Download Targeted Genetics Corporation - Morningstar Document Research

Form 8-K
AmpliPhi Biosciences Corp - APHB
Filed: November 30, 2005 (period: November 28, 2005)
Report of unscheduled material events or corporate changes.
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user
assumes all risks for any damages or losses arising from any use of this information, except to the extent such damages or losses cannot be
limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Table of Contents
8-K - FORM 8-K
Item 8.01 Other Events.
Item 9.01. Financial Statements and Exhibits.
SIGNATURES
EXHIBIT INDEX
EX-99.1 (EXHIBIT 99.1)
Source: AmpliPhi Biosciences Corp, 8-K, November 30, 2005
Powered by Morningstar Document Research.
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
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)
November 28, 2005
Targeted Genetics Corporation
(Exact name of registrant as specified in its charter)
Washington
(State or other jurisdiction
of incorporation)
0-23930
(Commission File
Number)
91-1549568
(IRS Employer
Identification No.)
1100 Olive Way, Suite 100, Seattle, Washington
(Address of principal executive offices)
98101
(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))
Source: AmpliPhi Biosciences Corp, 8-K, November 30, 2005
Powered by Morningstar Document Research.
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Item 8.01Other Events.
On November 28, 2005, Targeted Genetics Corporation and its scientific collaborators at The Children’s Hospital of Philadelphia
and Columbus Children’s Research Institute announced that the National Institute of Allergy and Infectious Disease has awarded a
$21.75 million contract to expand AAV-based HIV vaccine development, of which Targeted Genetics as a subcontractor is eligible to
receive up to $18 million over 5 years to be used to advance AAV-based vaccines against HIV. A copy of Targeted Genetics’ press
release announcing the contract award is attached as Exhibit 99.1 to this current report and is incorporated herein by reference.
Item 9.01.Financial Statements and Exhibits.
99.1 Press Release Dated November 28, 2005
2
Source: AmpliPhi Biosciences Corp, 8-K, November 30, 2005
Powered by Morningstar Document Research.
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
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 30, 2005
3
Source: AmpliPhi Biosciences Corp, 8-K, November 30, 2005
Powered by Morningstar Document Research.
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
EXHIBIT INDEX
99.1 Press Release Dated November 28, 2005
4
Source: AmpliPhi Biosciences Corp, 8-K, November 30, 2005
Powered by Morningstar Document Research.
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Exhibit 99.1
®
FOR IMMEDIATE RELEASE
Investor and Media Contact:
Stacie D. Byars
Director, Communications
Targeted Genetics Corporation
(206) 521-7392
TARGETED GENETICS NAMED AS SUBCONTRACTOR TO NIAID CONTRACT TO EXPAND
AAV-BASED HIV VACCINE PROGRAM
— NIAID funding to total approximately $22 Million —
— Contract provides funding mechanism to develop AAV-based vaccines against HIV
strains most prevalent in North America and Europe —
Seattle, WA — November 28, 2005 — Targeted Genetics Corporation (Nasdaq: TGEN) and its scientific collaborators at The
Children’s Hospital of Philadelphia and Columbus Children’s Research Institute (CCRI) today announced that the National Institute of
Allergy and Infectious Disease (NIAID) has awarded a $21.75 million contract to expand AAV-based HIV vaccine development. This
contract is being supported by the HIV Vaccine Design and Development Teams (HVDDT) program from the NIAID Division of
AIDS. Under the terms of this agreement, Targeted Genetics as a subcontractor is eligible to receive up to $18 million of the total over
5 years to be used to advance AAV-based vaccines against HIV.
“This program underscores the commitment and collaboration within the HIV vaccine community toward the potential for AAV-based
vaccines,” said H. Stewart Parker, President and Chief Executive Officer of Targeted Genetics. “Funding provided by this subcontract
will enable us to expand our HIV vaccine program beyond the scope of our important collaboration with the International AIDS
Vaccine Initiative (IAVI), which is focused on developing an AAV-based vaccine for use in developing nations. We believe that a
safe and effective vaccine against HIV is the best way to slow the growth of the AIDS pandemic. The focus of the program funded by
this contract is to develop an AAV-based HIV vaccine for worldwide use, and may represent a significant future product opportunity.”
“Our research to date in animal models of HIV infection suggest that AAV-based vaccines can stimulate robust B-cell and T-cell
responses, reduce viral load, and ultimately improve survival in vaccinated animals subsequently challenged with a virulent strain of
SIV,” said Philip R. Johnson Jr., M.D., Chief Scientific Officer at Children’s Hospital of Philadelphia and the
Source: AmpliPhi Biosciences Corp, 8-K, November 30, 2005
Powered by Morningstar Document Research.
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Principal Investigator for the contract. Johnson noted that the HVDDT will test a prime-boost vaccination protocol using rAAV
vectors based on two different serotypes of the AAV capsid. “If we are successful, this strategy can easily be applied to HIV vaccines
representing all clades of this genetically diverse human pathogen,” Johnson added.
