ZymoGenetics Presents PEG-Interferon Lambda Phase 1a Data.Program to Advance to Phase 1b Study in Patients with Chronic Hepatitis Chronic hepatitis Long lasting inflammation of the liver due to viruses or other causes. Mentioned in: Tube Compression of the Esophagus and Stomach chronic hepatitis C SEATTLE -- ZymoGenetics, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :ZGEN), today presented data from a Phase 1a clinical trial with PEG-Interferon lambda (also known as IL-29) in healthy volunteers showing that administration of single doses of PEG-Interferon lambda was well tolerated at doses that produced anticipated pharmacologic activity, including up-regulation of interferon response markers associated with antiviral effects. No fever or hematologic hematological, hematologic pertaining to or emanating from blood cells. hematological tests total and differential white cell counts, hematocrit estimation, erythrocyte count. effects, which are typically seen with interferon alpha Interferon alpha Potent immune-defense protein; used as an anti-cancer drug. Mentioned in: Waldenström's Macroglobulinemia , were observed at any of the dose levels tested. "Results from this single dose Phase 1a study in healthy volunteers support moving forward into a repeat dose Phase 1b study in patients with hepatitis C Hepatitis C Definition Hepatitis C is a form of liver inflammation that causes primarily a long-lasting (chronic) disease. Acute (newly developed) hepatitis C is rarely observed as the early disease is generally quite mild. ," said Nicole Onetto, M.D., Senior Vice President and Chief Medical Officer. "The biologically active dose levels observed in the Phase 1a study have been used to design a Phase 1b study to evaluate the safety and antiviral effects of repeat dosing in patients with relapsed hepatitis C infection. "We're hopeful this study will confirm preclinical findings indicating PEG-Interferon lambda has antiviral activity with greater tolerability for patients." About the Phase 1a Study The primary objectives of this randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , placebo-controlled, dose-escalation Phase 1a study were to characterize the safety, tolerability and pharmacokinetics of a single dose of PEG-Interferon lambda administered subcutaneously. Twenty subjects were treated with PEG-Interferon lambda at dose levels up to 7.5 mcg/kg (n=17) or placebo (n=3). Administration of a single dose of PEG-Interferon lambda was associated with dose-related pharmacokinetic and pharmacodynamic effects and was well tolerated at biologically active doses. Evidence of biological activity, including up-regulation of interferon response markers, was seen starting at doses of 1.5 mcg/kg. These results suggest that antiviral activity against hepatitis C virus
abbr. hepatitis C virus HCV 1 Hepatitis C virus, see there 2. Human coronavirus. See Coronavirus. ) might also be seen at these dose levels. Overall, administration of PEG-Interferon lambda was well tolerated at doses up to 5 mcg/kg. No fever or hematologic effects were observed at any of the dose levels tested. The primary safety observations consisted of dose-related increases in liver transaminases without associated increases in bilirubin Bilirubin The predominant orange pigment of bile. It is the major metabolic breakdown product of heme, the prosthetic group of hemoglobin in red blood cells, and other chromoproteins such as myoglobin, cytochrome, and catalase. in a subset of patients treated at doses of 5 mcg/kg and higher, and minor decreases in fibrinogen Fibrinogen The major clot-forming substrate in the blood plasma of vertebrates. Though fibrinogen represents a small fraction of plasma proteins (normal human plasma has a fibrinogen content of 2–4 mg/ml of a total of 70 mg protein/ml), its conversion not associated with bleeding or changes in platelet counts, all of which were reversible. Results of the Phase 1a study with PEG-Interferon lambda were presented at the HEP DART 2007 meeting. About PEG-Interferon Lambda The native human protein interferon lambda is generated by the immune system immune system Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. in response to viral infection viral infection, n an infection by a pathogenic virus. A virus acts on the cell nucleus, taking over the genetic material within the nucleus and replicating itself. . It mediates antiviral activity through a receptor that is distinct from that used by interferon alpha and is generally present on fewer cell types within the tissues of the body. Receptors for interferon lambda are present on several important sites of viral infection, most notably cells of the lung and liver. ZymoGenetics' product candidate recombinant PEG-Interferon lambda has shown in vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment. in vi·tro adj. In an artificial environment outside a living organism. anti-viral activity against several viruses, including hepatitis C. About Hepatitis C Chronic infection with HCV is a leading cause of cirrhosis, liver failure and hepatocellular carcinoma worldwide. In the United States, it is estimated that HCV is associated with up to 20,000 deaths per year, and is the main indication for liver transplantation. An estimated 4.1 million people in the United States have been exposed to HCV, and approximately 3.2 million have chronic HCV infection. Without effective intervention, the National Institutes of Health project that the number of deaths from chronic HCV infection may triple in the next 10-20 years. Current Standard of Care for Hepatitis C The current standard of care for chronic HCV infection involves treatment with interferon alpha and ribavirin ribavirin /ri·ba·vi·rin/ (ri?bah-vi´rin) a broad-spectrum antiviral used in the treatment of severe viral pneumonia caused by respiratory syncytial virus, particularly in high-risk infants; also used in conjunction with interferon . This form of HCV therapy has been associated with a number of significant side effects, including flu-like symptoms, anorexia, depression, hemolytic anemia and myelosuppression. This side-effect profile often necessitates additional medications to manage the side effects, and can lead to early discontinuation of treatment and poor adherence to prescribed therapy, leading to worsened treatment outcomes. Currently, the response rates for the most common form of HCV in the United States to standard treatment are only approximately 50%. There remains a need for better tolerated and more effective therapy for HCV infection. The development of PEG-Interferon lambda is intended to provide an alternative to interferon alpha. About ZymoGenetics ZymoGenetics creates novel protein drugs with the potential to significantly help patients fight their diseases. The Company is developing a diverse pipeline of product candidates that are moving into and through clinical development. These candidates span a wide array of clinical opportunities that include bleeding, autoimmune diseases and cancer. ZymoGenetics intends to commercialize these product candidates through internal development, collaborations with partners, and out-licensing of patents from its extensive patent portfolio. For further information, visit www.zymogenetics.com. This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. These forward-looking statements are based on the current intent and expectations of the management of ZymoGenetics. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. ZymoGenetics' actual results and the timing and outcome of events may differ materially from those expressed in or implied by the forward-looking statements because of risks associated with our unproven discovery strategy, preclinical and clinical development, regulatory oversight, intellectual property claims and litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. and other risks detailed in the company's public filings with the Securities and Exchange Commission, including the company's Annual Report on Form 10-K for the year ended December 31, 2006. Except as required by law, ZymoGenetics undertakes no obligation to update any forward-looking or other statements in this press release, whether as a result of new information, future events or otherwise. |
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