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Rafael Pharmaceuticals Crosses Halfway Enrollment Point in Pivotal Phase 3 Trial (AVENGER 500) of CPI-613®? (devimistat) for Patients with Metastatic Pancreatic Cancer
[January 14, 2020]

Rafael Pharmaceuticals Crosses Halfway Enrollment Point in Pivotal Phase 3 Trial (AVENGER 500) of CPI-613®? (devimistat) for Patients with Metastatic Pancreatic Cancer


Cranbury, NJ, Jan. 14, 2020 (GLOBE NEWSWIRE) -- Rafael Pharmaceuticals, Inc. (“Rafael” or the “Company”), a leader in the growing field of cancer metabolism-based therapeutics, today announced that it has reached an enrollment milestone of more than 250 patients in its pivotal Phase 3 clinical trial for metastatic pancreatic cancer (AVENGER 500), which is evaluating the efficacy and safety of Rafael’s lead compound CPI-613®? (devimistat) in combination with modified FOLFIRINOX (mFFX) as first-line therapy. This significant milestone comes ahead of schedule, halfway to enrolling the total goal of 500 patients. The global study is still open for patient enrollment in sites across the United States, Israel, South Korea and France with plans to begin enrolling in other regions of Europe including Germany, Italy, and Belgium in early 2020. 

“The speed at which patients are being enrolled into the trial is demonstrative of the tremendous need there is for effective treatments for metastatic pancreatic cancer and the hope people have in cancer metabolism,” said Sanjeev Luther, President and CEO of Rafael Pharmaceuticals. “We are aiming to keep the momentum going so that we can not only provide hope, but ultimately, an effective treatment.”

The principal investigator on Rafael’s Phase 3 clinical trial for patients with pancreatic cancer is Philip A. Philip, M.D., Professor of Oncology at the Barbara Ann Karmanos Cancer Institute at Wayne State University

“It is incredible to announce that we’ve reached 250 patients in this pivotal clinical trial for one o the deadliest cancers in the world,” said Dr. Philip. “Cancer metabolism is truly proving that it is a promising treatment for metastatic pancreatic cancer, and as we move into the new decade, I am hopeful that we will continue to see devimistat’s potential. I would like to thank all of the patients, their families and the doctors participating in this trial who have continued to help us reach these milestones.”



About CPI-613® (devimistat) 
CPI-613® (devimistat) is a first-in-class clinical lead compound of Rafael, which targets enzymes that are involved in cancer cell energy metabolism and are located in the mitochondria of cancer cells. Devimistat is designed to target the mitochondrial tricarboxylic acid (TCA) cycle, a process essential to tumor cell multiplication and survival, selectively in cancer cells. Devimistat substantially increases the sensitivity of cancer cells to a diverse range of chemotherapeutic agents. This synergy allows for potential combinations of devimistat with lower doses of these generally toxic drugs to be more effective with lower patient’s side effects. Combination with devimistat represent a diverse range of opportunities to substantially improve patient’s benefit in many different cancers. The U.S. Food and Drug Administration (FDA) has given Rafael approval to initiate pivotal Phase 3 clinical trials in pancreatic cancer (AVENGER 500) and acute myeloid leukemia (ARMADA 2000), and has designated devimistat as an orphan drug for the treatment of pancreatic cancer, acute myeloid leukemia, myelodysplastic syndrome, peripheral T-cell lymphoma and Burkitt’s lymphoma. The EMA has granted orphan drug designation to devimistat for pancreatic cancer and acute myeloid leukemia.

About Rafael Pharmaceuticals, Inc.
Rafael Pharmaceuticals is a leader in the growing field of cancer metabolism. The company is developing a new, first-in-class category of metabolic oncology therapeutics that attack hard-to-treat cancers by targeting the metabolic processes the disease needs to survive, grow and proliferate. Rafael Pharmaceuticals’ lead compound, CPI-613® (devimistat), is a highly selective, well-tolerated and effective anti-cancer agent that is being evaluated in ongoing and completed Phase 1, 2 and 3 clinical trials. Devimistat has been granted orphan drug status by the FDA for the treatment of pancreatic cancer, acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and Burkitt’s and peripheral T-cell lymphomas. The Company's investors include Rafael Holdings, Inc. (NYSE AMERICAN: RFL). For more information, please visit 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.

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Rafael Media Contact:
Holly Dugan
rafael@antennagroup.com 
(201) 465-8019

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