News Release
ZymoGenetics Presents Favorable RECOTHROM(R) Phase 3b Results
December 8, 2008
RECOTHROM did not produce immune response in patients who had antibodies to bovine thrombin
"In the Phase 3b study, 16% of patients entered surgery with
pre-existing antibodies to bovine thrombin," said
The Phase 3b open-label, single-group, multisite study evaluated the immunogenicity and safety of RECOTHROM among 205 subjects who were at increased risk for having anti-bovine thrombin product antibodies as a result of prior surgery with a high likelihood of bovine thrombin exposure. Topical RECOTHROM was applied during a single spinal or vascular surgical procedure. Immunogenicity was evaluated by enzyme-linked immunosorbent assay at baseline and Day 29. At baseline, 173 subjects (84%) were seronegative and 32 (16%) were seropositive for anti-bovine thrombin product antibodies.
At the end of the study, no patients had developed antibodies against RECOTHROM. The immunogenicity profile of RECOTHROM did not differ among patients who entered the study with or without pre-existing antibodies to the bovine thrombin product.
RECOTHROM was well tolerated and observed adverse events (AEs) were consistent with those commonly seen in post-surgical settings. The most common AEs (reported by 10% or more of subjects) included incision site pain, procedural pain, nausea, constipation, anemia, muscle spasms, hypotension, and pyrexia. The safety results in this study were consistent with those observed in previously reported clinical trials with RECOTHROM.
RECOTHROM is being commercialized by
About RECOTHROM(R) Thrombin, topical (Recombinant)
RECOTHROM received
RECOTHROM is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical. RECOTHROM may be used in conjunction with an absorbable gelatin sponge, USP.
IMPORTANT SAFETY INFORMATION
RECOTHROM is for topical use only and should not be injected directly into the circulatory system. There is a potential risk of thrombosis if the product is absorbed systemically. RECOTHROM should not be used for the treatment of massive or brisk arterial bleeding or in patients with known hypersensitivity to RECOTHROM, any components of RECOTHROM or hamster proteins.
No specific adverse events have been established as adverse reactions causally related to RECOTHROM administration. In a clinical study comparing RECOTHROM to bovine thrombin, adverse events were reported with similar frequency in both treatment groups, and no adverse events were considered causally related to antibody formation in either group. The most common event was incision site complication. Limited data (n = 6) are available on repeat exposure to RECOTHROM.
Please see full prescribing information at: http://www.zymogenetics.com/products/recothrom.html.
For additional information, please visit: http://www.recothrom.com.
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This press release contains "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995. These
forward-looking statements are based on the current intent and
expectations of the management of
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