Luveniq (LX211) phase 3 trials for uveitis

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Luveniq (LX211) phase 3 trials for uveitis

Post by Mike Bartolatz » Sun Feb 25, 2007 11:11 am

http://clinicaltrials.gov/show/NCT00404742

this would be the first drug approved for treatment of uveitis other than corticosteroids.

http://micro.newswire.ca/release.cgi?rk ... -0&Start=0
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Post by Mike Bartolatz » Mon Jan 14, 2008 3:02 pm

http://www.bio-medicine.org/medicine-te ... 007-783-1/

hopeful results lead to expansion of the trial with new trial initiated to include adolescents from 13 years old
(see clinical trials at NIH.gov for this new expanded trial)
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Post by Mike Bartolatz » Fri Jul 25, 2008 2:30 pm

http://www.luxbio.com/Uveitis.htm

above is the description of LX 211 from the manufacturerer. it talks about the need for better drugs for uveitis/
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LX 211 completion date of 25 June

Post by Mike Bartolatz » Fri Jul 25, 2008 2:39 pm

http://www.luxbio.com/pr062508.htm

the above announcement on 25 June 2008 is encouraging

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Re: LX211 phase 3 trials for uveitis

Post by Mike Bartolatz » Tue Dec 02, 2008 2:25 pm

http://www.google.com/search?hl=en&sa=X ... 17&spell=1

this search is on the ability of cyclosporine to inhibit IL 17 production, the molecule in in LX211 is made from cyclosporine molecule and explains why it is so effective in stopping inflammation in uveitis where the IL 17 cytokine is present

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Re: Luveniq (LX211) phase 3 trials for uveitis

Post by Mike Bartolatz » Sun Jan 11, 2009 12:33 pm

application for use in Children in Europe:

http://www.luxbio.com/pr112608.htm
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Re: Luveniq (LX211) phase 3 trials for uveitis

Post by Mike Bartolatz » Wed Apr 01, 2009 11:34 pm

http://micro.newswire.ca/release.cgi?rk ... -0&Start=0

final results of trials announced, lets hope they apply for FDA approval quickly and this the first drug for Uveitis will be approved
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Re: Luveniq (LX211) phase 3 trials for uveitis

Post by Mike Bartolatz » Fri May 08, 2009 9:15 am

Public release date: 4-May-2009
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Contact: Joan Kureczka
JKureczka@comcast.net
415-821-2413
Kureczka/Martin Associates

First oral uveitis drug reduces both inflammation and recurrence in potentially blinding eye disease
If approved, LX211 would address an important unmet medical need for patients with uveitis
Fort Lauderdale, FL (May 4, 2009): Uveitis, or inflammation within the eye, is a group of diseases responsible for years of visual loss roughly comparable to that caused by diabetes. Now, results from a pioneering international Phase 3 program in uveitis, the LUMINATE trials sponsored by Lux Biosciences, demonstrate the ability of LX211 (LUVENIQ™, voclosporin oral capsule) to significantly improve this chronic eye inflammation. Additionally, in patients who are discontinuing potentially toxic medications for uveitis, such as the corticosteroid prednisone, LX211 actively reduces the rate of inflammatory exacerbations by 50% at six months, compared to placebo. The study results also show a safety profile for LX211 at the 0.4 mg/kg bid dose that suggests the experimental drug would be suitable for chronic use as the first oral treatment for this sight-threatening inflammatory eye disease, while also providing a means to greatly reduce the serious health risks associated with long-term corticosteroid use. LX211 is a novel and proprietary next-generation calcineurin inhibitor that Lux Biosciences is developing for ophthalmic uses.

Dr. James T. Rosenbaum, M.D., Professor of Ophthalmology, Medicine and Cell Biology and Vice-Chair of the Department of Ophthalmology of the Casey Eye Institute – Oregon Health Sciences University (OHSU), represented the LUMINATE Investigator Network in presenting the Phase 3 LUMINATE program results for the first time at the 2009 annual meeting of the Association for Research in Vision and Ophthalmology (ARVO). The LUMINATE program, consisting of three randomized, double-masked, dose-ranging and placebo-controlled trials that enrolled a total of 558 patients at 56 sites in 7 countries (United States, Canada, United Kingdom, France, Germany, Austria and India), is the largest clinical program ever conducted in uveitis.

