Navigation Links
Nuvelo Initiates Phase 1 Clinical Trial of NU206 in Healthy Volunteers

SAN CARLOS, Calif., July 29 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO) today announced that it has enrolled the first subject in a single-center, Phase 1 trial of recombinant, secreted protein, NU206, the company's lead compound from its Wnt Therapeutics Program. This double-blind, placebo-controlled, single-ascending dose (SAD) trial will determine the safety, tolerance and pharmacokinetics of a single intravenous (IV) administration of NU206, in approximately 48 healthy male volunteers. Participants will be enrolled in up to six cohorts of varying doses, with a maximum dose of 0.80 mg/kg.

"The initiation of this healthy volunteer trial, coupled with the Phase 1b multiple-ascending dose study that will start later this year or early next year, allows us to accelerate NU206 development," said Dr. Ted W. Love, chairman and chief executive officer of Nuvelo. "Due to its ability to promote cell growth and repair in preclinical studies, we believe NU206 has the potential to offer a novel approach for the treatment of serious medical conditions including gastrointestinal (GI) injury, inflammatory bowel disease and bone disease. The two healthy volunteer trials will provide useful insight for the multiple indications that we plan to investigate with NU206."

About NU206

NU206 (R-spondin1) is a recombinant, secreted protein that acts as a key regulator of the Wnt pathway, the critical pathway that stimulates cell growth and differentiation during homeostasis and pathogenesis in specific tissues including the GI epithelium and bone. Preclinical studies suggest it can promote growth and repair in animal models of radiation or cancer chemotherapy induced GI injury, inflammatory bowel disease, bone disease and wound healing.

About Nuvelo and Kirin's Joint Collaborative Effort

Scientists from Nuvelo and Kirin worked together to identify and characterize NU206 as part of a collaboration focused on the discovery of novel, secreted proteins. Nuvelo signed a collaboration agreement with Kirin in April 2005 to develop NU206. Under the agreement, Nuvelo leads worldwide development, manufacturing and commercialization and all operating expenses and profits related to the development and commercialization of NU206 are shared 60% (Nuvelo)/40% (Kirin).

About Nuvelo

Nuvelo, Inc. is dedicated to improving the lives of patients through the discovery, development and commercialization of novel drugs for acute cardiovascular disease, cancer and other debilitating medical conditions. Nuvelo's development pipeline includes NU172, a direct thrombin inhibitor in Phase 1 development for use as a potential short-acting anticoagulant during medical or surgical procedures; and NU206, a Wnt pathway modulator in Phase 1 development for the potential treatment of chemotherapy/radiation therapy-induced mucositis and inflammatory bowel disease. In addition, Nuvelo is pursuing research programs in leukemia and lymphoma therapeutic antibodies and Wnt signaling pathway therapeutics to further expand its pipeline and create additional partnering and licensing opportunities.

Information about Nuvelo is available at our website at or by phoning 650-517-8000.

This press release contains "forward-looking statements," which include statements regarding the timing, progress and anticipated completion of Nuvelo's clinical stage and research programs, and the potential benefits that patients may experience from the use of our clinical stage compounds, which statements are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Such statements are based on our management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, uncertainties relating to drug discovery and the regulatory approval process; clinical development processes; enrollment rates for patients in our clinical trials; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; and the impact of competitive products and technological changes. These and other factors are identified and described in more detail in Nuvelo's filings with the SEC, including without limitation Nuvelo's quarterly report on Form 10-Q for the quarter ended June 30, 2008 and subsequent filings. We disclaim any intent or obligation to update these forward-looking statements.

SOURCE Nuvelo, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Nuvelo Reports First Quarter 2008 Financial Results and Updated Outlook for 2008
2. Nuvelo Reports Second Quarter 2008 Financial Results
3. Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the United States
4. Dawson James Securities Initiates Research Coverage on CryoCor, Inc. (Nasdaq: CRYO) with a Strong Buy Rating and $6.00 Target Price
5. Spectrum Pharmaceuticals Initiates Second Registrational Phase 3 Clinical Trial for EOquin(R) in Patients With Non-Invasive Bladder Cancer
6. XTL Biopharmaceuticals Initiates Phase IIb Clinical Trial of Bicifadine for the Treatment of Diabetic Neuropathic Pain
7. Nventa Initiates HspE7 Phase 1 Cervical Dysplasia Trial
8. Cytochroma initiates Phase I/II clinical trial of CTAP101 Capsules for vitamin D insufficiency in chronic kidney disease
9. Arena Pharmaceuticals Initiates Second and Third Pivotal Trials Evaluating Lorcaserin for the Treatment of Obesity
10. GeneNews initiates patient sample accrual for validation studies of colon cancer blood test
11. Human Genome Sciences Initiates Second Randomized Phase 2 Trial of HGS-ETR1 in Combination With Chemotherapy
Post Your Comments:
(Date:11/24/2015)... ... 2015 , ... The United States Golf Association (USGA) today announced Dr. Bruce ... Presented annually since 1961, the USGA Green Section Award recognizes an individual’s distinguished service ... , Clarke, of Iselin, N.J., is an extension specialist of turfgrass pathology in the ...
(Date:11/24/2015)... Nov. 24, 2015 /CNW/ - iCo Therapeutics ("iCo" or ... financial results for the quarter ended September 30, ... Canadian dollars and presented under International Financial Reporting ... ," said Andrew Rae , President ... iCo-008 are not only value enriching for this ...
(Date:11/24/2015)... QUEBEC CITY , Nov. 24, 2015 /PRNewswire/ - ... the request of IIROC on behalf of the Toronto ... this news release there are no corporate developments that ... price. --> --> ... --> . --> Aeterna Zentaris ...
(Date:11/24/2015)... ... 2015 , ... This fall, global software solutions leader SAP and AdVenture Capital ... and pitch their BIG ideas to improve health and wellness in their schools. , ... win the title of SAP's Teen Innovator, an all-expenses paid trip to Super Bowl ...
Breaking Biology Technology:
(Date:11/18/2015)... new scientific discoveries deepen our understanding of how cancer ... challenges in better using that knowledge to guide treatment ... children continue to survive pediatric cancer, that counseling may ... John M. Maris, M.D ., a pediatric oncologist ... --> John M. Maris, M.D ., ...
(Date:11/17/2015)... Paris from 17 th until ... from 17 th until 19 th November ... has invented the first combined scanner in the world which scans ... Until now two different scanners were required: one for passports ... on the same surface. This innovation is an ideal solution ...
(Date:11/17/2015)... Nov. 17, 2015  Vigilant Solutions announces today that ... Board of Directors. --> ... retiring from the partnership at TPG Capital, one of ... over $140 Billion in revenue.  He founded and led ... the TPG companies, from 1997 to 2013.  In his ...
Breaking Biology News(10 mins):