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Poniard Pharmaceuticals Announces Treatment of First Patient

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With Picoplatin in Pivotal Phase 3 Small Cell Lung Cancer Trial

http://www.prnewswire.com/cgi-bin/stori ... 612&EDATE=

SOUTH SAN FRANCISCO, Calif., May 1 /PRNewswire-

FirstCall/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused

on oncology, today announced treatment of the first patient with picoplatin

in its pivotal Phase 3 clinical trial in small cell lung cancer (SCLC).

Picoplatin, the Company's lead product candidate, is a new generation

platinum therapy with an improved safety profile designed to overcome and

prevent platinum resistance associated with chemotherapy in solid tumors.

The Phase 3 trial, known as SPEAR (Study of Picoplatin Efficacy After

Relapse), received a Special Protocol Assessment (SPA) agreement from the

U.S. Food and Drug Administration (FDA).

"With the initiation of our Phase 3 SPEAR trial, our goal is to obtain

regulatory approvals to bring picoplatin to market to address the critical

unmet medical need in small cell lung cancer. Our SPA agreement with the

FDA supports our plan to conduct a single pivotal Phase 3 trial that

evaluates overall survival as the primary endpoint as a basis for filing

for FDA approval to market picoplatin," said Jerry McMahon, Ph.D.,

chairman, president and CEO of Poniard. "We currently estimate that it will

take approximately 20 months to complete enrollment and follow up in the

SPEAR trial, potentially enabling us to file a New Drug Application in


Phase 3 SCLC Study Design

The international, multi-center, randomized, controlled Phase 3 SPEAR

trial is enrolling patients who are refractory to, or who have progressed

within six months of completing, treatment with first-line

platinum-containing chemotherapy (cisplatin or carboplatin). The primary

efficacy endpoint is overall survival. Overall response rates,

progression-free survival and disease control also will be evaluated. The

trial has a 2:1 randomization comparing the efficacy and safety of

intravenous picoplatin plus best supportive care to best supportive care

alone. The Company expects to enroll approximately 400 patients in the

trial, which is being conducted at clinical sites in Europe and India.

"Small cell lung cancer represents a critical unmet medical need as

platinum-resistant or -refractory patients with small cell lung cancer

often experience rapid disease progression and low overall survival despite

treatment with available drugs, which have significant associated

toxicities," said Paul A. Bunn, Jr., M.D., a member of Poniard's Clinical

Advisory Board and the director of the University of Colorado Cancer Center

in Aurora, Colo., where he holds the James Dudley Endowed Chair of Cancer

Research and is professor of medicine at the University of Colorado Health

Sciences Center. "Moreover, no new drugs have been approved by the FDA for

the treatment of platinum-resistant or -refractory small cell lung cancer

in nearly a decade."

Interim Phase 2 SCLC Survival Results

In November 2006, Poniard announced positive interim median overall

survival data from its Phase 2 open-label, multi-center clinical trial of

picoplatin in SCLC. The trial was designed to confirm the clinical activity

of picoplatin as second-line therapy in patients with platinum-refractory

disease or disease that had progressed within six months following

first-line treatment with a platinum-based chemotherapy, such as cisplatin

or carboplatin. The interim analysis showed a median overall survival of

26.7 weeks in the 72 evaluable patients treated with picoplatin. According

to the 2006 National Comprehensive Cancer Network practice guidelines, the

median survival for patients who receive second-line chemotherapy is

approximately 16 to 20 weeks, and patients who receive no chemotherapy have

been shown in published studies to live only 13 to 14 weeks.

"The median overall survival observed to date in our Phase 2 trial

suggests that picoplatin treatment may represent an improvement over best

supportive care alone," said David A. Karlin, M.D., senior vice president

of clinical development and regulatory affairs of Poniard.

Final results of the Phase 2 trial are expected in mid-2007 and will be

submitted for presentation at upcoming scientific conferences.

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. Poniard received orphan

drug designation in November 2005 from the FDA for picoplatin for the

treatment of SCLC.

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.

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. 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. 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: Poniard and Poniard Pharmaceuticals are trademarks of Poniard

Pharmaceuticals, Inc.

SOURCE Poniard Pharmaceuticals, Inc.

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