-----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, VEdwPS/DyjDmTR7KQKAWNuClGGxMoQiEIQ5EljZBbXQP0vTcsHE3mofMLvA8HJM/ 6i9gi3Q5nfSXq5IgW3K3rw== 0000950124-05-006084.txt : 20051102 0000950124-05-006084.hdr.sgml : 20051102 20051102140433 ACCESSION NUMBER: 0000950124-05-006084 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20051031 ITEM INFORMATION: Departure of Directors or Principal Officers; Election of Directors; Appointment of Principal Officers ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20051102 DATE AS OF CHANGE: 20051102 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: 051172637 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 v14035e8vk.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)   October 31, 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 5.02. Departure of Directors or Principal Officers; Election of Directors; Appointment of Principal Officers.
     On October 31, 2005, the Board of Directors of Targeted Genetics Corporation, or the Company, appointed a new member, Dr. Michael Perry as a Class III director, for a term that expires on the date of the Company’s 2006 annual meeting of shareholders or when his successor is duly elected and qualified. Dr. Perry will fill the vacancy on the Board of Directors resulting from the retirement of Mark H. Richmond, which was previously disclosed on the Company’s current report on Form 8-K filed September 13, 2005. At this time, the Board of Directors has not yet determined on which of its committees, if any, Dr. Perry will serve. Dr. Perry is currently Chief Development Officer at VIA Pharmaceuticals, Inc. Dr. Perry previously served as Chairman and CEO of Extropy Pharmaceuticals, Inc. from June 2003 to March 2005. From February 2002 to March 2003, Dr. Perry served as President and CEO of Pharsight Corporation. From 2000 to 2002, Dr. Perry served as Worldwide Head of Global Research and Development for Baxter BioScience. From 1994 to 2000, Dr. Perry was President and CEO of both SyStemix Inc. and Genetic Therapy Inc., two wholly owned subsidiaries of Novartis Corp. Prior to 1994, Dr. Perry held various management positions with Syntex Corporation, Schering-Plough Corporation, and BioResearch Laboratories, Inc. Dr. Perry holds a Doctor of Veterinary Medicine, a Ph.D. in Biomedical Science-CardioPulmonary Pharmacology, and a B.S. in Physics from the University of Guelph. A copy of the Company’s press release announcing Dr. Perry’s appointment is attached as Exhibit 99.1 to this current report and is incorporated herein by reference.
Item 8.01 Other Events.
     On October 31, 2005, the Company announced additional data from its Phase I clinical trial of tgAAC94 in patients with inflammatory arthritis. A copy of the Company’s press release announcing the preliminary results of the Phase I clinical trial is attached as Exhibit 99.2 to this current report and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
 
99.1 Press Release Dated October 31, 2005
 
99.2 Press Release Dated November 1, 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/  H. STEWART PARKER    
    H. Stewart Parker  
    President and Chief Executive Officer   
 
Dated:   November 1, 2005

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EXHIBIT INDEX
         
99.1   Press Release Dated October 31, 2005
 
99.2   Press Release Dated November 1, 2005

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EX-99.1 2 v14035exv99w1.htm EXHIBIT 99.1 exv99w1
 

Exhibit 99.1
Investor and Media Contact:
Stacie D. Byars
Director, Communications
Targeted Genetics Corporation
(206) 521-7392
TARGETED GENETICS PRESENTS ADDITIONAL DATA FROM ITS
INFLAMMATORY ARTHRITIS PROGRAM AT THE 13th ANNUAL
CONGRESS OF THE EUROPEAN SOCIETY OF GENE THERAPY
– Results demonstrate safety and reduction of mean tenderness and swelling
scores of the treated joint; results support continued study of tgAAC94 in
conjunction with TNF-alpha antagonists in inflammatory arthritis–
Seattle, WA and Prague, Czech Republic—October 31, 2005 — Targeted Genetics Corporation (Nasdaq: TGEN) presents additional results from its initial Phase I clinical trial of tgAAC94 in patients with inflammatory arthritis, in a poster session during the 13th Annual Congress of the European Society of Gene Therapy in Prague, Czech Republic, October 29 — November 1. Barrie J. Carter, Ph.D., Executive Vice President and Chief Scientific Officer at Targeted Genetics, is presenting the data in a poster session at the conference. This presentation highlights data from the Phase I clinical study evaluating the safety of intra-articular injection of two escalating dose levels of tgAAC94 in patients not on concomitant systemic TNF-alpha antagonist therapy.
The Phase I clinical trial was designed to evaluate safety of a single dose of tgAAC94 injected locally into the arthritic joint of subjects suffering from inflammatory arthritis. Enrollment was limited to those not currently on concomitant TNF-alpha antagonist therapies. Fifteen subjects who enrolled in the trial were randomized to receive either one of two escalating dose levels of tgAAC94 (n=11) or a placebo (n=4). The trial contained a placebo arm at each dose level, which was included to assess safety and determine whether any adverse events were attributable to an intra-articular injection itself, as opposed to an intra-articular injection of tgAAC94.
Preliminary safety data were previously reported by the Company after all subjects had been evaluated for 4 weeks after injection. Secondary endpoints were also reported on a subset of subjects that had completed up to eight weeks of follow-up. In those treated with tgAAC94 and followed for up to eight weeks, there was an indication of sustained improvement in signs and symptoms of disease in injected joints. The trial is closed for enrollment and patients will continue to be followed for 24 weeks after injection.


