LEXINGTON, Mass., May 31,
2018 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology
company focused on the development and commercialization of
innovative and effective therapeutics for the treatment of
cancer, announced today that the U.S. Food and Drug
Administration (FDA) has granted Fast Track designation for the
development of fimepinostat (CUDC-907) in patients with relapsed or
refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or
more lines of systemic therapy. Previously reported results from
Phase 1 and Phase 2 clinical studies demonstrated that treatment
with fimepinostat resulted in a complete or partial response in one
out of every four patients with R/R DLBCL with MYC alterations. The
median duration of response for all responding patients in these
studies was over one year.
"We are pleased with this Fast Track designation, which will
enable us to accelerate and efficiently develop fimepinostat for
patients with R/R DLBCL, especially patients whose tumors have MYC
alterations," said Ali Fattaey, Ph.D., Chief Executive Officer
of Curis. "R/R DLBCL with MYC alterations is a significant unmet
clinical need and patients with this disease have a very poor
prognosis. We are encouraged by the FDA's recognition of the
underserved patient population, as well as the potential durable
benefit that fimepinostat can provide for these patients to become
a new precision oncology therapy. We expect to re-initiate
enrollment as part of a pivotal study to assess fimepinostat
efficacy in this patient population this year. As we work toward
the start of this study, we are also continuing to lay the
groundwork for potential registration of fimepinostat, which
involves coordination with commercial product manufacturers as well
as a potential diagnostic test."
The FDA Fast Track process is designed to facilitate the
development and expedite review of drugs used to treat serious
conditions and fill an unmet medical need. Fast Track designation
provides the company with early and more frequent meetings and
written communications with the FDA regarding
fimepinostat's development plan, trial design and data collection
to support the drug's approval. Fast Track designation also
provides eligibility for Accelerated Approval and Priority Review,
given the appropriate criteria are met, as well as Rolling Review
with regards to the submission of the completed sections of the NDA
for review by the FDA.
About Curis, Inc.
Curis is a biotechnology company focused on the development and
commercialization of innovative and effective drug candidates for
the treatment of human cancers, including fimepinostat (CUDC-907),
which is being investigated in clinical studies in patients with
lymphomas and solid tumors. Curis is also engaged in a
collaboration with Aurigene in the areas of immuno-oncology and
precision oncology. As part of this collaboration, Curis has
exclusive licenses to oral small molecule dual antagonists of PD1
and VISTA, including PDL1/VISTA antagonist CA-170, and oral small
molecule dual antagonists of PD1 and TIM3, including PDL1/TIM3
antagonist CA-327, as well as to molecules designed to inhibit the
IRAK4 kinase, including CA-4948. CA-170 is currently undergoing
testing in a Phase 1 trial in patients with advanced solid tumors
and lymphomas and in a Phase 2 trial in India conducted by Aurigene. CA-4948 is
currently undergoing testing in a Phase 1 trial in patients with
non-Hodgkin lymphoma. Curis is also party to a collaboration with
Genentech, a member of the Roche Group, under which Genentech and
Roche are commercializing Erivedge® for the treatment of advanced
basal cell carcinoma. For more information, visit Curis's website
at www.curis.com.
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SOURCE Curis, Inc.