-----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, VLnF9kBQwWyWBL0elkYu3ktrljKuP9aHcuyE2yeiONAH2LVwnNvwxiEIPX+oImOy rtUL+7aTKB+qhwTiAVtAXA== 0001104659-03-013928.txt : 20030723 0001104659-03-013928.hdr.sgml : 20030723 20030702172451 ACCESSION NUMBER: 0001104659-03-013928 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20030630 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20030702 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: 03772981 BUSINESS ADDRESS: STREET 1: 410 W HARRISON ST CITY: SEATTLE STATE: WA ZIP: 98119 BUSINESS PHONE: 206-286-25 MAIL ADDRESS: STREET 1: 410 W HARRISON ST CITY: SEATTLE STATE: WA ZIP: 98119 8-K 1 j2709_8k.htm 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

 

June 30, 2003

(Date of Report)

 

NEORX CORPORATION

(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.)

 

300 Elliott Avenue West, Suite 500, Seattle, Washington 98119-4007

(Address of principal executive offices)                               (Zip Code)

 

(206) 281-7001

(Registrant’s telephone number, including area code)

 

 



 

Item 5.                              Other Events

 

On June 30, 2003, NeoRx Corporation announced that it named Jack L. Bowman as Chief Executive Officer of the Company and Karen Auditore-Hargreaves as Chief Operating Officer of the Company, effective immediately.  Douglass B. Given, MD, PhD, who served as President, Chief Executive Officer and Director of the Company resigned from those positions.  See press release attached as Exhibit 99.1.

 

NeoRx Corporation announced on July 1, 2003, that the Company has submitted a plan for its proposed STR pivotal clinical trials to the FDA.  See press release attached hereto as Exhibit 99.2.

 

Item 7.                              Exhibits

 

99.1                           Press release dated June 30, 2003

 

99.2                           Press release dated July 1, 2003

 



 

SIGNATURE

 

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:  July 2, 2003

By

/s/ MELINDA G. KILE

 

 

Melinda G. Kile

 

 

V-P, Finance

 

2


EX-99.1 3 j2709_ex99d1.htm EX-99.1

Exhibit 99.1

 

NEORX NAMES JACK L. BOWMAN CEO

AND KAREN AUDITORE-HARGREAVES COO

 

Seattle, WA, June 30, 2003 — NeoRx Corporation (Nasdaq: NERX) today announced that Jack L. Bowman has been appointed Chief Executive Officer, effective immediately.   A Director of NeoRx since 1994, Mr. Bowman was appointed Executive Chairman and Chairman of the Board of Directors in March 2003.  He continues to serve as Chairman of the Board of Directors.  Previously, Mr. Bowman was Company Group Chairman of Johnson & Johnson, from which he retired in 1993.  Douglass B. Given, MD, PhD, who has served as President, Chief Executive Officer, and a Director of NeoRx since July 2001, has resigned from these positions.  He is rejoining Bay City Capital as an Executive in Residence.  “I am very pleased to have Jack succeed me as CEO of NeoRx, and I will continue to provide him with any support he may request from me in the future,” said Dr. Given.

 

NeoRx also announced that Karen Auditore-Hargreaves, PhD, was promoted to Chief Operating Officer, effective immediately.  Dr. Auditore-Hargreaves joined NeoRx as Vice President, Research and Development in May 1999, and became Senior Vice President, Research and Development in September 2001.  In this capacity, Dr. Auditore-Hargreaves was responsible for clinical and manufacturing operations as well as R&D.  She played a key role in recent interactions with the FDA that led to lifting the clinical hold on the company’s Skeletal Targeted Radiotherapy (STR) product candidate.  Before joining NeoRx, she was Vice President of Research at CellPro, Inc.  Dr. Auditore-Hargreaves earned a PhD in Genetics from the University of California, Davis, and received her postdoctoral training at the Massachusetts Institute of Technology Center for Cancer Research.

