Phase II Clinical Trial Protocol Design Underway
SEATTLE, WA, Nov 26, 2007 (MARKET WIRE via COMTEX News Network) -- Targeted Genetics Corporation (NASDAQ: TGEN) today announced that
the U.S. Food and Drug Administration (FDA) removed the hold on the
Company's Phase I/II clinical trial of tgACC94 for inflammatory
arthritis. This action follows the agency's review of the safety data
to date on all 127 subjects and all data from a fatal serious adverse
event (SAE), which led to a clinical trial hold in July of this year.
The Company will host a conference call and webcast discussion today
beginning at 10:30 a.m. Eastern Time / 7:30 a.m. Pacific Time. You
may access the live webcast via the "Events" section of the Company's
website at www.targetedgenetics.com or via telephone at 800.240.2134
(domestic) or 303.275.2170 (international).
The data obtained during the investigation indicates that tgAAC94 did
not contribute to the patient's death, which was due to disseminated
histoplasmosis. Final molecular test results presented earlier this
month at the 71st annual meeting of the American College of
Rheumatology (ACR), supported initial observations that no
amplification of viral vector occurred in the patient's body as a
result of the investigational therapy, that only trace amounts of
vector DNA were detected in tissues outside the treated joint, and
that the amount of circulating TNF-alpha antagonist protein was as
expected from the background therapy. The subject was on adalimumab,
methotrexate and prednisone, which are known to be immunosuppressive
and a risk factor for histoplasma infection.
Targeted Genetics is revising the Phase I/II trial's informed consent
to include information about the SAE, and will amend the protocol to
encompass suggestions made by the FDA and its independent data safety
monitoring board. Over the next several weeks, the Company will work
with trial sites to obtain Institutional Review Board approval of the
amended protocol and revised informed consent and to re-consent the
approximately 35 patients who have yet to receive the second
injection. Patients in this trial are followed for 30 weeks after the
second injection.
"We are working closely with trial site physicians to ensure we
resume development in the most efficient manner possible with patient
safety, as always, of paramount importance," said H. Stewart Parker,
president and chief executive officer of Targeted Genetics. "We
anticipate having full data from the Phase I/II trial in the second
half of 2008. In the meantime, we believe we have the information
needed from this trial to simultaneously plan initiation of a Phase
II trial of tgACC94 in the second-half of 2008."
The Phase II clinical trial of tgAAC94 will be designed to evaluate
efficacy and duration of response, as well as further assess safety,
in patients with inflammatory arthritis who are not candidates for
systemic protein therapy, because they have one or few inflamed joints
or they do not fully respond to systemic anti-TNF protein therapy.
Phase I/II Study Details
The ongoing Phase I/II study is designed to assess the safety and
potential efficacy of different doses of tgAAC94 administered directly
to affected joints of subjects with inflammatory arthritis. Subjects
already enrolled in the study will continue to be followed and
monitored. Since the trial began in October 2005, 127 subjects have
received an initial dose of active drug or placebo into the knee,
ankle, wrist, metacarpophalangeal or elbow, and 74 subjects out of
the total 127 have received a second dose of active drug. Of those 74
subjects, 52 have received two doses of active drug.
The Company recently reported interim data from 66 subjects enrolled
in the Phase II portion of the trial at the ACR meeting. A higher
percentage of subjects who received tgAAC94 reported improvement in
joint symptoms, function and pain compared to the placebo injected
group. These interim data also indicated that tgAAC94 is
well-tolerated for doses up to 5x10(13) DRP. The most common adverse
events noted were injection site reactions, seen in 10% of patients
treated.
Inflammatory arthritis is a serious disease affecting more than two
million people in the United States and can lead to debilitating
chronic pain, permanent nerve, bone and joint damage, and, in some
cases, death. While medications are available to slow and sometimes
stop symptoms, they can compromise the immune system and leave
patients with side effects, such as chronic infections. The Company's
tgAAC94 product candidate, a locally targeted therapy approach, is
designed to reduce inflammation locally in the joints and avoid the
potential for systemic side effects.
About tgAAC94
tgAAC94 is being developed as a supplemental therapeutic to systemic
anti-TNF-alpha protein therapy for use in patients with inflammatory
arthritis who have one or few inflamed joints or who do not fully
respond to systemic protein therapy. The product candidate uses
Targeted Genetics' recombinant AAV (rAAV) vector technology to
deliver a DNA sequence that encodes a soluble form of the TNF-alpha
receptor (TNFR: Fc). Soluble TNFR:Fc inhibits the immune stimulating
activity of TNF-alpha. Direct injection of tgAAC94 into affected
joints leads to the localized production of secreted TNFR:Fc within
joint cells, reducing the activity of TNF-alpha within the joint and,
potentially, leading to a decrease in the signs and symptoms of
inflammatory disease and inhibition of joint destruction.
Teleconference Replay Access
Webcast replay will be available for approximately 30 days at
www.targetedgenetics.com; telephone replay will be available
following today's call at approximately 9:30 p.m. PT through 11:59
p.m. PT, Sunday, December 23, 2007, by calling 800.405.2236
(domestic) or 303.590.3000 (international); pass code 11089229#.
About Targeted Genetics
Targeted Genetics Corporation is a biotechnology company committed to
the development of innovative targeted molecular therapies for the
prevention and treatment of acquired and inherited diseases with
significant unmet medical need. Targeted Genetics' proprietary
Adeno-Associated Virus (AAV) technology platform allows it to deliver
genes that encode proteins to increase gene function or RNAi to
decrease or silence gene function. Targeted Genetics' product
development efforts target inflammatory arthritis, AIDS prophylaxis,
congestive heart failure and Huntington's disease. To learn more
about Targeted Genetics, visit Targeted Genetics' 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
continuation and results of its clinical trial of tgACC94, the data
collected in the tgAAC94 program, the cause of the serious adverse
event, establishment or determination of efficacy endpoints from the
data collected in the trial, and the timely and complete accrual of
patients in the trial. 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 actual future events or results
include, but are not limited to, the timing, nature and results of
the Company's clinical trials, the Company's ability to obtain and
maintain regulatory or institutional approvals, and the Company's
ability to obtain, maintain and protect its intellectual property, as
well as other risk factors described in "Item 1A. Risk Factors" in
the Company's most recent annual report on Form 10-K for the year
ended December 31, 2006 filed with the SEC and in its most recently
filed quarterly report on Form 10-Q for the quarter ended September
30, 2007. You should not rely unduly on these forward-looking
statements, which apply only as of the date of this release. The
Company undertakes no duty to publicly announce or report revisions
to these statements as new information becomes available that may
change the Company's expectations.
Investor and Media Contact:
Stacie D. Byars
Director, Communications
Targeted Genetics Corporation
206.521.7392
SOURCE: Targeted Genetics