-----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, FQS2qOWXk0tk61sGgucXgLabYLYn5Kd482gvtZeSp9Z2c4v3A2ULRcl5DvApk2Pt 2Prbvw60fm3ugWDZxw3p8Q== 0000950124-06-002310.txt : 20060428 0000950124-06-002310.hdr.sgml : 20060428 20060428144812 ACCESSION NUMBER: 0000950124-06-002310 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20060426 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060428 DATE AS OF CHANGE: 20060428 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: 06789267 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 v19988e8vk.htm FORM 8-K e8vk
Table of Contents

 
 
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) April 26, 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):
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))
 
 

 


TABLE OF CONTENTS

Item 1.01. Entry into a Material Definitive Agreement
Item 8.01. Other Events
Item 9.01. Financial Statements and Exhibits
SIGNATURES
INDEX TO EXHIBITS
EXHIBIT 99.1


Table of Contents

Item 1.01. Entry into a Material Definitive Agreement.
          On April 26, 2006, Targeted Genetics Corporation amended its lease agreement with its landlord, Walton Street Capital, for a portion of its office space at Metropolitan Park at 1100 Olive Way in Seattle, Washington. Under the terms of the agreement, Targeted will terminate its lease on the 12th floor of Metropolitan Park, and paid a termination fee of $102,000.00. Targeted will consolidate its operations to its office space on the first floor of Metropolitan Park. In addition, the lease agreement provides that Targeted will pay base rent equal to the fair market value of the rentable space as determined by agreement between the tenant and landlord. The lease agreement for the first floor of Metropolitan Park was extended by a term of five years until 2014 as a result of the restructuring.
Item 8.01. Other Events.
          On April 26, 2006, Targeted Genetics Corporation, Zambia Emory HIV Research Project, and the International AIDS Vaccine Initiative announced the initiation of a clinical trial in Zambia. A copy of Targeted Genetics’ press release announcing the commencement of the trial 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 April 26, 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/ David J. Poston    
    David J. Poston   
    Chief Financial Officer   
 
Dated: April 26, 2006

 


Table of Contents

INDEX TO EXHIBITS
     
Exhibit    
Number   Description
99.1
  Press Release of Targeted Genetics Corporation dated April 26, 2006

 

EX-99.1 2 v19988exv99w1.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
ZAMBIA BEGINS FIRST PREVENTIVE HIV VACCINE TRIAL
Lusaka, Zambia and Seattle, Washington, USA—April 26, 2006—The Zambia Emory HIV Research Project (ZEHRP), the International AIDS Vaccine Initiative (IAVI) and Targeted Genetics Corporation (Nasdaq: TGEN) today announced the initiation of a clinical trial in Zambia to test the safety and immunogenicity of tgAAC09, a preventive HIV vaccine.
This is the first preventive HIV vaccine trial to be conducted in Zambia, and will take place at the Zambia Emory HIV Research Project Center in Lusaka with Dr. Elwyn Chomba acting as the Principal Investigator. It is an early-stage, multi-national trial, also being conducted at three sites in South Africa and Uganda.
“Zambia is proud today to be among the leading countries in Africa to spearhead the testing of vaccine candidates, given their great potential for the prevention of HIV/AIDS,” said Dr. Elwyn Chomba, ZEHRP and Principal Investigator for the trial.
“IAVI is pleased to be working with the excellent team at ZEHRP. Supported by the government of Zambia, and in collaboration with the scientific and medical community in Lusaka, the Zambia Emory HIV Research Project has contributed to HIV/AIDS prevention in the country,” said Seth Berkley, President and CEO of IAVI. “The Zambia study, along with other vaccine trials worldwide, will help us all take the field one step further in our search for a preventive HIV vaccine.”
The vaccine candidate, tgAAC09, was developed by Targeted Genetics, based in Seattle. The vaccine is based on HIV subtype C, the subtype of the virus most prevalent in southern Africa. tgAAC09 is designed as a preventive vaccine, intended to protect people not infected with HIV from contracting the disease. It is designed to elicit two different types of immune responses — an antibody response and a cell-mediated response.
“Expanding the evaluation of tgAAC09 to another region in need further advances the development of this vaccine candidate. We continue to be optimistic about the potential of AAV-based vaccines in the fight against HIV/AIDS and are pleased to be working in partnership with IAVI and ZEHRP in support of the global effort to halt the HIV pandemic. This is another example of the kind of