“We are pleased that the NIAID recognizes the potential of this coordinated approach to HIV vaccine, prevention, and treatment
research and are looking forward to continuing to advance the development of AAV-based vaccines against HIV,” said K. Reed Clark,
Ph.D., Director, Viral Vector Core Facility and investigator in the Center for Gene Therapy at Columbus Children’s Research Institute
(CCRI) and Associate Professor of Pediatrics at The Ohio State University College of Medicine and Public Health.
The contract is designed to provide funding to optimize the manufacturing process for AAV-based vaccines and support preclinical
and clinical development of a vaccine against HIV. Clinical trials of a candidate vaccine will be coordinated through the
NIH-sponsored HIV/AIDS Vaccine Trials Network (HVTN).
Federal funding will be provided for this project by the National Institute of Allergy and Infectious Diseases, National Institutes of
Health, Department of Health and Human Services, under Contract No. HHSN266200500008C, ADB No. N01-AI-50008. The project
will be 100% federally funded in the amount of $21,752,051.
The Targeted Genetics-IAVI-CCRI-Children’s Hospital of Philadelphia collaboration has an ongoing Phase I HIV Vaccine clinical
study in Belgium, Germany, and India. The study is designed to assess safety and immune responses following immunization with
tgAAC09, its AAV-based HIV/AIDS vaccine, in healthy volunteers who are uninfected with HIV. In early 2005, the collaborative
group reported preliminary Phase I results demonstrating that the vaccine candidate met the safety endpoint and was well tolerated.
In November, 2005, the collaborative group announced the start of a Phase II trial in South Africa to test the safety and
immunogenicity of tgAAC09, a preventive HIV vaccine candidate that is based on HIV subtype C, the subtype of the virus most
prevalent in southern and eastern Africa. This is the first Phase II HIV vaccine trial to be held in South Africa. The trial is being
conducted in three sites in South Africa, anticipated to take about 18 months to complete and designed to enroll 78 volunteers who are
in good health. tgAAC09 is designed to elicit two different types of immune responses, an antibody response and a cell mediated
response, which is thought to be critical for an effective vaccine to prevent AIDS.
About Targeted Genetics Corporation
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 .
Contact: Stacie D. Byars, 206-521-7392
About The Children’s Hospital of Philadelphia
2
Source: AmpliPhi Biosciences Corp, 8-K, November 30, 2005
Powered by Morningstar Document Research.
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
The Children’s Hospital of Philadelphia was founded in 1855 as the nation’s first pediatric hospital. Through its long-standing
commitment to providing exceptional patient care, training new generations of pediatric healthcare professionals, and pioneering
major research initiatives, The Children’s Hospital of Philadelphia has fostered many discoveries that have benefited children
worldwide. Its pediatric research program is among the largest in the country, ranking second in National Institutes of Health funding.
In addition, its unique family-centered care and public service programs have brought the 430-bed hospital recognition as a leading
advocate for children and adolescents. For more information about The Children’s Hospital of Philadelphia, visit www.chop.edu .
Contact: Peggy Flynn, 267-426-6080
About Columbus Children’s Research Institute
Columbus Children’s Hospital ranks among the top 10 in National Institutes of Health research awards and grants to freestanding
children’s hospitals in the country and houses the Department of Pediatrics of The Ohio State University College of Medicine and
Public Health. The Columbus Children’s Research Institute (CCRI) conducts more than 400 research projects annually and is the
home of Centers of Emphasis encompassing gene therapy; molecular and human genetics; vaccines and immunity; childhood cancer;
cell and vascular biology; developmental pharmacology and toxicology; injury research and policy; microbial pathogenesis;
cardiovascular medicine; and biobehavioral health. Pediatric Clinical Trials International (PCTI), a site management organization
affiliated with the hospital, also coordinates more than 50 clinical trials annually. More information about Children’s Hospital of
Columbus or CCRI is available by calling (614) 722-KIDS or through the hospital’s web site at www.columbuschildrens.org .
Contact: Pam Barber, 614-722-4595
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995:
This release contains forward-looking statements regarding Targeted Genetics’ anticipated revenues, regulatory filings, research
programs, clinical trials, product development and potential related to Targeted Genetics’ AAV based vaccine initiatives. 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 its actual results include, but are not limited to, Targeted Genetics’ ability to recruit and enroll suitable trial participants,
the timing, nature and results of research and clinical trials, Targeted Genetics’ ability to raise capital when needed, Targeted
Genetics’ ability to obtain and maintain regulatory or institutional approvals, and, Targeted Genetics’ ability to protect its
intellectual property, as well as other risk factors described in the section entitled “Factors Affecting Our Operating Results, Our
Business and Our Stock Price” in Targeted Genetics’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2005. You
should not rely unduly on these forward-looking statements, which apply only as of the date of this release. Targeted Genetics’
undertakes no duty to publicly announce or report revisions to these statements as new information becomes available that may
change expectations.
###
3
Source: AmpliPhi Biosciences Corp, 8-K, November 30, 2005
Powered by Morningstar Document Research.
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.