ZymoGenetics Highlights Development Programs at Annual Analyst & Investor Briefing
Thursday December 14, 4:10 pm ET
- Atacicept program to include multiple sclerosis -
SEATTLE, Dec. 14 /PRNewswire-FirstCall/ -- ZymoGenetics, Inc. (Nasdaq: ZGEN - News) today provided research and development program updates at an annual Analyst & Investor Briefing in New York City. Highlights of the meeting follow. An archived webcast of the ZymoGenetics Analyst and Investor Briefing may be accessed at www.zymogenetics.com.
"ZymoGenetics is making significant progress toward our goal of introducing novel therapies for patients in need," said Bruce L.A. Carter, President and Chief Executive Officer. "Early on, we adopted a diversified strategy involving the development of multiple products in multiple disease indications. We continue to pursue this strategy and, with the potential approval and launch of rhThrombin, hope to see it begin to bear fruit in the coming year."
Highlights
Company highlights discussed at the meeting include the following:
Recombinant human Thrombin (rhThrombin)
-- ZymoGenetics is on track to file a biologics license application for
rhThrombin with the U.S. Food and Drug Administration (FDA) by year
end. In a recently completed Phase 3 pivotal study, rhThrombin had
comparable efficacy to the approved bovine thrombin product and showed
a far lower rate of immune response. Phase 3 clinical trial results
were presented at the Society for the Advancement of Blood Management
Annual Meeting in September 2006.
-- The company continues to enroll patients in a Phase 2 clinical trial
with rhThrombin delivered from a spray applicator. A spray registration
trial is expected to begin in mid-2007.
-- Senior management reported its strategy and plans for launch of
rhThrombin in the U.S. The strategy reflects the relative
concentration of the U.S. thrombin market, where approximately 80% of
bovine thrombin sales revenues come from about 900 hospitals. The
company reviewed its plans for building a sales force and related
infrastructure to address this market.
Atacicept (formerly TACI-Ig)
-- ZymoGenetics and partner Serono will pursue a clinical trial program
with atacicept in multiple sclerosis (MS), and plan to initiate a
clinical trial in MS in 2007.
-- A Phase 2 clinical trial with atacicept in patients with rheumatoid
arthritis (RA) will be initiated shortly. The randomized, double-blind,
placebo-controlled, multi-center dose finding study will test three
dose levels in approximately 300 patients whose disease has failed to
respond to TNF inhibitors.
-- ZymoGenetics and Serono are in discussions with regulatory authorities,
and are planning follow-on clinical trials with atacicept in patients
with Systemic Lupus Erythematosus (SLE). A registration study is
expected to start in 2007.
-- Results from Phase 1b clinical trials with atacicept in patients with
multiple myeloma and non-Hodgkin's Lymphoma were recently reported at
the American Society of Hematology Annual Meeting. In the two trials,
atacicept was found to be well tolerated, and biological activity was
observed. The companies will evaluate the atacicept B-cell cancer
program after completing an ongoing Phase 1b trial in patients with
chronic lymphocytic leukemia (B-CLL).
-- Results from a Phase 1b clinical trial in patients with SLE were
presented at the American College of Rheumatology Annual Meeting in
November 2006. Atacicept was well tolerated and showed signs of
biological activity, such as dose-dependent reductions in
immunoglobulin and B-cell levels.
Interleukin 21 (IL-21)
-- ZymoGenetics is developing IL-21 as a potential treatment for renal
cell cancer (RCC), metastatic melanoma and lymphoma in collaboration
with Novo Nordisk A/S, which has commercial rights to IL-21 outside
North America. Results were reviewed from recent presentations of two
Phase 1 studies conducted by ZymoGenetics and Novo Nordisk. The Phase 1
studies indicated that IL-21 showed evidence of anti-tumor activity and
the tolerability allows for it to be administered in an outpatient
regimen.
-- ZymoGenetics initiated a Phase 1/2 clinical trial with IL-21 in
combination with Nexavar® in patients with RCC. Treatment with both a
tyrosine kinase inhibitor such as Nexavar and IL-21 may result in
greater efficacy than treatment with either agent alone. Preclinical
research using concurrent dosing of IL-21 with Nexavar showed in vivo
additive effects in a preclinical model of RCC. ZymoGenetics plans to
complete Phase 1 and start the Phase 2 part of this combination trial
in 2007.
-- Preclinical studies have shown that IL-21 enhances Rituxan-mediated
ADCC both in vitro and in vivo. ZymoGenetics has started a Phase 1 open
label dose escalation study with IL-21 and Rituxan in patients with NHL
who have failed prior therapies, and plans to complete that study
in 2007.
PEG-Interferon lambda (IL-29)
-- ZymoGenetics is investigating PEG-Interferon lambda as a treatment for
viral infection with the potential for fewer side effects than current
therapies. The company plans to evaluate this agent in patients with
chronic hepatitis C infection. ZymoGenetics recently submitted an
Investigational New Drug application for a Phase 1 study in healthy
volunteers, and expects to begin the trial in Q1 2007.
Preclinical Research
-- ZymoGenetics is developing preclinical candidates Interleukin 31 with
partner Serono and Interleukin 17-RC with partners Serono and Novo
Nordisk. Preclinical studies for both molecules have shown promising
results in inflammatory diseases with unmet medical needs. Preclinical
research activities are continuing for these potential product
candidates.
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 potential proprietary product candidates that are moving into and through clinical development. These 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. |
