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Trial Demonstrates Safety and Preliminary Efficacy and Supports Further
Clinical Development of tgAAC94
BOSTON and SEATTLE, May 30 /PRNewswire-FirstCall/ -- Targeted Genetics Corporation (Nasdaq: TGEN) issued a news release earlier today, entitled "Targeted Genetics Reports Additional Data From Inflammatory Arthritis Clinical Trial," announcing additional interim data from its Phase 1/2 clinical study of tgAAC94 in patients with inflammatory arthritis. Pervin Anklesaria, Ph.D., 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 (ASGT) in Seattle.
To clarify, the data demonstrated that a 30 percent decrease in the global visual analog scale (VAS) was experienced by 21/50 (42 percent) of subjects and 3/16 (19 percent) placebo subjects 12 weeks after the first injection. The global VAS is a clinically meaningful and commonly used pain assessment tool to help patients describe the intensity of their pain. A two-point decrease in swelling was noted in 8/50 (16 percent) treated subjects and 3/16 (19 percent) placebo subjects 12 weeks after the first injection. It appears that the patient-reported outcome measures of clinical response yielded greater differentiation between tgAAC94 and placebo than physical examination. In a subset of subjects, MRI was also performed on treated joints and a decrease in effusion was noted in 1/10 subjects tested.
"We are very pleased that the trial met safety endpoints and
demonstrated preliminary efficacy," said H. Stewart Parker, president and
chief executive officer of Targeted Genetics. "We believe the data suggest
that tgAAC94 has the potential
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