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:11/26/2015)... Nov. 26, 2015 Research and Markets ... the "2016 Future Horizons and Growth Strategies ... Supplier Shares, Country Segment Forecasts, Competitive Intelligence, Emerging ... --> --> This ... the Italian therapeutic drug monitoring market, including emerging ...
(Date:11/26/2015)... , November 26, 2015 ... the addition of the  "2016 Future ... European Cell Surface Marker Testing Market: ...  report to their offering.  --> ... addition of the  "2016 Future Horizons ...
(Date:11/25/2015)...  The total global healthcare industry is expected to grow ... Latin America has the highest projected growth at ... Japan ), is second with growth projected at 11.5%. ... healthcare expenditure. In 2013-2014, total government funded healthcare was nearly ... to 41.2% in 2013-2014. In real terms, out of pocket ...
Breaking Medicine Technology:
(Date:11/29/2015)... San Jose, CA (PRWEB) , ... November 29, 2015 , ... ... Bay Area, is proud to announce their December, 2015, featured apartment community: Epic. In ... looking for corporate housing in the tight Bay Area rental market to efficiently find ...
(Date:11/28/2015)... ... 2015 , ... Safe storage for contraceptive devices may not always be easy ... Jersey and the other from Bradley Beach, New Jersey, there is an easy solution ... having to replace NuvaRings more often than necessary. As such, it affords peace of ...
(Date:11/28/2015)... ... , ... Beginning November 30th at 6:00 a.m. EST until 11:59 p.m. EST, ... of up to 20% off orders $80 or more to free gifts with purchases, there ... , As a competitive e-commerce website for skin care and cosmetic needs, customers will save ...
(Date:11/27/2015)... ... November 28, 2015 , ... There is only one major question facing ... last year? , This question has not been an easy question to answer. Especially ... age and the younger workforce don’t share the same discipline around working long hours. ...
(Date:11/27/2015)... ... November 27, 2015 , ... According to an article published ... Toronto and the University of British Columbia suggested that laws requiring bicyclists to wear ... explains that part of the reason for the controversial conclusion is that, while helmets ...
Breaking Medicine News(10 mins):