"Uveitis, a term used to classify a group of autoimmune diseases characterized by chronic inflammation of the eye, is the 4th leading cause of blindness and often affects patients under the age of 40, but the disease remains frequently mistreated," commented Dr. Rosenbaum. "Uveitis has many causes and experts often disagree about what constitutes successful treatment. Accordingly, no pharmaceutical company previously has attempted to demonstrate that an oral medication can successfully treat uveitis, and there are currently no FDA-approved oral medications for this condition. Treating physicians often prescribe corticosteroids, which are burdened with a variety of serious systemic side effects when given orally. Even if applied as drops to the eye, corticosteroids can cause cataract formation and glaucoma. Based on the results of the LUMINATE trial program, LX211 appears to offer a therapeutic and safety profile that would meet the critical need for an oral medication for uveitis. LX211 is not a corticosteroid, but allows the reduced use of corticosteroids like prednisone, which in turn reduces the serious side-effects associated with those drugs."

Dr. Rosenbaum noted that a poster presentation at ARVO from a survey of U.S. ophthalmologists and rheumatologists from 27 states, presented by researchers from the Wilmer Eye Institute of Johns Hopkins University, Baltimore, found that the dose of oral corticosteroids used commonly to keep chronic inflammation within the eye under control is in the range of 25 mg/day. This compares to a recommended chronic dose by the uveitis community of 10 mg/day or less. Of additional note, patients enrolled in the LX211-02 protocol, which evaluated the use of LX-211 in subjects with treated but quiescent disease, received doses of corticosteroids that were more than 50% higher than this recommendation. It is well documented that systemic steroids at doses above 10 mg/day cause a myriad of adverse effects, such as osteoporosis, resulting in increased risk for hip or spinal fractures, and metabolic disturbances including obesity, heart disease, and diabetes. Mood disturbances are also associated with chronic corticosteroid use.

"The tapering of systemic corticosteroids to 5 mg or less per day, as implemented successfully in the LUMINATE studies, provides for additional safety from steroid morbidities," Dr. Rosenbaum commented.

"We are pleased with the demonstrated clinical effect of LX211 (Luveniq™) in uveitis, coupled with what appears to be an acceptable side effect profile while reducing the need for systemic corticosteroid to half of the current guideline recommendation," commented Ulrich Grau, Ph.D., Lux Biosciences' President and Chief Executive Officer. "We're now pursuing regulatory filings, and if approved for commercialization by the appropriate regulatory agencies, LX211 would become the first agent in this class available in the United States and most other markets for the treatment of uveitis."

For more information on uveitis, its incidence, and how the disease is currently treated, please see http://www.luxbio.com/Uveitis%20Backgrounder.pdf

Overview of LUMINATE Trial Results

The LUMINATE program consists of three protocols that included 218 patients with active non-infectious uveitis with posterior (behind the lens of the eye) manifestation of the disease (LX211-01); 232 patients with clinically quiescent disease (LX211-02); and 108 patients with active uveitis with anterior (front of the eye) manifestation of the disease (LX211-03). Data from these trials showed:


•Of the three doses studied, the 0.4 mg/kg BID dose had the most acceptable safety profile relative to effect on the disease. The adverse effects on the kidney (8.2% of subjects with decrease from baseline by ≥30% in glomerular filtration rate vs. 4.1 % in placebo) and blood pressure (mean increase in systolic BP by 6 mm Hg) will require monitoring, but were overall moderate and manageable. Triglycerides and cholesterol were not elevated and had no negative impact on the cardiovascular safety profile. Hair growth (hirsutism) was observed in 5% of patients. Otherwise the safety profile was similar to placebo.


•In study LX211-01 the 0.4 mg/kg BID dose fully met the primary endpoint of superiority to placebo at both weeks 16 (p=0.008) and week 24 (p=0.027) for mean change from baseline in vitreous haze, a validated measure of inflammation of the posterior segment of the eye. The magnitude of the effect was >1 step change from baseline, demonstrating a clinically relevant benefit.


•In study LX211-02 the 0.4 mg/kg BID dose showed a reduction by 50% vs. placebo in rate of recurrence of inflammation at 6 months using a pre-specified analysis that accounted for data censoring due to non-efficacy-related discontinuations. This reduction was statistically significant (p=0.045), thus confirming the positive results from LX211-01.


•In study LX211-03, treated patients reduced the cellular response in the front of the eye from an average of more than 25 white blood cells per high power microscopic field to an average of 6 to 10 cells per high power field. However, placebo-treated patients also improved in this study and it was therefore not possible to show that LX211 was effective for this rare subset of uveitis patients, those with refractory disease in the anterior portion of the eye.

The LUMINATE program was conducted under the sponsorship of Lux Biosciences.