 


 

international collaboration that is critical to an expedited pursuit of an effective vaccine,” said H. Stewart Parker, President and Chief Executive Officer of Targeted Genetics.
About the Vaccine Candidate
The vaccine candidate, tgAAC09, utilizes a recombinant adeno-associated viral vector (AAV) that was developed with and manufactured by Targeted Genetics. Under the terms of a public-private collaboration, IAVI is funding development, pre-clinical and clinical studies to test the vaccine. The early-stage trial follows positive safety data received from the Phase I trial conducted over the past two years in Belgium, Germany, and India where volunteers received a lower-dose range.
Targeted Genetics’ AAV development process is based on a cell line which was designed by Philip R. Johnson, MD., at the Children’s Research Institute on the campus of Children’s Hospital, in Columbus, Ohio, USA. Dr. Johnson is now Chief Scientific Officer at the Children’s Hospital of Philadelphia, Pennsylvania, USA.
About the Trial
The trial should take about 18 months to complete. At the Lusaka clinical trial site, 16 volunteers (men and women) who are in good health will be enrolled. IAVI estimates that there are 30 preventive HIV vaccine candidates in human trials on six continents.
About IAVI
The International AIDS Vaccine Initiative (IAVI) is a global not-for-profit organization working to accelerate the development of a vaccine to prevent HIV infection and AIDS. Founded in 1996 and operational in 23 countries, IAVI and its network of collaborators research and develop vaccine candidates. IAVI also advocates for a vaccine to be a global priority and works to ensure that a future vaccine will be accessible to all who need it. IAVI’s financial and in-kind supporters include the Bill & Melinda Gates Foundation, the New York Community Trust, the Rockefeller Foundation, the Starr Foundation, the Governments of the Basque Country, Canada, Denmark, the European Union, Ireland, the Netherlands, Norway, Sweden, the United Kingdom, and the United States; multilateral organizations such as the World Bank; corporate donors including BD (Becton, Dickinson & Co.), Continental Airlines, DHL and Pfizer; leading AIDS charities such as Broadway Cares/Equity Fights AIDS, Crusaid, Deutsche AIDS-Stiftung, and the Until There’s A Cure Foundation; other private donors such as the Haas Charitable Trusts; and many generous individuals from around the world. For more information, see www.iavi.org.
About ZEHRP
The Zambia Emory HIV Research Project (ZEHRP), located in Lusaka, Zambia. The ZEHRP Ndola and Kitwe sites located in the Copperbelt and their sister project, Project San Francisco (PSF), located in Kigali, Rwanda, comprise the Rwanda Zambia HIV Research Group (RZHRG). The organization works with couples and has ongoing studies to 1) promote couples voluntary counseling and testing (CVCT), 2) measure the transmission between discordant (one HIV-positive and one HIV-negative) couples (Heterosexual Transmission study) and 3) assess the contraceptive choices of women (Family Planning study). The RZHRG sites are also currently participating in a multi-site Phase III clinical trial assessing the effect of Acyclovir in lowering the transmission of HIV in discordant couples. The Lusaka site was established in 1994 when Project San Francisco relocated to Zambia during the Rwandan genocide. ZEHRP boasts three CVCT centres as well as a well-equipped immunology and clinical laboratory.
About Targeted Genetics
Targeted Genetics Corporation (Nasdaq: TGEN) 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 tgAAC94, our expected use of these proceeds 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 ability to recruit and enroll suitable trial participants, 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 the section entitled “Factors Affecting Our Operating Results, Our Business and Our Stock Price” in our report on Form 10-K for the year ended December 31, 2005. 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.
Contacts
Katherine Moore, IAVI, New York, + 212 847 1097 kmoore@iavi.org
Ellena Friedman, IAVI, New York, +212 847 1090/+646 755 1973 efriedman@iavi.org
Stacie D. Byars, Targeted Genetics, Seattle, + 206 521 7392/ +206 660 2588
stacie.byars@targen.com
# # #

 

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