Health & Wellness

Press Releases

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

a07d2d57403ac43db2c4_Dr._Angela_Alistar_2017.jpg
a07d2d57403ac43db2c4_Dr._Angela_Alistar_2017.jpg

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:

Sign Up for E-News

(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.

TAP Into Another Town's News:

You May Also Be Interested In

Sign Up for E-News

Union

The Week Ahead in Union

June 25, 2018

UNION, NJ - Happenings in Union this week:

Monday, 6/25

Union Township Active Retirees (Monday Club), 10:00 a.m., Senior Center
Let's Create: Rock Art, 1:00 p.m., Union Public Library
Construction Zone, 3:30 p.m., Union Public Library
Read to Waldi, 4:15 p.m., Union Public Library
Hilton Readers Book Discussion Group - Closing Ceremony, 6:00 p.m., Vauxhall Public ...

Construction Update on Vauxhall Ave. Bridge, Chestnut St. Bridge and Morris Avenue Work

UNION, NJ – A CodeRed alert about road construction, the resulting congestion, and what can be expected, was sent to residents Tuesday morning.

The message said the work on these state roads is being performed by the New Jersey Department of Transportation.  The message outlined the following work scheduled for June and July:

The Vauxhall Bridge over Route 22.  Work ...

The Week Ahead in Union

UNION, NJ - Happenings in Union this week:

Monday, 6/18

Union Township Active Retirees (Monday Club), 10:00 a.m., Senior Center
Adult Coloring, 1:15 p.m., Vauxhall Public Library
Construction Zone, 3:30 p.m., Union Public Library
Read to Waldi, 4:15 p.m., Union Public Library
Connect, Explore & Discover Digital Resources, 7:00 p.m., Union Public Library

Tuesday, ...

Upcoming Events

Carousel_image_415aacf78687dcb7fab9_rock_painting

Mon, June 25, 1:00 PM

Union Public Library, Union

Let's Create Rock Art

Carousel_image_ec9461df1cd0015cf41f_mini_magick20180620-4048-snbre5

Mon, June 25, 3:30 PM

Union Public Library, Union

Construction Zone

Carousel_image_62d6e8e01b2ca6b48806_flagship

Tue, June 26, 7:00 PM

Union Public Library, Union

The History of Route 22

Carousel_image_1745e208dced874ffd8b_e6e6158b48ac79ad3add_chair_yoga__1_

Wed, June 27, 10:15 AM

Union Public Library, Union

Chair Yoga in the Library

Jordan Moass of Union has been named to the Spring 2018 Dean's List at the University at Albany

June 23, 2018

ALBANY, NY - Jordan Moass from Union has been named to the Spring 2018 Dean's List at the University at Albany. Students named to the Dean's List earned at least a 3.5 GPA.

About the University at Albany

A comprehensive public research university, the University at Albany-SUNY offers more than 120 undergraduate majors and minors and 125 master's, doctoral, and graduate ...

Taylor Heggins Named to Spring 2018 Dean's List at American International College

SPRINGFIELD, MA - Taylor Heggins, of Union, has been named to the Spring 2018 Dean's List at American International College (AIC) in Springfield, MA. Dean's List students are full-time students with a grade point average between 3.3 and 4.0.Heggins is majoring in Health Science at AIC.

Founded in 1885, American International College (AIC) is a private, co-educational, doctoral granting ...

Union Residents Make Dean's List at the University of Delaware

NEWARK, DE - Students from Union have been named to the University of Delaware Dean's List for the Spring 2018 semester:

Natalie Caggiano 

Julia Hayes 

Steven Medina 

Maria Rocha 

To meet eligibility requirements for the Dean's List, a student must be enrolled full-time and earn a GPA of 3.33 or above (on a 4.0 scale) for the semester.

 

Assembly Votes to Rename Part of Route 27 as Jerry Green Memorial Highway

June 25, 2018

TRENTON, NJ  – The New Jersey General Assembly approved legislation, 77-0, Thursday sponsored by Jamel C. Holley, Linda Carter, James Kennedy and Annette Quijano to designate the portion of the State Highway Route 27 in Union County as “Jerry Green Memorial Highway” in honor of the life-long career in public service of the Assemblyman who represented Legislative ...

Fatal shooting in Plainfield under investigation

TAPinto Plainfield received this release from the Union County's Prosecutor's office:

PLAINFIELD, NJ  A shooting that left a man dead and a woman seriously injured in Plainfield overnight is under investigation, acting Union County Prosecutor Michael A. Monahan announced Sunday.

The deceased victim has been identified as Michael Welsh, 34, of Plainfield.

Plainfield ...

Video: Union County Celebrates Pride Month with CommUNITY PRIDE Day Picnic

RAHWAY, NJ - Parents, children, friends, and all family members came out on Saturday afternoon to Rahway River Park for the Union County CommUNITY PRIDE Day Picnic.

The family-friendly celebration hosted by the Union County Board of Chosen Freeholders, was a day of fun activities of arts and crafts, family lawn games, inflatable bounce houses, playground fun and more, along with music by the ...

Boundless Talent on Display at Hannah Caldwell School

June 15, 2018

UNION, NJ –Talent was on full display last week as over 40 students participated in Hannah Caldwell School’s Talent Show, with singing, dancing, musical instrument performances, and even a comedian.

“This is a special performance because the children are in control.  All of the acts in the show were prepared outside of school by the students,” said music teacher ...

Battle Hill and Hannah Caldwell Students Celebrate Reading Accomplishments

UNION, NJ – Young readers in Hannah Caldwell and Battle Hill Elementary Schools enjoyed the fruits of their labor on Wednesday when they celebrated their accomplishments in this year's Olympic Reading Programs.

