe and India.

“Since the initiation of the SPEAR trial in the second quarter of 2007, we have made significant progress in opening approximately 100 clinical sites and in treating patients,” said David A. Karlin, M.D., senior vice president, clinical development and regulatory affairs for Poniard. “We anticipate reaching our enrollment target in the first half of 2008, potentially supporting a New Drug Application filing in 2009.”

About Picoplatin Picoplatin is a new generation platinum chemotherapy agent. It was designed to overcome platinum resistance and to prolong the time to relapse after chemotherapy in the treatment of solid tumors, and to have an improved safety profile compared with existing platinum-based chemotherapeutics. Poniard received orphan drug designation from the FDA in November 2005 for picoplatin for the treatment of SCLC.

In addition to the ongoing SPEAR trial, Poniard is also evaluating intravenous picoplatin in an ongoing Phase 1 clinical trial as a first-line treatment for metastatic colorectal cancer and in an ongoing Phase 2 trial in combination with docetaxel (Taxotere(R)) and prednisone in patients with metastatic hormone-refractory prostate cancer.

About Small Cell Lung Cancer

SCLC is the most aggressive and deadly form of lung cancer and accounts for approximately 20 percent of all lung cancer cases. The current two-year survival rate for patients with extensive SCLC is less than 10 percent with current management options. The estimated incidence of lung cancer in the United States in 2006 was 174,500, according to the National Cancer Institute. The estimated incidence in Europe in 2006 was 386,300, according to the International Agency for Research on Cancer.

SCLC is currently treated with platinum therapies, but many patients do not respond, and if they do respond, they typically relapse within a short time after treatment. There is currently no FDA-approved therapy and no consistent and effective therapy for SCLC patients who have platinum-resistant or -refractory disease after treatment failure with first-line combination therapy with either cisplatin or carboplatin. No new drugs have been approved by the FDA for the treatment of platinum-resistant or -refractory SCLC in nearly a decade.

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. Intravenous picoplatin is currently being studied in clinical trials for the treatment of small cell lung, colorectal and hormone-refractory prostate cancer, and oral picoplatin is in a clinical trial in solid tumors. 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. 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

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 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 the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2007. 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.

© 2007 Poniard Pharmaceuticals, Inc. All Rights Reserved.

Poniard and Poniard Pharmaceuticals are trademarks of Poniard Pharmaceuticals, Inc.

For Further Information:

Julie Rathbun

Poniard Pharmaceuticals

Corporate Communications

7000 Shoreline Court, Suite 270

South San Francisco, CA  94080

206-286-2517

jrathbun@poniard.com

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EX-99.2

Exhibit 99.2

Poniard Pharmaceuticals Receives FDA Fast Track Designation for Picoplatin for Treatment of Small Cell Lung Cancer

Phase 2 Median Overall Survival Confirmed and Extended at the 12th World Conference on Lung Cancer in Seoul

South San Francisco, Calif. (September 5, 2007) – Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on oncology, today announced that it has been granted fast track designation by the U.S. Food and Drug Administration (FDA) for its lead product candidate, picoplatin, for the second-line treatment of refractory or resistant small cell lung cancer (SCLC). Picoplatin is currently being studied in the pivotal Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) trial in SCLC, which is evaluating overall survival as the primary endpoint and is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. Yesterday, Poniard presented updated data from its Phase 2 SCLC trial at the 12th World Conference on Lung Cancer in Seoul, which confirmed and extended a median overall survival of 27 weeks (based on an analysis of 63 patients), which compares favorably to a median survival of approximately 17 to 22 weeks for patients who receive other second-line chemotherapy according to the 2007 National Comprehensive Cancer Network practice guidelines.

“Our receipt of fast track designation is the result of our ongoing communications with the FDA, and has the potential to accelerate the development of picoplatin for the treatment of small cell lung cancer, a difficult-to-treat disease, and a patient population with very limited treatment options,” said Jerry McMahon, Ph.D., chairman and CEO of Poniard. “We are focused on executing our ongoing Phase 3 SPEAR trial to facilitate the expeditious filing of a New Drug Application and obtaining the approvals required to make picoplatin available to this severely underserved patient population.”

About Fast Track Designation

The fast track programs of the FDA are designed to facilitate the development and expedite the review of drugs and biologics that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast track designation enables the product candidate to become approved and reach the market expeditiously. This may include priority review (i.e., six-month versus the standard ten-month review) and the option to submit a New Drug Application on a rolling basis, enabling FDA to begin reviewing sections of the application before receiving the complete application. According to the FDA, picoplatin is eligible for Fast Track designation due to the unmet medical need —with no approved therapy for refractory disease, responses seen in two Phase 2 studies, and Poniard’s randomized, controlled Phase 3 trial of picoplatin and best supportive care (BSC) versus BSC alone.

About Picoplatin

Picoplatin is a new generation platinum chemotherapy agent. It was designed to overcome platinum resistance and to prolong the time to relapse after chemotherapy in the treatment of solid tumors, and to have an improved safety profile compared with existing platinum-based chemotherapeutics. Poniard received orphan drug designation from the FDA in November 2005 for picoplatin for the treatment of SCLC.

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In addition to the SPEAR trial of intravenous picoplatin in SCLC, Poniard is also evaluating intravenous picoplatin in an ongoing Phase 1 clinical trial as a first-line treatment for metastatic colorectal cancer and in an ongoing Phase 2 trial in combination with docetaxel (Taxotere(R)) and prednisone in patients with metastatic hormone-refractory prostate cancer. Oral picoplatin is being evaluated in a Phase 1 clinical trial in solid tumors.

About Small Cell Lung Cancer

SCLC is the most aggressive and deadly form of lung cancer and accounts for approximately 20 percent of all lung cancer cases. The current two-year survival rate for patients with extensive SCLC is less than 10 percent with current management options. The estimated incidence of lung cancer in the United States in 2006 was 174,500, according to the National Cancer Institute. The estimated incidence in Europe in 2006 was 386,300, according to the International Agency for Research on Cancer.

SCLC is currently treated with platinum therapies, but many patients do not respond, and if they do respond, they typically relapse within a short time after treatment. There is currently no FDA-approved therapy and no consistent and effective therapy for SCLC patients who have platinum-resistant or -refractory disease after treatment failure with first-line combination therapy with either cisplatin or carboplatin. No new drugs have been approved by the FDA for the treatment of platinum-resistant or -refractory SCLC in nearly a decade.

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. Intravenous picoplatin is currently being studied in clinical trials for the treatment of small cell lung, colorectal and hormone-refractory prostate cancer, and oral picoplatin is in a clinical trial in solid tumors. 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. 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, 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.

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© 2007 Poniard Pharmaceuticals, Inc. All Rights Reserved.

Poniard and Poniard Pharmaceuticals are trademarks of Poniard Pharmaceuticals, Inc.

For Further Information:

Julie Rathbun

Poniard Pharmaceuticals

Corporate Communications

7000 Shoreline Court, Suite 270

South San Francisco, CA  94080

206-286-2517

jrathbun@poniard.com

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