Celcuity Announces Clinical Trial Collaboration with University of Rochester Wilmot Cancer Center and Puma to Study Patients with Breast Cancer Brain Metastases
18 Outubro 2021 - 5:09PM
Business Wire
- Study will evaluate the efficacy and safety of NERLYNX® plus
XELODA® in patients selected by the CELsignia® Test who have
metastatic HER2-negative breast cancer with brain metastases
- The unique tumor insights CELsignia generates enable
identification of new potential applications for targeted therapies
and development of potential first-in-class drugs
Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology
company pursuing an integrated companion diagnostic and therapeutic
strategy for treating patients with cancer, today announced a
clinical trial collaboration with the University of Rochester
Wilmot Cancer Center and Puma Biotechnology (Nasdaq: PBYI), a
biopharmaceutical company, to conduct a Phase 2 clinical trial.
This open-label Phase 2 trial will evaluate the efficacy and
safety of Puma's drug, NERLYNX (neratinib), and Xeloda
(capecitabine), a Genentech/Roche drug, in previously treated
patients selected with Celcuity's CELsignia HER2 Activity Test who
have metastatic HER2-negative breast cancer. Under the agreement,
The University of Rochester Wilmot Cancer Center will serve as the
sponsor and Ajay Dhakal, M.D., a medical oncologist at the
University of Rochester Medical Center, will serve as the principal
investigator of this study. The University of Rochester Wilmot
Cancer Center is one of the 51 NCI-Designated Comprehensive Cancer
Centers in the U.S. tasked with developing new approaches to
diagnosing and treating cancer.
“This clinical trial could play a key role in creating a new
treatment paradigm for metastatic HER2-negative breast cancer
patients with brain metastases,” said Dr. Dhakal. “We are eager to
begin working with Celcuity’s cutting-edge CELsignia technology to
identify a new subset of patients who may respond to NERLYNX.”
Puma will supply NERLYNX, its pan-HER inhibitor currently
approved by the U.S. Food and Drug Administration (FDA) for early
and late-stage HER2-positive breast cancer. Celcuity will provide
its CELsignia HER2 Activity Test to select HER2-negative metastatic
breast cancer patients with brain metastases who have hyperactive
HER2-driven signaling pathways for the trial and will fund the
patient-related trial costs. Based on its estimates of patient
enrollment rates, Celcuity expects to obtain interim results 12 to
15 months after initiation of the trial followed by the final
results 12 to 15 months later. Celcuity expects enrollment to begin
by early to mid-2022.
The goal of the trial is to demonstrate that previously treated
HER2-negative metastatic breast cancer patients with brain
metastases who have hyperactive HER2 signaling tumors, as
identified by the CELsignia test, respond to treatment with NERLYNX
in combination with XELODA, a chemotherapy commonly used in
metastatic breast cancer patients. Celcuity believes there is
significant clinical interest in finding new diagnostic tests and
targeted therapies for metastatic HER2- negative breast cancer
patients with brain metastases.
"We are excited about the opportunity to collaborate with Dr.
Dhakal, The University of Rochester Wilmot Cancer Center, and Puma
Biotechnology on this important clinical trial," said Brian
Sullivan, CEO and co-founder of Celcuity. "This will be our first
collaboration to study metastatic breast cancer patients with brain
metastases selected for treatment using our CELsignia HER2 Activity
Test. Patients with HER2-negative breast cancer who have brain
metastases have few good options today. Approximately 20% of the
280,000 HER2-negative breast cancer patients receiving drug
treatment annually have tumors with hyperactive HER2 signaling.1
For these patients, this trial represents a critical step towards a
potential new therapeutic option."
About Celcuity
Celcuity is a clinical-stage biotechnology company seeking to
extend the lives of cancer patients by pursuing an integrated
companion diagnostic and therapeutic strategy. Its CELsignia
companion diagnostic platform is uniquely able to analyze live
patient tumor cells to identify new groups of cancer patients
likely to benefit from already approved targeted therapies. Its
therapeutic efforts are focused on in-licensing and developing
molecularly targeted therapies that address the same cancer driver
its companion diagnostics can identify. Celcuity is headquartered
in Minneapolis. Further information about Celcuity can be found at
www.celcuity.com.
Forward-Looking Statements
This press release contains statements that constitute
"forward-looking statements" that involve risks and uncertainties
including, but not limited to, expectations with respect to
commencement of clinical trial patient enrollment and the rates of
such enrollment, timing of clinical trial results, the actual
results of such clinical trials and interest from outside parties
in such clinical trials, the results and any new treatment
paradigms that may result therefrom. In some cases, you can
identify forward-looking statements by terminology such as "may,"
"should," "expects," "plans," "anticipates," "believes,"
"estimates," "predicts," "potential," "intends" or "continue," and
other similar expressions that are predictions of or indicate
future events and future trends, or the negative of these terms or
other comparable terminology. Forward-looking statements are
subject to numerous conditions, many of which are beyond the
control of Celcuity, which include, but are not limited to, the
unknown impact of the COVID-19 pandemic on Celcuity's business and
those other risks set forth in the Risk Factors section in
Celcuity's Annual Report on Form 10-K for the year ended December
31, 2020 filed with the Securities and Exchange Commission on
February 16, 2021 and in Exhibit 99.4 to Celcuity's Current Report
on Form 8-K filed with the Securities and Exchange Commission on
April 8, 2021. Readers are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date
hereof. Celcuity undertakes no obligation to update these
statements for revisions or changes after the date of this press
release, except as required by law.
1. MacNeil IA, Burns DJ, Rich BE, Soltani SM, Kharbush S,
Osterhaus NG, Sullivan BF, Hawkins DM, Pietruska JR, Laing LG. New
HER2-negative breast cancer subtype responsive to anti-HER2 therapy
identified. J Cancer Res Clin Oncol. 2020 Mar;146(3):605-619.
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version on businesswire.com: https://www.businesswire.com/news/home/20211018005920/en/
Celcuity Inc. Brian Sullivan, bsullivan@celcuity.com Vicky
Hahne, vhahne@celcuity.com 763-392-0123
Westwicke ICR Robert Uhl, robert.uhl@westwicke.com (619)
228-5886
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