In the news release, Curis Announces FDA Fast Track Designation
for Fimepinostat (CUDC-907) Development in Patients with Relapsed
or Refractory Diffuse Large B-Cell Lymphoma, issued 31-May-2018 by Curis, Inc. over PR Newswire, we
are advised by the company that some information that is imperative
for the investor community was not included in the original release
. The complete, corrected release follows:
Curis Announces FDA Fast Track Designation for Fimepinostat
Development in Patients with Relapsed or Refractory Diffuse Large
B-Cell Lymphoma
LEXINGTON, Mass., May 31,
2018 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology
company focused on the development and commercialization of
innovative 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 (formerly CUDC-907) in adult 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
approximately 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 the development
of fimepinostat for patients with R/R DLBCL, including patients whose tumors have MYC
alterations," said Ali Fattaey, Ph.D., Chief Executive Officer
of Curis. "Patients with this
disease have a very poor prognosis and
we are encouraged by the FDA's recognition of the unmet need
that may be addressed by fimepinostat, as well as the
potential durable benefit that fimepinostat can provide for these
patients. We expect to re-initiate enrollment this year as part of a pivotal study to
assess fimepinostat's efficacy in
this patient population. 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 Curis with 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, if the relevant 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, 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.