Navigation Links
Velcura Therapeutics, Inc. Can Begin Clinical Trials Following Successful Investigational New Drug Application to U.S. FDA

ANN ARBOR, Mich., Jan. 28 /PRNewswire/ -- Velcura Therapeutics Inc., an early stage biotechnology company developing therapies for bone disease, recently completed a successful Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA). The IND enables Velcura to proceed with the first-in-man clinical trials for its lead compound, VEL-0230.

VEL-0230 is a new chemical entity that has dual-acting properties, in that it both stimulates bone formation and inhibits bone loss. As part of the application, Velcura presented efficacy, safety, and toxicology data to the FDA, as well as plans for its early-stage clinical trials of VEL-0230. The company plans to investigate VEL-0230 as a treatment of diseases involving bone mineral disorders, such as bone loss related to multiple myeloma, bone metastases, rheumatoid arthritis and osteoporosis.

"The successful completion of the FDA's evaluation within the 30-day review period validates our pre-clinical work and allows us to begin studies of VEL-0230 in humans. Its dual-action bone properties make VEL-0203 an ideal therapy for treating multiple bone diseases," said Michael W. Long, Ph.D., President and Chief Executive Officer of Velcura. "We plan to move into multiple clinical studies as rapidly as possible."

VEL-0230 is being studied as an orally available molecule that promotes bone formation, inhibits bone loss and reduces plasma calcium levels. Extensive laboratory investigations, in vivo animal models, and non-clinical toxicology evaluations demonstrate that VEL-0230 is a safe and effective molecule in these systems. The first phase of clinical trials in humans is planned to begin at the end of February 2008.

About Velcura Therapeutics, Inc.

Velcura Therapeutics Inc. is an early stage biotechnology company headquartered in Ann Arbor, Michigan. Velcura's research focus is to understand human bone disease and to discover novel therapeutics that restore bone health. Velcura develops highly differentiated therapies for bone disease; specifically, dual-acting therapies that demonstrate both bone building and anti-bone loss activities in a single molecule. Velcura uses its patented platform technologies to discover and optimize these compounds. Velcura's lead compound, VEL-0230 was identified using these bone assays. More information is at
Available Topic Expert(s): For information on the listed expert(s), click appropriate link. Michael W. Long, Ph.D.

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

Related biology technology :

1. Velcura Therapeutics, Inc. Appoints Industry Executive to Lead Regulatory Affairs
2. Former Pfizer Director of Inflammation Molecular Sciences to Spearhead Velcura Therapeutics Inflammatory Disease Initiatives
3. Cell Therapeutics, Inc. (CTI) Prices $1.27 million (euros 856.000) Offering of Common Stock through Societe Generale
4. Cell Therapeutics, Inc. Announces Authorization to Publish Italian Listing Prospectus
5. Cell Therapeutics, Inc. (CTI) Hosts Conference Call to Discuss Update on Zevalin(R) Acquisition, CMS Reimbursement, and PIX301 Timeline
6. Pearl Therapeutics, Inc. Expands Its Senior Management Team With Top Talent in Clinical Development and Regulatory Affairs
7. Cell Therapeutics, Inc. (CTI) to Submit Marketing Authorization Application for XYOTAX(TM) for First-line Non-small Cell Lung Cancer Ahead of Schedule
8. Cell Therapeutics, Inc. Announces Issuance of $23.25 Million in New Convertible Senior Notes in Exchange for $36.08 Million of Existing Convertible Senior Subordinated and Subordinated Notes
9. ARYx Therapeutics, Inc. Announces Pricing of its Initial Public Offering
10. Bioenergy Life Science and Integrative Therapeutics, Inc. Form Exclusive Co-Marketing Alliance
11. Cell Therapeutics, Inc. (CTI) BIO Presentation to Be Webcast
Post Your Comments:
(Date:11/24/2015)... HILLS, N.J. (PRWEB) , ... November 24, 2015 , ... ... as the recipient of the 2016 USGA Green Section Award. Presented annually since 1961, ... golf through his or her work with turfgrass. , Clarke, of Iselin, ...
(Date:11/24/2015)... ... November 24, 2015 , ... Copper ... unless it is bound to proteins, copper is also toxic to cells. With ... Worcester Polytechnic Institute (WPI) will conduct a systematic study of copper in the ...
(Date:11/24/2015)... November 24, 2015 --> ... research report "Oligonucleotide Synthesis Market by Product & Services ... Synthesis, Diagnostic, DNA, RNAi), End-User (Research, Pharmaceutical & Biotech, ... MarketsandMarkets, the market is expected to reach USD 1,918.6 ... at a CAGR of 10.1% during the forecast period. ...
(Date:11/24/2015)... , November 24, 2015 ... recent market research report released by Transparency Market Research, ... expand at a CAGR of 17.5% during the period ... Testing Market - Global Industry Analysis, Size, Volume, Share, ... global non-invasive prenatal testing market to reach a valuation ...
Breaking Biology Technology:
(Date:10/29/2015)... , Oct. 29, 2015  Connected health pioneer, ... driving the explosion of technology-enabled health and wellness, and ... new book, The Internet of Healthy Things ... sensors or smartphones even existed, Dr. Kvedar, vice president, ... of health care delivery, moving care from the hospital ...
(Date:10/27/2015)... Calif. , Oct. 27, 2015 Synaptics Inc. ... solutions, today announced that Google has adopted the Synaptics ... touch controller solutions to power its newest flagship smartphones, ... by Huawei. --> ... like Google to provide strategic collaboration in the joint ...
(Date:10/23/2015)... and GOLETA, California , October 23, ... BIOPAC and SensoMotoric Instruments (SMI) announce a mobile plug ... data captured during interactive real-world tasks SensoMotoric ... integration of their established wearable solutions for eye tracking ... gaze behavior captured with SMI Eye Tracking Glasses ...
Breaking Biology News(10 mins):