 

All subjects have now been followed for at least 12 weeks after injection of tgAAC94 or placebo. Data presented at this time point demonstrate that:
  Intra-articular injections of tgAAC94 were safe and well-tolerated at doses up to 1x1011 DRP per mL of joint volume among patients currently taking conventional disease modifying anti-rheumatic drugs (DMARDS).
  No drug-related serious adverse events have been reported to date (n=11).
  Although the study is not powered to show efficacy, in those treated with a single dose of tgAAC94, continued measurable improvements in swelling and tenderness were observed (n=11). The reduction in mean scores appears to be greater at the higher dose, suggesting a dose to response correlation (n=6). There was some improvement noted in mean tenderness and swelling scores in subjects receiving placebo (n=4). These subjects were primarily included for safety analysis.
  In the non-injected joints of the tgAAC94 treated groups there also appears to be a trend in the decrease in mean tenderness and swelling scores over time, which was not observed in the subjects receiving placebo.
“I am very encouraged that the results from later time points in the study continue to demonstrate the safety of injecting tgAAC94 directly into affected joints, and the observed trends in improvements in tenderness and swelling scores of treated joints persist,” said Carter. “We believe that the data presented today support the potential of our experimental therapeutic product, tgAAC94, to treat patients who suffer with inflammatory arthritis. We are excited to have recently initiated our next Phase I clinical study in patients with inflammatory arthritis who have not experienced an adequate response to anti-TNF-alpha therapy and who might have ongoing destructive inflammation in select joints.”
About the Follow-on Phase I Clinical Trial of tgAAC94
In October, 2005, Targeted Genetics initiated a follow-on Phase I clinical trial of tgAAC94 administered directly to affected joints of patients with inflammatory arthritis who may be receiving concomitant systemic TNF-alpha antagonist therapy. The study is designed to enroll up to 40 subjects and will evaluate tgAAC94 at two dose levels in patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and who may be receiving concomitant treatments of anti-TNF-alpha therapy. tgAAC94 is being developed initially as a complementary therapy for patients who may not achieve adequate relief with existing arthritis treatments or others who have disease limited to a few joints and therefore, may not need systemic protein therapies. This targeted, localized approach to treatment is intended to provide therapeutic benefit that will enable patients to achieve better control and relief of the signs and symptoms of their disease.
In the first segment of the double-blind, placebo-controlled study, subjects will receive a single intra-articular injection of tgAAC94 or placebo in the affected joint and be monitored until swelling in the target joint reaches pre-determined criteria for re-injection. At that time, both tgAAC94-injected subjects and those initially injected with placebo will receive a second injection of tgAAC94 in the affected joint as part of the open-label segment of the study. The primary endpoint of the study is to establish the safety of a higher dose and of repeat administration of tgAAC94 into the joints of subjects with or without concomitant TNF-alpha inhibitor therapy. Secondary endpoints include evaluation of pain, swelling, duration of response, and overall disease activity following intra-articular administration of tgAAC94 to affected joints, as well as molecular markers of disease. Additionally, changes in joint inflammation and joint damage will be assessed in a subset of patients using magnetic resonance imaging.

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About tgAAC94
tgAAC94 uses Targeted Genetics’ recombinant AAV (rAAV) vector technology and contains a gene that encodes a soluble form of the TNF-alpha receptor (TNFR:Fc). Soluble TNFR inhibits the immune stimulating activity of TNF-alpha. Direct injection of tgAAC94 into affected joints leads to the localized production of soluble TNFR by the patient’s joint cells. Localized production of TNFR reduces the activity of TNF-alpha within the joint, potentially leading to a decrease in the signs and symptoms of inflammatory disease and inhibition of joint destruction. Preclinical studies have demonstrated the efficacy of tgAAC94 in reducing inflammation and joint damage. Data from preclinical studies conducted in an animal model of inflammatory arthritis demonstrated that a single injection of rAAV encoding a soluble form of the rat TNFR:Fc vector into the ankles of arthritic rats resulted in a significant reduction in ankle and hind paw swelling as measured by arthritis index scores.
tgAAC94 is being developed as a potential supplement to systemic anti-TNF-alpha protein therapy for use in patients with inflammatory arthritis who have one or more joints that do not respond to systemic protein therapy. Local administration of a DNA sequence encoding a soluble TNFR potentially may supplement currently used drugs in a number of inflammatory conditions. In addition, a locally administered anti-TNF-alpha therapy could also be useful in patients who have a limited number of joints affected by inflammatory arthritis that are at a risk for progressive joint damage but who may not require systemic therapy. The characteristics of AAV vectors make them well suited for delivery of genetic material to joints and other organs. The Company’s rAAV technology platform is used to deliver genes and is based on AAV, a naturally-occurring virus that has not been associated with any disease in humans.
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 and other acquired and inherited diseases with significant unmet medical need. We use our considerable knowledge and capabilities in the development and manufacturing of gene delivery technologies to advance a diverse product development pipeline. Our product development efforts target inflammatory arthritis, AIDS prophylaxis, congestive heart failure, Huntington’s disease and hyperlipidemia. To learn more about Targeted Genetics, visit our 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 intellectual property, research programs and clinical trials, our product development and our potential development platforms including tgAAC94 and other statements about our plans, objectives, intentions and expectations. In particular, the statements regarding the Company’s pipeline, ability to maintain patients in the trial for follow-up and future clinical trial plans 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, initial trial results not indicative of results from the completion of the trial, the timing, nature and results of 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 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 period ended June 30, 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.
# # #

