Isotechnika's lead drug, ISA247, receives fast track designation from FDA for the treatment of uveitis
EDMONTON, Aug. 7, 2007 (Canada NewsWire via COMTEX News Network) --
Isotechnika announced today that the Food and Drug Administration (FDA) of the United States granted fast track designation for the Company's lead drug, ISA247 under section 506 of the Federal Food, Drug and Cosmetic Act. The FDA based its decision on the following reasons:
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- ISA247 is intended for the treatment of a serious or life-threatening
condition, namely non-infectious posterior, intermediate and
panuveitis, and
- ISA247 demonstrates the potential to address medical needs unmet by
available treatments for non-infectious posterior, intermediate and
panuveitis.
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Fast Track designation will provide various means to expedite the development and review of ISA247. 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 New Drug Application (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 (referred to as ISA247 by Isotechnika) would be the first thoroughly tested and approved steroid-sparing therapy for the treatment of uveitis."
"We are extremely excited that Lux received Fast-Track designation for ISA247 for the treatment of uveitis," stated Dr. Randall Yatscoff, Isotechnika's president & chief executive officer. "We are continually encouraged by the broad potential use of ISA247 in transplantation, psoriasis, and uveitis."
Lux Biosciences began enrolling patients in pivotal clinical trials for ISA247 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. |
