New Publication Supports Safety Profile of RECOTHROM Thrombin, Topical (Recombinant) in Numerous Surgical Settings
Pooled Observations Show Low Rate of Immunogenicity
SEATTLE--(BUSINESS WIRE)--Feb 2, 2010 - ZymoGenetics, Inc. (NASDAQ:ZGEN), today announced the publication of pooled safety and immunogenicity observations from eight clinical trials of RECOTHROM in the February issue of the Journal of the American College of Surgeons. The authors concluded that RECOTHROM is a well-tolerated topical hemostatic agent in numerous surgical settings and has a low rate of anti-product antibody formation. In the pooled data from all trials, less than one percent of treated patients developed product-specific antibodies. None of the antibodies neutralized native coagulation proteins.
“These pooled safety data are significant, as they provide a robust clinical trial data set for a topical hemostat,” said Fred Weaver, MD, FACS, a study author and Professor of Surgery at USC CardioVascular Thoracic Institute, USC University Hospital, Keck School of Medicine, University of Southern California, Los Angeles, CA. “The adverse events observed were consistent with those expected in the surgical populations studied, and immune response to RECOTHROM was consistently low, with no development of antibodies that neutralized native human thrombin.”
The eight clinical trials (one Phase 1 trial, five Phase 2 trials, one randomized, double-blind Phase 3 trial, and one open-label Phase 3b trial) included 583 patients, ranging in age from 12 through 89 years, with no hypersensitivity to thrombin or other coagulation factors. Surgical procedures included spinal (33%), hepatic resection (14%), peripheral arterial bypass (23%), arteriovenous graft formation for hemodialysis access (18%), and skin graft after burn wound excision (12%).
In each of the studies, RECOTHROM was administered during a single surgical procedure; adverse events as well as clinical hematology and coagulation laboratory parameters were monitored through post-operative (post-op) day 29. Patients were tested for anti-RECOTHROM antibodies at baseline and at the post-op day 29 assessment.
Adverse events reported for ‰¥ 10% of RECOTHROM-treated patients included incision site pain, procedural pain, nausea, constipation, pyrexia, anemia, insomnia, vomiting, and pruritis. These adverse events are commonly reported in patients undergoing surgery, and variation in the observed incidence of these events across surgery types was consistent with the specific type of procedure and surgical patient population.
After treatment with RECOTHROM, less than one percent of patients for whom complete immunogenicity observations were available developed anti-RECOTHROM antibodies (5 of 552 patients or 0.9%). The antibodies identified did not neutralize the activity of native human thrombin.
About RECOTHROM® Thrombin, topical (Recombinant)
RECOTHROM is a recombinant form of human thrombin that is structurally and functionally similar to native human thrombin. It is not derived from animal or human blood.
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. The most common adverse event was incision site complication.
Please see full prescribing information at: http://www.recothrom.com.
ZymoGenetics is a biopharmaceutical company focused on the development and commercialization of therapeutic proteins for the treatment of human diseases. In the past, ZymoGenetics has conducted extensive discovery research to identify potential product candidates, with a primary focus in autoimmune disorders and oncology. After a series of strategic initiatives undertaken in 2008 and 2009, ZymoGenetics is now focused on developing and commercializing a limited number of product candidates, which it believes have substantial medical and commercial potential. ZymoGenetics has developed and is marketing RECOTHROM® Thrombin, topical (Recombinant) in the United States. ZymoGenetics has two product candidates in clinical development: PEG-Interferon lambda, being studied in collaboration with Bristol Myers Squibb (BMS) for treatment of hepatitis C virus (HCV) infection, and IL-21, being tested by ZymoGenetics as a potential treatment for metastatic melanoma. In addition, ZymoGenetics has an anti-IL-31 monoclonal antibody in preclinical development, which it expects to test initially as a treatment for atopic dermatitis. Several of the product candidates previously identified through ZymoGenetics' discovery research efforts have been licensed to and are being developed by third parties, including Merck Serono and Novo Nordisk. ZymoGenetics is eligible to receive milestone payments and royalties related to these assets. For further information, visit www.zymogenetics.com.
Susan W. Specht, 206-442-6592
Brandkarma Public Relations
Maggie Hoffman, 330-653-3196
Posted: February 2010