-----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, H4xFXtleiPPIpLrsFfLkrNBKDeX3wqriZW80G49ZLZ3UDRUguHfG2cCG4+NIviJZ yywpGutKhuDpRZm31tlUpw== 0000950124-05-001650.txt : 20050317 0000950124-05-001650.hdr.sgml : 20050317 20050317164836 ACCESSION NUMBER: 0000950124-05-001650 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20050317 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050317 DATE AS OF CHANGE: 20050317 FILER: COMPANY DATA: COMPANY CONFORMED NAME: TARGETED GENETICS CORP /WA/ CENTRAL INDEX KEY: 0000921114 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 911549568 STATE OF INCORPORATION: WA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-23930 FILM NUMBER: 05689406 BUSINESS ADDRESS: STREET 1: 1100 OLIVE WAY STREET 2: STE 100 CITY: SEATTLE STATE: WA ZIP: 98101 BUSINESS PHONE: 2066237612 MAIL ADDRESS: STREET 1: 1100 OLIVE WAY STREET 2: STE 100 CITY: SEATTLE STATE: WA ZIP: 98101 8-K 1 v07029e8vk.htm FORM 8-K e8vk
 

 
 

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

Date of Report (Date of earliest event reported)     March 17, 2005

Targeted Genetics Corporation


(Exact name of registrant as specified in its charter)
         
Washington   0-23930   91-1549568
         
(State or other jurisdiction
of incorporation)
  (Commission File
Number)
  (IRS Employer
Identification No.)
     
1100 Olive Way, Suite 100, Seattle, Washington   98101
     
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code     (206) 623-7612

Not Applicable


(Former name or former address if changed since last report)

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 (see General Instruction A.2. below):

o   Written communications 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))

 
 

 


 

Item 8.01 OTHER EVENTS.

Preliminary phase II clinical trial results for our Cystic Fibrosis candidate, tgAAVCF

     On March 17, 2005, Targeted Genetics Corporation, or the Company, announced that its Phase II clinical trial of tgAAVCF in patients with mild to moderate cystic fibrosis failed to meet its primary endpoint of statistically significant improvement in lung function, 30 days following initial administration of tgAAVCF compared to placebo and that based on these results, the Company has decided not to pursue further development of tgAAVCF. A copy of the Company’s press release announcing the trial results is attached as Exhibit 99.1 to this current report.

Item 9.01. Financial Statements and Exhibits.

99.1     Press Release Dated March 17, 2005

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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.

           
    Targeted Genetics Corporation
 
         
  By:   /s/ Todd E. Simpson
         
        Todd E. Simpson
Vice President, Finance and Administration and
Chief Financial Officer, Secretary and Treasurer
(Principal Financial and Accounting Officer)
 
       
Dated: March 17, 2005
       

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EXHIBIT INDEX

99.1     Press Release Dated March 17, 2005

4

EX-99.1 2 v07029exv99w1.htm EXHIBIT 99.1 exv99w1
 

Exhibit 99.1

(TARGETED GENETICS LOGO)

Investor and Media Contact:
Stacie D. Byars
Director, Communications
Targeted Genetics Corporation
(206) 521-7392

TARGETED GENETICS ANNOUNCES PRELIMINARY RESULTS FROM ITS PHASE II TRIAL
OF tgAAVCF IN CYSTIC FIBROSIS

Seattle, WA – March 17, 2005 – Targeted Genetics Corporation (Nasdaq: TGEN) today reported that its Phase II clinical trial of tgAAVCF in patients with mild to moderate cystic fibrosis (CF) failed to meet its primary endpoint of statistically significant improvement in lung function, 30 days following initial administration of tgAAVCF compared to placebo. Based on these results, the Company has decided not to pursue further development of tgAAVCF. The Company will hold a conference call via webcast at 10:30 a.m. EST today, which can be accessed, along with replay information, at www.targetedgenetics.com

“Although we are obviously disappointed that these results did not confirm findings from our earlier Phase II trial in cystic fibrosis, we have significantly expanded our adeno-associated virus (AAV)-related development capabilities and infrastructure through the evaluation of this product candidate,” said H. Stewart Parker, President and Chief Executive Officer of Targeted Genetics. “We are dedicated to developing products with both clinical and commercial potential and our experience in CF and understanding of AAV from this program will be leveraged into our other development programs. We plan to focus our efforts on our clinical programs in HIV/AIDS prophylaxis, inflammatory arthritis, and our preclinical programs in hyperlipidemia congestive heart failure and Huntington’s disease.”

Parker further stated, “I would like to take this opportunity to thank the Cystic Fibrosis Foundation, the members of the CF medical community and, especially, CF patients and their families for their support of our efforts to develop a new approach to treating this disease.”

This Phase II, double-blind, randomized, placebo-controlled study was partially funded by Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT), the drug discovery and development affiliate of the Cystic Fibrosis Foundation, and was being conducted through CFFT’s

 


 

Therapeutics Development Network. The primary end-point of this trial was an improvement in FEV1 lung function 30-days following initial administration of tgAAVCF. The study also evaluated improvement in lung function at day 90, which was 60 days following the administration of a second dose of tgAAVCF, and monitored the safety and tolerability profile of tgAAVCF. A total of 102 patients, 12 years of age and older, were evaluated, 51 in the treatment group and 51 in the placebo group. Study participants received two doses of 1x1013 DNAse resistant particles (DRP) of tgAAVCF or placebo, delivered via nebulizer at day 0 and day 30 of the study and were evaluated for change in FEV1 lung function every two weeks over the course of 90 days. The Company expects to present the complete data set from the study in a peer reviewed forum later this year. The company will continue to collect safety data through the end of the study.

About Targeted Genetics
Targeted Genetics Corporation develops gene-based products for preventing and treating acquired and inherited diseases. The Company has clinical product development programs, targeting AIDS prophylaxis and inflammatory arthritis. The Company also has a promising pipeline of product candidates focused on hyperlipidemia, congestive heart failure and Huntington’s disease that are being developed under collaboration agreements with others, and a broad platform of gene delivery technologies for application in nucleic acid-based drug development. For more information about Targeted Genetics, visit its website at www.targetedgenetics.com.

Contact: Stacie D. Byars
206-521-7392

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995:
This release contains forward-looking statements regarding our research programs, clinical trials, our revised product development and clinical trial focus and our potential to leverage our development platforms and other statements about our plans, objectives, intentions and expectations. In particular, the statements regarding the Company’s new strategic direction and its potential effects on the Company’s business are forward-looking statements. These statements, involve current expectations, forecasts of future events and other statements that are not historical facts. Inaccurate assumptions and known and unknown risks and uncertainties can affect the accuracy of forward-looking statements. Factors that could affect our actual results include, but are not limited to, delay or failure in developing our other product candidates, the timing, nature and results of our research and our clinical trials, potential development of alternative technologies or more effective products by competitors, our ability to obtain and maintain regulatory or institutional approvals, our ability to obtain, maintain and protect our intellectual property related to any of our product candidates, and our ability to raise capital when needed, as well as other risk factors described in the section entitled “Factors Affecting Our Operating Results, Our Business and Our Stock Price” in our Annual Report on Form 10-K for the year ended December 31, 2004. You should not rely unduly on these forward-looking statements, which apply only as of the date of this release. We undertake no duty to publicly announce or report revisions to these statements as new information becomes available that may change our expectations.

###

2

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