PRINCETON, N.J., March 3, 2021 /PRNewswire/ -- Oblato,
Inc. (the Company), a wholly owned U.S. subsidiary of the
Korean biotech company GtreeBNT Co., Ltd., announces that the FDA
granted Fast Track Designation of OKN-007, the proprietary drug for
Diffuse Intrinsic Pontine Glioma (DIPG).
The FDA Fast Track is a process designed to facilitate the
development and expedite the review of drugs to treat serious
conditions and fill an unmet medical need.
With the Fast Track Designation of OKN-007 for the treatment of
DIPG, Oblato is eligible for Accelerated Approval and Priority
Review and for Rolling Review that allows the Company to submit
completed sections of its New Drug Application (NDA) for review by
FDA before the entire application can be reviewed. The Company
expects that the period of the regulatory approval process will be
reduced.
DIPG is a rare pediatric brainstem cancer with limited treatment
options. After a DIPG diagnosis, ninety percent of the patients die
within 24 months, and the overall 5-year survival is less than one
percent.
In addition to the Fast Track Designation, Oblato has already
received Rare Pediatric Disease designation for DIPG. The Company
is eligible for a rare pediatric disease priority review voucher
from the FDA that can be redeemed for a priority review of a
marketing application of a different product and is transferrable,
when the Company receives NDA approval.
"We anticipate that the Fast Track Designation for DIPG will
shorten the NDA review process. The Company will make every effort
to develop this treatment for this rare pediatric disease," stated
an official from the Company.
About Oblato, Inc.
Oblato, Inc., a wholly-owned subsidiary of the Korean
biotech company GtreeBNT, is incorporated in Delaware and
has its principal place of business in New Jersey. Since 2016, the company has
been developing a new drug, OKN-007, to treat brain cancers,
especially, glioblastoma multiforme (GBM) as a rare disease and
diffuse intrinsic pontine glioma (DIPG) as a rare pediatric
disease. Currently, clinical trials are ongoing to
investigate the safety and efficacy of a combination therapy with
both OKN-007 and temozolomide for patients with both newly
diagnosed and recurrent GBM. Oblato also plans to conduct a
Phase 1/2 trial in 2021 for DIPG.
CONTACT:
For Oblato:
contact@oblatoinc.com
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SOURCE Oblato, Inc.