-----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, S3VTiO7SRktvHM2nrxMf4wqE5mQW23+OGplgR68AtczdgitFEymmrvS5G3tIzYxt Bq78OjgnM6533E8MtsiXGQ== 0000950124-05-000998.txt : 20050223 0000950124-05-000998.hdr.sgml : 20050223 20050223095647 ACCESSION NUMBER: 0000950124-05-000998 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20050222 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050223 DATE AS OF CHANGE: 20050223 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: 05633013 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 v06133e8vk.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)
  February 22, 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):

     
¨
  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨
  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨
  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨
  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 

 


 

Item 8.01 OTHER EVENTS.

Phase I trial of tgAAC09

On February 22, 2005, Targeted Genetics Corporation, or the Company, announced preliminary results from the Phase I trial of tgAAC09, an investigational recombinant adeno-associated viral vector (rAAV)-based HIV/AIDS vaccine candidate. A copy of the Company’s press release announcing the collaboration is attached as Exhibit 99.1 to this current report.

Phase II clinical trial for its Cystic Fibrosis candidate, tgAAVCF

In July 2003, we initiated, in collaboration with Cystic Fibrosis Foundation Therapeutics, a confirmatory Phase II clinical trial for our cystic fibrosis product candidate, tgAAVCF, in the United States. We expect to unblind the study and begin to analyze the data from this Phase II trial during the first week of March 2005. We will review and evaluate the trial result data, and following our analysis, we will announce our conclusions. We expect to announce the data before the end of March 2005. If we receive the data after the first week of March, the date when we complete our analysis will be a correspondingly later date.

The cystic fibrosis Phase II trial is a double blinded placebo controlled study and the trial data remain blinded to us, study investigators and participants. Currently, we do not have any information on any of the results of the Phase II clinical trial for our cystic fibrosis product candidate, and we will not have any information on the Phase II clinical trial results until the study is unblinded and the preliminary statistical results are tabulated by an independent contract research organization.

If the data from our confirmatory Phase II clinical trial for our cystic fibrosis product candidate is negative or inconclusive, we may discontinue developments therefore eliminating the potential to develop, or generate any revenue from a cystic fibrosis product. We may be unable to develop or obtain other drug candidates that could lead to collaborations that could help us maintain our business both operationally and financially. Even if the trial results are positive and show statistically significant improvements in lung function, we do not expect to generate any product revenue from a cystic fibrosis product for at least several years, and then only if we can successfully develop and commercialize our product candidate. Commercializing our product depends on successful completion of additional research, development and testing, and approval of our product for marketing.

Even if our cystic fibrosis product succeeds in clinical trials and is approved for marketing, it may never achieve market acceptance. If we are unsuccessful in commercializing our product candidate for any reason, including greater effectiveness or economic feasibility of competing products or treatments, the failure of the medical community or the public to accept or use any products based on gene delivery, inadequate marketing and distribution capabilities, the greater relative cost or development difficulty of our cystic fibrosis product as compared to other product, candidates or other reasons discussed elsewhere in this section, we may be unable to generate sufficient product revenue to maintain our business.

Item 9.01. Financial Statements and Exhibits.

99.1      Press Release Dated February 22, 2004

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.

         
    TARGETED GENETICS CORPORATION
 
       
  By:   /s/ Barrie J. Carter
       
      Barrie J. Carter
Executive Vice President
and Chief Scientific Officer

Dated: February 22, 2005

3


 

EXHIBIT INDEX

99.1      Press Release Dated February 22, 2004

4

EX-99.1 2 v06133exv99w1.htm EXHIBIT 99.1 exv99w1
 

Exhibit 99.1

(TARGETED GENETICS)

Contact:
Targeted Genetics Corporation
Stacie Byars
206-660-2588

TARGETED GENETICS ANNOUNCES PRELIMINARY SAFETY DATA FROM PHASE I HIV VACCINE TRIAL

Seattle, WA – February 22, 2005 – Targeted Genetics Corp. (Nasdaq: TGEN) today reported preliminary results from a Phase I trial of tgAAC09, an investigational recombinant adeno-associated viral vector (rAAV)-based HIV/AIDS vaccine candidate, enrolling healthy volunteers who are not infected with HIV. The trial is being conducted in Belgium, Germany and India.

The Phase I trial is the first ever to test a rAAV-based vaccine and is primarily designed to evaluate safety and tolerability of the vaccine at escalating dose levels. The study is also designed to evaluate immune responses following vaccination. No safety concerns were identified and the vaccine was well tolerated. In addition, a single administration of the vaccine at the doses evaluated in this initial study did not elicit significant immune responses.

“The favorable tolerability data from this trial are consistent with our growing clinical experience with AAV and now position us to continue the clinical development of this vaccine program. We can begin to evaluate higher dose levels and repeat administration of this vaccine,” said H. Stewart Parker, President and Chief Executive Officer of Targeted Genetics. “In addition, our comprehensive development strategy for this AIDS vaccine includes the development of an AAV1-based vaccine, as well as a multi-component approach involving multiple HIV antigens. We are also examining in preclinical studies the use of AAV vaccines in a prime boost approach, to potentially increase immune responses to the HIV antigens further. In short, we continue to be optimistic about the potential of AAV-based vaccines against HIV/AIDS.”

 


 

The Phase I clinical trial is a double-blind, placebo-controlled, dose-escalation safety study that also monitors immune responses to the product candidate. The portion of the study conducted in Belgium and Germany enrolled 50 volunteers who were in good general health and not infected with HIV. Each volunteer received a single intramuscular injection into the upper arm. The portion of the trial being conducted in India will enroll 30 healthy HIV-negative volunteers. A subset of volunteers also will receive a second dose of the vaccine to determine if repeat dosing is safe, and if it increases immune responses

The phase I trial for tgAAC09 is being studied in collaboration with the not-for-profit International AIDS Vaccine Initiative and researchers at Columbus Children’s Research Institute and The Children’s Hospital of Philadelphia.

About Targeted Genetics

Targeted Genetics Corporation develops gene-based products for preventing and treating acquired and inherited diseases. The Company has three clinical product development programs, targeting cystic fibrosis, 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.

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995:
This release contains forward-looking statements regarding our research programs, clinical trials, product development and potential related to tgAAC09 and other statements about our plans, objectives, intentions and expectations. 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, the risk that future clinical results could negatively differ from those announce today, the timing, nature and results of our research and our clinical trials, our preclinical results with animals are not necessarily indicative of results that will be obtained in humans, our ability to obtain and maintain regulatory or institutional approvals, our ability to obtain, maintain and protect our intellectual property related to tgAAC09, 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 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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