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Rafael Pharmaceuticals, in Collaboration with Atlantic Health System, Announces Initiation of a Phase I Study of CPI-613 in Combination with Gemcitabine and Nab-Paclitaxel for Patients with Locally Advanced or Metastatic Pancreatic Cancer

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Rafael Pharmaceuticals, Inc., a clinical stage company and leader in the field of cancer metabolism-based therapeutics, announced today, the initiation of a Phase I clinical trial of CPI-613 in combination with chemotherapeutic agents, gemcitabine and nab-paclitaxel, for patients with locally advanced or metastatic pancreatic cancer. The study will be conducted in collaboration with Atlantic Health System. CPI-613 is a first-in-class drug with a unique mode of action and is Rafael’s lead altered energy metabolism directed (AEMD) drug candidate. The drug is designed to disrupt the altered energy-production pathways in cancer cells by targeting their mitochondrial metabolism.

The primary aim of the study is to establish the maximum tolerated dose of CPI-613 when given in combination with gemcitabine/nab-paclitaxel for patients with locally advanced or metastatic pancreatic cancer.

Secondary aims include:

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(1) To describe the safety profile for the gemcitabine/nab-paclitaxel/CPI-613 combination.
(2) To determine the clinical activity of gemcitabine/nab-paclitaxel/CPI-613 in metastatic pancreatic cancer as measured by tumor response rate (RR) by RECIST criteria, progression-free survival (PFS), and overall survival (OS).

Encouraging results observed in earlier trials, including Phase I data from a trial led by Angela Alistar, MD that was recently published in The Lancet Oncology, demonstrated the preliminary efficacy of CPI-613 in combination with modified FOLFIRINOX (a multidrug treatment for advanced pancreatic cancer) in patients with metastatic pancreatic cancer. These results support further evaluation of CPI-613 in this indication.[1] 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.

In 2013, the MPACT study, a multinational, phase III clinical trial comparing gemcitabine/nab-paclitaxel to gemcitabine alone, demonstrated an improved median survival of 8.5 months as compared with 6.7 months for gemcitabine monotherapy (p=0.000015). While some clinical benefit was shown, these outcomes also highlight the need for new combination strategies to improve upon the outcomes seen with gemcitabine/nab-paclitaxel in the treatment of metastatic pancreatic cancer.

Dr. Alistar, medical director of GI Medical Oncology at the Carol G. Simon Cancer Center of Morristown Medical Center, Atlantic Health System, and the Principal Investigator for this trial, remarked, “Strategies to enhance our current standard of care options are sorely needed in pancreatic cancer. Due to the low toxicity profile of CPI -613 as a single agent, I anticipate good tolerance in combination with the gemcitabine/nab-paclitaxel regimen. I am excited to be able to offer this novel option to our patients with pancreatic cancer. Targeting metabolism in pancreatic cancer has a strong scientific rationale.”

Sanjeev Luther, Rafael Pharmaceuticals’ Chief Executive Officer, commented, “Our company’s motto of “One Patient at a Time” is especially relevant in this situation. Patients with a low tolerance for toxicity may not be eligible for the FOLFIRINOX combo. We believe that the gemcitabine/nab-paclitaxel regimen has the potential to be a potent treatment with less toxicity. It is especially meaningful for us to announce the initiation of this study on World Pancreatic Cancer Day.”

About Atlantic Health System

Atlantic Health System, headquartered in Morristown, N.J., is an integrated health care delivery system powered by a workforce of 16,000 team members dedicated to building healthier communities. The system is comprised of 350 sites of care, including six hospitals: Morristown Medical Center, Overlook Medical Center, Newton Medical Center, Chilton Medical Center, Hackettstown Medical Center and Goryeb Children’s Hospital. Atlantic Health System also supports communities through Atlantic Medical Group, Atlantic Rehabilitation, Atlantic Home Care and Hospice, and its subsidiary, Atlantic Ambulance Corporation. Atlantic Health System sponsors the Atlantic Accountable Care Organization, one of the larger ACOs in the nation, and Optimus Healthcare Partners. 

About Rafael Pharmaceuticals, Inc.

Rafael Pharmaceuticals, Inc. is a clinical-stage, oncology-focused pharmaceutical company committed to the development and commercialization of therapies that exploit the metabolic differences between normal cells and cancer cells. Rafael’s primary objective is to develop highly selective and effective agents with minimal toxic effects on normal cells and tissues. Rafael’s first-in-class clinical lead compound, CPI-613 is being evaluated in multiple Phase I, I/II, and II clinical studies. The U.S. Food and Drug Administration (FDA) has given Rafael approval to initiate pivotal clinical trials in pancreatic cancer and acute myeloid leukemia (AML), and has designated CPI-613 an orphan drug for the treatment of pancreatic cancer, AML, and myelodysplastic syndromes (MDS). The company's investors include IDT Corporation (NYSE: IDT). For more information, visit http://www.rafaelpharma.com/.

Safe Harbor Statement

This press release contains forward-looking statements. These statements relate to future events or the 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.

Reference

[1] Alistar A, Morris BB, Desnoyer R, et al. (2017). Safety and tolerability of the first-in-class agent CPI-613 in combination with modified FOLFIRINOX in patients with metastatic pancreatic cancer: a single-centre, open-label, dose-escalation, phase 1 trial. The Lancet Oncology. doi: 10.1016/S1470-2045(17)30314-5.

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