News Release
ZymoGenetics Reports Encouraging Preliminary Results from Phase 2 Study of IL-21 in Metastatic Melanoma Conducted by NCIC
May 13, 2009
SEATTLE--(BUSINESS WIRE)--May. 13, 2009--
ZymoGenetics, Inc. (NASDAQ:ZGEN) today announced that Interleukin 21
(IL-21) demonstrated an impressive overall response rate in the
treatment of metastatic melanoma. In interim Phase 2 results from 24
patients, 29 percent showed a partial response, with an additional 33
percent of patients showing stable disease in this difficult to treat
disease.
“We are seeing promising anti-tumor response with IL-21 in patients with
metastatic melanoma in this Phase 2 study,” said Nicole Onetto, M.D.,
Senior Vice President and Chief Medical Officer of ZymoGenetics. “The
response rate is favorable, particularly when compared to those of
approved agents. Patients with advanced melanoma have few effective
treatment options, so a clear need exists for new agents to manage this
disease.”
Results from the Phase 2 clinical trial in patients with metastatic
melanoma were presented at the World Congress on Melanoma meeting in
Vienna, Austria. The single-agent multi-center clinical trial is being
conducted by the NCIC Clinical Trials Group in Canada and is evaluating
three dosing regimens of IL-21 in patients with no prior systemic
therapy for metastatic melanoma. The primary endpoint is efficacy, as
measured by objective response or lack of early disease progression.
To date 7 of the 24 patients (29%) had a partial response (5 confirmed
by RECIST criteria). Eight patients (33%) had stable disease. The most
common adverse events were mild or moderate fatigue and rash.
Two schedules testing 50 mcg/kg were evaluated in a total of 10 patients
but were poorly tolerated due to adverse events including neutropenia
and skin rash. The trial will be completed with a full cohort of 30
patients to be treated at the 30 mcg/kg dose, which is tolerable for
outpatient dosing and active as assessed by tumor response.
About Interleukin 21 (IL-21)
IL-21, a cytokine that enhances CD8+ T cell and NK cell activity, has
single-agent anti-tumor activity (J Clin Oncol 26:2034, 2008).
ZymoGenetics has worldwide rights to IL-21 and is developing IL-21 for
the treatment of renal cell carcinoma and metastatic melanoma.
About ZymoGenetics
ZymoGenetics creates novel protein drugs that help patients fight
disease. The Company developed and markets RECOTHROM®
Thrombin, topical (Recombinant). Other product candidates are focused on
cancer, autoimmune and viral diseases. ZymoGenetics intends to
commercialize 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 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 preclinical and clinical development,
product sales and marketing abilities, discovery strategy, strategic
partnering, regulatory oversight, intellectual property claims and
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, 2008 and subsequent
Quarterly Report on Form 10-Q. 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.
Source: ZymoGenetics, Inc.
ZymoGenetics, Inc.
Susan W. Specht
Director, Corporate
Communications
206-442-6592
*****************************************
« Back to News Releases
"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.