Celcuity Inc. (Nasdaq: CELC), a functional cellular analysis company that is discovering new cancer subtypes and commercializing diagnostic tests designed to significantly improve clinical outcomes of cancer patients treated with targeted therapies, today announced a clinical trial agreement with Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, and West Cancer Center, to conduct a Phase II clinical trial.
This open-label Phase II trial will evaluate the efficacy and safety of Puma’s drug, NERLYNX ®(neratinib), and chemotherapy in up to 27 early stage triple-negative breast cancer patients selected with Celcuity’s CELx HER2 Signaling Function (“CELx HSF”) Test. Under this agreement, West Cancer Center will serve as the sponsor and principal investigator of the trial and is responsible for enrolling patients and managing clinical data. Puma will supply NERLYNX, its pan-HER inhibitor currently approved by the U.S. Food and Drug Administration (“FDA”) for extended adjuvant treatment of early-stage HER2-positive breast cancer. Celcuity will provide its CELx HSF Test to select triple-negative breast cancer patients who have hyperactive HER2-driven signaling pathways for the trial and will initially fund the patient-related trial costs. Based on its estimates of patient enrollment rates, Celcuity expects to obtain interim results in 10 to 12 months after the first patient is enrolled and final results within 18 to 24 months. Celcuity expects enrollment to begin in early 2019.
The most common adverse reactions (> 5%) for NERLYNX were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, weight decreased and urinary tract infection.
The goal of the trial is to demonstrate that triple-negative breast cancer patients who have a hyperactive HER2 signaling tumor, as identified by the CELx HSF test, respond to treatment with NERLYNX, a matching HER2 therapy. Celcuity believes there is significant clinical interest in finding new diagnostic tests and targeted therapies for triple-negative breast cancer patients because fewer drug treatment options are available to them relative to other breast cancer sub-types.
Celcuity submitted an Investigational Device Exemption, or IDE, application to the FDA to use its CELx HSF Test for this clinical trial and received approval in mid-2018.
“The opportunity to study NERLYNX in the neoadjuvant setting utilizing Celcuity’s cutting-edge CELx technology to select breast cancer patients whom may benefit from it is exciting,” said Gregory Vidal, M.D., Ph.D., a breast medical oncologist at West Cancer Center and principal investigator of this study. According to Dr. Vidal, “this clinical trial could play a key role in creating a new treatment paradigm for certain triple negative breast cancer patients.”
“We are excited to collaborate with Dr. Vidal, West Cancer Center and Puma Biotechnology on this important clinical trial,“ said Brian Sullivan, CEO and Co-Founder of Celcuity. “NERLYNX is a pan-HER inhibitor that is well-suited to treat hyperactive HER2 signaling activity in breast tumors. Establishing collaborations to evaluate the efficacy of a pharmaceutical company’s therapy in patients selected with our CELx HSF test is an important objective for Celcuity. It is the first step in what we hope can eventually lead to better treatment options for breast cancer patients.”
Celcuity Inc. is a cellular analysis company that is discovering new cancer sub-types and commercializing diagnostic tests designed to significantly improve the clinical outcomes of cancer patients treated with targeted therapies. Celcuity’s proprietary CELx diagnostic platform uses a patient’s living tumor cells to identify the specific abnormal cellular activity driving a patient’s cancer and the targeted therapy that can best treat that patient’s disease. Celcuity is headquartered in Minneapolis, MN. Further information about Celcuity can be found at www.celcuity.com.
About Puma Biotechnology
Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Neratinib, oral was approved by the U.S. Food and Drug Administration in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. NERLYNX was granted marketing authorization by the European Commission for the extended adjuvant treatment of hormone receptor-positive HER2-positive early stage breast cancer in September 2018. NERLYNX is a registered trademark of Puma Biotechnology, Inc.
About West Cancer Center
West Cancer Center is a multi-specialty, academic, regional cancer center specializing in adult cancer and blood disorder treatment, research and prevention having treated 37,000 patients across our 13 locations in 2017. As a member of the National Comprehensive Cancer Network (NCCN), West Cancer Center is committed to translating cancer science into revolutionary treatment protocols. West Cancer Center’s focus on genomic testing and precision medicine, subspecialty care, translational research and new clinical pathways provide patients with the latest, most innovative, personalized cancer treatment plans. Further information about West Cancer Center can be found at www.westcancercenter.org.
This press release contains statements that constitute “forward-looking statements.” In some cases, you can identify forward-looking statements by terminology such as “may,” “can,” “could,” “expects,” “estimates,” or “plans,” 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 in this release include, without limitation, expectations with respect to commencement of patient enrollment, patient enrollment rates and timing of expected results, and beliefs regarding clinical interest of the trial, the use of new diagnostic tests and targeted therapies in treating cancer patients, and the potential role of the trial and CELx HSF Test in developing new treatment options for cancer patients. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of Celcuity, which include, but are not limited to, those set forth in the Risk Factors section in our Annual Report on Form 10-K for the year ended December 31, 2017 filed with the Securities and Exchange Commission on March 15, 2018. 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 release, except as required by law.