Oncoceutics, Inc. announced that the first patient has begun treatment in a clinical trial of the company’s lead compound, ONC201, at the Fox Chase Cancer Center (FCCC) in relapsed/refractory multiple myeloma. The Phase I/II trial, identified as NCT02863991 on www.clinicaltrials.gov, will investigate the use of ONC201 in combination with dexamethasone in adult patients with multiple myeloma who have relapsed or are refractory to other therapies.
Henry Fung, MD, FACP, FRCPE, Vice Chair of the Department of Hematology/Oncology at Fox Chase Cancer Center, is the Principal Investigator. This study is supported by a $1.7 million grant from the FDA’s Office of Orphan Products Development and is expected to enroll 42 patients.
Multiple myeloma is one of the most sensitive tumors to ONC201 treatment based on preclinical models. As previously reported, ONC201’s engagement of dopamine receptor D2 (DRD2) activates the integrated stress response (ISR), which upregulates a host of proteins that induce tumor cell death and inhibit the synthesis of proteins that are key for cancer growth. Multiple myeloma cells are particularly sensitive to ISR activation, which is a key mechanism of action utilized by proteasome inhibitors such as bortezomib (Velcade), which is already approved for the treatment of multiple myeloma. Because of ONC201’s unique way of activating the ISR, it retains its efficacy in patients who have become resistant to these other drugs.
“I am excited to bring this novel therapy to my patients,” said Dr. Fung. “These patients, who have become refractory to approved therapeutic agents, have no other options, and ONC201 provides them with a new hope.”
Wafik El-Deiry MD, PhD, FACP, Scientific Founder of Oncoceutics and Deputy Cancer Center Director for Translational Research of the Fox Chase Cancer Center, added “it is richly rewarding to see the work of Oncoceutics, my lab, and the plethora of academic collaborators who have worked on this compound be translated into this important trial. It is especially gratifying to be able to continue to participate in the development of this potentially lifesaving compound here at my home institution, Fox Chase Cancer Center.”
Oncoceutics, Inc. is a clinical-stage drug discovery and development company with a novel class of compounds that selectively target G protein-coupled receptors for oncology. The first lead compound to result from this program is ONC201, an orally active DRD2 small molecule antagonist that is well-tolerated and effective against advanced cancers. The company has completed a successful Phase I study in solid tumors and has begun additional Phase I/II and Phase II clinical programs in both solid and hematological malignancies. Oncoceutics and collaborative groups have received more than $7 million in grants over the last two years, including grants from the National Cancer Institute, the U.S. Food and Drug Administration, the Pennsylvania Department of Health, and The Musella Foundation. In addition, outside interest in the company’s portfolio has resulted in several R&D alliance agreements between Oncoceutics and leading comprehensive cancer centers, including The University of Texas MD Anderson Cancer Center and the Fox Chase Cancer Center. The company has established a robust intellectual property position, including several issued patents.
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About Fox Chase Cancer Center
Fox Chase Cancer Center, part of the Temple University Health System, is one of the leading cancer research and treatment centers in the United States. Founded in 1904 in Philadelphia as one of the nation’s first cancer hospitals, Fox Chase was also among the first institutions to be designated a National Cancer Institute Comprehensive Cancer Center in 1974. Fox Chase researchers have won the highest awards in their fields, including two Nobel Prizes. Fox Chase physicians are also routinely recognized in national rankings, and the Center’s nursing program has received the Magnet recognition for excellence four consecutive times. Today, Fox Chase conducts a broad array of nationally competitive basic, translational, and clinical research, with special programs in cancer prevention, detection, survivorship, and community outreach. For more information, call 1-888-FOX CHASE or (1-888-369-2427).
Barbara Jacoby is an award winning blogger that has contributed her writings to multiple online publications that have touched readers worldwide.