09-01-2012. Akinion Pharmaceuticals AB, a Karolinska Development AB portfolio company, announced today the appointment of Carl Harald Janson as new CEO. Carl Harald Janson, MD, PhD and CEFA, has over 25 years of experience in medicine, pharmaceutical development and asset management

 

22-06-2011. Lipid Therapeutics, a biotechnology company focused on novel treatments for inflammatory bowel disease, today announced positive topline results from a Phase IIb clinical trial with its lead product, LT-02, in patients with ulcerative colitis. LT-02 is a controlled release formulation of phosphatidylcholine that has been specifically designed to treat ulcerative colitis by improving the barrier function of the mucosal layer of the colon, a concept that has now been successfully tested in several clinical trials.

The Phase IIb trial met the primary end point, change in  SCCAI (Simple Clinical Colitis Activity Index), for patients refractory to standard first-line intervention who were treated with LT-02 at 0.8g four times a day (51% reduction with LT-02 vs 33% reduction with placebo; p <0.05). Patients who received one of two lower doses of LT-02 also showed a positive benefit. The excellent safety profile of LT-02 treatment was comparable to placebo at all three doses. The Phase IIb trial was a randomized, multi-center, double-blind, parallel group, placebo-controlled, dose ranging study that was designed to investigate the efficacy and safety of LT-02 in patients with mesalazine-refractory ulcerative colitis. 156 patients were enrolled into the trial at 24 centers in Germany, Lithuania and Romania. Patients were randomized to receive one of three doses of LT-02 or placebo and were treated for a period of 12 weeks.
Dr. Gerhard Keilhauer, CEO of Lipid Therapeutics, said: “The results that we have announced today are a key milestone for Lipid Therapeutics. We are delighted that LT-02, which has a novel mode of action, has been shown to be of significant benefit to patients with ulcerative colitis whose condition has not responded to the current mainstay of therapy, i.e. mesalazine. We will now discuss with our European partner, Dr. Falk Pharma, and with potential partners in the US and Japan how we can rapidly move this innovative therapeutic into a pivotal Phase III study, the next key step in making it available to ulcerative colitis patients as quickly as possible.”

LT-02 is a novel controlled release formulation of phosphatidylcholine that augments the natural protective mucosal barrier in the lower gut. It is the first product candidate worldwide that targets the pathological changes in the lower gut barrier function of colitis patients which are thought to be one of the main underlying disease causes.

 

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Background

by B2Bioworld Editor*

 

Lipid Therapeutic GmbH’s drug candidate is based on the work of Prof. Dr. Walter Stremmel, Medical Director at Transplant Centre Surgery, Universitätsklinikum Heidelberg (DE) and his collaborators. Dr. Stremmel discovered that inflammatory, ischemic or degenerative disorders (in particular liver diseases) could be treated with lysophosphatidylethanolamine coupled to ursodeoxycholate which is converted to a ester LysoPE-DOCA. In ulcerative colitis the lack of phosphatidylcholine in the colonic mucus is hypothesized to cause the disease. The current trial aims to study the effects of a retarded release preparation of phosphatidylcholine on restoring the mucosal barrier function.

In addition to ulcerative colitis LT-02 is under study for conditions of abdominal pain, diarrhea, and large intestine.

 

The therapeutically active lipid Ursodeoxycholate, a LysoPE conjugate:

 

Source: Stemmler, US0166401, 10-07-2008.

 

In an interview (in German) Dr. Stremmel details the treatment. The non-dated interview is published by Heidelberg University Clinic and targeted to the general public resp. patients interested to participate in the clinical trial.

 

 

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23-02-2011. iBio, Inc. today announced it has acquired Orphan Drug Designation for plant-produced human alpha galactosidase A (“α-Gal A”) and related property rights from an affiliate of Kentucky Bioprocessing LLC (“KBP”) and has initiated a program, based on its iBioLaunch™ platform, to develop an improved version of the enzyme for therapy of Fabry disease. iBio will work with its regular research and development collaborator, Fraunhofer USA Center for Molecular Biotechnology, for product development, and with KBP for manufacture of clinical and commercial quantities of the new product for iBio or its licensees.
This Fabry disease therapeutic program will be part of iBio’s broader program to bring forward approximately ten more candidate proteins for commercialization as “biosimilar” or “biobetter” therapeutic products. iBio intends to advance these candidates to a point sufficient to demonstrate the advantages of making them using the iBioLaunch platform technology and then license them to industry partners. iBio already has demonstrated the applicability of its platform technology to most therapeutic protein classes, ranging from cytokines and growth factors to enzymes and antibodies.
Under its current program, iBio is selecting commercial targets that exemplify advantages of the iBioLaunch technology and meet apparent market needs. Selection of the Fabry disease candidate was influenced by: the current worldwide shortage of α-Gal A for enzyme replacement therapy for Fabry disease; the likelihood that the disease is significantly under-diagnosed; the opportunity to acquire Orphan Drug Designation for plant-produced α-Gal A (which can provide significant market protection and tax advantages); and iBio’s belief this will further demonstrate some of the advantages of our technology such as scalability for Orphan Drug applications, more rapid product development, and improved efficacy compared to other systems.  “We believe the unusual scalability, speed and efficiency of iBio’s plant-based protein expression platform technology can make important contributions to rapid development and availability of therapies against orphan diseases such as Fabry Disease,” said Robert Erwin, President of iBio.
Current estimates indicate a patient population affected by Fabry Disease of approximately 8,000 to 10,000. Current therapies are estimated to cost more than $200,000 per patient year. Symptoms usually begin in childhood. Unless continuously treated, Fabry Disease results in many severe health problems such as kidney failure, heart damage and cerebrovascular problems.

 

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Disclaimer: You agree that  B2Bioworld is not responsible and will not be held liable for any third party content on its sites or any third-party content, products or services available on other web sites accessed through links from B2Bioworld sites. Links to third-party sites are for your convenience only, and their inclusion on   B2Bioworld's sites does not imply any endorsement, guarantee, warranty or representation by  B2Bioworld.

 

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Note by B2Bioworld Editor: 

The affiliate is Alpha Gal LLC spun-off by Kentucky Bioprocessing. This company resp. Alpha Gal LLC acquired IP assets from Large Scale Biology Corporation which went bankrupt in 2006. Its plant-produced human A-Glactosidase A received orphan drug status in January 2003. To date tthe drug is not yet FDA approved.

 

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January 2011. An unmasked account of decisions about investing into cancer stem cell research and the fate of regenerative medicine projects in Japan. Dr Busch summarises results and evaluates technology platforms like novel antibodies and wnt mechanisms. He voices his expectations from current key drug development partnerships, in particular with Oncomed and Micromet. Will these include companion diagnostics? To what extent does Bayer retain respective intellectual property rights? A comment on personalised medicine and cancer stem cells research pursued by Merck KGaA and others. What are prospects for classic oncology drugs?

 

 

 

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