New Data Presented at American Burn Association's Annual Meeting Support Safety Profile of RECOTHROM Thrombin, Topical (Recombinant) in Pediatric Patients
SEATTLE--(BUSINESS WIRE)--Mar 9, 2010 - ZymoGenetics, Inc. (NASDAQ:ZGEN), today announced the presentation of safety and immunogenicity data among pediatric burn patients at the 42nd Annual Meeting of the American Burn Association in Boston, MA. The study marks the first dedicated look at the safety and immunogenicity of any stand-alone thrombin in pediatric surgical patients. The investigators concluded that RECOTHROM did not appear to be associated with any treatment-related adverse events when used as an aid to hemostasis in pediatric patients undergoing synchronous burn wound excision and skin grafting. Additionally, none of the pediatric burn patients who were administered RECOTHROM during their surgical procedure developed product-specific antibodies through post-operative (post-op) day 29.
“Even though the use of thrombin as a hemostatic adjunct in pediatric burn patients is a common practice, we have had limited safety and immunogenicity information about these products until now,” said Kevin Foster, MD, the lead investigator and attending physician at Maricopa Medical Center, Phoenix, AZ. “These positive safety and immunogenicity data in this vulnerable pediatric surgical population are important and reassuring.”
The open-label, single-group, multisite study included 30 patients (newborn through 17 years of age) who underwent synchronous burn wound excision and skin grafting procedures and were administered RECOTHROM as an aid to hemostasis during a single surgical procedure. Patients in the pediatric study received more drug per square meter of body surface area than adults in previous trials of RECOTHROM. Adverse events were monitored through post-op day 29. Patients were tested for anti-RECOTHROM antibodies at baseline and at the post-op day 29 assessment.
There were no adverse events considered related to study drug. In the study, one serious adverse event (graft failure) occurred in one patient and was deemed not related to study drug. Common adverse events reported for ‰¥ 10% of RECOTHROM-treated patients included procedural pain, pruritus, anemia, skin graft failure and fever. These adverse events were consistent with those commonly observed in the post-surgical setting and with those seen in the trial of RECOTHROM in the adult burn population [Greenhalgh, et al, 2009]. The fact that RECOTHROM was well tolerated over the range of exposures and in all age groups is consistent with prior safety observations in adults.
After treatment with RECOTHROM, none of the 27 patients for whom complete immunogenicity data were available developed anti-RECOTHROM antibodies.
About RECOTHROM® Thrombin, topical (Recombinant)
RECOTHROM is human thrombin made using recombinant technology and 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 (such as suture, ligature, or cautery) 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.
Adverse events reported in clinical trials of RECOTHROM were consistent with those commonly observed in surgical patients. 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
Lori Shachtman, 847-975-2330
Posted: March 2010