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Press Release

Rafael Pharmaceuticals Announces Activation of Second Clinical Trial Site for the Phase I Study of CPI-613 in Patients with Relapsed or Refractory T-Cell Lymphoma


Posted on: 13 Aug 18

Interim results of CPI-613 in combination with bendamustine in patients with T-Cell Lymphoma exhibited an 86% Objective Response Rate

Newark, NJ, Aug. 13, 2018 (GLOBE NEWSWIRE) -- Rafael Pharmaceuticals, Inc., a leader in the growing field of cancer metabolism-based therapeutics, today announced the activation of a second clinical trial site for the phase I study of CPI-613 in combination with bendamustine in patients with relapsed or refractory T-Cell Lymphoma at the Abramson Cancer Center of the University of Pennsylvania.

The primary objective of this study will be to determine the Maximum Tolerated Dose (MTD) of CPI-613, when used in combination with bendamustine, in patients with relapsed or refractory T-Cell Lymphoma, or classic Hodgkin Lymphoma, and to evaluate the safety of the CPI-613 and bendamustine combination.

This study is currently ongoing at the Comprehensive Cancer Center at Wake Forest Baptist Medical Center. 10 patients were dosed to date and 7 were evaluated for efficacy. The interim results of CPI-613 in combination with bendamustine in patients with T-Cell Lymphoma exhibited a very good signal of efficacy with an 86% Objective Response Rate (43% Complete Response and 43% Partial Response). The results from this study were first presented at the American Society of Hematology (ASH) Annual Meeting in 2016.

In February 2018, Rafael Pharmaceuticals received Orphan Drug Designation (ODD) for CPI-613 in the treatment of Peripheral T-Cell Lymphoma (PTCL). T-Cell Lymphomas account for 10-15% of lymphoid malignancies and display significant heterogeneity. T-Cell Lymphomas have a worse prognosis than most B-Cell Lymphomas. There is no standard treatment for relapsed or refractory disease, and median progression free and overall survival rates have been reported as 3.7 and 6.5 months respectively. There is clear unmet clinical need for relapsed or refractory T-Cell Lymphoma treatments.

Zanetta Lamar, MD, the Principal Investigator of this trial at Wake Forest Baptist commented: “This study of CPI-613 in combination with bendamustine in patients with relapsed or refractory T-Cell Lymphoma showed a good safety profile and encouraging efficacy, with an overall response rate of 86%. Although the number of patients was small, these results warrant continued investigation with this novel combination in the poor-risk patient population.”

Sunita Nasta, MD, FACP, Associate Professor of Clinical Medicine in the Division of Hematology Oncology at the Perelman School of Medicine at the University of Pennsylvania, is the Principal Investigator of this study. Dr. Nasta commented, “I am excited to launch this study at Penn with CPI-613 in combination with bendamustine for patients with relapsed or refractory T-Cell Lymphoma who currently do not have adequate treatment options.”

Sanjeev Luther, Rafael Pharmaceutical’s President and Chief Executive Officer, said, “Our motto, ‘To Save A Life Is To Save A Universe,’ illustrates our desire to develop potential treatments for patients with severe unmet clinical need. We are fortunate to have the opportunity to activate the second site of this T-Cell Lymphoma trial with Dr. Nasta as its Principal Investigator at the University of Pennsylvania.”

About Rafael Pharmaceuticals, Inc.
Rafael Pharmaceuticals, Inc. is a privately held, 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, CPI-613 is being evaluated in multiple Phase I, I/II, and II clinical studies. CPI-613 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). 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

GlobeNewswire
globenewswire.com

Last updated on: 13/08/2018

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