Full Press Release Details
| Stacie D. Byars | Carolyn Wang |
| WeissComm Partners | WeissComm Partners |
| 415.946.1072 | 415.946.1065 |
| sdbyars@wcpglobal.com | cbwang@wcpglobal.com |
GENETICS REPORTS ADDITIONAL DATA FROM
ARTHRITIS CLINICAL TRIAL
Mass. and SEATTLE, Wash.
30, 2008- Targeted Genetics Corporation (Nasdaq: TGEN) today announced
additional interim data from its Phase 1/2 clinical study of tgAAC94 in patients
with inflammatory arthritis. Pervin Anklesaria, PhD, Vice President of
Therapeutic Development for Targeted Genetics, presented the data in an oral
presentation at the 11th Annual Meeting of the American Society of Gene Therapy
presented on 127 adults who received a single intra-articular injection of
either active drug (tgAAC94) or placebo, followed by an open-label injection
12-30 weeks later, depending on when the treated joint met pre-determined
criteria for re-injection. tgAAC94 is an investigational therapeutic designed
inhibit the activity of tumor necrosis factor-alpha (TNF-alpha), a key mediator
of inflammation. The Phase 1/2 study is designed to assess the safety and
potential effect of multiple doses of tgAAC94 administered directly to affected
joints of subjects with inflammatory arthritis with or without concurrent use
systemic TNF antagonist therapies.
reported that 127 subjects received the 1st injection of blinded study drug
95 of those subjects received a 2nd
injection of open-label study drug. The drug resulted in administrative site
reactions following 12% of injections, but was otherwise well-tolerated. There
was only one serious adverse event (SAE), a culture negative septic arthritis,
which was determined to be probably related to tgAAC94. Other SAEs included
case of fatal disseminated histoplasmosis in a subject receiving systemic
anti-TNF therapy that was ultimately deemed unrelated to study agent, and 10
other unrelated SAEs.
responses were assessed in the 66 subjects in the Segment B portion using
patient reported outcomes. Although the trial was not powered to detect a
significant difference between treated and placebo subjects, a 30% decrease
the global visual analog scale (VAS) was experienced by 21/50 (42%) subjects
3/16 (19%) placebo subjects 12 weeks after 1st injection. The global VAS is
clinically meaningful and commonly used pain assessment tool to help patients
describe the intensity of their pain. A 2-point decrease in swelling was noted
in 8/50 (16%) treated subjects and 3/16 (19%) placebo subjects 12 weeks after
1st injection. It appears that the patient reported outcome measures of clinical
response yielded greater differentiation between tgAAC94 and placebo than
physical examination.
these results do not provide statistical evidence of efficacy, we believe they
suggest that tgAAC94 has the potential to improve disease symptoms that are
refractory to other therapies, including systemic TNF antagonists," said H.
Stewart Parker, president and chief executive officer of Targeted Genetics.
"These clinical observations will help guide further clinical development.
Additional treatment options are essential for allowing all patients with
inflammatory arthritis to achieve optimal relief of their symptoms."
in this Phase 1/2 study continue to be followed for safety and measures aimed
assess functional improvement in treated joints. In a subset of subjects MRI
also performed on treated joints and decrease in effusion was noted in 1/10
Anklesaria will also be presenting in a Scientific Symposium on safety and
clinical outcomes of intra-articular injection of tgAAC94.
Targeted Genetics Corporation
Genetics Corporation is a biotechnology company committed to the development
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.
Harbor Statement under the Private Securities Litigation Reform Act of
release contains forward-looking statements regarding the Company's business
strategy and product development, including statements regarding the data
collected in the inflammatory arthritis study, the potential efficacy of
tgAAC94, the potential impact of the study on our results of operations and
other statements about the Company's 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 actual future
events or results include, but are not limited to, payments
anticipated by the Company under product development collaborations and
contracts, the Company's actual expenses,
Company's ability to raise capital when needed, the timing, nature and results
of the Company's clinical trials, potential development of alternative
technologies or more effective products by competitors, the Company's ability
obtain and maintain regulatory or institutional approvals, the Company's ability
to maintain its listing on the NASDAQ Capital Market and the Company's ability
to obtain, maintain and protect its intellectual property, as well as other
factors described in its filings with the Securities and Exchange Commission
(SEC), including in "Item 1A. Risk Factors" in the Company's most recent
quarterly report on Form 10-Q for the quarter ended March 31, 2008 filed with
the SEC. 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.