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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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AtlantiCast

AtlantiCast: Episode 15

On this week’s AtlantiCast, learn some important tips for controlling and avoiding diabetes from an Atlantic Health System expert, see how Atlantic Health is advancing cutting-edge research, hear what’s being done to keep health care environmentally friendly and much more!

 

Maplewood Police Blotter - Two Motor Vehicle Thefts Reported, One Recovered

May 16, 2018

May 7 - Burglary; Sometime during the prior two days, entry was forced to a business on Newark Way.  The keys to a GMC van were then taken from inside the business and the van was stolen.

 

May 7 - Motor Vehicle Theft; At approximately 9:30 p.m., a Jeep left unattended and running in the parking lot of 7-11 on Irvington Ave was stolen. The vehicle was later recovered in ...

South Orange Police Blotter - More Than 10 Vehicle Burglaries Reported

South Orange Police Blotter as of May 14

Auto Theft - A Roland Ave resident reported that sometime between 10:30 pm, Thursday 5-10-18 & 7:30 am, Friday 5-11-18 actor(s) unknown stole his vehicle (2016 Mitsubishi), which was parked in his driveway of his residence at the time.

Burglary to Auto - A Vose Ave resident reported that sometime between 10:45 pm, Wednesday 5-2-18 & 8:00 ...

South Orange-Maplewood Adult School Honors Melissa Kopecky and Sarah Lester at Annual Meeting

May 23, 2018

SOUTH ORANGE AND MAPLEWOOD, NJ - The South Orange-Maplewood Adult School (SOMAS) honored Melissa Kopecky, Director of the South Orange Library, and Sarah Lester, Director of the Maplewood Memorial Library, at its Annual meeting on May 21, according to a press release from SOMAS.

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Thank you to Carl Patterson of CP Photo Op Photography for use of ...

Upcoming Events

Wed, May 23, 12:00 PM

Temple Sharey Tefilo-Israel, South Orange

The Purposes and Rhythms of Jewish Living

Education Religions And Spirituality

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Fri, May 25, 7:00 PM

Par 440 Restaurant & Lounge, Short Hills

The Extra Rich In Class Dinner Show with E.R.I.C.

Arts & Entertainment Food & Drink

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Fri, May 25, 7:00 PM

Par 440 Restaurant & Lounge, Short Hills

The Extra Rich In Class Dinner Show with E.R.I.C.

Arts & Entertainment Food & Drink

Sun, May 27, 11:00 AM

The Ethical Culture Society of Essex County, Maplewood

Memorial Day Colloquy: What We Honor and How We ...

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Parsippany Septuagenarian Becomes NJIT's Oldest Engineering Grad

May 23, 2018

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In fact, he could. “I’m a student in this class,” replied Chris Antholis, then 72, who was six years into his quest to earn a Bachelor of ...

Uniacke Named Bridges Outreach Executive Director as Bhatt, Tulloch Announce Retirement

SUMMIT, NJ - Bridges Outreach, Inc. Executive Director Lois Bhatt and Deputy Executive Director Bethany Tulloch have announced their retirement and, effective May 29, Richard J. Uniacke will begin his tenure as the Summit-based nonprofit's new Executive Director.

Uniacke, who will become just the organization's third executive director in three decades, was ...

Phase II of the Stuyvesant Avenue Streetscape Project Set to Begin in Union

May 22, 2018

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“Phase I is complete and everyone loves it,” said Deputy Mayor Joseph Florio.  Florio said construction on the south end of Stuyvesant Avenue, from Morris Ave. to the cannon turnaround near Elmwood, should be complete by ...

DAWN of a New Day: New Treatment Insights Shared at Atlantic Health's 18th Annual 'Stroke Symposium'

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Porchlight Post - Shedding Light On These Old Homes

May 23, 2018

You bought a new house (congratulations!) and its your first night in the new house. You get cozy and settle in for the night. Your husband wakes up early for work and then so do the kids. Its 5:30 a.m., and your hardwood floors creak so loudly it sounds like someone was trying to break-in. How did you not notice this before you moved in?

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2nd Annual Theater in The Park Returns to Founders Park in South Orange on June 3

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Bring your blankets and chairs, grab some food and fun from one of our vendors and enjoy one or all of the performances by local talent. The event is free and open to everyone who wants to stop in and enjoy some entertainment.

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Career Change for Working Moms Presentation at Millburn Library

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