Navigation Links
LX211 highlighted as potential disease modifying therapy for noninfectious uveitis
Date:10/29/2009

JERSEY CITY, NJ (October 26, 2009): An experimental drug, LX211 (LUVENIQ; oral voclosporin), may become the first approved oral treatment capable of modifying the course of uveitis, a group of serious eye conditions inevitably associated with either severe vision loss or substantial morbidity from steroid use. Results of international Phase 2/3 clinical trials conducted by Lux Biosciences, to be the subject of two podium presentations at the American Association of Ophthalmology (AAO) meeting and of a presentation at the satellite meeting of the American Uveitis Society (AUS) in San Francisco, October 24-27, highlight the ability of LX211 to control the inflammation that characterizes this potentially blinding eye disease and significantly reduce its rate of recurrence. Lux Biosciences plans to file an NDA and MAA for marketing approvals around year-end 2009 and early 2010 in the United States and Europe, respectively.

"The LX211-02 study was a double-masked, placebo-controlled, dose-ranging study that included 232 patients at 57 centers in North America, Europe and India with clinically inactive uveitis involving any location within the eye," said Bahram Bodaghi, M.D., Ph.D., Piti Salptrire Hospital Paris, France, who will present the study results on Monday October 26 at 8:50 am PT. "Results of this trial showed that LX211 was able to reduce recurrence of inflammation by 50% over placebo at the 0.4 mg/kg twice daily dose (p<0.05) and may therefore effectively increase the interval between inflammatory relapses to 24 months compared to 10 months with placebo."

"Given that inflammatory exacerbation is a direct trigger of vision loss," Prof. Bodaghi commented, "this result for LX211 is impressive. In addition to a marked reduction in recurrence of inflammation, visual acuity was preserved in this study. Moreover, these results suggest the potential for disease modification whereby treatment with LX211 alters the course of the disease leading ultimately to improved outcomes in this difficult-to-treat condition."

Results of the LX211-01 study, which investigated LX211 in 218 patients with active, sight-threatening uveitis affecting the posterior segment of the eye, will also be presented at AAO on Monday October 26 at 9:00 am PT by clinical investigator Quan D. Nguyen, M.D., of the Wilmer Eye Institute at The Johns Hopkins University, Baltimore, MD. "In this study, also a double-masked, placebo-controlled, dose-ranging trial conducted in North America, Europe and India, control of inflammation was evaluated by means of change in vitreous haze at weeks 16 and 24. Results showed the LX211 presumed label dose of 0.4 mg/kg twice daily to be statistically significantly superior to placebo at both time points. Preservation of vision was also demonstrated in this study."

In explaining the overall clinical benefit, C. Stephen Foster, MD, President, Massachusetts Eye Research and Surgery Institution (MERSI), highlighted the ability of LX211 to control inflammation and to significantly delay recurrence of inflammatory exacerbation compared to the control group. Moreover, this result was achieved while successfully reducing corticosteroids to 5 mg/day or less. "Therapy with LUVENIQ conforms to the 2000 uveitis treatment guidelines, and is supported by randomized clinical trials that offer the highest level of evidence-based support. Once approved, LUVENIQ would be the only uveitis therapy so rated and thus, one that should always be offered," Dr. Foster stated in his presentation to the AUS on Sunday October 25 at 8:00 pm PT.

Treatment with LX211 was overall well tolerated at the twice-daily 0.4 mg/kg dose, demonstrating a safety profile that appears suitable for chronic use. Adverse effects on renal function (8.2% of subjects with decrease from baseline of ≥30% in glomerular filtration rate vs. 4.1 % in placebo) and blood pressure (mean increase in systolic BP by 6 mm Hg) were moderate and manageable. Abnormal hair growth (hirsutism) was observed in 5% of patients. Otherwise the safety profile was similar to placebo, and triglycerides and cholesterol were not elevated.

