Healthcare Industry News:  Age-related Macular Degeneration 

Biopharmaceuticals Ophthalmology FDA

 News Release - August 7, 2007

Lux Granted Fast Track Designation by FDA for LX211 for the Treatment of Uveitis

JERSEY CITY, N.J.--(HSMN NewsFeed)--Lux Biosciences, Inc., a privately held biotechnology company specialized in the field of ophthalmic diseases, announced today that FDA granted fast track designation for LX211 under section 506 of the Federal Food, Drug and Cosmetic Act. LX211 is a next-generation calcineurin inhibitor intended for the treatment of non-infectious posterior, intermediate and panuveitis (an autoimmune disease characterized by chronic inflammation of the eye).

The FDA based its decision on the following reasons:
  • LX211 is intended for the treatment of a serious or life-threatening condition, namely non-infectious posterior, intermediate and panuveitis, and
  • LX211 demonstrates the potential to address medical needs unmet by available treatments for non-infectious posterior, intermediate and panuveitis.
Fast Track designation will provide various means to expedite the development and review of LX211. The process could be facilitated through meetings and other correspondence with the FDA reviewers, consideration for priority review, and the ability to submit portions of the NDA early for review as part of a "rolling" submission.

"Thanks to the FDA's approval for Fast-Track designation, we have the potential to more rapidly deliver to patients a much needed drug for uveitis," comments Ulrich Grau, PhD, president and chief executive officer of Lux Biosciences. "If successful, LX211 would be the first thoroughly tested and approved steroid-sparing therapy for the treatment of uveitis."

Lux Biosciences began enrolling patients in pivotal clinical trials for LX211 earlier this year. The company is conducting three controlled, double-masked studies aimed at supporting the approval of that product as a treatment for uveitis, collectively designated the LUMINATE program. Enrollment for the LUMINATE trial program is expected to be completed by early 2008 and, if successful, Lux plans to seek regulatory approval for LX211 in late 2008. The LUMINATE program represents the largest and most comprehensive clinical program ever undertaken in the field of uveitis.

About LX211

LX211 is a next-generation calcineurin inhibitor to which Lux Biosciences has an exclusive worldwide license for ophthalmic indications from Isotechnika, Inc, of Edmonton, Canada (Isotechnika's code ISA247). Isotechnika is currently investigating ISA247 in phase 3 clinical trials in psoriasis patients, and in a phase 2b clinical trial in solid organ transplant recipients. The clinical data gathered to date indicate that LX211 is a potent calcineurin inhibitor - a biological mechanism demonstrated to provide efficacy in a range of autoimmune diseases such as noninfectious uveitis - and also appears to be well-tolerated. In addition to uveitis, Lux Biosciences plans to develop this molecule in other ophthalmic indications, including dry eye syndrome and Age-related Macular Degeneration. Lux Biosciences was previously granted orphan drug status for LX211 by the FDA in USA.

About Lux Biosciences

Lux Biosciences is a privately held biotechnology company dedicated to the identification, optimization, development and commercialization of products for the treatment of ophthalmic diseases. The company's business strategy is characterized by:
  • A focus on compounds already marketed or with clinical proof-of-concept in non-ophthalmic indications that Lux Biosciences will develop as unique, targeted therapies for corresponding ophthalmic diseases, with potentially greater efficacy and safety than existing treatments.
  • A clinical-stage portfolio of projects including: i) LX211, a next-generation calcineurin inhibitor that has potential in several ophthalmic diseases and, as such, represents a pipeline of product opportunities; and ii) LX201, a silicone matrix ocular (episcleral) implant that steadily releases therapeutic doses of cyclosporine A locally to the eye. Both the LUMINATE pivotal clinical program for LX211 for the treatment of uveitis, as well as the LUCIDA pivotal clinical program with LX201 for the prevention of corneal transplant rejection were initiated in early 2007.
  • 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 www.luxbio.com.


Source: Lux Biosciences

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