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CST: 17/08/2019 10:40:55   

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

16 Days ago

Cranbury, NJ, Aug. 01, 2019 (GLOBE NEWSWIRE) -- Rafael Pharmaceuticals Announces Expansion into Austria, South Korea and Spain of Pivotal Phase 3 Trial (ARMADA 2000) of CPI-613® (devimistat) in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)

CRANBURY, N.J., August 1, 2019 - 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 (ARMADA 2000) of CPI-613® (devimistat) in patients with relapsed or refractory acute myeloid leukemia (AML) into Austria, South Korea and Spain. 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) in older patients with relapsed or refractory AML. The global study, currently in multiple U.S. sites, will open in three sites in Austria, several sites in South Korea and six sites in Spain.

“Every year, more than 30,000 people throughout Europe and 2,000 people in South Korea are diagnosed with AML, and their five-year survival rate is less than 30%, with worse outcomes for the elderly,” said Sanjeev Luther, President and CEO of Rafael Pharmaceuticals. “Our trial, which received orphan drug designation, offers hope to relapsed AML patients more than 60 years old. Our goal at Rafael has always been to help patients with significant unmet medical needs, and I am honored to bring that commitment overseas with these trials.”

Dr. Heinz Sill, hematologist at the University Hospital Graz, will be the lead investigator on the clinical trials in Austria.

“I am excited to help initiate the spread of devimistat globally,” said Dr. Sill. “There are currently limited therapeutic options for AML, and I look forward to helping to develop another option.”

Dr. Pau Montesinos, from the department of hematology at the University and Polytechnic Hospital of La Fe, will be the lead investigator on the clinical trials in Spain.

“After seeing the advancements of cancer metabolism in the United States, and the promising results from previous trials, I am hopeful this trial can continue making strides for AML patients as it expands into Europe,” said Dr. Montesinos.

“It is very encouraging the focus on cancer metabolism as an important element of cancer biology and a target of cancer therapy is being addressed by devimistat in this clinical trial for AML which is now expanding into Europe and other regions of the world,” said Dr. Jorge Cortes, deputy chair and professor of medicine in the department of leukemia at MD Anderson Cancer Center and principal investigator on the global trial. “I am optimistic that devimistat will help us improve the treatment for AML and ultimately the outcome of AML patients worldwide.”

Phase 3 clinical trials for devimistat are projected to open in other cities 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 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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