3

EX-99.2 3 v14035exv99w2.htm EXHIBIT 99.2 exv99w2
 

Exhibit 99.2
Investor and Media Contact:
Stacie D. Byars
Director, Communications
Targeted Genetics Corporation
(206) 521-7392
TARGETED GENETICS ANNOUNCES APPOINTMENT OF MICHAEL S. PERRY,
18 YEAR BIOTECHNOLOGY/PHARMACEUTICAL INDUSTRY VETERAN,
TO ITS BOARD OF DIRECTORS
Seattle, WA — November 1, 2005 — Targeted Genetics Corporation (NASDAQ: TGEN) announced today that it has appointed Michael S. Perry, D.V.M., Ph.D., to its board of directors.
Dr. Perry brings over 18 years of successful biotechnology and pharmaceutical management experience. He has a proven track record in research and development innovation with special emphasis on product development and approval, strategic portfolio management, integration of company mergers and acquisitions, business development, and driving shareholder value. Dr. Perry is currently Chief Development Officer at VIA Pharmaceuticals, Inc., a company that is developing therapeutics to treat cardiovascular inflammation at the level of the vessel wall to stabilize the disease process and reduce cardiovascular events.
“Mike adds extensive technical expertise in traditional and cutting-edge biomedical science to our Board of Directors,” said H. Stewart Parker, President and CEO of Targeted Genetics. “In addition, his widespread knowledge in strategic business development transactions and product assessment will be important as we continue to execute on our partnership and broader business strategies. I believe Mike’s experience will be particularly relevant and valuable to achieving our ongoing goals and objectives.”
Previous to his role at VIA Pharmaceuticals, Dr. Perry was President, Chief Executive Officer and Co-founder of Extropy Pharmaceuticals, Inc., a pediatric-focused specialty pharmaceutical company. Dr. Perry also served as President, CEO and Director of Pharsight Corporation; Worldwide Head of Global R&D of Baxter’s Biopharmaceuticals Business, a division of Baxter Healthcare Corporation; President, CEO and Director of SyStemix Inc. and Genetic Therapy Inc., two wholly owned Biotech subsidiaries of Sandoz/Novartis Pharma, as well as held various management positions in regulatory and scientific affairs at Novartis, Syntex Corporation, Schering-Plough Corporation and BioResearch Laboratories, Inc. Dr. Perry has also held previous board positions with BioTransplant, California Healthcare Institute, Arriva Pharmaceuticals, Pharsight Corporation, and Extropy Pharmaceuticals. Dr. Perry holds a B.Sc. in Physics, a Ph.D. in Biomedical Science with a specialization in Cardiopulmonary Pharmacology and a doctorate in Veterinary Medicine & Surgery (D.V.M.) from the University of Guelph, Ontario, Canada.


 

“I look forward to serving on the Targeted Genetics Board of Directors,” said Perry.
“The company has a proven AAV technology platform that shows promise in the genetic therapeutics marketplace and is an attractive attribute to potential partners. I look forward to contributing to Targeted Genetics’ continuing future success as an independent director.”
Dr. Michael Perry has been appointed as a director to fill the vacant board seat resulting from Dr. Mark Richmond’s recent retirement.
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 and other acquired and inherited diseases with significant unmet medical need. We use our considerable knowledge and capabilities in the development and manufacturing of gene delivery technologies to advance a diverse product development pipeline. Our product development efforts target inflammatory arthritis, AIDS prophylaxis, congestive heart failure, Huntington’s disease and hyperlipidemia. To learn more about Targeted Genetics, visit our 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 business strategy, our product development and other statements about our plans, objectives, intentions and expectations. In particular, the statements regarding the Company’s future plans 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, the timing, nature and results of 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 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 period ended June 30, 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.
# # #

2

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