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Rafael Pharmaceuticals Announces Expansion into Israel of Pivotal Phase 3 Trial (AVENGER 500) of CPI-613®️ (devimistat) in Combination with Modified FOLFIRINOX as First-Line Treatment for Patients with Metastatic Pancreatic Cancer

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Cranbury, NJ, July 18, 2019 (GLOBE NEWSWIRE) -- Rafael Pharmaceuticals, Inc. ("Rafael" or the "Company"), a leader in the growing field of cancer metabolism-based therapeutics, today announced the expansion of its Phase 3 clinical trial for patients with metastatic pancreatic cancer (AVENGER 500) into Israel. The multicenter, open-label, randomized pivotal trial is evaluating the efficacy and safety of Rafael's lead compound CPI-613®️ (devimistat) in combination with modified FOLFIRINOX (mFFX) as first-line therapy in patients with metastatic adenocarcinoma of the pancreas. The global study, currently in multiple U.S. sites, will now open in eight sites throughout Israel.

"Every day, more than 1,200 people around the world receive a pancreatic cancer diagnosis, and our trial brings hope as the only Phase 3 clinical trial in metastatic pancreatic cancer," said Sanjeev Luther, President and Chief Executive Officer of Rafael Pharmaceuticals. "The expansion of our trial into Israel is the first step in bringing our commitment to developing treatments for patients with significant unmet medical needs to a global level."

Dr. Talia Golan, head of Sheba Pancreatic Cancer Center at Tel Hashomer Hospital, will be the lead investigator on the clinical trials in Israel. "I'm extremely grateful to be a part of the devimistat clinical trials for pancreatic cancer as they begin to open in Israel," said Dr. Golan. "It's exciting to see the growth of cancer metabolism in this region following the strides that devimistat has been making in the United States."

"With pancreatic cancer being the fourth leading cause of death in Israel, we wanted to expand the trial to a region in need," said Howard Jonas, Chairman of Rafael Pharmaceuticals. "We are optimistic about the success of the AVENGER 500 clinical trials in Israel and hope that eventually we will also enroll patients in trials for other hard-to-treat cancers in the region."

The clinical trials in Israel will open in the following sites: Hillel Yafe, Assaf Harofe, Soroka, Sheba, Rambam, Laniado, Sourasky, and Shaare Zedek. Phase III clinical trials for devimistat are projected to also open in Europe and other regions in the future.

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: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:
Vanessa Donohue
rafael@antennagroup.com
201-465-8008

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