July 22, 2014 5:59 AM ET

Pharmaceuticals

Company Overview of Cornerstone Pharmaceuticals, Inc.

Company Overview

Cornerstone Pharmaceuticals, Inc. discovers and develops cancer therapies. The company’s products include EmPAC, an emulsiphan-based composition that delivers anti-mitotic agents selectively on cancer cells; altered energy metabolism directed drugs, which convert glucose to energy that is used to kill human tumor cells; and CPI-613, drug from Altered Energy Metabolism Directed (AEMD) platform, which targets enzymes that are involved in cancer cell energy metabolism and are located in the mitochondria of cancer cells. CPI-613 is currently in Phase I/II clinical trials. The company was founded in 2000 and is based in Cranbury, New Jersey. It has additional offices and laboratory facilities in ...

1 Duncan Drive

Cranbury, NJ 08512

United States

Founded in 2000

14 Employees

Phone:

609-409-7050

Fax:

609-409-6035

Key Executives for Cornerstone Pharmaceuticals, Inc.

Chief Executive Officer and Director
Age: 60
President
Age: 52
Chief Financial Officer
Age: 69
Vice President and General Counsel
Age: 42
Vice President of Regulatory & Clinical Affairs
Age: 61
Compensation as of Fiscal Year 2014.

Cornerstone Pharmaceuticals, Inc. Key Developments

Cornerstone Pharmaceuticals Clinical Data on CPI-613 to Be Presented at ASCO 2014

Cornerstone Pharmaceuticals, Inc. announced that data from a Phase I clinical trial of its proprietary first-in-class anticancer compound CPI-613 in patients with relapsed or refractory acute myeloid leukemia (AML) will be presented during a Poster Highlights Session at the American Society of Clinical Oncology (ASCO) Annual Meeting at McCormick Place, Chicago, IL, on May 31, 2014. The study data show that CPI-613 in combination with high dose Ara-C (HDAC) and mitoxantrone is a promising salvage therapy regimen, especially in older patients and those with high risk disease. A phase I study of the mitochondrial metabolism inhibitor CPI-613 in combination with high dose Ara-C (HDAC) and mitoxantrone for relapsed or refractory acute myeloid leukemia (AML). The information provided in the abstract reflects data from an ongoing dose escalation study and reports on 24 AML patients between the ages of 21 and 76, studying the safety and efficacy of CPI-613 in combination with high dose Ara-C (HDAC) and mitoxantrone. The study showed promising results with patients achieving a complete remission (CR/CRi) rate of 54% overall and 55% in patients 60 years or older. In particular, the CR/CRi rate was 53% in patients with poor risk cytogenetics, compared to only 25% in a historical cohort of patients treated with HDAC, mitoxantrone and asparaginase.

Cornerstone Pharmaceuticals Presents Updated Phase I Data for CPI-613 at 2013 American Society of Hematology Annual Meeting

Cornerstone Pharmaceuticals, Inc. announced updated results from a Phase I clinical study of its first-in-class cancer metabolism targeted therapeutic, CPI-613, for the treatment of advanced hematological malignancies. The results were presented by the principal investigator, Timothy S. Pardee, MD, of the Comprehensive Cancer Center of Wake Forest Baptist Medical Center, during an oral presentation on Monday, December 9, 2013, at the 2013 American Society of Hematology (ASH) Annual Meeting and Exposition, in New Orleans, LA. In addition to the Burkitt's lymphoma patient, all three of the patients with myelodysplastic syndrome (MDS) achieved a response of stable disease or better. In one case, a 49 year old patient with therapy related MDS was transfusion dependent prior to enrollment. Shortly following the first cycle of treatment with CPI-613, the patient achieved significant and durable improvement in their white blood cell and platelet counts and became transfusion independent. By the eighth cycle, the patient achieved complete remission which has lasted for almost three years. CPI-613 is a first-in-class agent that induces cancer-specific inhibition of pyruvate dehydrogenase (PDH) and alpha ketoglutarate dehydrogenase (KGDH), key mitochondrial enzymes involved in fueling cancer cell metabolism. Disruption of PDH and KGDH function cuts off the tumor's energy supply and starves the cancer cell, leading to cancer cell death. CPI-613 is currently being evaluated in Phase I, I/II and II human clinical trials in solid tumors and hematological malignancies. CPI-613 is the drug candidate from Cornerstone's proprietary Altered Energy Metabolism Directed (AEMD) platform. Cornerstone's AEMD drug platform disrupts biochemical alterations in the conversion of glucose to energy that occur in many types of cancer cells. These essential bioenergetic differences are linked to critical pathways, particularly those that support cancer cell growth and development.

Cornerstone Pharmaceuticals Announces Initiation of Phase II Clinical Trial of CPI-613 in Patients With Locally Advanced or Metastatic Pancreatic Cancer

Cornerstone Pharmaceuticals, Inc. announced the initiation of a pilot Phase II clinical trial of CPI-613 for the treatment of patients with locally advanced or metastatic pancreatic cancer. CPI-613 is the company's lead Altered Energy Metabolism Directed (AEMD) drug candidate, which is designed to disrupt the altered energy-production pathways in cancer cells. Pancreatic cancer begins in the tissues of the pancreas -- an organ in the abdomen that lies behind the lower part of the stomach and aids in digestion and helps regulate the metabolism of sugars. In the United States, pancreatic cancer, which will be diagnosed in more than 45,000 Americans this year, is the fourth leading cause of cancer-related deaths due to the majority of cases being found during the late stages of the disease after it has spread. The 1- and 5-year relative survival rates, for all stages combined, are 25% and 6%, respectively. The interventional clinical study, sponsored by the Comprehensive Cancer Center of Wake Forest Baptist Medical Center, will enroll patients with locally advanced or metastatic pancreatic cancer documented as having progression on a scan and that cannot be removed by surgery and have failed current available therapies. The primary endpoint of the study is to evaluate the overall survival, with secondary endpoints evaluating the overall response rate, progression free survival, and safety. The US FDA granted orphan drug status to CPI-613 for the treatment of pancreatic cancer in 2006.

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