Mr. Luther will discuss the status of the Company's clinical development strategy, as well as provide an update on the drug development pipeline and its plans for new trials in 2020. Rafael is currently conducting two pivotal Phase 3 clinical trials for its drug CPI-613® (devimistat) in patients with metastatic pancreatic cancer and acute myeloid leukemia (AML). The Company is also conducting a Phase 2 clinical trial for patients with relapsed Burkitt's lymphoma, for which devimistat has received orphan drug designation.
Presentation Details: Date: Tuesday, January 14, 2020 Time: 4:00 p.m. - 4:25 p.m. Location: Elizabethan C Westin St. Francis Hotel, San Francisco, CA
"Over the past year, since presenting at last year's J.P. Morgan Healthcare Conference, Rafael has achieved significant milestones, some of which include our out-licensing agreement with Ono Pharmaceutical, the global expansion of our late stage clinical trials, our National Institutes of Health (NIH) collaboration, additional peer-reviewed publications of studies on devimistat, orphan drug designation for two indications by the European Medicines Agency, enrolling patients to our trials ahead of schedule, the growth of our team and more," said Mr. Luther. "All of our achievements bring us closer to our ultimate mission: to provide hope to patients and deliver more effective cancer treatments. As we move into the new year and a new decade, I'm thrilled to share more on how far we have come and where we are headed."
A live webcast of the presentation can be viewed here by logging in or by filling in the fields under "General Access."
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.