Corgentech Presents Additional Phase 2 Data Demonstrating 4975 Provides Early, Sustained Relief of Pain and improved function i
04 5월 2006 - 9:30PM
PR Newswire (US)
Additional Data in Morton's Neuroma Also Presented; Abstracts #5659
and #5663 at American Pain Society Meeting SAN ANTONIO and SOUTH
SAN FRANCISCO, Calif., May 4 /PRNewswire-FirstCall/ -- Corgentech
Inc. (NASDAQ:CGTK) today announced the presentation of promising
primary and secondary data from two Phase 2 clinical trials of
4975, Corgentech's novel, long-acting, non-opioid drug candidate,
in patients with elbow tendonitis (acute lateral epicondylitis) and
Morton's neuroma (intermetatarsal neuroma), a painful foot
condition, at the 25th Annual Scientific Meeting of the American
Pain Society. New, secondary data from the tendonitis trial
demonstrated that patients treated with a single, local injection
of 4975 exhibited sustained, significant reductions at all pain
endpoints and a significant improvement in function, compared to
the placebo group at the 4-week observation period. The meeting is
being held in San Antonio, TX. "Tendonitis is a debilitating
condition with very painful symptoms that can last for months and
current treatment options have inconsistent efficacy. This study
shows that treatment with 4975 not only effectively manages pain,
but improves function by more than 50 percent at four weeks,"
stated Daniel J. Gennevois, M.D., vice president of Medical Affairs
at Corgentech. 4975 Reduces Pain of Acute Lateral Epicondylitis:
Preliminary Results of a Randomized, Double-Blind,
Placebo-Controlled, Phase 2, Multicenter Clinical Trial In this
Phase 2 trial, patients with acute elbow tendonitis received a
single, local injection of 100 micrograms of 4975 or placebo at the
site of pain, preceded by an injection of a local anesthetic. At 4
weeks, 64 percent (14/22) of patients treated with 4975 experienced
decreased pain during resisted wrist movement, compared to 30
percent (7/23) of patients treated with placebo (p = 0.026).
Treatment with 4975 also resulted in an approximately 60 percent
improvement from baseline in grip strength at 4 weeks, compared to
an approximate 14 percent improvement in the placebo group (p =
0.009). Importantly, treatment with 4975 produced a significant
improvement on patients' global impression of change in pain at all
post treatment time points compared to placebo. At week 4, 64
percent (14/22) of the 4975 patients categorized themselves as
"very much improved" or "improved" since elbow injection versus 22
percent (5/23) of patients in the placebo group. With the exception
of pain on injection (which was managed with icepacks), 4975 was
well tolerated, causing no other treatment-related adverse events,
no decreases in sensory function, and no significant local
reactions of the skin. 4975 Reduces Pain of Intermetatarsal
Neuroma: Preliminary Results from a Randomized, Double-Blind,
Placebo-Controlled, Phase 2, Multicenter Clinical Trial In the
Phase 2 Morton's neuroma trial, patients who had failed
conservative treatments including analgesics and steroid injections
received a single local injection of 100 micrograms of 4975 or
placebo at the site of pain, preceded by an injection of a local
anesthetic. Patients treated with 4975 experienced greater pain
relief compared to placebo as measured by change from baseline in
average weekly foot pain, sum of average foot pain intensity,
change from baseline in pain-related interference items of the
Brief Pain Inventory, and patients' use of supplemental analgesic
medication. Importantly, significantly superior pain reduction
occurred early, at 1 week after start of treatment, and was
sustained at the 4-week observation period (p
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