Navigation Links
Inspiration Biopharmaceuticals, Inc. Initiates Phase 1 Clinical Trial of IB1001 for the Treatment of Hemophilia B

IB1001, an Intravenous Recombinant Factor IX (rFIX) Product for the Treatment of Hemophilia B

LAGUNA NIGUEL, Calif., Feb. 12 /PRNewswire/ -- Inspiration Biopharmaceuticals, Inc., today announced the initiation of a Phase 1 clinical trial of IB1001, an intravenous (IV) recombinant Factor IX (rFIX) product for control and prevention of hemorrhagic episodes in patients with hemophilia B. It is estimated that the market for therapies to treat this disorder is in excess of $600 million.

The Phase 1 clinical trial is designed to assess the safety, tolerability and pharmacokinetics of IB1001 in patients with hemophilia B, compared with the commercially available rFIX product. Following the successful completion of this study, patients will then be followed for the six month Phase 2/3 trial either based on an on-demand or prophylaxis protocol.

"The initiation of this Phase 1 trial is an important milestone for the Company and for the hemophilia community," said John Taylor, Chairman and Co-founder, Inspiration Biopharmaceuticals. "This is the first therapy for hemophilia B patients in the past two decades. We continue to develop a Factor product portfolio in both IV and non-invasive dosage forms for hemophilia and other coagulation disorders."

About IB1001

IB1001 is an intravenous recombinant Factor IX product for the acute and preventative treatment of the bleeding disorder associated with hemophilia B. IB1001 is produced with Inspiration's proprietary recombinant protein manufacturing technology, which significantly increases cell-line productivity.

About Hemophilia

Hemophilia is a lifelong, inherited bleeding disorder caused by low levels or absence of a protein called a clotting factor, essential for blood clotting. This inability to clot results from an error in a person's genetic code, and occurs in approximately 1 in 10,000 male births. It is estimated that over 400,000 people worldwide suffer from hemophilia, of which only 25% currently receive therapy. It is estimated that the market for hemophilia treatment is in excess of seven billion dollars annually. There are two types of hemophilia, hemophilia A and hemophilia B. Hemophilia A is caused by a lack of Factor VIII and hemophilia B is caused by a deficiency of Factor IX.

About Inspiration Biopharmaceuticals

Inspiration Biopharmaceuticals was founded in 2004 with the mission to revolutionize treatments for hemophilia. The Company is focused on developing products that have the potential to broaden patient access to therapy, including prophylactic use. Greater access and more frequent prophylactic therapy have been shown to reduce complications of the disease and enhance patients' long-term health and quality of life.

Underlying the Company's programs is a novel, proprietary manufacturing technology that allows a greater yield of high-quality protein. Inspiration is utilizing this technology to develop a portfolio of hemophilia and bleeding disorder products that address a $7 billion market worldwide.

Inspiration's lead product candidate IB1001, an intravenous recombinant Factor IX, has completed preclinical testing and is now entering clinical studies in the United States and is poised to enter clinical testing in Europe and Israel.

SOURCE Inspiration Biopharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Inspiration Biopharmaceuticals Announces Filing of IND for Novel Recombinant Factor IX Product, IB1001, for the Treatment of Hemophilia B
2. Keryx Biopharmaceuticals, Inc. Reports Phase 1/2 Data on KRX-0401 (Perifosine) at 50th Annual Meeting of American Society of Hematology
3. Keryx Biopharmaceuticals, Inc. Announces Phase 2 Results on KRX-0401 (Perifosine) in Patients with Relapsed/Refractory Waldenstroms Macroglobulinemia at the 44th Annual Meeting of the American Society of Clinical Oncology
4. Keryx Biopharmaceuticals, Inc. Announces Poster Presentation Highlighting Observed Clinical Activity of KRX-0401 (Perifosine) at the American Society of Clinical Oncology Meeting in Chicago, Illinois
5. Keryx Biopharmaceuticals, Inc. Announces Phase 1 and Phase 2 Data on KRX-0401 (Perifosine) in Patients with Relapsed/Refractory Multiple Myeloma at 49th Annual Meeting of American Society of Hematology
6. Keryx Biopharmaceuticals, Inc. Announces Positive Preliminary Phase 2 Data on KRX-0401 in Patients with Chemo-Insensitive Rare Sarcoma
7. Meritage Pharma Initiates Phase 2b Clinical Trial of Oral Viscous Budesonide for Pediatric Patients With Eosinophilic Esophagitis
8. Takeda Initiates Two Phase III Studies with Vedolizumab (MLN0002) in Patients with Inflammatory Bowel Disease
9. Alexza Initiates AZ-104 (Staccato(R) Loxapine) Phase 2b Clinical Trial in Patients With Migraine Headaches
10. Idenix Pharmaceuticals Initiates Proof-of-Concept Study of IDX184 for the Treatment of Hepatitis C Virus (HCV)
11. Cara Therapeutics Initiates Phase II Proof-Of-Concept Trial of Novel Analgesic in Acute Post-Operative Pain
Post Your Comments:
(Date:6/23/2016)... 23, 2016 , , , ... 7, 2016 , , , , LOCATION: , , , ... , , , EXPERT PANELISTS:  , , , Frost & Sullivan,s ... Christi Bird; Senior Industry Analyst, Divyaa Ravishankar and Unmesh Lal, Program ... global pharmaceutical industry is witnessing an exceptional era. Several new demand ...
(Date:6/23/2016)... Revolutionary technology includes multi-speaker listening ... industry leaders in advanced audiology and hearing aid technology, ... ™, the world,s first internet connected hearing aid that ...      (Photo: ) , ... ,world firsts,: , TwinLink™ - the first ...
(Date:6/23/2016)... Research and Markets has announced the addition ... States, China, Japan, Brazil, United Kingdom, Germany, France, Italy, ... Surgical Procedure Volumes: Global ... surgical procedure volume data in a geographic context. The ... of growth drivers and inhibitors, including world population growth, ...
Breaking Medicine Technology:
(Date:6/26/2016)... , ... June 26, 2016 , ... On June 10-11, ... of the 2016 Cereal Festival and World’s Longest Breakfast Table in Battle Creek, MI, ... the city’s history as home to some of the world’s leading providers of cereal ...
(Date:6/26/2016)... , ... June 26, 2016 , ... PawPaws brand ... new product that was developed to enhance the health of felines. The formula is ... The two main herbs in the PawPaws Cat Kidney Support Supplement Soft ...
(Date:6/26/2016)... Lake Orion, Clarkston, Michigan (PRWEB) , ... June ... ... direction with respect to fertility once they have been diagnosed with endometriosis. These ... tolerable intercourse but they also require a comprehensive approach that can help for ...
(Date:6/25/2016)... ... ... Austin residents seeking Mohs surgery services, can now turn to Dr. Jessica Scruggs ... for medical and surgical dermatology. , Dr. Dorsey brings specialization to include Mohs surgery, ... Micrographic Surgery completed by Dr. Dorsey was under the direction of Glenn Goldstein, MD, ...
(Date:6/25/2016)... Viejo, California (PRWEB) , ... June 25, 2016 , ... ... to fit their specific project," said Christina Austin - CEO of Pixel Film Studios. ... fully customizable and all within Final Cut Pro X . Simply select a ...
Breaking Medicine News(10 mins):