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

Westfield

Clark Officials Say Latest Scam is Fueled by OPRA Regulations

May 26, 2018

CLARK, NJ — Township officials have released a statement encouraging residents to exercise caution if they are approached by an individual or organization promising to help with property tax related issues for a fee.   

The Town of Clark is urging citizens to contact the Tax Collector's office with questions before agreeing to use the services provided ...

Open Letter to Dr. Dolan & Westfield High School Administration About Graduation

May 23, 2018

Editor's note: The following is a response to a letter sent to parents from Westfield High School Principal Derrick Nelson telling parents that, due to the potential of Kehler Field being re-turfed, this year’s graduation will be held on the back field behind Westfield High School, with the inclement weather location the varsity gymnasium. The letter tells parents ...

Upcoming Events

Sat, May 26, 9:00 AM

Miller-Cory House Museum, Westfield

Aunt Carrie's Attic Sale

Other

Carousel_image_d58a47f28bf47b0c40d6_spb-4937_newsletter_june_24

Sat, May 26, 12:00 PM

TD Bank Ballpark, Bridgewater

Somerset Patriots vs. Southern Maryland Blue ...

Sports

Carousel_image_8cd695f8ea6f03939eb0_mini_magick20180405-26868-1g02rrv

Mon, May 28, 9:00 AM

Westfield

Memorial Day Parade

Westfield Police Blotter: Package Stolen from Porch, Shoplifting & More

May 23, 2018

May 15, 2018 11:40 a.m.

A resident of Vernon Terrace reported the theft of a package from their front porch on May 12, 2018 between 11:40 a.m. and 5 p.m.

 

May 19, 2018 1:16 p.m.

Rhonda Boston, age 32, of Newark, NJ was arrested on the strength of an outstanding warrant for her arrest from Westfield Municipal Court in the amount of $580. Subject was picked up at New Jersey State ...

Obituaries

Eric Lieberman, 47, of Scotch Plains, passed away suddenly and unexpectedly Tuesday, May 22, 2018 ...
Read more

Union County Honors the Westfield High School Blue Devils Football Team

May 26, 2018

Union County Freeholder Chairman Sergio Granados and Freeholder Alexander Mirabella present a resolution to the players and coaches of the Westfield High School Blue Devils Football Team congratulating them on winning their third straight North Jersey, Section 2, Group 5 Championship with a 20-7 victory over Bridgewater-Raritan. They were joined by Assemblywoman Linda Carter.

Westfield's Wilson School Receives Surprise Visit from Governor Murphy

New Jersey Governor Phil Murphy took a few moments out of a busy schedule to drop in on a 5th grade class at Wilson School in Westfield on Thursday, May 24.

“Fifth grade is one of the coolest grades,” said the governor as he greeted the students.  “What are you studying today?”

A brief discussion of the formulas for surface area and volume needed to build an ...

There are Really 3 Reason Buyers Choose the Homes They Buy

Susan Massa Broker Associate CRS SRES ABR 

Keller Williams Premier Properties 188 Elm St Westfield NJ 07090

488 Springfield Ave, Summit, NJ 07901

908-400-0778 cell

www.summitwestfieldhomes.com     www.NJHomeshowcase.com

susan@susanmassa.com

Dedicated to Excellence, Dedicated to You “Your Home Your Realtor”

download my smart phone app ...

Ask Maria: How can I help my son? 

Q: My son's best friend's mom just passed away. I am concerned for my son and don't know what to do for him. He is distraught. How can I help my son? 

Response:

Grief is a normal and natural reaction to the death of a loved one. No two people grieve the same, even in the family. I am certain that your son’s friend and mom are like family to your son. Losing his ...

Dog Missing from Fanwood Home

UPDATE: Reunited with owner!

ORIGINAL POST: Lexi was seen north side of Fanwood Thursday. She's 25 lbs., tall and looks like a fox.

Lexi is friendly and was wearing a collar with a tag. Call 732-259-5570 if you spot her.

IRS Grants Relief for Taxpayers Affected by Reduction of Maximum Deductible HSA Contributions

The IRS recently announced relief for taxpayers with family coverage under a High Deductible Health Plan (HDHP) who contribute to a Health Savings Account (HSA).

 

For 2018, taxpayers with family coverage under an HDHP may treat $6,900 as the maximum deductible HSA contribution.

 

The annual amount had been reduced to $6,850 for 2018 under the Tax Cuts and Jobs ...

TAPinto Featured Franchisee: Steve Lenox of TAPinto Paterson

This week's feature will focus on TAPinto Paterson's franchisee, Steve Lenox. Find out how the current owner of a public affairs firm went from a former State Director for Senator Frank Lautenberg to a proud TAPinto franchisee for New Jersey's third largest city.

 

Q. When did you join TAPinto.net?

I joined TAPinto.net in September, ...

‘Chambers USA 2018’ Recognizes John Schmidt Among List of America’s Leading Lawyers for Business

Lindabury, McCormick, Estabrook & Cooper is pleased to announce that John H. Schmidt has once again been recognized by “Chambers USA” in their annual list of leading lawyers for business. Chambers and Partners, which produces “Chambers USA,” is a client referral organization that researches and subjectively ranks attorneys and law firm practice groups nationwide ...

'Turning Off the Morning News' brings comic twist

‘Turning Off the Morning News’ tackles today’s issues with a comic twist

By Liz Keill

PRINCETON, N J – Despite the late night comics, no one quite captures the insanity of the political/social status world like Christopher Durang.

His latest play, “Turning off the Morning News” hit the ground running.  John Pankow as Jimmy addresses the audience, ...

SURVIVING A STROKE: Quick Medical Response Gives Mom Her Life Back

Carotid artery dissection. It’s one of the most common causes of stroke in younger adults.

And while you might not associate the word “stroke” with younger patients, the condition – if not treated immediately – could lead to paralysis and even death.

Lindsey Singh can attest to the importance of immediacy. The 31-year-old mother of two from Flanders experienced ...

Capitalist or Communist?

Karl Marx may have been the pioneer, but many other Jews were also involved in the struggle for communism, particularly in the early days of the Russian revolution. Personally, I don’t think that we have any apologies to make for this phenomenon. Having suffered unbearably under successive oppressive regimes, many of those political activists genuinely thought communism would be better ...

Stocks Can Rise in a Rising Interest Rate Environment

Investors remain concerned about the potential impact of higher interest rates on stocks. In their most recently released minutes, the Federal Reserve Open Markets Committee indicated the US economy is on solid footing and the economic conditions warrant continued gradual increasing of interest rates. This set off a sale in the stock and bond markets as investors began pricing in a fourth ...

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!

 

Vehicular Homicide Charges for Driver of Paramus School Bus

May 24, 2018

MORRISTOWN, NJ — The driver of a school bus involved in a crash on Route 80 last week that killed two people faces two counts of second-degree vehicular homicide/death by auto, it was announced today.

The driver, Hudy Muldrow, 77, of Woodland Park, attempted to make an illegal U-Turn on the highway in an attempt to find his way to Waterloo Village, the planned destination of the bus that ...