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Source: Rafael Pharmaceuticals, Inc.

Rafael Pharmaceuticals Enters into Research Collaboration with Roswell Park Comprehensive Cancer Center to Evaluate the Effects of CPI-613® (Devimistat) on Esophageal Cancer

Cranbury, NJ, May 05, 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 entered into a research collaboration with Roswell Park Comprehensive Cancer Center. Through this collaboration, researchers will evaluate the effects of CPI-613® (devimistat) with or without chemotherapy agents, including oxaliplatin/cisplatin/5-FU/carboplatin/taxol, on esophageal cancer cells.


“With our focus on hard-to-treat cancers, especially those in the gastrointestinal tract, research in treating esophageal cancer has been a significant goal for us,” said Sanjeev Luther, President and CEO of Rafael Pharmaceuticals. “The high standards and caliber of researchers at Roswell Park made this research possible, and we are honored to partner with them.”


Rafael has several active clinical trials focusing on cancers in the gastrointestinal tract. Its Phase 3 clinical trial in metastatic pancreatic cancer (AVENGER 500) is enrolling significantly ahead of schedule, with more than 80% of the patients needed for the trial already enrolled. The company also has Phase 1 and 2 clinical trials in pancreatic cancer, as well as a Phase 1 trial in colorectal cancer.


“Through this research, we expect to determine whether devimistat inhibition of PDH and KGDH with or without chemotherapy synergistically decreases DNA replication and increases cell death in esophageal cancer cells,” said Steven Hochwald, M.D., M.B.A., Chief of Gastrointestinal/Endocrine Surgery and Professor of Oncology at Roswell Park Comprehensive Cancer Center in Buffalo, N.Y. He is also the principal investigator on the preclinical study. “We will focus on the effects of devimistat on proliferation and cell death using esophageal cancer cell models.” 

Collaborative clinical trials in patients are planned after the initial analyses are completed.


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

Roswell Park Media Contact:
Annie Deck-Miller
annie.deck-miller@roswellpark.org
(716) 602-5817