Navigation Links
Poniard Pharmaceuticals Announces European Commission Grants Orphan Medicinal Product Designation to Picoplatin for Treatment of Small Cell Lung Cancer

SOUTH SAN FRANCISCO, Calif., Oct. 17 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on oncology, today announced that its lead product candidate, picoplatin, has been granted orphan medicinal product designation for the treatment of small cell lung cancer (SCLC) by the European Commission. This designation is based on a recommendation from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA).

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.

"The receipt of orphan drug designation in the EU for picoplatin for the treatment of small cell lung cancer is an important achievement and builds on our success of obtaining orphan drug designation for picoplatin in the U.S.," said Jerry McMahon, Ph.D., chairman and CEO of Poniard. "Because many SCLC patients who are treated with platinum therapies relapse quickly or do not respond at all, new therapies that are active in this disease and that can overcome platinum resistance are urgently needed. We are committed to bringing picoplatin to market in the U.S. and the EU for this severely underserved patient population and are making significant progress in enrolling patients in our pivotal SPEAR trial for this indication."

About Orphan Drug Designation in the European Union

The EU orphan medicinal product designation aims to encourage the development of drugs involved in the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition that affects no more than five in 10,000 persons in the European Union.

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 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

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.

SOURCE Poniard Pharmaceuticals, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related biology technology :

1. Deltanoid Pharmaceuticals begins phase II osteoporosis study
2. The Coming of Biotech Generic Pharmaceuticals
3. Speaker announces business members of IT Task Force
4. Doyle announces technology tax credits for Berbee
5. Doyle announces new energy, global warming policies
6. Doyle announces $80M renewable energy strategy
7. GE announces first installation of Discovery VCT
8. UWM announces winners of RGI awards
9. Third Wave announces two senior management appointments
10. Mirus announces new method for making antibodies
11. Merge announces sofware updates, upcoming acquisition
Post Your Comments:
(Date:11/24/2015)... ... 2015 , ... Copper is an essential micronutrient that all ... copper is also toxic to cells. With a $1.3 million award from the ... a systematic study of copper in the bacteria Pseudomonas aeruginosa (P. aeruginosa), a ...
(Date:11/24/2015)... ... 24, 2015 , ... This fall, global software solutions leader SAP and AdVenture ... develop and pitch their BIG ideas to improve health and wellness in their schools. ... to win the title of SAP's Teen Innovator, an all-expenses paid trip to Super ...
(Date:11/24/2015)... /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ:  AEZS) (TSX: ... 11,000 post-share consolidation (or 1,100,000 pre-share consolidation) Series ... Warrants") subject to the previously disclosed November 1, ... which will result in the issuance of 365,518 ... issuance of such shares, there will be approximately ...
(Date:11/24/2015)... LAVAL, QC , Nov. 24, 2015 /CNW Telbec/ - ... the "Corporation") announced today that Mr. Pierre Laurin , ... a corporate presentation at the upcoming Piper Jaffray 27 th ... York Palace Hotel, on December 1-2, 2015. ... be available for one-on-one meetings throughout the day. The presentation ...
Breaking Biology Technology:
(Date:10/29/2015)... 2015 NXTD ) ("NXT-ID" ... on the growing mobile commerce market and creator ... a leading marketplace to discover and buy innovative ... wallet on StackSocial for this holiday season.   ... "Company"), a biometric authentication company focused on the ...
(Date:10/26/2015)... India , October 26, 2015 ... --> adds ... 2015 to 2021 as well as ... 2015-2019 research reports to its collection ... . --> ...
(Date:10/22/2015)... BEDFORD, Mass., Oct. 22, 2015  Aware, Inc. (NASDAQ: AWRE ... financial results for its third quarter ended September 30, 2015.  ... third quarter of 2015 was $4.0 million, a decrease of 33% ... income in the third quarter of 2015 was $2.2 million, or ... per diluted share, in the same period a year ago.  ...
Breaking Biology News(10 mins):