Librarian Karen Franciosa said, “I couldn't be more proud of the students who worked diligently throughout the year to accomplish their personal reading ...

Cranford Resident Rode His Bike Nearly 500 Miles

June 25, 2018

CRANFORD – Cranford resident Kent Lucas was one of 150 commuters who embraced a more sustainable commute by trading in his car keys for pedals during TransOptions’ annual Bike to Work Challenge.

Through TransOptions’ GoForGood app, riders tracked their bicycle commute trips and miles from May 1st through May 31st. Participants who joined the challenge were entered to win ...

Linden Man Arrested After Explosion in Cranford

CRANFORD - On Wednesday, June 20, 2018 at 7:06 p.m. the Cranford Police Department received
information that an explosion was heard in the area of Raritan Road and Summit Terrace. Through
a joint investigation with the Union County Prosecutor's Office and Linden Police Department, the
Cranford Police Department Detective Bureau identified a suspect through surveillance video ...

Cranford High Student Competes at U.S. Junior Amateur Sectional Qualifier

SCOTCH PLAINS - Cranford soon-to-be senior Johnny Bush took his shot to qualify for a USGA championship on Wednesday.

Bush shot a 6-over-par 76 (38-38) to finish in a five-way tie for 21st place in a U.S. Junior Amateur Sectional Qualifier at the par 70, 6,558-yard Shackamaxon Country Club in nearby Scotch Plains.

65 golfers, including 54 from the Garden State, took a ...

Charges Pending Against Roselle Man Found with More than 40 Dogs Living in Squalor

ROSELLE, NJ - A Roselle man will be charged with multiple criminal offenses after more than 40 dogs were discovered living in severely unsanitary and inhumane living conditions in his home last week, according to the Union County Prosecutor’s Office and New Jersey Society for the Prevention of Cruelty to Animals (SPCA).

According to the authorities, members of those two agencies, the ...

Westfield High School Sophomore Dies; Counselors on Hand at School

WESTFIELD, NJ — Carthoris “Carter” Uziel, a sophomore at Westfield High School, died Sunday night, according to Westfield Public Schools and a letter sent to parents by Principal Dr. Derrick Nelson.

“Words cannot convey the grief we feel in the Westfield Public Schools community over the death of Carthoris ‘Carter’ Uziel, a sophomore at Westfield High ...

Register Today for Summer Youth Courses Offered at Union County College

June 23, 2018

CRANFORD – This summer the Office of Continuing Education at Union County College is expanding its course offerings for youth ages 11-18. Classes are taught by NJ-certified teachers and subject matter experts that specialize in delivering high-quality youth programs. Classes begin the week of June 25 and run through August 23.

Classes offered include Introduction to Musical Theater, ...

Shakespeare in the Park Returns to Union County, Sunday, July 8

LINDEN, NJ -- The Union County Board of Chosen Freeholders is pleased to announce the return of Shakespeare in the Park this summer. The first performance will be presented on Sunday, July 8 at 7:00 p.m. at the Raymond Wood Bauer Promenade in Linden.

The Shrew Mechanicals Troupe from The Shakespeare Theatre of New jersey will present an hour long performance of “Powerful Trouble,” ...

June 22 Concert Moved Indoors Due to Weather Forecast

Due to the weather forecast, tonight’s concert originally located at Echo Lake Park is now MOVED INDOORS to the Main Stage of the Union County Performing Arts Center, at 1601 Irving Street in Rahway.

Come an enjoy an evening with the New Jersey Symphony Orchestra at this beautifully restored 1920's era former vaudeville hall. Concert begins at 7:30 sharp (sorry, no yoga ...

Reminder: Eligible Seniors Can Receive $25 in Free Vouchers for Farmer’s Markets, Starting June 25

The Union County Board of Chosen Freeholders reminds income-eligible senior residents age 60 and over that they can apply for a total of $25 in free vouchers to purchase fresh produce. The vouchers may be used only at Farmer’s Markets in Union County that display a yellow and black WIC sign.

“Farmer’s Markets are a feature of community life throughout Union County in the ...

Columns

AtlantiCast

AtlantiCast Episode 17

On this week’s AtlantiCast, it’s National Men’s Health Month, so check out important health tips for you or the men in your life, learn about groundbreaking research into breast cancer treatment that could mean an end to chemotherapy for some patients, meet a local sports hero who’s living his baseball dreams thanks to Goryeb Children’s Hospital and much ...

'Half Time' delivers with sterling cast

MILLBURN, NJ – The Paper Mill Playhouse is putting on a smashing new production of “Half Time” to round out its current season.

With actress Georgia Engel in an engaging performance, the cast also features Donna McKehnie, Andre De Shieilds and Lilias White, among a host of other talents.

The musical centers on an effort to have seniors perform a dance number during ...

'Half Time' lights up Paper Mill stage

‘Half Time’ turns the tables on aging in gleeful production

By Liz Keill

MILLBURN, NJ – The Paper Mill Playhouse is putting on a smashing new production of “Half Time” to round out its current season.

With actress Georgia Engel in an engaging performance, the cast also features Donna McKehnie, Andre De Shieilds and Lilias White, among a host of other ...

Could Monmouth Park's Haskell Invitational Be on Justify's Agenda?

June 13, 2018

ELMONT, NY — Triple Crown winner Justify came out of his stall to meet the media bright and bouncing on the morning after his gate-to-wire win in the 150th running of the Belmont Stakes.

When asked to assess his colt's win, Hall of Fame trainer Bob Baffert reported, “We were watching replays of the race. He could have gone around again.”

The brilliantly colored ...

Letters to the Editor