ZymoGenetics, Inc. (NASDAQ: ZGEN) presented positive results today from a Phase 3b clinical trial with RECOTHROM® Thrombin, topical (Recombinant). The study provided additional information about the immunologic safety of RECOTHROM and demonstrated that RECOTHROM was well tolerated when applied as an aid to hemostasis in patients, including those with pre-existing antibodies to bovine thrombin.
"In the Phase 3b study, 16% of patients entered surgery with pre-existing antibodies to bovine thrombin,” said Douglas E. Williams, Ph.D., President of ZymoGenetics. "The product label for bovine thrombin states that patients with antibodies to bovine thrombin preparations should not be re-exposed. This study indicates that RECOTHROM can be safely applied regardless of baseline anti-bovine thrombin product antibody status.”
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 ZymoGenetics and Bayer HealthCare. ZymoGenetics retains U.S. market rights, and Bayer provides its trained surgical sales force to support the first three years of the US market launch that began in early 2008. Bayer acquired rights to RECOTHROM in all markets outside the U.S. and is responsible for commercializing RECOTHROM in global markets.
"In the Phase 3b study, 16% of patients entered surgery with pre-existing antibodies to bovine thrombin,” said Douglas E. Williams, Ph.D., President of ZymoGenetics. "The product label for bovine thrombin states that patients with antibodies to bovine thrombin preparations should not be re-exposed. This study indicates that RECOTHROM can be safely applied regardless of baseline anti-bovine thrombin product antibody status.”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 ZymoGenetics and Bayer HealthCare. ZymoGenetics retains U.S. market rights, and Bayer provides its trained surgical sales force to support the first three years of the US market launch that began in early 2008. Bayer acquired rights to RECOTHROM in all markets outside the U.S. and is responsible for commercializing RECOTHROM in global markets.
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