###
About Lux Biosciences

Lux Biosciences, Inc. is a privately held biotechnology company focused on ophthalmic diseases. The company has a staged product portfolio of potentially first-in-class therapies distinguished by their short-term path to commercialization and potential to generate high revenue growth. The portfolio includes:


•Two Phase 3 clinical-stage projects including: i) LUVENIQ™, the oral formulation of a next-generation calcineurin inhibitor (voclosporin) developed as steroid-sparing therapy for the treatment of sight-threatening non-infectious uveitis, and ii) LUMITECT™, a silicone matrix ocular (episcleral) implant that steadily releases therapeutic doses of cyclosporine A locally to the eye for the prevention of rejection in corneal transplant recipients. Both the LUMINATE pivotal clinical program for LUVENIQ for the treatment of uveitis, as well as the LUCIDA pivotal clinical program with LUMITECT™, for the prevention of corneal transplant rejection were initiated in early 2007 and include sites in North America, Europe and India. Enrollment in the LUMINATE program was completed in June 2008. Enrollment in the LUCIDA program was completed in March 2009. Lux Biosciences has licensed voclosporin from Isotechnika, Inc. for development in ophthalmic indications.


•LX214 is a novel topical eye drop formulation that entered human clinical testing for dry eye syndrome in February 2009. Based on Lux's proprietary next-generation calcineurin inhibitor, LX214 is targeted towards other chronic inflammatory diseases of the eye, most notably dry eye syndrome, blepharitis and atopic keratoconjunctivitis.


•Several earlier stage projects based on proprietary product-enabling bio-erodible polymer technologies that facilitate targeted and sustained delivery of molecules to the eye.

For more information on Lux Biosciences, please visit the company's website at http://www.luxbio.com.

Forward-Looking Statements

This press release is not made on behalf of, or with authorization by, any other company or issuer of securities. To the extent that this press release may refer to any other issuer of securities, Lux Biosciences, Inc. makes no statement and expresses no recommendation or other opinion about any transaction or potential transaction concerning such securities.

This press release may contain forward-looking statements, including Lux Bioscience's belief as to the medical and commercial potential of its product candidates, Lux Bioscience's plans to pursue business and regulatory strategy, and Lux Bioscience's expectations regarding actions and decisions solely within the control and purview of other parties. These forward-looking statements involve important known and unknown risks and uncertainties, which could cause actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the exercise of discretion by regulatory agencies and other parties, the availability to Lux Biosciences of funds and resources to pursue research and development projects, the performance of activities and generation of scientific data by parties other than Lux Biosciences, the ability of Lux Biosciences to economically manufacture and commercialize its products once approved, acceptance by the medical community of Lux Biosciences' products once approved and the availability of alternative therapeutic agents, approval for reimbursement by third-party payors of Lux Biosciences' products once approved, the success and timely completion of clinical trials and other scientific studies, the ability of Lux Biosciences and its licensors to defend its and their patents from infringement by third parties, and the risk that such patents may be subsequently shown to be invalid or that the practice of such patents may infringe the patents of others. Further, Lux Biosciences disclaims any undertaking to issue further press releases or otherwise advice about changes to these beliefs, plans and expectations.

CONTACTS:
Lux Biosciences, Inc.
Ulrich Grau, Ph.D.
+1 201-946-0221
Ulrich.grau@luxbio.com

Kureczka/Martin Associates (media)
Joan Kureczka
+1 415-821-2413
Mobile +1 415-690-0210
Jkureczka@comcast.net
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Re: Luveniq (LX211) phase 3 trials for uveitis

Post by Mike Bartolatz » Wed May 27, 2009 10:10 am

http://www.earthtimes.org/articles/show ... 6524.shtml

here is information on the latest information presented in Europe on the study by Specialsts from around the World.

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Re: Luveniq (LX211) phase 3 trials for uveitis

Post by Mike Bartolatz » Wed Aug 05, 2009 3:32 pm

http://www.youtube.com/watch?v=6EfTR3wVwCo
news clip on Luveniq, LX211

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Re: Luveniq (LX211) phase 3 trials for uveitis

Post by Mike Bartolatz » Tue Feb 16, 2010 2:11 pm

http://micro.newswire.ca/release.cgi?rk ... rt=0&htm=0

Earlier this month application to the FDA for approval of Luveniq, Voclosporine (formerly LX211) was made by the manufacturer.
application in the EU was also made. this process could be completed as early as about 8 months from now according to the article here in the USA and about a year from now in the EU.
Lets pray it gets approved!
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