Cranbury, NJ, April 28, 2020 (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 2 clinical trial of CPI-613® (devimistat) for patients with relapsed or refractory Burkitt’s lymphoma/leukemia. The clinical trial will begin enrolling patients at MD Anderson Cancer Center, where Dr. Raphael Steiner will serve as principal investigator. The trial is led by Ariela Noy, M.D., at Memorial Sloan Kettering Cancer Center in New York City. Patients can also enroll at City of Hope in Duarte, California and at Massachusetts General Hospital in Boston.

“We are happy to expand access to our clinical trial for patients with Burkitt’s lymphoma, especially through the highly prestigious institution of MD Anderson, alongside the other world-renowned sites for this trial,” said Sanjeev Luther, President and CEO of Rafael Pharmaceuticals. “Our mission at Rafael has always been, and will continue to be, to deliver effective treatment options for patients with rare cancers. Partnering with the leading institutions in the world is part of what makes our mission possible.”

MD Anderson Cancer Center is one of the world’s most respected centers devoted exclusively to cancer patient care, research, education and prevention. When it comes to Burkitt’s lymphoma, among additional forms of non-Hodgkin lymphomas and other cancers, MD Anderson aims to deliver treatments that are strong on the disease, but as gentle as possible on the body. As such, its oncologists draw upon a wide range of treatments for every stage of the disease, as well as clinical trials of new and novel agents. Cancer metabolism and devimistat can fill significant gaps in cancer treatment.

“The aggressive nature of both double/triple hit lymphomas and Burkitt’s lymphoma, the limited treatment options and the high rate of relapse has made it difficult to effectively treat these patients,” said Ariela Noy, M.D., an oncologist at Memorial Sloan Kettering Cancer Center and principal investigator on this trial. “These are rare diseases, making the expansion of this trial to other sites so encouraging.”

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. Disclosure: Dr. Ariela Noy receives research funding from Rafael Pharmaceuticals, Inc. 


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