Houston CRO Pharm-Olam is on board to help Infinity Pharmaceuticals ($INFI) get its in-development lymphoma therapy through a Phase II trial, recruiting 230 patients in hopes of demonstrating an effect on survival.
The drug, duvelisib, is an inhibitor of the proteins PI3K-delta and PI3K-gamma, designed to interrupt the signaling process that allows malignant B-cells to proliferate. Infinity, partnered with AbbVie ($ABBV), is working through 7 clinical trials in an attempt to establish duvelisib's efficacy in a range of hematological cancers.
The drug developer has now recruited Pharm-Olam to handle FRESCO, a Phase II study pitting duvelisib against chemotherapy in patients with relapsed or refractory follicular lymphoma who are already receiving Roche's ($RHHBY) Rituxan. The primary endpoint is a significant benefit in progression-free survival, and secondary goals include complete response rate, overall response, overall survival and duration of response.
Infinity previously tapped Pharm-Olam to handle data and project management for DYNAMO, a single-arm Phase II study testing duvelisib in non-Hodgkin lymphoma.
"In working with Pharm-Olam on the DYNAMO study, Pharm-Olam assigned Infinity a team of very capable individuals who complement one another in their unique strengths," Infinity Vice President Ross Pettit said in a statement. "We are pleased that they are now also supporting our Phase II FRESCO study."
AbbVie bought into duvelisib's potential in 2014, paying $275 million up front and promising $530 million more in exchange for commercial rights to the drug.
- read the statement
- get more on FRESCO