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Fox Chase Cancer Center to Conduct ONC201 Dose Intensification Trial

Compound with encouraging early clinical results has unique tumor depleting activity that effectively eliminates cancer stem cells and spares normal cells

July 13, 2015

HUMMELSTOWN, PA (July 13, 2015) – Oncoceutics and Fox Chase Cancer Center have announced an agreement to conduct clinical testing with ONC201, a novel first-in-class small molecule compound being developed by the company. The study led by Dr. Anthony Olszanski, director of the Phase I Experimental Therapeutics Program at Fox Chase Cancer Center, will systematically assess dose escalation with three different schedules for oral ONC201 ranging from every three week to one week administration.

ONC201 showed a benign safety profile, as well as early signs of activity, at therapeutic doses in the first Phase I study conducted at the Cancer Institute of New Jersey. The clinical trial at Fox Chase Cancer Center makes use of the excellent tolerability of ONC201 and recent preclinical data generated at Fox Chase Cancer Center that suggests single agent ONC201 has profound antitumor activity that, in certain circumstances, can be further optimized when given more frequently. The strong tumor-depleting activity as a single agent is a feature that is facilitated by its ability to eliminate cancer stem cells and spare normal cells.

"Clinical trials testing new therapeutics with selective tumor targeting that originate from our research laboratories represent the finest that cancer centers have to offer patients and we are thrilled to be involved at the earliest stages of this testing at Fox Chase Cancer Center," said Dr. Olszanski.

The clinical study is part of a larger academic/corporate partnership between Fox Chase Cancer Center and Oncoceutics. This close relationship is rooted in a long history of Dr. Wafik El-Deiry’s research on cell death pathways that allow cancer cells to escape the lethal effects of anti-cancer drugs. ONC201 emerged from laboratory research in his group as a first-in-class oral compound that is effective in a broad spectrum of tumor types that are being evaluated in the clinic. Dr. El-Deiry is a Professor of Medical Oncology, Deputy Director for Translational Research and co-Leader of the Molecular Therapeutics Program at Fox Chase Cancer Center. He is also an American Cancer Society Research Professor and the Scientific Founder of Oncoceutics.

"We are delighted to see the pioneering work of Dr. El-Deiry with an innovative cancer therapy translate into clinical trials including early phase trials at Fox Chase Cancer Center,” said Dr. Richard Fisher, president and CEO of Fox Chase Cancer Center. "Fox Chase Cancer Center has one of the leading clinical early phase experimental therapeutics programs in the country under the leadership of Dr. Olszanski. We are proud of our portfolio of investigator-initiated clinical trials that provide our patients with unique and innovative therapeutic options."

"The collaboration between Oncoceutics and Fox Chase Cancer Center allows our scientists and clinicians to translate their discoveries to the clinic and offers new treatment options for our patients at Fox Chase Cancer Center," said Kurt Schwinghammer, vice president for research & development alliances at Fox Chase Cancer Center.

Financial Disclosures:

Dr. El-Deiry's laboratory research on ONC201 at Fox Chase Cancer Center is supported by grants from the National Institutes of Health and the American Cancer Society. As a founding partner, Dr. El-Deiry has a financial stake in Oncoceutics and ONC201; however, Fox Chase Cancer Center has no financial ties to the company.

About Oncoceutics

Oncoceutics, Inc. is a drug discovery and development company targeting the most potent suppressor pathways in human cancer. The first lead compound to result from this program is ONC201, a small molecule drug with a unique mechanism of action that causes significant anti-tumor activity in a variety of types of human cancer. The Company is currently enrolling patients in clinical trials of ONC201, which began in January 2015, following acceptance by the U.S. Food and Drug Administration of the Company’s Investigational New Drug (IND) application for ONC201 in 2014. Oncoceutics and collaborative groups have received approximately $5 million in grants over the last two years from the National Institutes of Health, the Pennsylvania Department of Health, and The Musella Foundation, and the company has leveraged additional funding from academic medical research partners that support multiple Phase I/II Clinical trials.

Visit Oncoceutics or contact Rohinton Tarapore for more information.

 

       

The Hospital of Fox Chase Cancer Center and its affiliates (collectively “Fox Chase Cancer Center”), a member 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 five 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. It is the policy of Fox Chase Cancer Center that there shall be no exclusion from, or participation in, and no one denied the benefits of, the delivery of quality medical care on the basis of race, ethnicity, religion, sexual orientation, gender, gender identity/expression, disability, age, ancestry, color, national origin, physical ability, level of education, or source of payment.
For more information, call 1-888-FOX CHASE or (1-888-369-2427).

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