8-K

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

June 5, 2003 (Date of Report) (Date of Earliest Event Reported)

TARGETED GENETICS CORPORATION

(Exact Name of Registrant as Specified in Charter)

Washington (State or Other Jurisdiction of Incorporation) 0-23930 (Commission File No.) 91-1549568 (IRS Employer Identification No.)

1100 Olive Way, Suite 100, Seattle, WA 98101

(Address of Principal Executive Offices, Including Zip Code)

(206) 623-7612

(Registrant’s Telephone Number, Including Area Code)

Not applicable

(Former Name or Former Address, if Changed Since Last Report)

Item 5.

On June 7, 2003, Targeted Genetics Corporation announced preclinical data in support of its arthritis program at the 6^th annual meeting of the American Society of Gene Therapy. A copy of the press release dated June 9, 2003 relating to this announcement is attached as Exhibit 99.1 and is incorporated into this current report by reference.

On June 6, 2003, Targeted Genetics announced preclinical data in support of its AIDS vaccine program at the 6^th annual meeting of the American Society of Gene Therapy. A copy of the press release dated June 6, 2003 relating to this announcement is attached Exhibit 99.2 and is incorporated into this current report by reference.

On June 5, 2003, Targeted Genetics announced final results of its Phase II clinical trial in patients with cystic fibrosis at the 6^th annual meeting of the American Society of Gene Therapy. A copy of the press release dated June 5, 2003 relating to this announcement is attached as Exhibit 99.3 and is incorporated into this current report by reference.

Item 7. Financial Statements and Exhibits.

(c) Exhibits.

99.1	Press Release of Targeted Genetics Corporation dated June 9, 2003
99.2	Press Release of Targeted Genetics Corporation dated June 6, 2003
99.3	Press Release of Targeted Genetics Corporation dated June 5, 2003

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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
Date: June 10, 2003	By:	/s/    TODD E. SIMPSON
		Todd E. Simpson Vice President, Finance and Administration, Chief Financial Officer, Secretary and Treasurer

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INDEX TO EXHIBITS

Exhibit Number	Description
99.1	Press Release of Targeted Genetics Corporation dated June 9, 2003
99.2	Press Release of Targeted Genetics Corporation dated June 6, 2003
99.3	Press Release of Targeted Genetics Corporation dated June 5, 2003

EX-99.1

Exhibit 99.1

TARGETED GENETICS PRESENTS PRECLINICAL SAFETY DATA FROM ITS ARTHRITIS PROGRAM, 6/9/03 Seattle, WA and Washington, DC – June 9, 2003

Targeted Genetics Corporation (Nasdaq: TGEN) presented encouraging preclinical safety data in support of its arthritis program on Saturday, June 7, 2003, at the 6th Annual Meeting of the American Society of Gene Therapy in Washington, DC. These studies were conducted by the Company as part of its development plan for its product candidate, tgAAV-TNFR:Fc, for the treatment of rheumatoid arthritis. tgAAV-TNFR:Fc consists of a gene encoding the TNF-a antagonist TNFR:Fc, which is delivered using an adeno-associated virus (AAV) vector directly to an arthritic joint. In preclinical studies, intra-articular administration of the product candidate resulted in localized expression of the therapeutic protein and a suppression of arthritis symptoms. Targeted Genetics plans to submit regulatory filings in the second half of 2003 to initiate a Phase I human clinical trial.

The first poster presentation (Abstract #1051) was presented by Laurie M. Tatalick, DVM, Ph.D., DACFP, Senior Scientist at Targeted Genetics Corporation. This study, titled “Comparison of the Biodistribution of tgAAV-ratTNFR:Fc Administered Via Intra-Articular Injection to Normal and Arthritic Lewis Rats,” was designed to measure biodistribution and safety of intra-articular, or local, administration of the product candidate to normal and arthritic joints. Analysis of the resulting data determined the following:

No toxicity attributable to tgAAV-rat TNFR:Fc was noted at the maximal dose level. Local TNFR:Fc expression was confirmed in the injected joint after intra-articular administration of tgAAV-rat TNFR:Fc in both normal and arthritic rats without significant systemic TNFR:Fc protein levels.

Local administration of tgAAV-ratTNFR:Fc to normal and arthritic joints resulted in vector biodistribution that was detectable in a limited number of tissues on the fourth day of the study. TgAAV-ratTNFR:Fc was not detected at extra-articular sites after local delivery in either model at the end of the study on day 90 for non-arthritic animals and day 30 for arthritic animals.

