Navigation Links
Proteolix's Carfilzomib Receives Orphan Drug Designation for Treatment of Multiple Myeloma
Date:4/2/2008

SOUTH SAN FRANCISCO, Calif., April 2, 2008 /PRNewswire/ -- Proteolix, Inc., a clinical-stage company engaged in the development of novel pharmaceutical therapies for the treatment of cancer and immunological conditions, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to carfilzomib, a selective blocker of proteasome activity for the treatment of multiple myeloma. The orphan drug designation encompasses all subsets of multiple myeloma and Waldenstrom's macroglobulinemia.

"I am very pleased by our receipt of this designation for carfilzomib," said Susan Molineaux, Ph.D., the Company's President and CEO. "To date we have been encouraged by carfilzomib's early-stage clinical results in multiple myeloma, and we continue to believe it has the potential to offer cancer patients a new and effective treatment for their disease."

The Orphan Drug Act of 1983 allows the FDA to grant orphan drug status to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. According to the SEER Database of the National Cancer Institute (2004), the U.S. prevalence of multiple myeloma was 53,712 patients. The Orphan Drug Act provides the drug developer with several financial benefits and incentives related to the orphan drug, including tax credits for clinical research costs, ability to apply for annual grant funding, clinical research trial design assistance, waiver of Prescription Drug User Fee Act (PDUFA) filing fees, and a seven-year period of U.S. marketing exclusivity if the drug is the first of its type approved for the specified indication.

About Multiple Myeloma

Multiple myeloma is cancer of the plasma cell. It begins in the bone marrow, where blood cells are made. The plasma cell is a type of white blood cell that fights infections by making antibodies. Cancerous plasma cells, also called myeloma cells, divide and grow out of control, building up in the marrow and crowding out healthy blood cells. The myeloma cells do not make effective antibodies and instead release abnormal proteins, called M proteins. M proteins can damage the immediate area and travel through the bloodstream and damage other parts of the body. Left untreated, multiple myeloma can cause bone damage, elevated blood calcium, anemia, and predisposition to infection and kidney damage. In 2007, there were an estimated 19,900 new cases diagnosed and 10,790 deaths due to multiple myeloma in the United States. For more information on multiple myeloma go to http://www.cancer.gov/cancertopics/types/myeloma.

About Waldenstrom's Macroglobulinemia

Waldenstrom's Macroglobulinemia (WM) is a slow-growing type of non-Hodgkin's lymphoma that starts in white blood cells called B lymphocytes. WM is also called lymphoplasmacytic lymphoma because it occurs when abnormal lymphoplasmacytic cells multiply out of control, producing large amounts of a protein called monoclonal immunoglobulin M. WM can result in enlargement of the liver and spleen due to anemia and large amounts of immunoglobulin M can lead to hyperviscosity syndrome, in which the blood becomes abnormally thick. Symptoms of this syndrome include visual problems such as blurring or loss of vision and neurological problems including headache, dizziness, or vertigo. WM is a rare cancer with only about 1,500 new cases diagnosed annually in the United States. For more information about WM, go to http://www.cancer.gov/cancertopics/factsheet/Sites-Types/WM.

About Proteolix

Proteolix, Inc. is a privately-held biopharmaceutical company, headquartered in South San Francisco, and dedicated to discovering, developing and commercializing pharmaceutical therapies that target certain cancers and immunological conditions by inhibiting the proteasome and thereby disrupting protein turnover in cells. Phase 1 clinical studies with carfilzomib, the Company's lead product, have shown that patients with hematologic malignancies who have relapsed or progressed following multiple therapies can achieve durable anti-tumor responses. Carfilzomib is currently in Phase 2 clinical studies to evaluate its safety and efficacy in multiple myeloma, lymphoma and solid tumor malignancies. Proteolix is also developing a pipeline of next-generation proteasome inhibitors, including an oral proteasome inhibitor and a selective immunoproteasome inhibitor. For more information, please visit the Company's website at http://www.proteolix.com.

Contact information:

Matthew Ferguson

investors@proteolix.com

650-266-2825


'/>"/>
SOURCE Proteolix, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. The Multiple Myeloma Research Consortium (MMRC) and Proteolix Initiate Phase 2 Clinical Trial Investigating Carfilzomib for the Treatment of Multiple Myeloma
2. Vermillion Meets Minimum Bid Price and Receives NASDAQ Staff Determination Letter for Minimum Market Capitalization
3. Pharmasset Receives $10 Million of Working Capital
4. Memory Pharmaceuticals Receives Audit Opinion Containing Going Concern Qualification
5. Actavis Receives Approval of Generic Wellbutrin SR(R) and Zyban(R) Tablets in the U.S.
6. Seneca Valley High School Student Receives Science Award From MedImmune
7. Cephalon Receives FDA Approval for TREANDA, a Novel Chemotherapy for Chronic Lymphocytic Leukemia
8. Medarex Receives Milestone Payment for Submission of Regulatory Application Requesting Approval of Golimumab (CNTO 148) in Europe for the Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
9. Oregon Health Care Quality Corporation Receives Important Designation from U.S. Department of Health and Human Services
10. AdvanDx Receives Frost & Sullivans Rapid In-Vitro Diagnostic Technology Innovation of the Year Award
11. Axial Biotech Meets Major Scientific Milestones; Receives $6 Million Tranche of Series B Financing
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/25/2016)... Md. (PRWEB) , ... May 25, 2016 , ... ... request for information (RFI) issued by the Office of the National Coordinator for ... patient experience, and determines if clinically relevant data were available when and where ...
(Date:5/24/2016)... ... May 24, 2016 , ... ... traumatic injuries, will be accelerated by research at Worcester Polytechnic Institute (WPI) that ... wound healing and tissue regeneration. , The novel method, developed by WPI faculty ...
(Date:5/23/2016)... ... May 23, 2016 , ... ... Drive Precision Farming in 2017 and Beyond. The paper outlines the key trends ... precision ag industry. , “We’ve witnessed a lot of highs and lows as ...
(Date:5/23/2016)... ... 23, 2016 , ... Foresight Institute , a leading ... for the 2015 Foresight Institute Feynman Prizes. , These prestigious prizes, named ... for experiment and the other for theory in nanotechnology. Prof. Markus J. Buehler, ...
Breaking Biology Technology:
(Date:5/3/2016)... May 3, 2016  Neurotechnology, a provider of ... MegaMatcher Automated Biometric Identification System (ABIS) , a ... projects. MegaMatcher ABIS can process multiple complex biometric ... combination of fingerprint, face or iris biometrics. It ... and MegaMatcher Accelerator , which have ...
(Date:4/26/2016)... DUBLIN , April 27, 2016 ... of the  "Global Multi-modal Biometrics Market 2016-2020"  report ... ) , The analysts forecast ... a CAGR of 15.49% during the period 2016-2020.  ... a number of sectors such as the healthcare, ...
(Date:4/14/2016)... , April 14, 2016 ... Malware Detection, today announced the appointment of Eyal ... new role. Goldwerger,s leadership appointment comes at ... heels of the deployment of its platform at several ... biometric technology, which discerns unique cognitive and physiological factors, ...
Breaking Biology News(10 mins):