Cranbury, NJ, March 03, 2020 (GLOBE NEWSWIRE) — Rafael Pharmaceuticals, Inc. (“Rafael” or the “Company”), a leader in the growing field of cancer metabolism-based therapeutics, today announced the appointment of Sanjay Sehgal, Ph.D., to Chief Regulatory Affairs and Quality Assurance Officer. The newly created position is indicative of the Company’s continued commitment and dedication to adhere to global governmental regulations and standards, surrounding its lead compound CPI-613® (devimistat). The current Vice President of Regulatory Affairs, Dr. Jehan Rowlands, Senior Director of Quality Assurance, Jerome Hayes, and Director of Regulatory Affairs CMC, Jason Tao, will report to Dr. Sehgal as the Company continues to grow. “With the recent progress in both Phase 3 trials for pancreatic cancer and acute myeloid leukemia (AML), it is important to continue to build the regulatory affairs arm of our company,” said Sanjeev Luther, President and CEO of Rafael Pharmaceuticals. “Dr. Sehgal has exceptional experience in leading regulatory affairs, and we are confident that he will help bring Rafael into the next stage as a company.”Dr. Sehgal has more than 25 years of experience working with both multinational and small biotechnology companies. Most recently, he served as the Senior Vice President of Regulatory Affairs and Conformance at Celularity, Inc. Over his career, he has successfully led and/or supported drug product regulatory strategy development, authored and negotiated approval for approximately a dozen New Drug Applications globally. Dr. Sehgal has also served the American Association of Pharmaceutical Scientists (AAPS) in a variety of roles including the Chair of Regulatory Sciences from 2007-2008. He received his Ph.D. in Pharmaceutics from the University of Alberta and a Bachelor of Pharmacy degree in India. “Rafael Pharmaceuticals has demonstrated true leadership in cancer metabolism, with its strong pipeline in rare cancers,” said Dr. Sehgal. “It’s an exciting time to join the Company as it continues to grow, and I aim to ensure that we continue to advance our product candidate(s) to meet the needs of patients with advanced solid tumors and hematologic cancers.”
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.
###Rafael Media Contact:
Holly Dugan
rafael@antennagroup.com
(201) 465-8019
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