"Non-infectious uveitis involving the posterior segment of the eye is a leading cause of vision loss and long-term disability and the fourth leading cause of legal blindness in the industrialized world" said Ulrich Grau, Ph.D., Lux Biosciences' President and Chief Executive Officer. "As the majority of patients are first diagnosed at ages under 40 years, the socio-economic burden of uveitis is higher than that of other serious ocular conditions such as AMD and diabetic macular edema. The results from these clinical trials suggest that LX211 may have the potential to significantly change the face of uveitis therapy, based on its ability to modify the course of the disease. This is analogous to the advent of disease-modifying anti-rheumatic drugs (DMARD's) and their impact on the course of rheumatoid arthritis."


'/>"/>

Contact: Joan Kureczka
JKureczka@comcast.net
415-821-2413
Kureczka/Martin Associates
Source:Eurekalert

Related biology technology :

1. Sugarcane as a Key Element Against Global Warming to be Highlighted at Green Week in Brussels
2. Bio-Matrix Scientific Group, Inc. Highlighted in LifeSciencesWorld.com Special Report; Stem Cell Market Projected to Exceed $8 Billion Worldwide by 2016
3. Inverseons Asthma Therapy Receives Notice of Allowance; Clinical Trial Highlighted in Lancet
4. Significant Anti-Tumor Activity and Extended Half-Life of NKTR-102 (PEG-irinotecan) Highlighted in Phase 1 Data Presented at EORTC-NCI-AACR Symposium
5. Pharmaxis Research Programs Highlighted at European Respiratory Society Congress
6. Pressure Cycling Technology (PCT) Highlighted in Five Podium Presentations at the Fifth International Conference on High Pressure; PBI Introduces the Patent-pending PCT Shredder at the Meeting
7. Epeius Biotechnologies Lead Product, Rexin-G for Metastatic Cancer, Aptly Highlighted by National Cancer Institute Journal
8. Depth of MedImmunes Respiratory Disease Research Program Highlighted at Annual Meeting of the American Thoracic Society
9. Nektars PEGylation Technology Enables Peptide Mimetic, Highlighted by Data Presented at 45th ERA-EDTA Congress
10. Stereotaxis Market Leadership Highlighted at Heart Rhythm 2008
11. Arius highlighted at AACR-NCI-EORTC 2007 International Cancer Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/18/2017)... ... January 18, 2017 , ... Total Orthopedics ... implanted SpineFrontier’s A-CIFT™ Solofuse-P™. The operation took place on Wednesday, January 11, 2017 ... procedure was an anterior cervical discectomy and fusion on a 42 year old ...
(Date:1/18/2017)... ... ... from a new study are stating that if levels of the blood test called ... there is still remaining prostate cancer cells that are more likely to come back, spreading ... an indicator of whether a man’s prostate cancer is growing or not,” stated Dr. ...
(Date:1/18/2017)... ... January 18, 2017 , ... Thirty-six startup companies in ... by the Pennsylvania Department of Community and Economic Development in 2016 as part of ... in the University City Keystone Innovation Zone and represent the highest number of awards ...
(Date:1/18/2017)... 18, 2017 /PRNewswire/ - SQI Diagnostics Inc. (TSX-V: ... company that develops and commercializes proprietary technologies and ... "Company"), today announced that Cameron Prange , ... resigned from its Board of Directors.  Mr. Prange,s ... regulations that have limited both his ability to ...
Breaking Biology Technology:
(Date:12/16/2016)... global wearable medical device market, in terms of value, is projected ... in 2016, at a CAGR of 18.0% during the forecast period. ... Growth in ... launch of a growing number of smartphone-based healthcare apps compatible with ... increasing focus on physical fitness. Furthermore, growing trend ...
(Date:12/15/2016)...  There is much more to innovative access systems ... Continental will demonstrate the intelligence of today,s solutions at ... Through the combination of the keyless entry and start ... the international technology company is opening up new possibilities ... "The integration of biometric elements brings our expertise ...
(Date:12/7/2016)... According to a new market research report "Emotion Detection ... Voice Recognition), Service, Application Area, End User, And Region - Global Forecast to ... 6.72 Billion in 2016 to USD 36.07 Billion by 2021, at a Compound ... ... MarketsandMarkets Logo ...
Breaking Biology News(10 mins):