 

“Jack and Karen have the demonstrated expertise, experience and vision to successfully lead the company and fulfill its objectives: to advance STR through the anticipated pivotal program, obtain additional financing, and bring in product candidates to expand our oncology product pipeline and commercial opportunities,” said Frederick B. Craves, PhD, Vice Chairman of the Board of Directors of NeoRx.  “We thank Doug Given for his service to the company, restructuring and streamlining NeoRx for continued progress and future growth.”

 

1



 

NeoRx is a cancer therapeutics company developing products for targeted delivery of anti-cancer agents, including radiopharmaceuticals, to tumor sites.  The company’s Skeletal Targeted Radiotherapy (STR) is in late-stage development for treatment of multiple myeloma, the second most common blood cancer.

 

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,” 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 results include conditions in the capital markets in general and in the life science capital market specifically which may affect potential financing sources for the development of NeoRx’s business, the progress and costs of clinical trials and the timing of regulatory approvals, the ability to successfully develop and commercialize products and the risks and uncertainties described in NeoRx’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, 2002 and its latest 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.

 

Visit NeoRx at www.neorx.com.

 

NeoRx is a registered trademark of NeoRx Corporation in the United States and/or foreign countries.

 

Ó 2003 NeoRx Corporation. All Rights Reserved.

 

2


EX-99.2 4 j2709_ex99d2.htm EX-99.2

Exhibit No. 99.2

 

NEORX SUBMITS PLAN FOR STR PIVOTAL CLINICAL
PROGRAM TO FDA

 

Complete Response Rates of Approximately 40% Achieved at
Proposed STR Dose

 

Seattle, WA, July 1, 2003 — NeoRx Corporation (Nasdaq: NERX) today announced that it has submitted to the US Food and Drug Administration (FDA) its proposed pivotal clinical program for registration of Skeletal Targeted Radiotherapy (STR).  NeoRx is developing STR for use with high-dose chemotherapy (melphalan) and autologous stem cell transplantation for treatment of patients with multiple myeloma.  Subject to authorization from the FDA, NeoRx plans to begin patient enrollment in early 2004.

 

Data from phase I/II clinical trials, presented recently at the 50th Annual Meeting of the Society for Nuclear Medicine, show that STR in combination with melphalan at the doses proposed for the pivotal clinical program achieved complete response rates of approximately 40%.  Patient response to therapy was independently assessed using rigorous established criteria (Bladé criteria).  These data for STR compare very favorably with complete response rates reported for multiple myeloma patients treated with the available chemotherapeutics.  Standard and recently approved chemotherapeutics for non-transplant regimens for multiple myeloma generally provide complete response rates of less than 5%.

 

STR has been shown to have a favorable acute toxicity profile.  The potential for delayed toxicity, as experienced by some phase I/II patients, can be prevented effectively with modified administration and patient management, and a controlled maximum radiation dose.

 

STR is a targeted therapeutic comprised of a small-molecule bone-seeking agent coupled to the radionuclide holmium-166.  NeoRx’s initial therapeutic focus is multiple myeloma, a cancer of the bone marrow.  STR also has therapeutic potential for other cancers that arise in the bone marrow (e.g., leukemias), and cancers that metastasize to the bone from other tissues and organs (e.g., breast and prostate cancer).

 

NeoRx is a cancer therapeutics company developing products for targeted delivery of anti-cancer agents, including radiopharmaceuticals, to tumor sites.

 

1



 

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,” 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 results include conditions in the capital markets in general and in the life science capital market specifically which may affect potential financing sources for the development of NeoRx’s business, the progress and costs of clinical trials and the timing of regulatory approvals, the ability to successfully develop and commercialize products and the risks and uncertainties described in NeoRx’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, 2002 and its latest 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.

 

Visit NeoRx at www.neorx.com.

 

NeoRx is a registered trademark of NeoRx Corporation in the United States and/or foreign countries.

 

Ó 2003 NeoRx Corporation. All Rights Reserved.

 

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