Navigation Links
Inspiration Biopharmaceuticals Announces Filing of IND for Novel Recombinant Factor IX Product, IB1001, for the Treatment of Hemophilia B
Date:11/13/2007

LAGUNA NIGUEL, Calif., Nov. 13 /PRNewswire/ -- Inspiration Biopharmaceuticals announced today that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin clinical trials with IB1001, an intravenous recombinant Factor IX (rFIX) product for the on demand and prophylactic treatment of the bleeding disorder associated with hemophilia B.

Upon FDA approval of the IND application, Inspiration Biopharmaceuticals intends to enter Phase 1/2 clinical trials to evaluate the pharmacokinetics (PK) and safety profile of IB1001, compared with the commercially available Factor IX products; rFIX, BeneFix(R) and plasma-derived Factor, MonoNine(R). Following successful completion of the PK phase of this study, patients will then enroll in one of two trials: a six month Phase 1/2 On Demand trial to document safety and efficacy in treating spontaneous bleeding episodes or a pivotal Phase 2/3 Prophylaxis trial to document safety and efficacy in the prevention of spontaneous bleeding. In addition, the safety and efficacy of peri-surgical prophylactic administration of IB1001 to control bleeding during surgical procedures will be evaluated. The rate of inhibitor formation will be evaluated throughout all phases of the clinical investigation of IB1001.

"We are excited to be filing an IND for IB1001," said Michael Griffith, Ph.D., President and CEO, Inspiration Biopharmaceuticals. "Preclinical studies have demonstrated the expected PK and safety profile for IB1001 when compared to the clinically proven commercial Factor IX products. Our cost-effective manufacturing platform for Factor IX positions Inspiration to expand the global supply of i.v. rFIX and to develop next generation products to facilitate prophylactic care of the hemophilia B patients worldwide. Our ultimate goal is to leverage our low cost manufacturing technology to find the means for non-invasive delivery of Factor IX which we believe may represent the equivalent of a therapeutic cure for patients suffering from this disease.

"Our vision is that one day all patients with hemophilia, regardless of where they live, will have access to treatment. More affordable treatment is critical to achieving treatment for all," stated Mark Skinner, President, World Federation of Hemophilia. "The availability of lower-cost rFIX products to treat hemophilia B could facilitate more prophylactic use, as well as make treatment more accessible to people worldwide."

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. 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 Recombinant Protein Manufacturing Technology

Inspiration Biopharmaceuticals uses novel patent protected, recombinant protein manufacturing technologies, which significantly increase cell-line productivity. This in turn decreases manufacturing capacity requirements, and significantly lowers the overall production cost for Factor products compared with existing manufacturing processes. Inspiration believes that its technologies will allow introduction of patient friendly, cost-effective products, which will provide equal or enhanced potency compared to those currently available.

About Inspiration Biopharmaceuticals

Inspiration Biopharmaceuticals, founded in 2004, is developing treatments for hemophilia 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 at a significantly lower cost than is currently available. Inspiration is utilizing this technology to develop a portfolio of hemophilia and bleeding disorder products that address a $5 billion market worldwide.

Inspiration's lead product candidate, an intravenous recombinant Factor IX, has completed preclinical testing and is poised to enter Phase I/II clinical studies in the United States.


'/>"/>
SOURCE Inspiration Biopharmaceuticals
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. WallSt.net (www.wallst.net) Updates the Investment Community Through an All-New Interview With RegeneRx Biopharmaceuticals CEO
2. Nabi Biopharmaceuticals Announces Second Quarter 2007 Financial Results
3. Nabi Biopharmaceuticals Announces Continued Positive NicVAX Phase 2b Data at Nine Months
4. Keryx Biopharmaceuticals to Present at William Blair & Company Small-Cap Growth Stock Conference
5. Morria Biopharmaceuticals Plc Initiates Phase I Clinical Study of MRX-4 in Allergic Rhinitis
6. Keryx Biopharmaceuticals, Inc. Announces Positive Preliminary Phase 2 Data on KRX-0401 in Patients with Chemo-Insensitive Rare Sarcoma
7. Nabi Biopharmaceuticals Announces Successful Completion of NicVAX(R) Phase 2b Trial; Drug Shows Statistically Significant Rates of Smoking Cessation and Continuous Long-Term Smoking Abstinence at 12 Months
8. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
9. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
10. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
11. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... June 24, 2016   Bay Area Lyme ... Dean Center for Tick Borne Illness , ... Rehabilitation, MIT Hacking Medicine, University of California, Berkeley, ... announced the five finalists of Lyme Innovation ... More than 100 scientists, clinicians, researchers, entrepreneurs, and ...
(Date:6/24/2016)... Calif. , June 24, 2016  American Respiratory Labs (ARL), ... is now able to perform sophisticated lung assessments in patients, homes, ... , Inc. Patients are no longer limited to ... EasyOne PRO ® , ARL patients like Jeanne R. of ... in the comfort of her own home. ...
(Date:6/24/2016)... 2016  Arkis BioSciences, a leading innovator in ... durable cerebrospinal fluid treatments, today announced it has ... is led by Innova Memphis, followed by Angel ... investors.  Arkis, new financing will accelerate the commercialization ... release of its in-licensed Endexo® technology. ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... TopConsumerReviews.com recently awarded their highest five-star rating ... Millions of individuals in the United States and Canada wear eyeglasses. Once considered to ... correct vision and make a fashion statement. Even celebrities use glasses as a way ...
(Date:6/26/2016)... ... June 26, 2016 , ... On June 10-11, 2016, A Forever ... Cereal Festival and World’s Longest Breakfast Table in Battle Creek, MI, where the rehabilitation ... as home to some of the world’s leading providers of cereal and other breakfast ...
(Date:6/26/2016)... ... 26, 2016 , ... PawPaws brand pet supplements owned by Whole ... enhance the health of felines. The formula is all-natural and is made from Chinese ... PawPaws Cat Kidney Support Supplement Soft Chews are Astragalus Root Extract and ...
(Date:6/26/2016)... ... June 26, 2016 , ... Many women ... diagnosed with endometriosis. These women need a treatment plan to not only alleviate ... that can help for preservation of fertility and ultimately achieving a pregnancy. The ...
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs surgery services, ... Mohs Surgery and to Dr. Russell Peckham for medical and surgical dermatology. , Dr. ... skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was ...
Breaking Medicine News(10 mins):