Cornerstone Pharmaceuticals Adds New Clinical Trial Site for the Evaluation of Its First-in-Class Anti-Cancer Agent CPI-613

CRANBURY, N.J., Aug. 5 /PRNewswire/ -- Cornerstone Pharmaceuticals, Inc. today announced the addition of Mary Crowley Cancer Research Centers to its roster of sites for its ongoing Phase I/II clinical trials of its first-in-class anti-cancer agent, CPI-613.  Cornerstone is a leader in the discovery and development of cancer therapies that capitalize upon and disrupt the unique metabolic processes of cancer cells.

"As one of the national pioneers in early phase clinical trials, the Mary Crowley Cancer Research Center in Dallas is an ideal site addition to our ongoing clinical evaluation of CPI-613 in cancer patients," said Dr. Robert Shorr, Chief Executive Officer of Cornerstone Pharmaceuticals. "Our trials will benefit greatly from the center's vast expertise in cancer therapies research. "

The trials, which are currently enrolling patients suffering from multiple types of cancer, are to be led by Neil Nathan Senzer, M.D., Scientific Director of the Mary Crowley Research Centers. The two separate trials evaluate CPI-613: the first as a single agent and the second combining CPI-613 with gemcitabine.

"Our ongoing objective at Mary Crowley Cancer Research Centers is to improve patient outcomes by providing novel agents available only through clinical trials in addition to standard-of-care therapies," said Neil Nathan Senzer, M.D. "With that objective in mind, we are excited to support the advancement of Cornerstone's unique anti-cancer drug CPI-613 by serving as a site for its clinical evaluation."

Physicians and patients seeking more information about the trial can visit www.marycrowley.org.

About Cornerstone Pharmaceuticals

Cornerstone Pharmaceuticals, Inc. is a privately held company that is committed to changing the way cancer is treated through the discovery and development of innovative therapies capitalizing on the unique metabolic processes of cancer cells. The company's founding members, management and scientific advisory team include pre-eminent scientists focused on cancer cell metabolism, cancer research and drug development.

Cornerstone currently has a drug in clinical trials targeting certain key enzymes crucial to cancer cell metabolism.  AEMD, the company's unique approach to cancer treatment, is the leading platform in cancer metabolism.

It has facilitated the discovery of first-in-class drugs with the potential to transform the way cancer is treated.  Cornerstone's lead drug, CPI-613, is currently being evaluated in three ongoing Phase I and Phase I/II clinical trials in a variety of tumor types.

For further information, visit www.cornerstonepharma.com.

About Mary Crowley Cancer Research Centers

Mary Crowley Cancer Research Centers, founded by Christian businesswoman and philanthropist Mary C. Crowley, offers patients access to innovative clinical trials using new therapies targeting the molecular pathways that impact cancer growth.  The Mary Crowley team believes that a paradigm shift is occurring in cancer care, by which personalized molecular medicine will ultimately transform the way patients are treated,  Its globally renowned medical team, with decades of experience in new drug development and hundreds of peer-reviewed publications, is paving the way for personalized cancer vaccines and targeted gene therapies in conjunction with the FDA.  Affiliate clinics are located in Dallas, TX at Baylor University Medical Center and Medical City Hospital; Midland, TX; Abilene, TX; Greenville, SC; Maryville, IL and Cedar Rapids, IA. For more information, visit www.marycrowley.org

About CPI-613

CPI-613 is the first drug in a new chemical class that, through a novel mechanism, targets metabolic changes considered to be common to many, if not all, cancer types and  minimally functional in normal cells. Patients with solid tumors and hematologic cancers are currently being enrolled in multiple Phase I and Phase I/II human clinical trials evaluating CPI-613. These trials include a Phase I/II single agent trial for patients with solid tumors who have been failed by other therapy options, a Phase I/II combination trial with gemcitabine in newly diagnosed or relapsed patients, and a single agent trial in hematologic malignancies.  CPI-613 was granted orphan drug status by the US FDA for pancreatic cancer, which has a poor prognosis, spreads rapidly and often goes undetected in its early stages.

About Cancer Metabolism

Cancer cell metabolism is an exciting and promising area for the development of drugs to treat cancer. While it has been known for nearly a century that cancer cells have a unique metabolism, only recently has there been a broad and significant renewal of scientific interest focused on exploring this unique metabolic difference to facilitate the discovery and development of groundbreaking therapies. Unlike normal cell metabolism, cancer cell metabolism utilizes less oxygen and has different nutritional requirements to survive and proliferate. This metabolic difference is considered to be fundamental to the transformation of normal cells into cancer cells and is believed to be conserved in all cancers, including solid tumors, lymphoma and leukemia.  By better understanding these cancer-specific metabolic processes, researchers in the field hope to find new drugs to revolutionize cancer treatment.

This release contains forward-looking statements. These statements relate to future events or each company's future financial performance. In some cases, you can identify forward-looking statements by terminology such as "may", "will", "should", "expect", "plan", "anticipate", "believe", "estimate", "predict", "potential" or "continue", the negative of such terms, or other comparable terminology. These statements are only predictions. Actual events or results may differ materially from those in the forward-looking statements as a result of various important factors. Although we believe that the expectations reflected in the forward-looking statements are reasonable, such statements should not be regarded as a representation by the company, or any other person, that such forward-looking statements will be achieved. The business and operations of the company are subject to substantial risks which increase the uncertainty inherent in forward-looking statements. We undertake no duty to update any of the forward-looking statements, whether as a result of new information, future events or otherwise. In light of the foregoing, readers are cautioned not to place undue reliance on such forward-looking statements.

SOURCE Cornerstone Pharmaceuticals, Inc.

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