Newswise — The lead product from a new class of agents called Altered Energy Metabolism Directed (AEMD) compounds developed by Cornerstone Pharmaceuticals, Inc., from technology licensed from The Research Foundation of the State University of New York, on behalf of Stony Brook University, has been approved by the U.S. Food and Drug Administration (FDA) for evaluation in Phase I/II clinical trials to treat cancer. The technology resulted from research by SBU Professors Paul M. Bingham, Ph.D., and Zuzana Zachar, Ph.D., of the Department of Biochemistry and Cell Biology.
An initial clinical trial will be sponsored by Cornerstone Pharmaceuticals, the exclusive licensee and developer of discoveries made by Drs. Bingham and Zachar. Cornerstone Pharmaceuticals, based in Stony Brook, N.Y., and Cranbury, N.J. will evaluate the drug family member designated CPI-613, the first of this novel class of agents, in cancer patients. The clinical trial is classified as FDA-approved safety and early efficacy trial. The approved study will be conducted at selected sites in North America.
"The energy metabolism of tumor cells has long been known to differ from normal cells, but to date no agents that attack these targets are in clinical use," says Dr. Bingham. "In our laboratory tumor models and animal studies, this new class of altered energy metabolism drugs produced remarkable anti-cancer effects, as well as very few adverse side effects."
Such findings led Cornerstone Pharmaceuticals to seek regulatory approval to begin this human clinical trial. Strengthening their case for a clinical trial is the concept that altered energy metabolism is a nearly universal property of cancers, and the fact that the new class of drugs in preclinical testing showed the agents to be effective against a broad spectrum of human solid tumors. Additionally, the drugs were effective in preclinical models against tumor types that are difficult to treat with traditional chemotherapy, such as tumors of the lung and pancreas.
The CPI-613 trial is designed to be an open label, dose-escalation study to evaluate the safety, tolerability (including maximum tolerated dose), efficacy, and pharmacokinetics of this specific compound in patients with various forms of cancer.
"We are optimistic that FDA approval to conduct this clinical trial of CPI-613 may mark an important step toward the establishment of a safer, more effective way to treat a wide variety of cancer types and make a significant difference in the lives of cancer patients," says Robert Shorr, Ph.D., Chief Executive Officer of Cornerstone Pharmaceuticals.
Cornerstone Pharmaceuticals is a privately held company singularly focused on the discovery and development of innovative cancer therapies that exploit the metabolic pathways that are common to different cancer types but different from normal cells and tissues.
The Department of Biochemistry and Cell Biology is one of 25 academic departments of Stony Brook University School of Medicine. Departmental faculty carry out research and educate undergraduate and graduate students in areas such as molecular and cell biology, biochemistry, structural biology, and genetics. Part of the SBU School of Medicine mission is to educate medical specialists and investigators in the biomedical and clinical sciences to be well prepared to advance the frontiers of research, clinical practice and education.
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