ZymoGenetics Reports Favorable Survival Data from IL-21 Phase 2a Clinical Trial in Melanoma
September 29 2010 - 6:00AM
Business Wire
ZymoGenetics, Inc. (NASDAQ:ZGEN) today announced positive
survival data from a Phase 2a clinical trial in metastatic melanoma
with recombinant Interleukin 21 (IL-21) as a single agent. Median
overall survival was 12.4 months, and the percentage of patients
surviving at 12 months was 53%.
“The median overall survival of 12.4 months in the Phase 2 study
with IL-21 in advanced melanoma patients is very encouraging,” said
Eleanor L. Ramos, M.D., Senior Vice President and Chief Medical
Officer of ZymoGenetics. “We look forward to further results from
an ongoing IL-21 Phase 2b randomized clinical trial in
melanoma.”
The open-label, single-arm, multi-center Phase 2 study was
conducted by the NCIC Clinical Trials Group in Canada. A total of
40 patients with Stage 4 melanoma were enrolled and treated with
IL-21 using 3 dosing regimens. Previous results for the clinical
trial were presented at the American Society of Clinical Oncology
2010 meeting. Overall response rate was 23% in 39 evaluable
patients, and median progression-free survival was 4.3 months.
Common adverse events were fatigue, rash, fever, myalgia, anorexia,
chills and nausea. Responses were not dependent on B-Raf
status.
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 with IL-21 in clinical trials. The lead
indication is metastatic melanoma, where IL-21 has shown
efficacy.
About the NCIC Clinical Trials Group
The NCIC Clinical Trials Group (NCIC CTG) is a cancer clinical
trials cooperative group that conducts phase I-III trials testing
anti-cancer and supportive therapies across Canada and
internationally. It is one of the national programmes and networks
of the Canadian Cancer Society Research Institute (CCSRI), and is
supported by the CCSRI with funds raised by the Canadian Cancer
Society (CCS). The NCIC CTG’s Central Office is located at Queen’s
University in Kingston, Ontario, Canada.
About ZymoGenetics
ZymoGenetics is a biopharmaceutical company focused on the
development and commercialization of therapeutic proteins for the
treatment of human diseases. The company developed and is marketing
RECOTHROM® 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
infection, and IL-21, being tested 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.
ZymoGenetics Forward-Looking Statement
This press release contains forward-looking statements,
including statements related to conducting and analyzing the
results of clinical trials. Phrases such as “look forward” 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 ZymoGenetics’ ability
to design and conduct clinical trials, the possibility that
clinical trial results may vary between different arms of a
clinical trial and the difficulty of using prior clinical trial
results to predict future outcomes, as well as those 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 these
forward-looking statements, 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.
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