Navigation Links
Velcura Therapeutics, Inc. Reports Positive Pre-IND Meeting With FDA and Plans Early Clinical Trials for New Drug to Treat Multiple Myeloma Bone Disease

ANN ARBOR, Mich. Sept. 24 /PRNewswire/ -- Velcura Therapeutics, Inc., a biotechnology company developing therapies for bone disease, met with the U.S. Food and Drug Administration (FDA) Sept. 20 to clarify details for the early clinical development of VEL-0230, a drug developed to treat bone disease. The focus of the Pre-Investigational New Drug Application (IND) meeting was to obtain feedback from the FDA's Division of Oncology Drug Products about Velcura's completed preclinical studies, as well as Velcura's near-term clinical development plans for VEL-0230. VEL-0230 is a new chemical entity that has dual-acting properties that both stimulates bone formation and inhibits loss. The company, a 2007 Michigan 50 Companies to Watch award winner, plans to initiate clinical trials in 2008 for the use of this drug as a treatment for Multiple Myeloma, a blood cancer associated with profound bone loss.

Michael W. Long, PhD, President and Chief Executive Officer of Velcura, said, "We appreciate the thoughtful, comprehensive and responsive feedback we received in our pre-IND meeting with the FDA. This clear regulatory advice and direction will greatly assist our IND application planned for late 2007. Our laboratory investigations, in vivo animal models, and extensive non- clinical toxicology evaluations demonstrate that VEL-0230 is a safe and effective molecule. Its dual-action bone properties make it an ideal therapy for multiple bone diseases," Dr. Long added.

VEL-0230 is being studied preclinically for the treatment of diseases involving bone mineral disorders such as bone loss related to multiple myeloma, osteoporosis, bone metastases, and rheumatoid arthritis. Given VEL- 0230's promotion of bone formation, inhibition of bone loss and reduction of calcium levels, Velcura has chosen Myeloma as its lead indication, as the bone fragility, bone pain, high calcium levels and eventual kidney involvement present serious medical and quality of life issues to affected patients.

About Multiple Myeloma

Multiple Myeloma is a blood malignancy characterized by the accumulation of malignant cells in the bone marrow. The clinical manifestations of the disease are overproduction of immunoglobulin, bone destruction, bone pain, anemia, high calcium levels and kidney dysfunction. The incidence of Multiple Myeloma is especially high in African-Americans, in whom it is the most common blood cancer. Unlike the bone loss associated with other bone tumors, the Myeloma bone lesions are unique in that they do not heal or repair, despite the patients' having many years of complete remission. This may be related to the inhibition and/or loss of the bone-forming cells during disease progression and increased numbers/activity of cells causing bone loss. Thus Myeloma is a disorder that would benefit from therapies that both stimulate bone formation and retard its loss. To date, no such therapies exist and Velcura believes that VEL-0230 may help those suffering from Multiple Myeloma.

For more information on this disease, contact the Multiple Myeloma Research Foundation (

About Velcura Therapeutics, Inc.

Velcura Therapeutics Inc. is an early stage biotechnology company headquartered in Ann Arbor, Michigan. Velcura's research focus is to better 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 anabolic bone-building and anti-bone-loss activities in a single molecule. Velcura uses its patented platform technologies to discover and optimize compounds that both simulate and inhibit bone growth. 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©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Cell Therapeutics, Inc. Management to Discuss Todays Announcement of Interim Pixantrone Study Results
2. Protalix BioTherapeutics, Inc. Receives Approval from the FDA to Initiate a Phase III Clinical Trial of prGCD
3. Mersana Therapeutics, Inc. to Present Preclinical Data on XMT-1001 at American Association of Cancer Research Annual Meeting
4. Corgenix Reports New Clinical Data Correlating AtherOx Technology With Vascular Disease
5. Cobalis Reports Phase III Trial Results for PreHistin in Seasonal Allergic Rhinitis
6. Cosmo Pharmaceuticals Reports Positive Preliminary Phase II/III Data with Rifamycin MMX in Infectious Diarrhea
7. Cytos Biotechnology Reports Results from Phase IIa Study with CYT003-QbG10 in Patients Suffering from Atopic Dermatitis
8. Cytokinetics Reports Additional Clinical Trials Data for Ispinesib
9. The European Myeloma Platform Reports New Survival data for Revlimid Presented at the International Myeloma Workshop in Greece
10. Cytochroma Reports Positive Phase I Clinical Data for CTA018 Injection
11. Speedel Reports Successful SPP635 Phase IIa Trial in Hypertension
Post Your Comments:
(Date:6/23/2016)... Research and Markets has announced the addition of the ... to 2022" report to their offering. ... financial data derived from varied research sources to present unique ... on the market during the next five years, including a ... markets, regional and country level analysis. The report provides a ...
(Date:6/23/2016)... INDIANAPOLIS , June 23, 2016 If ... Leaders Scholarship is any indication, the future is in ... at by the Diabetes Scholars Foundation ... the way of academic and community service excellence. ... since 2012, and continues to advocate for people with ...
(Date:6/23/2016)... , June 23, 2016 ... "Surgical Procedure Volumes: Global Analysis (United States, China, ... Canada)" report to their offering. ... essential tool for healthcare business planners, provides surgical procedure ... at surgery trends with an in-depth analysis of growth ...
Breaking Medicine Technology:
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... ... athletes and non-athletes recover from injury. Recently, he has implemented orthobiologic procedures as ... City area —Johnson is one of the first doctors to perform the treatment. ...
(Date:6/25/2016)... ... 25, 2016 , ... Conventional wisdom preaches the benefits of moderation, whether it’s ... setting the bar too high can result in disappointment, perhaps even self-loathing. However, those ... goal. , Research from reveals that behind the tendency to ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic events may ... to unhealthy avenues, such as drug or alcohol abuse, as a coping mechanism. To ... for healthy coping following a traumatic event. , Trauma sufferers tend to feel a ...
(Date:6/24/2016)... ... ... Marcy was in a crisis. Her son James, eight, was out of control. Prone to ... , “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If there ... my other children and say he was going to kill them. If we were ...
(Date:6/24/2016)... ... June 24, 2016 , ... Global law firm Greenberg Traurig, ... Elite. The attorneys chosen by their peers for this recognition are considered among the ... Traurig Shareholders received special honors as members of this year’s Legal Elite Hall of ...
Breaking Medicine News(10 mins):