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August 15, 2018

Rafael activates new site for Phase I of CPI-613 and bendamustine

Rafael Pharmaceuticals has activated the second clinical trial site for its Phase I trial of CPI-613 in combination with bendamustine to treat patients with relapsed or refractory T-Cell Lymphoma at the University of Pennsylvania's Abramson Cancer Center in the US.

Rafael Pharmaceuticals has activated the second clinical trial site for its Phase I trial of CPI-613 in combination with bendamustine to treat patients with relapsed or refractory T-Cell Lymphoma at the University of Pennsylvania’s Abramson Cancer Center in the US.

The trial is currently being conducted at the Comprehensive Cancer Center at Wake Forest Baptist Medical Center in North Carolina, US.

Its primary objective is to determine the maximum tolerated dose (MTD) of CPI-613 when used in combination with bendamustine, for the treatment of patients with relapsed or refractory T-Cell Lymphoma, or classic Hodgkin Lymphoma.

The trial also seeks to examine the safety of the CPI-613 and bendamustine combination.

It has so far dosed ten patients, seven of whom were evaluated for efficacy.

Interim results from the trial have demonstrated a significant rate of efficacy with an 86% objective response rate, which includes 43% complete response and 43% partial response.

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“Although the number of patients was small, these results warrant continued investigation with this novel combination in the poor-risk patient population.”

The trial’s principal investigator at Wake Forest Baptist, Zanetta Lamar said: “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.”

In February this year, Rafael received orphan drug designation (ODD) for CPI-613 in the treatment of Peripheral T-Cell Lymphoma (PTCL).

T-Cell Lymphomas is estimated to account for 10-15% of lymphoid malignancies and exhibit significant heterogeneity.

There is currently no standard treatment available for relapsed or refractory disease, while the median progression free and overall survival rates for the patients suffering from the disease have been reported as 3.7 and 6.5 months, respectively.

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