TEL AVIV, Sept 10 Israeli biotechnology firm
Atox Bio said the U.S. Food and Drug Administration has granted
fast track designation to AB103, its product in development for
the treatment of necrotizing soft tissue infections (NSTI), also
known as flesh-eating bacteria.
Fast track programmes facilitate the development and
expedite the review of new drugs that are intended to treat
serious conditions and that demonstrate the potential to address
unmet medical needs, the company said on Monday.
The benefits of fast track include scheduled meetings to
seek FDA input into development plans and the option of
submitting a new drug application in sections rather than all
components simultaneously. These meetings can help the FDA and
sponsors reach early agreement on design of the clinical
efficacy studies that will be needed to support approval.
"This is a major milestone for Atox Bio that comes after the
FDA has granted AB103 orphan drug designation in October 2011,"
said Dan Teleman, Atox Bio's chief executive.
Teleman told Reuters last week the company expects to have
results of Phase II clinical trials underway at seven U.S.
medical centres by the end of the year. Atox Bio expects to ask
investors for more money this year to fund extended phase II
Currently, there are no approved treatments for NSTI.
"Patients with necrotizing soft tissue infections have a
devastating disease with a high risk of death. Those who survive
require multiple surgeries and many require amputations," said
Eileen Bulger, professor of surgery and chief of trauma at the
University of Washington Harborview Medical Center.
(Reporting by Tova Cohen)