“Today’s presentations illustrate a clean safety profile in support of Targeted Genetics’ arthritis program,” said Barrie J. Carter, Ph.D., Executive Vice President and Chief Scientific Officer of Targeted Genetics Corporation. “Together with the preclinical efficacy in support of both intra-articular and intramuscular administration of our TNF-R:Fc-based gene delivery product candidate, these data provide a complete preclinical package to move forward with regulatory filings in the second half of 2003 to initiate a Phase I clinical trial. Based on previous therapeutic experience with TNF-antagonist based treatments, we believe there is great potential for tgAAV-TNFR:Fc to provide an alternative therapy for those patients who do not benefit from currently approved treatments.”

A concurrent poster (Abstract #1035) was presented by Dana Martin, Clinical Research Associate at Targeted Genetics Corporation. In this study, titled “Biodistribution and Expression of AAV-huTNFR:Fc after Intra-Articular Injection to Cynomolgous Monkeys,” expression of human (hu)TNFR:Fc and distribution of vector (AAV-huTNFR:Fc) DNA was measured after a single intra-articular injection, into a small number of cynomolgous monkeys. Vector-specific DNA and RNA was detected in joint tissue for at least 90 days after intra-articular injection. Human TNFR:Fc protein was also detected in joint fluid and circulating human TNFR:Fc protein was detected at very low levels. Thus, intra-articular delivery of rAAV-huTNFR:Fc vector results in local expression of huTNFR:Fc protein and may be an alternate therapeutic modality in rheumatoid arthritis and psoriatic arthritis patients having a limited number of arthritic joints or who have persistently problematic joints despite current systemic therapy.

Proteins that inhibit the action of TNF-a are currently approved for the treatment of rheumatoid arthritis, psoriatic arthritis and Crohn’s disease. Use of TNF-a antagonists has resulted in a reduction in levels of TNF and the delay in disease progression in patients with rheumatoid arthritis. There is still a significant portion of the chronic inflammatory arthritis patient population that does not completely benefit from currently approved therapies. There may be unique benefits to local delivery of the gene encoding an inhibitor of TNF-a utilizing an AAV vector. Because of the safety profile of AAV vectors, localized delivery of TNFR:Fc could provide hope to those who have had a partial response to standard treatment.

Targeted Genetics develops gene therapy products for treating acquired and inherited diseases. The Company has a lead clinical product development program targeting cystic fibrosis and a promising pipeline of product candidates focused on arthritis, an AIDS vaccine, hemophilia and cancer. The Company has a broad platform of gene delivery technologies, as well as a promising body of technology for cellular therapy. For more information about Targeted Genetics Corporation, please visit the Company’s web site at http://www.targetedgenetics.com.

NOTE: This release contains forward-looking statements regarding our regulatory filings, research programs, product development and clinical trials. 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 research and our clinical trials, our ability to obtain regulatory approvals, our ability to 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 report on Form 10-Q for the quarter ended March 31, 2003. 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.

EX-99.2

Exhibit 99.2

TARGETED GENETICS PRESENTS PRECLINICAL RESULTS FROM AIDS VACCINE PROGRAM Completed Data Package to Support Regulatory Filings for Phase I Clinical Trial, 6/6/03

Seattle, WA and Washington, DC—June 6, 2003 – Targeted Genetics Corporation (Nasdaq: TGEN) will present positive data in support of its AIDS vaccine program today at the 6th Annual Meeting of the American Society of Gene Therapy in Washington, DC. Studies presented today discuss preclinical results that demonstrate the safety profile and robust immune response of the Company’s preventive HIV vaccine candidate, tgAAC09, which is based on recombinant adeno-associated viral (rAAV) vector technology. The completion of these studies supports initiation of a Phase I AAV-based AIDS vaccine clinical trial in humans in the second half of 2003.

In an oral presentation (Abstract #405) titled, “Genome-Wide Amplification for the Detection of Integrated rAAV-2 Vector DNA in Rabbit Tissues,” Bruce C. Schnepp, Ph.D., of the Center for Gene Therapy at the Columbus Children’s Research Institute (CCRI) will present results of studies measuring HIV-vaccine DNA integration. Studies were conducted in animals receiving a single intramuscular injection of tgAAC09. Animals were observed after 90 and 180 days.

Data highlights include:

No vaccine DNA was detected in the animals’ gonads at 90 and 180 days.

At 180 days, vaccine DNA was detected only at the site of injection and in a limited number of tissues.

Dissemination of the vaccine DNA throughout the body of those animals receiving the product candidate was dose-dependent and decreased over time.

Data suggest that the rAAV-based vaccine candidate delivered via intramuscular administration demonstrates safety properties similar to plasmid DNA.

