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Biotech / Medical : ZymoGenetics ZGEN -- Ignore unavailable to you. Want to Upgrade?

To: tuck who wrote (175)	5/13/2009 11:53:52 AM
From: Steve Lokness	Respond to of 210

Using a mouse model of chronic viral infection, we demonstrate that interleukin-21 (IL-21) is an essential component of CD4(+) T cell help. .......... Thus, IL-21 specifically sustains CD8(+) T cell effector activity and provides a mechanism of CD4(+) T cell help during chronic virus infection. So ZGEN must be serious regarding IL-21 as they get rights back? Seems to me the news today would suggest the possibility of broad application? ZymoGenetics Reports Encouraging Preliminary Results from Phase 2 Study of IL-21 in Metastatic Melanoma Conducted by NCIC On Wednesday May 13, 2009, 8:30 am EDT Buzz up! Print Related:ZymoGenetics, Inc. SEATTLE--(BUSINESS WIRE)--ZymoGenetics, Inc. (NASDAQ:ZGEN - News) 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. finance.yahoo.com

To: tuck who wrote (175)	5/15/2009 12:20:30 AM
From: Steve Lokness	Read Replies (1) \| Respond to of 210

More on IL-21; Final Phase 2 Results for IL-21 in Renal Cell Cancer Show Tolerability and Enhanced Efficacy of Nexavar Combination Favorable Response Rate in Patients Who Have Failed Prior Therapy Progression-Free Survival Results to Be Presented at ASCO Meeting On Thursday May 14, 2009, 6:01 pm EDT Buzz up! Print Related:ZymoGenetics, Inc. SEATTLE--(BUSINESS WIRE)--ZymoGenetics, Inc. (NASDAQ:ZGEN - News), will present final results from a Phase 2 clinical trial in patients with renal cell cancer at the American Society of Clinical Oncology (ASCO) annual meeting on May 31, 2009, in a poster presentation. The clinical trial evaluated Interleukin 21 (IL-21) in combination with Nexavar® (sorafenib) tablets. Abstracts are available on the ASCO website www.asco.org. Related Quotes Symbol Price Change ZGEN 4.36 +0.11 “We see encouraging anti-tumor activity with IL-21 combined with Nexavar. The ASCO abstract, available today, reports a 26 percent response rate in 2nd- or 3rd-line renal cell carcinoma patients,” said Nicole Onetto, M.D., Senior Vice President and Chief Medical Officer of ZymoGenetics. “The final poster presentation will also include progression-free survival results. We believe the combination of IL-21 and Nexavar could be more effective than Nexavar alone.” The multi-center Phase 2 clinical trial was conducted at 14 sites in the U.S. and Canada and enrolled 33 patients. Efficacy endpoints included overall response rate and progression-free survival per RECIST (Response Evaluation Criteria In Solid Tumors). Response was assessed by the investigator and by independent radiologic review. ASCO Poster Title: Phase II study of recombinant IL-21 (rIL-21) plus sorafenib as second- or third-line therapy for metastatic renal cell cancer (mRCC): Final results. Abstract: 3023 Presenter: Shailender Bhatia, MD, Medical Oncology, UWMC/FHCRC/SCCA Date: Sunday, May 31, 2009 Time: 2:00 PM - 6:00 PM Presentation Order: 18 Poster Board: 15 Location: Level 3, W315A About Interleukin 21 (IL-21) Despite the positive impact of targeted therapies on treatment for renal cell cancer, the efficacy of these agents appears to decrease beyond the first-line setting. There is an unmet need for novel therapies after failure of the targeted agents. 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. finance.yahoo.com