Cornerstone Pharmaceuticals Addresses Hot Topics in Clinical Trial Design as Novel Therapeutics Advance Towards Personalized Medicine and Oncology

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Dr. Robert Shorr, CEO of Cornerstone Pharmaceuticals, Inc., a privately held pharmaceutical company, recently addressed an international audience at the Clinical Trial Summit on regulatory considerations for oncology clinical trials hosted by the Center for Business Intelligence and held at the Hyatt Regency in Bethesda, MD.

However, as various cancers are able to be characterized at the gene or metabolic level and the likelihood of success for a particular drug being at least rendered more predictable, the relationship between genotype and phenotype, and drug benefit are increasingly important.

Dr. Robert Shorr, CEO of Cornerstone Pharmaceuticals, Inc., a privately held pharmaceutical company, recently addressed an international audience at the Clinical Trial Summit on regulatory considerations for oncology clinical trials hosted by the Center for Business Intelligence and held at the Hyatt Regency in Bethesda, MD.

In his address, Dr. Shorr spoke about how changes and emerging pressures to further reform health care, as well as advances in basic science and medical practice are having a profound influence on the design of clinical trials for future oncology drugs.

"The demonstration of survival and improvement in quality of life are the ultimate milestones for any therapeutic drug," said Dr. Shorr. "However, as various cancers are able to be characterized at the gene or metabolic level and the likelihood of success for a particular drug being at least rendered more predictable, the relationship between genotype and phenotype, and drug benefit are increasingly important."

During his address, Dr. Shorr pointed to the intense study of the role of genetic and other biomarkers as well as current criteria for the determination of therapeutic benefit such as imaging in order to provide a rational and reliable surrogate endpoint during clinical development. Already a number of targeted products have shown a better risk-reward profile for selected patient populations and have received FDA approval as drugs that have been determined to be more useful in a special patient population.

Cornerstone Pharmaceuticals presented an update on its lead clinical candidate entitled, Selective Disruption of Cancer Cell Energy Metabolism-Challenges in the Clinical Development of CPI-613, a First-in-Class Compound with Highly Specific Anticancer Activity. CPI-613 is currently in multiple phase I/II human clinical trials and has shown promising activity against diverse tumor types. In addition, Dr. Shorr reported on the compound's selectivity towards cancer cells and efforts to determine which patients would be most likely to benefit given the drug's broad spectrum of activity.

About Cornerstone Pharmaceuticals
Cornerstone Pharmaceuticals, Inc. is a privately held pharmaceutical 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. This unique approach, i.e. understanding and addressing what is similar to multiple cancer types rather than the differences between each, offers a significant opportunity to make a profound impact on the clinical treatment of a variety of cancers.

Cornerstone's AEMD technology platform was is based upon cancer metabolism research performed in the laboratories of Paul M. Bingham, Ph.D. and Zuzana Zachar, Ph.D., at the State University of New York at Stony Brook, Stony Brook, NY.

Cornerstone has offices and laboratory facilities in both Cranbury, NJ. and Stony Brook, NY. For further information, please log onto http://www.cornerstonepharma.com.

For further information or to arrange an interview with Cornerstone Pharmaceuticals senior management please call (212) 843-8073 or email amazur(at)rubensteinpr(dot)com.

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Adam Mazur
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