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CST: 05/12/2019 10:53:42   

Rafael Pharmaceuticals Announces Expansion into South Korea of Pivotal Phase 3 Trial (ARMADA 2000) of CPI-613® (devimistat) in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)

77 Days ago

CRANBURY, N.J., Sept. 19, 2019 (GLOBE NEWSWIRE) -- Rafael Pharmaceuticals, Inc. (“Rafael” or the “Company”), a leader in the growing field of cancer metabolism-based therapeutics, today announced that the Phase 3 clinical trial (ARMADA 2000) of CPI-613® (devimistat) in older patients with relapsed or refractory acute myeloid leukemia (AML) is now active and enrolling patients in South Korea. The multicenter, open-label, randomized pivotal trial is evaluating the efficacy and safety of its lead compound devimistat in combination with high dose cytarabine and mitoxantrone (CHAM). The clinical trials will kick off with an investigator meeting held on Sept. 19 in Seoul.

“Bringing our Phase 3 clinical trials for patients with AML to South Korea will mark the first of Rafael’s devimistat trials in Asia, with additional trials in the region planned for patients with pancreatic cancer in the near future,” said Sanjeev Luther, President and CEO of Rafael Pharmaceuticals. “This expansion is part of our larger goal to treat patients with unmet clinical needs around the world.” 

The study, currently in multiple U.S. and European sites, will now expand to the following four sites in South Korea: Asan Medical Center, Samsung Medical Center, Seoul National University Hospital and Severance Hospital. Lead investigators include Dr. Eun-Ji Choi, Dr. Jun Ho Jang, Dr. Sung-Soo Yoon and Dr. June-Won Cheong.

“The opening of clinical trials in South Korea is imperative for treating elderly patients with refractory AML in the region, as they have a lower survival rate,” said Dr. Jorge Cortes, principal investigator on the global trial. “I have hopes for the success of devimistat in treating patients.”

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:
Vanessa Donohue
rafael@antennagroup.com
(201) 465-8036

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