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Devimistat (CPI-613®) to be Explored in a New Combination for T-Cell Lymphoma Treatment as Part of Stand Up To Cancer’s T-Cell Lymphoma “Dream Team Research Grant”

This study will be conducted under the ‘Tailoring CAR-based immunotherapy strategies to T-Cell Lymphoma’ project

Newark, NJ, Feb. 07, 2019 (GLOBE NEWSWIRE) -- Rafael Pharmaceuticals, Inc. (“Rafael” or the “Company”), a leader in the growing field of cancer metabolism-based therapeutics, today announced that devimistat will be investigated in a new combination for the treatment of T-Cell Lymphoma under the ‘Tailoring CAR-based immunotherapy strategies to T-Cell Lymphoma’ project as a part of Stand Up To Cancer’s T-Cell Lymphoma Dream Team Research Grant.

In addition to studying the new drug combination, investigators will perform sophisticated genetic tests to determine potential responders to the drug and whether this combination may be used prior to chimeric antigen receptor therapy (CAR-T) under the direction of Dr. Wei Zhang and Dr. Timothy Pardee.

According to Dr. Zanetta Lamar, a lymphoma specialist and an investigator on the grant, “We must develop better treatments for those with T-Cell Lymphomas. Although treatments are available, many patients who achieve remission will, unfortunately, experience a relapse. In addition, there is no consensus treatment for patients with this recurrent and difficult to treat disease.” She added that this new combination therapy of devimistat is a unique way to treat cancer and does not have some of the common chemotherapeutic side effects such as hair loss.

Sanjeev Luther, President and Chief Executive Officer of Rafael Pharmaceuticals, commented, “Our motto, ‘To Save A Life Is To Save A Universe,’ illustrates our desire to develop potential treatments for patients with significant unmet clinical need. Research under this grant will explore devimistat in a new combination for T-Cell Lymphoma, and we believe this will help in identifying new therapeutic options.”

About devimistat (CPI-613®):
Devimistat is a first-in-class drug developed based on Rafael’s Altered Metabolism Directed (AMD) platform. Devimistat targets the altered regulation of metabolic processes specific to cancer cells. It is highly specific, simultaneously attacks multiple targets, minimally toxic and has broad spectrum activity across a wide variety of cancers. Devimistat has been evaluated in 19 ongoing or completed trials as a single agent, as well as in combination with standard drug therapies for hematological malignancies and solid tumors. To date, over 330 patients have received one or more doses of devimistat and the drug has exhibited a very good signal of efficacy with excellent response rates and extended durations of response in several tumor types. In pancreatic cancer, devimistat in combination with modified FOLFIRINOX exhibited an objective response rate of 61%, median overall survival of 19.9 months and median progression free survival of 9.9 months. In elderly patients with AML, devimistat in combination with high dose cytarabine and mitoxantrone exhibited a 52% CR+CRi and 12.4 months median overall survival. In both of these trials, the efficacy of devimistat combinations was substantially higher than standard therapy. In T-Cell Lymphoma, devimistat in combination with bendamustine exhibited a 75% objective response rate. Devimistat also showed a very good safety profile both as a single agent and in combination with other standard-of-care drugs. The U.S. FDA has granted devimistat orphan drug designations for Pancreatic Cancer, AML, MDS, Peripheral T-Cell Lymphoma and Burkitt’s Lymphoma. The EMA has granted devimistat orphan drug designations for Pancreatic Cancer and AML.

About Rafael Pharmaceuticals, Inc.
Rafael Pharmaceuticals, Inc. is a clinical-stage, metabolic oncology therapeutics company committed to the development and commercialization of therapies that exploit the metabolic differences between normal cells and cancer cells. Rafael’s primary objective is to develop innovative, highly selective, well tolerated and highly effective anti-cancer agents by selectively targeting altered metabolism in cancer cells. Rafael’s first-in-class clinical lead compound, devimistat is being evaluated in multiple Phase I, I/II, and II clinical studies. Devimistat has been granted orphan drug designation for the treatment of Pancreatic Cancer, Acute Myeloid Leukemia (AML), Peripheral T-Cell Lymphoma (PTCL), Burkitt Lymphoma and myelodysplastic syndromes (MDS). Investors in Rafael Pharmaceuticals include Rafael Holdings, Inc. (NYSE AMERICAN: RFL).

For more information, visit http://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.

Contact
Sanjeev Luther
President & CEO Rafael Pharmaceuticals, Inc. 
sanjeev.luther@rafaelpharma.com

Jacob Jonas
Public Relations, Rafael Pharmaceuticals, Inc.
jacob.jonas@rafaelpharma.com

Thursday, February 7, 2019 - 08:55