“Studies presented today demonstrate a solid safety profile related to this AAV-based HIV vaccine candidate, supported by multiple data, including absence of detectable integration into host chromosomal DNA and no dose-related clinically significant safety issues. At the same time, tgAAC09 maintains a robust and sustained immune response after a single intramuscular injection,” said Philip Johnson, M.D., President of CCRI on the campus of Columbus Children’s Hospital. “These data, in addition to other results from our preclinical program, support the clinical utility of tgAAC09, and initiation of a Phase I clinical trial in humans is expected in the second half of 2003.”

Promising preclinical data from Targeted Genetics’ AIDS vaccine program will also be presented today by Dr. Johnson in a poster presentation (Abstract #668) titled, “Preclinical Evaluation of a Novel HIV Vaccine Based on an Adeno-Associated Virus Vector.” In this study, four groups of non-human primates received escalating doses of tgAAC09. The vaccine was delivered at initiation of study via single injection into muscle. Non-human primates were observed over a period of six months for antigen specific T-cell responses and antibody responses throughout the course of the study. Results demonstrate that a dose-dependent robust antibody response in vaccinated animals was detected and sustained throughout the duration of study. A similar dose response was observed in antigen-specific T cell responses, which persisted throughout the duration of study in all animals tested.

Results of safety studies from Targeted Genetics’ AIDS vaccine program will also be discussed today in a poster presentation (Abstract #690) titled, “Safety, Local Tolerability and Biodistribution of AAV2-gag-PR-DRT” by Keith Munson, Toxicology Scientist at Targeted Genetics. In these studies, animals were given a single intramuscular injection of tgAAC09 at three different dose levels and were monitored over a period of six months. There were no dose-related clinically significant safety issues. Overall distribution of the vaccine from the site of injection was limited.

Targeted Genetics, the International AIDS Vaccine Initiative (IAVI) and CCRI are collaborating on the development of tgAAC09. The vaccine is intended to protect people who are uninfected with HIV from becoming infected or developing AIDS. This collaboration was established in February 2000 with the goal of providing an AIDS vaccine to developing nations in a cost-effective manner.

Targeted Genetics develops gene therapy products for treating acquired and inherited diseases. The Company has a lead clinical product development program targeting cystic fibrosis and a promising pipeline of product candidates focused on arthritis, an AIDS vaccine, hemophilia and cancer. The Company has a broad platform of gene delivery technologies, as well as a promising body of technology for cellular therapy. For more information about Targeted Genetics Corporation, please visit the Company’s web site at http://www.targetedgenetics.com.

NOTE: This release contains forward-looking statements regarding our regulatory filings, research programs, product development and clinical trials. 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 research and our clinical trials, our ability to obtain regulatory approvals, our ability to 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 report on Form 10-Q for the quarter ended March 31, 2003. 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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EX-99.3

Exhibit 99.3

TARGETED GENETICS PRESENTS FINAL RESULTS FROM PHASE II CYSTIC FIBROSIS CLINICAL TRIAL -Complete Data Analysis Confirms Strong Safety Profile and Improvement in Lung Function- 6/5/03

Washington, DC and Seattle, WA—June 5, 2003 – Targeted Genetics Corporation (Nasdaq: TGEN) today announced final results of its Phase II clinical trial in patients with cystic fibrosis. The product candidate, tgAAVCF, met its primary endpoint demonstrating safety and tolerability in this first ever repeat dosing study. Positive trends in pulmonary function, inflammatory cytokine (IL-8) levels and gene transfer were also observed.

Data will be presented today at the 6th Annual American Society of Gene Therapy Meeting in Washington, DC by Richard B. Moss, M.D., Pediatric Pulmonary Medicine, Stanford University Medical Center and lead clinical investigator in this study. Dr. Moss will present a complete data analysis at a workshop titled, “Respiratory Tract: Planning and Executing a Gene Therapy Trial for the Respiratory Tract.”

tgAAVCF, Targeted Genetics’ lead gene therapy product candidate for the treatment of cystic fibrosis, was tested in a randomized, double-blind, placebo-controlled clinical trial that included 37 patients with mild cystic fibrosis. Patients were monitored for approximately five months. The complete data analysis confirmed preliminary results presented at the 16th Annual North American Cystic Fibrosis Conference in October of 2002. Data highlights are as follows:

• A clean safety profile was sustained over the entire 150-day study period. No clinically significant differences in adverse events between the product candidate and placebo were observed.

• Statistically significant improvements in lung function (FEV1) were observed after 30 days. In addition, positive trends were observed in various measurements of lung function after 60 and 90 days in the treated population, compared to the placebo group.

