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
Date:9/24/2007

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 (http://www.multiplemyeloma.org)

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 http://www.velcura.com. Available Topic Expert(s): For information on the listed expert(s), click appropriate link. Michael W. Long, Ph.D. http://profnet.prnewswire.com/Subscriber/ExpertProfile.aspx?ei=49215


'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:10/7/2017)... --  Provista, a proven leader in the supply ... power, today announced a new resource area on Provistaco.com ... is the online home for case studies, articles on ... releases, slideshows and events. ... at their fingertips, viewers can also watch short videos ...
(Date:10/4/2017)... to the Centers for Disease Control and Prevention (CDC), influenza vaccination ... is helping communities across Massachusetts , Connecticut ... flu shots through the end of the month. *Some exclusions ... ... shot is by the end of October, according to the Centers for ...
(Date:10/2/2017)... , Oct. 2, 2017  Eli Lilly and ... financial results for the third quarter of 2017 on ... conference call on that day with the investment community ... The conference call will begin at 9 ... can access a live webcast of the conference call ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... The International Association ... standards of excellence for the field of eating disorders, announces the opening of ... 2018 in Orlando, Florida at the Omni Resort at ChampionsGate. , ...
(Date:10/13/2017)... ... October 13, 2017 , ... Apple Rehab Shelton Lakes , which ... evacuation of the facility as part of a disaster drill on October 3rd. , ... and Shelton City Emergency Manager, as well as the Connecticut Long Term Care ...
(Date:10/13/2017)... ... October 13, 2017 , ... Global Healthcare Management’s 4th Annual Kids ... Milford, NJ. This free event, sponsored by Global Healthcare Management’s CEO, Jon Letko, ... run is geared towards children of all ages; it is a non-competitive, non-timed event, ...
(Date:10/13/2017)... ... 2017 , ... “The Journey: From the Mountains to the Mission Field”: the ... in the Philippines. “The Journey: From the Mountains to the Mission Field” is the ... She has taught all ages and currently teaches a class of ladies at her ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest and fastest ... to open a flagship location in Covington, LA at 401 N. U.S. Highway 190, ... next to Office Depot in the Holiday Square shopping center. Its location allows it ...
Breaking Medicine News(10 mins):