-----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, D4Q5yly6fjKPIz8RJyGPJ6Xg6j3Q+IaN77vElPdSDWAzPLQ5HtpSRE8nxqkNo8et valkbBTq6/CjHzKXhK/L5Q== 0001144204-06-036913.txt : 20060905 0001144204-06-036913.hdr.sgml : 20060904 20060905092552 ACCESSION NUMBER: 0001144204-06-036913 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20060830 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060905 DATE AS OF CHANGE: 20060905 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: 061072750 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 v052017_8k.htm


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)    August 30, 2006
 
 
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.

On August 30, 2006, Targeted Genetics Corporation announced the presentation and the interim data from its ongoing Phase I trial of tgAAC09, its HIV/AIDS vaccine candidate. A copy of Targeted Genetics’ press release announcing the presentation of the interim data and describing the interim data is attached as Exhibit 99.1 to this current report and is incorporated herein by reference.


Item 9.01. Financial Statements and Exhibits.

    Exhibits.

    99.1           Press Release of Targeted Genetics Corporation dated August 30, 2006


SIGNATURES

    Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 
  Targeted Genetics Corporation
     
 
By:  
/s/ H. Stewart Parker
   

H. Stewart Parker 
   
President & Chief Executive Officer 

Dated: September 1, 2006


 
 

 
INDEX TO EXHIBITS


 
Exhibit
Number
 
Description
99.1
 
Press Release of Targeted Genetics Corporation dated August 30, 2006

 
EX-99.1 2 v052017_ex99-1.htm
Exhibit 99.1

 
 
FOR IMMEDIATE RELEASE

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

INTERIM DATA FROM TARGETED GENETICS' PHASE I HIV/AIDS VACCINE TRIAL
TO BE PRESENTED AT LEADING EUROPEAN AIDS VACCINE MEETING

Vaccine candidate well tolerated; modest immune response observed in a subset of patients

Amsterdam and Seattle, WA - August 30, 2006 - Targeted Genetics Corporation (Nasdaq: TGEN) announced that Nathan Clumeck, MD, PhD, Head of the Department of Infectious Diseases, St. Pierre University Hospital in Brussels, Belgium, will present interim results today from a Phase I clinical trial of tgAAC09, an investigational HIV/AIDS vaccine candidate based on recombinant adeno-associated virus vector serotype 2 (AAV2). The trials for tgAAC09 are being conducted in collaboration with the International AIDS Vaccine Initiative (IAVI). The trial, enrolling healthy volunteers who are not infected with HIV, was conducted in Belgium and Germany, and is ongoing in India. Professor Clumeck is a principal investigator for this study and will present this data at the AIDS Vaccine 2006 Conference, taking place in Amsterdam August 29 until September 1, 2006, in Amsterdam, Netherlands. A second clinical trial of tgAAC09 is ongoing in South Africa, Uganda and Zambia to evaluate a higher dose and to systematically evaluate the utility and optimal timing of boost vaccination.

The Phase I trial is the first ever to test a recombinant AAV-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 a subset of the volunteers receiving a single administration of the highest dose of the vaccine, modest immune responses were observed. Further studies are planned to determine the clinical relevance of this observation.

“We are very encouraged by the immune responses observed in a subset of patients receiving the highest dose of tgAAC09 in this study,” said H. Stewart Parker, President and Chief Executive Officer of Targeted Genetics, “This is the first human evidence that an AAV-based vaccine can stimulate the immune system to respond to HIV proteins. While these data require confirmation and additional analysis, they provide critical insight into the activity of tgAAC09 that will help inform our comprehensive development program for AAV-based vaccines designed to protect against HIV/AIDS. In conjunction with data from other trials evaluating higher doses of tgAAC09 and a variety of dosing schedules, these data support our efforts to develop a vaccine that has the potential to impact the global HIV/AIDS pandemic.”

 
 

 

About the Clinical Program
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. The portion of the trial being conducted in India enrolled 30 healthy HIV-negative volunteers. Each volunteer received a single intramuscular injection into the upper arm. A subset of volunteers also received a second dose of the vaccine to determine if repeat dosing is safe, and if it boosts immune responses. The Phase I trial in Germany, Belgium and India is being conducted in collaboration with researchers at Columbus Children’s Research Institute and The Children’s Hospital of Philadelphia.

A Phase II trial of a vaccine based on AAV2 is being conducted in collaboration with the Chris Hani Baragwanath Hospital, the Desmond Tutu Institute for HIV Research and the University of Limpopo in South Africa; the Uganda Virus Research Institute, and the Zambia Emory HIV Research Project. This trial is being conducted in order to evaluate the potential impact of a higher dose of tgAAC09 and boost vaccination on the strength and duration of immune responses.

About Targeted Genetics
Targeted Genetics Corporation is a biotechnology company committed to the development and commercialization of innovative targeted molecular therapies for the prevention and treatment of inflammatory arthritis, HIV/AIDS and other acquired and inherited diseases with significant unmet medical need. Targeted Genetics uses its considerable knowledge and capabilities in the development and manufacturing of gene delivery technologies to advance a diverse product development pipeline. Its product development efforts target inflammatory arthritis, HIV/AIDS, congestive heart failure, Huntington's disease, and hyperlipidemia. To learn more 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 the data to be collected in this trial, the establishment or determination of efficacy endpoints from the data collected in the trial, the timely and complete accrual of patients in the trial and our ability to commercialize 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, our ability to obtain, maintain and protect our intellectual property, our ability to raise capital when needed, our partners ability to recruit and enroll suitable trial participants, our partners continued support of this clinical program, the timing, nature and results of research and clinical trials, potential development of alternative technologies or more effective processes by competitors, and, our ability to obtain and maintain regulatory or institutional approvals, as well as other risk factors described in Item 1A. Risk Factors in our report on Form 10-K for the year ended December 31, 2005 and updated in Item 1A. Risk Factors in our subsequent reports on Form 10-Q. 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.

# # #

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