• A statistically significant decrease in IL-8 levels (a cytokine associated with inflammation) was observed after 14 days compared to placebo.

• Excellent gene transfer was observed in all patients tested.

After complete data analysis, additional data highlights included:

• Chest computerized tomography (CT) scans utilized to measure additional safety showed no statistically significant changes in CT scores between days 0 and 90, further supporting a strong safety profile associated with tgAAVCF.

• 22 percent of patients treated with tgAAVCF sustained a 5 percent or greater improvement in lung function at 90 days, while no patients receiving placebo achieved this response.

• 17 percent of patients treated with tgAAVCF sustained a 10 percent or greater improvement in lung function at 90 days, while no patients receiving placebo achieved this response.

• No correlation was observed between the levels of AAV neutralizing antibodies and patients’ FEV1 measurements, suggesting that antibodies to the AAV vector do not appear to impact the therapeutic profile of tgAAVCF when administered via repeat dosing.

“Targeted Genetics Corporation is the only organization to demonstrate a statistically significant improvement in lung function in a repeat-dosing gene therapy trial in humans with cystic fibrosis. In addition to demonstrating a favorable safety profile over a five-month period, the CF clinician community was encouraged by improvement trends observed in lung function throughout this study,” said Dr. Moss. “Based on these positive findings, we plan to initiate a larger, confirmatory study in patients with cystic fibrosis. This Phase IIb clinical trial will almost triple the number of study participants and will focus primarily on the change in lung function – a well-established measurement of improvement in patients with this debilitating disease. We look forward to launching this study in the coming months and to further our understanding of the potential of tgAAVCF to go beyond management of signs and symptoms of cystic fibrosis and treat the underlying cause of the disease.”

This phase II clinical trial involved 37 CF patients with mild lung disease, 17 who received placebo and 20 who received tgAAVCF. The mean age in this study was 24 years. Following approvals from an independent data safety monitoring board, patients as young as 12 years of age were included in the clinical trial. Patients were randomized to receive three doses at 30-day intervals of tgAAVCF, 1013 DNAse resistant particles (DRP) per dose, or placebo. Patients were followed for 90 days after receiving their last dose. The primary endpoint of this study was the safety and tolerability of repeat dosing with tgAAVCF. Activity measures included lung function (FEV1 – a standard measurement of lung function), inflammation and microbiology. In a subset of six patients undergoing bronchoscopy one to two months after last dosing, gene expression, measured by determining levels of mRNA, was not demonstrated in cells brushed from the largest airways within the limit of detection of the assay. Over the course of the clinical trial, AAV neutralizing antibody response occurred systemically and locally, although no correlation was noted between the levels of AAV neutralizing antibodies and patients’ change in lung function (FEV1).

About tgAAVCF and Cystic Fibrosis

tgAAVCF uses an AAV vector to deliver a functionally correct copy of the CFTR gene to the airways of patients with CF. Loss of proper function of the CFTR gene is the cause of CF. While current therapies treat the symptoms of CF, tgAAVCF has the potential to address the underlying cause of the disease. Normally, the protein encoded by this gene is found in the respiratory passageways, pancreas, salivary and sweat glands, where it helps to regulate the cellular concentration of chloride ions and water. In CF patients, the loss of this gene’s function leads to the production and build-up in the lungs and sinuses of thick sticky mucus, colonization by bacteria and the invasion of white blood cells, thus causing inflammation. These events produce scarring in the lung, which ultimately results in loss of respiratory function. Common symptoms include very salty-tasting skin, persistent coughing, wheezing or pneumonia, excessive appetite but poor weight gain, and bulky stools. It is estimated that 60,000 people worldwide have cystic fibrosis, including approximately 30,000 people in the United States. The median age of survival for patients with CF is approximately 33 years. For more information about CF and Cystic Fibrosis Foundation please visit http://www.cff.org.

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Targeted Genetics develops gene therapy products for treating acquired and inherited diseases. The Company has a lead clinical product development program targeting cystic fibrosis and a promising pipeline of product candidates focused on arthritis, an AIDS vaccine, hemophilia and cancer. The Company has a broad platform of gene delivery technologies, as well as a promising body of technology for cellular therapy. For more information about Targeted Genetics Corporation, please visit the Company’s web site at http://www.targetedgenetics.com.

NOTE: This release contains forward-looking statements regarding our regulatory filings, research programs, product development and clinical trials. 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 research and our clinical trials, our ability to obtain regulatory approvals, our ability to 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 report on Form 10-Q for the quarter ended March 31, 2003. 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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