Targeted Genetics Reports Additional Data From Inflammatory Arthritis Clinical Trial
30 5월 2008 - 9:00PM
Marketwired
BOSTON, MA and SEATTLE, WA 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 in Seattle (ASGT).
Data were 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 to
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 of systemic
TNF antagonist therapies.
It was reported that 127 subjects received the 1st injection of
blinded study drug and 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 a 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.
Clinical 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 in the global visual
analog scale (VAS) was experienced by 21/50 (42%) subjects and 3/16
(19%) placebo subjects 12 weeks after 1st injection. The global VAS
is a 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.
"Although 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."
Patients in this Phase 1/2 study continue to be followed for
safety and measures aimed to assess functional improvement in
treated joints. In a subset of subjects MRI was also performed on
treated joints and decrease in effusion was noted in 1/10 subjects
tested.
Dr. Anklesaria will also be presenting in a Scientific Symposium
on safety and clinical outcomes of intra-articular injection of
tgAAC94.
About Targeted Genetics Corporation
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
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, the 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 to 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 risk 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.
Investor and Media Contact: Stacie D. Byars WeissComm Partners
415.946.1072 Email Contact Carolyn Wang WeissComm Partners
415.946.1065 Email Contact
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