-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, OlwaXJThaJIFOZdQYPtjM9Ln/K3TxuUoPsyrwNQY6xHUTh40gcfBNGY3q9Fbwy70 F9XQ9r/ncskkEHm0Bp6TLA== 0001104659-05-055218.txt : 20051114 0001104659-05-055218.hdr.sgml : 20051111 20051114122235 ACCESSION NUMBER: 0001104659-05-055218 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20051107 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20051114 DATE AS OF CHANGE: 20051114 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NEORX CORP CENTRAL INDEX KEY: 0000755806 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 911261311 STATE OF INCORPORATION: WA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-16614 FILM NUMBER: 051198479 BUSINESS ADDRESS: STREET 1: 300 ELLIOTT AVENUE WEST STREET 2: SUITE 500 CITY: SEATTLE STATE: WA ZIP: 98119-4114 BUSINESS PHONE: 2062817001 MAIL ADDRESS: STREET 1: 300 ELLIOTT AVENUE WEST STREET 2: SUITE 500 CITY: SEATTLE STATE: WA ZIP: 98119-4114 8-K 1 a05-20169_18k.htm CURRENT REPORT OF MATERIAL EVENTS OR CORPORATE CHANGES

 

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

 

November 7, 2005

Date of Report (Date of earliest event reported)

 

NeoRx Corporation

(Exact Name of Registrant as Specified in Charter)

 

Washington

 

0-16614

 

91-1261311

(State or Other Jurisdiction

 

(Commission File No.)

 

(IRS Employer

of Incorporation)

 

 

 

Identification No.)

 

 

 

 

 

300 Elliott Avenue West, Suite 500, Seattle, WA

 

98119-4114

(Address of principal executive offices)

 

(Zip Code)

 

(206) 281-7001

(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 November 7, 2005, the FDA granted the Company’s request for orphan drug designation of picoplatin (NX 473) for treatment of small cell lung cancer.  See press release attached hereto as Exhibit 99.1 and incorporated herein by reference.

 

Item 9.01.

Financial Statements and Exhibits.

 

 

(d)

Exhibits.

 

 

 

99.1 - Press release dated November 10, 2005.

 

2



 

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.

 

 

NeoRx Corporation

 

 

 

Dated:  November 10, 2005

By:

s/ Susan D. Berland

 

 

 

Name: Susan D. Berland

 

 

Title: Chief Financial Officer

 

3



 

EXHIBIT INDEX

 

Exhibit No.

 

Description

99.1

 

Press Release dated November 10, 2005

 

4


EX-99.1 2 a05-20169_1ex99d1.htm EXHIBIT 99

Exhibit 99.1

 

 

NeoRx Announces Orphan Drug Designation for Picoplatin
for Treatment of Small Cell Lung Cancer

 

SEATTLE (November 10, 2005) – NeoRx Corporation (NASDAQ:NERX) today announced that it has received orphan drug designation from the Office of Orphan Products Development at the U.S. Food and Drug Administration for the Company’s investigational product picoplatin, a next-generation platinum therapy, for the treatment of small cell lung cancer (SCLC).

 

“We are pleased to have received orphan drug designation for picoplatin in SCLC.  While platinum therapies are currently used to treat SCLC, many patients do not respond or relapse within a short time after chemotherapy.  As a result, there is a critical need for new therapies that are active in this disease and that can overcome the resistance that occurs with platinum compounds,” said Jerry McMahon, Ph.D., chairman and CEO of NeoRx.  “This designation from the FDA reinforces our belief that picoplatin could be an important potential treatment option for SCLC patients.”

 

Picoplatin is an intravenous platinum chemotherapeutic agent specifically designed to overcome platinum resistance.  In addition, testing in more than 500 patients indicates that picoplatin may have less toxicity than current platinum-based therapies.

 

Orphan designation is granted for treatments that offer potential therapeutic value for diseases that affect fewer than 200,000 people in the United States.  Orphan drug designation provides an accelerated review process, tax advantages and a seven-year period of market exclusivity in the United States upon product approval.

 

Phase II SCLC Trial

 

Picoplatin is currently being studied in an ongoing randomized, open-label, multi-center Phase II clinical trial in patients with platinum-resistant or refractory SCLC.  The trial is presently open to enrollment at approximately 25 clinical sites throughout the United States and Canada. NeoRx plans to commence clinical trials of picoplatin in Europe in the first quarter of 2006.

 

About Small Cell Lung Cancer

 

Small cell lung cancer is the most aggressive and deadly form of lung cancer, affecting approximately 15 percent of all lung cancer patients.  Approximately 25,000 new cases occur in the United States each year.  Although platinum therapies are the preferred treatment, no FDA-approved therapies are available for patients with platinum- refractory or –resistant disease.

 

About NeoRx

 

NeoRx is dedicated to the development and commercialization of oncology drugs that impact the lives of individuals afflicted with cancer and metastases.  The Company currently is focusing its development efforts on picoplatin (NX 473), a next-generation platinum therapy with improved safety features that is designed to overcome platinum-based chemoresistance.  NeoRx also is collaborating with the Scripps Florida Research Institute on the discovery of

 



 

novel, small-molecule, multi-targeted protein kinase inhibitors for the treatment of cancer.  For more information, visit www.neorx.com.

 

This release contains forward-looking statements relating to the development of the Company’s products and future operating results that are subject to certain risks and uncertainties that could cause actual results to differ materially from those projected.  The words “believe,” “expect,” “intend,” “anticipate,” “plan,” variations of such words, and similar expressions identify forward-looking statements, but their absence does not mean that the statement is not forward-looking.  These statements are not guarantees of future performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict.  Factors that could affect the Company’s actual product development activities and operating results include the risk that the Company may be unable to raise additional capital to fund its picoplatin program in 2006 and future operations, the uncertainty and timing of obtaining additional financing, actions by the FDA and other regulators, the Company’s ability to obtain required regulatory approvals, the progress and costs of the Company’s picoplatin clinical trials, the Company’s ability to generate future revenue from product sales or other sources such as collaborative relationships and future profitability, the Company’s dependence on patents and other proprietary rights, and the other risks and uncertainties described in the Company’s current and periodic reports filed with the Securities and Exchange Commission, including NeoRx’s Annual Report on Form 10-K for the year ended December 31, 2004 and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2005.  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.

 

© 2005 NeoRx Corporation. All Rights Reserved.

 

For Further Information:

 

NeoRx Corporation

Julie Rathbun

Corporate Communications

206-286-2517

jrathbun@neorx.com

 

# # #

 


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