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April 25, 2015 7:42 PM 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: 52
President, Chief Operating Officer, Treasurer and Director
Age: 52
Chief Financial Officer, Principal Accounting Officer and Vice President
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, 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.

Cornerstone Pharmaceuticals, Inc. Presents at 7th annual Biotech Showcase Conference 2015, Jan-12-2015 09:45 AM

Cornerstone Pharmaceuticals, Inc. Presents at 7th annual Biotech Showcase Conference 2015, Jan-12-2015 09:45 AM. Venue: Parc 55 Wyndham San, Francisco - Union Square, San Francisco, CA 94102, United States.

Cornerstone Pharmaceuticals Announces Positive Phase I Data for CPI-613 in Relapsed or Refractory AML Patients to be Presented at 2014 ASH Annual Meeting

Cornerstone Pharmaceuticals, Inc. announced positive data from an ongoing Phase I study evaluating lead compound CPI-613 given in combination with high dose Ara-C, or cytarabine, (HiDAC) and mitoxantrone in patients with relapsed or refractory acute myeloid leukemia (AML). Results from the study, which is sponsored by Wake Forest Baptist Medical Center, will be presented at the 56(th) American Society of Hematology (ASH) Annual Meeting, being held December 6-9, 2014 in San Francisco, California. CPI-613 is the company's lead Altered Energy Metabolism Directed (AEMD) drug candidate, a anticancer compound designed to disrupt the altered energy-production pathways in cancer cells by targeting mitochondrial metabolism. The Phase I trial was designed to determine the maximum tolerated dose (MTD), safety, and efficacy of CPI-613 given in combination with HiDAC and mitoxantrone in patients with relapsed or refractory AML. In the study, patients were given escalating doses of CPI-613 daily for five consecutive days at a starting dose of 500mg/m(2). On day three patients were also started on a dose of HiDAC (3,000 mg/m(2) or 1,500 mg/m(2) for patients 60 years of age or older) given every 12 hours for five doses as well as three doses of mitoxantrone (6 mg/m(2)) given daily. Overall, the regimen was found to be well tolerated. The information provided in the abstract reports on 36 patients, with median age of 60. Eight patients had refractory disease and nine received two or more previous lines of therapy. In patients with relapsed disease, where data were available, the median duration of complete response was 8.4 months. The study showed promising results with patients in the intent to treat group achieving complete remission or complete remission with incomplete blood count recovery (CR/CRi) response rate of 50% (16 CR and 2 CRi; total 18 of 36 patients) and patients 60 years or older also achieving CR/CRi response rate of 50% (10 of 20 patients). In particular, the CR/CRi rate was higher, 53%, in patients with poor risk cytogenetics, compared to only 25% in a historical cohort of patients treated with HDAC, mitoxantrone and asparaginase. Additionally, nine patients (25%) went on to allogeneic stem cell transportation which compared favorably with the 17% recorded in historical data. Median survival for the entire cohort was 6.4 months, with a median of 3.1 months of follow-up. Five patients (14%) died on or before day 30 and were not evaluable. The study showed that the combination regimen is well tolerated with no dose limiting toxicities observed to date.

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