August 29, 2016 5:51 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: 54
President, Chief Operating Officer, Treasurer and Director
Age: 54
Chief Financial Officer, Principal Accounting Officer and Vice President
Age: 71
Vice President and General Counsel
Age: 44
Vice President of Regulatory & Clinical Affairs
Age: 63
Compensation as of Fiscal Year 2016.

Cornerstone Pharmaceuticals, Inc. Key Developments

Cornerstone Pharmaceuticals, Inc. Announces Data from the Phase I Clinical Trial Evaluating CPI-613

Cornerstone Pharmaceuticals, Inc. announced that data from the Phase I clinical trial evaluating CPI-613 in combination with modified fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFIRINOX) to treat metastatic pancreatic adenocarcinoma was presented at the Annual Gastrointestinal Cancers Symposium, held by the American Society of Clinical Oncology (ASCO) in San Francisco, California on January 22, 2016. CPI-613 is the company's lead Altered Energy Metabolism Directed (AEMD) drug candidate, a first-in-class anticancer compound designed to disrupt the altered energy production pathways in cancer cells by targeting mitochondrial metabolism. The trial was performed at Wake Forest Baptist Medical Center. The open-label, dose-escalation Phase I trial was designed to determine the maximum tolerated dose (MTD), safety, and efficacy of CPI-613 given intravenously in combination with mFOLFIRINOX. A total of 20 patients presenting with Stage IV pancreatic adenocarcinoma were enrolled in the trial. The MTD for CPI-613 was identified at 500mg/m2. The treatment combination was determined to be feasible and well-tolerated, with no Grade 5 adverse events reported, and the combination treatment was further found not to have higher toxicity than FOLFIRINOX alone. The objective response rate for the treatment combination was 56%, higher than that for FOLFIRINOX alone, which was reported in published Phase 3 trial results as 31.6%. One patient demonstrated a complete radiologic and clinical response, while two other patients showed near-complete responses. The preliminary efficacy data of this Phase I trial shall inform a multi-institutional randomized phase II study of FOLFIRINOX vs. mFOLFIRINOX + CPI-613 in the near future.

Cornerstone Pharmaceuticals, Inc. Presents at The Leerink Partners 5th Annual Global Healthcare Conference, Feb-10-2016 11:55 AM

Cornerstone Pharmaceuticals, Inc. Presents at The Leerink Partners 5th Annual Global Healthcare Conference, Feb-10-2016 11:55 AM. Venue: The Waldorf Astoria, New York, New York, United States. Speakers: Stefano R. Carchedi, Chief Executive Officer and Director.

Cornerstone Pharmaceuticals, Inc. Initiates Phase I Clinical Trial of CPI-613 for the Treatment of Metastatic Colorectal Cancer

Cornerstone Pharmaceuticals, Inc. announced the initiation of a Phase I clinical trial of CPI-613, in combination with fluorouracil (5-FU), for patients with non-resectable metastatic colorectal cancer who have failed prior therapy. CPI-613 is the company's lead Altered Energy Metabolism Directed (AEMD) drug candidate, designed to disrupt the altered energy-production pathways in cancer cells by targeting their altered mitochondrial metabolism. Encouraging results and patient benefit observed in earlier trials including patients diagnosed with metastatic colorectal cancer support further evaluation of CPI-613 in this indication. The safety profile of CPI-613 in earlier trials, which shows the drug to be well tolerated, provides further support for evaluation of CPI-613 in combination with other drugs to maximize benefit. Worldwide, colorectal cancer is the third most common cancer in men and the second in women and is diagnosed in nearly 1.3 million people annually, resulting in nearly 700,000 deaths each year. Furthermore, most colorectal cancer patients have non-resectable tumors 'meaning the tumors are unable to be removed by surgery' and about 50% of patients develop metastases. The single site study, sponsored by Wake Forest Baptist Medical Center and in collaboration with the National Cancer Institute (NCI), is a Phase I, open label, dose-escalating study designed to determine the maximum tolerated dose of CPI-613 in combination with 5-FU. The study will also assess as secondary endpoints the pharmacokinetics, safety and efficacy of various doses of CPI-613 when used in combination with 5-FU. Overall response rates, progression-free survival (PFS) and disease control rates will also be measured. 5-FU has been used as a standard chemotherapeutic agent in the treatment of colon, rectum, and head and neck cancers with commonly accepted response rates of less than 20% and acquired drug resistance. CPI-613 is the lead drug candidate from Cornerstone's proprietary AEMD platform. Cornerstone's AEMD drug platform disrupts the metabolism (energy producing) pathways that support the growth and development of many types of cancer cells. CPI-613 has been shown in-vitro to be highly selective in inducing the simultaneous inhibition of two key mitochondrial enzymes involved in cancer cell metabolism: pyruvate dehydrogenase (PDH) and alpha ketoglutarate dehydrogenase (KGDH). Disruption of PDH and KGDH function cuts off the tumor's mitochondrial energy supply, culminating in cell death. CPI-613 is currently being evaluated in several Phase I, I/II and II human clinical trials in solid tumors and hematological malignancies.

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