News Release
ZymoGenetics Announces Upcoming Presentation of Positive IL-21 Phase 2 Results in Metastatic Melanoma at ASCO Meeting
May 20, 2010
SEATTLE, May 20, 2010 (BUSINESS WIRE) --ZymoGenetics, Inc. (NASDAQ:ZGEN) announced that final progression-free survival results will be presented from a Phase 2 clinical trial in patients with Stage 4 metastatic melanoma at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago on June 5, 2010 in an oral presentation. The open-label multi-center clinical trial evaluated 3 dose regimens of Interleukin 21 (IL-21) in 40 patients with no prior systemic therapy for metastatic melanoma.
The ASCO Annual Meeting abstract reported an overall objective response rate to IL-21 of 24% and median progression-free survival of 5.19 months, which will be updated with the final analysis for the oral presentation. In a historical database of other Phase 2 melanoma studies conducted by the National Cancer Institute of Canada Clinical Trials Group with similar entry criteria, median progression-free survival was 1.58 months. The objective response rate was not dependent on BRAF mutation status. The most common adverse events were fatigue, rash, diarrhea and myalgia. The IL-21 abstract is available at ASCO.org. Updated results will be presented at ASCO.
"We're encouraged by the progression-free survival and response rate in patients with advanced melanoma," said Eleanor L. Ramos, M.D., Senior Vice President and Chief Medical Officer of ZymoGenetics. "We selected 30ug/kg/day as the dose for further investigation and are planning a randomized Phase 2b study with the National Cancer Institute of Canada Clinical Trials Group that will seek to further validate the efficacy of IL-21 as a treatment for metastatic melanoma."
ASCO Oral Presentation
Abstract title: Interleukin-21(IL-21) has activity in patients (pts) with metastatic melanoma (MM)
Abstract #: 8507
Presenter: Teresa Petrella, MD, MSc, FRCPC, Odette Cancer Centre, NCIC Clinical Trials Group
Date: June 5, 2010
Time: 2:00 p.m.
Place: S406 (Vista Room)
About Interleukin 21 (IL-21)
Interleukin 21 (IL-21) is a cytokine that modifies the function of cells in the immune system. IL-21 activates several types of immune cells thought to be critical in eliminating cancerous or virally infected cells from the body. Specifically, IL-21 enhances the activity of natural killer cells and has multiple effects on cytotoxic T cells. This novel immunotherapy has demonstrated antitumor activity in multiple tumor types (metastatic melanoma, renal cell cancer and non-Hodgkin's lymphoma) as a single agent and in combination with other therapies. More than 250 patients have been treated in clinical trials with IL-21. The lead indication is metastatic melanoma, where IL-21 has shown efficacy and there is no consensus standard of care.
About ZymoGenetics
ZymoGenetics is a biopharmaceutical company focused on the development and commercialization of therapeutic proteins for the treatment of human diseases. The company has developed and is marketing RECOTHROM(R) Thrombin, topical (Recombinant) in the United States. ZymoGenetics has two product candidates in Phase 2 clinical development: PEG-Interferon lambda, being studied in collaboration with Bristol-Myers Squibb 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.
Forward-Looking Statements
This press release contains forward-looking statements, including statements related to the sale by ZymoGenetics of its securities. Words such as "seeks", "believes", "anticipates", "plans", "expects", "intend", "will", "goal", "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon ZymoGenetics' current expectations and involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to the ongoing clinical studies associated with IL-21 and other risks detailed in ZymoGenetics' filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2009 and periodic reports on Form 10-Q and current reports on Form 8-K. Do not place undue reliance on the forward-looking statements contained in this press release, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and, except where required by law, ZymoGenetics undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.
SOURCE: ZymoGenetics, Inc.
ZymoGenetics, Inc.
Susan W. Specht, 206-442-6592
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"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding ZymoGenetics Inc.'s business which are not historical facts are "forward-looking statements" that involve risks and uncertainties. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see "Risk Factors" in the Company's Annual Report or Form 10-K for the most recently ended fiscal year.